Applied Science, Faculty of
Biomedical Engineering, School of
DSpace
UBCV
Gheorghe, Florin
Master of Applied Science - MASc
University of British Columbia
Orthopaedic injury is set to become the 3rd leading cause globally of disability and death by 2030. Despite the cost-effectiveness and efficacy of orthopaedic surgery, there is a significant gap in access to care. Of importance to delivering safe, modern, and timely treatment is access to high quality medical devices. This access however is limited by a mismatch between the technology that industry is developing and what is needed in low- and middle-income country (LMIC) contexts. Through field study in a Ugandan hospital setting, this research examined two methods for participatory design of medical devices in LMICs that seek to overcome gaps in understanding between designers and users across different cultural and professional backgrounds, as well as the "Expert User" problem. The use of Cultural Probes and Outcome-Driven Innovation has proven useful to perform detailed needs finding, filtering and prioritization, which are critical early steps of the design process. The results point to a myriad of challenges across domains: technology, systemic, infrastructure, staff, and patients, which all contribute to difficulty in providing timely, safe surgical care. They also give designers insight into which technology areas are the most underserved, and which attributes of technology might warrant special consideration in the design process. From these results, the design of a bone reduction and alignment device was prototyped, with feedback sought from Ugandan surgeons. The many lessons from this research have been applied in the past five years to the development and commercialization of the DrillCover product through Arbutus Medical. It is our hope that industry, engineers, and designers take the lead in addressing the medical device mismatch by leveraging these participatory design methods when embarking on medical device innovation projects for LMIC users, and importantly, include these users in a collaborative design process for a higher likelihood of success.
PARTICIPATORY DESIGN METHODS FOR MEDICAL DEVICE INNOVATION IN UGANDA by FLORIN GHEORGHE B.A.Sc, The University of British Columbia, 2011 A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF APPLIED SCIENCE in THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Biomedical Engineering) THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver) August 2018 © Florin Gheorghe, 2018 ii Committee The following individuals certify that they have read, and recommend to the Faculty of Graduate and Postdoctoral Studies for acceptance, a thesis/dissertation entitled: Participatory design methods for medical device innovation in Uganda submitted by Florin Gheorghe in partial fulfillment of the requirements for the degree of Master of Applied Science in Biomedical Engineering Examining Committee: Dr. Machiel Van der Loos, Mechanical Engineering Supervisor Dr. Antony Hodgson, Mechanical Engineering Supervisory Committee Member Dr. Moura Quayle, Public Policy and Global Affairs Supervisory Committee Member iii Abstract Orthopaedic injury is set to become the 3rd leading cause globally of disability and death by 2030. Despite the cost-effectiveness and efficacy of orthopaedic surgery, there is a significant gap in access to care. Of importance to delivering safe, modern, and timely treatment is access to high quality medical devices. This access however is limited by a mismatch between the technology that industry is developing and what is needed in low- and middle-income country (LMIC) contexts. Through field study in a Ugandan hospital setting, this research examined two methods for participatory design of medical devices in LMICs that seek to overcome gaps in understanding between designers and users across different cultural and professional backgrounds, as well as the “Expert User” problem. The use of Cultural Probes and Outcome-Driven Innovation has proven useful to perform detailed needs finding, filtering and prioritization, which are critical early steps of the design process. The results point to a myriad of challenges across domains: technology, systemic, infrastructure, staff, and patients, which all contribute to difficulty in providing timely, safe surgical care. They also give designers insight into which technology areas are the most underserved, and which attributes of technology might warrant special consideration in the design process. From these results, the design of a bone reduction and alignment device was prototyped, with feedback sought from Ugandan surgeons. The many lessons from this research have been applied in the past five years to the development and commercialization of the DrillCover product through Arbutus Medical. It is our hope that industry, engineers, and designers take the lead in addressing the medical device mismatch by leveraging these participatory design methods when embarking on medical device innovation projects for LMIC users, and importantly, include these users in a collaborative design process for a higher likelihood of success. iv Lay Summary Injury and trauma is a major global health burden, with over 90% of that burden in the developing world. While surgery is an effective way of treating injury, modern surgery requires access to safe and appropriate medical devices, and such devices are often not available in the developing world. The purpose of this research is to inform how engineering and designers in the West can approach the design process for medical devices using methods that include end users (i.e. clinicians) in the design process itself. It is hoped that the methods described and tested in this research will lead the medical device industry to better engage end users, and thus develop and commercialize medical devices with a higher likelihood of appropriateness and success in the developing world. v Preface This dissertation is original, unpublished, independent work by the author, Florin Gheorghe. This research was performed with approval from UBC’s Behavioural Research Ethics Board under application “Design Innovation” and number H12-01640. vi Table of Contents Committee .................................................................................................................................. ii Abstract ..................................................................................................................................... iii Lay Summary ............................................................................................................................ iv Preface ....................................................................................................................................... v Table of Contents ...................................................................................................................... vi List of Tables ............................................................................................................................ xii List of Figures ......................................................................................................................... xiii Glossary ................................................................................................................................. xvii Acknowledgements ................................................................................................................. xix Dedication ............................................................................................................................... xxi 1 Introduction ........................................................................................................................ 1 1.1 Motivation................................................................................................................... 1 1.2 Thesis Outline ............................................................................................................. 2 2 Background......................................................................................................................... 4 2.1 Trauma and injury in LMICs ....................................................................................... 4 2.1.1 The Socio-Economic Burden of Disease .............................................................. 4 2.1.2 Global Health Trends ........................................................................................... 6 vii 2.1.3 An Under-Rated Contributor to the SDGs ............................................................ 7 2.1.4 Cost-Effectiveness of Surgery.............................................................................. 8 2.1.5 Technical vs. Adaptive Challenges ...................................................................... 9 2.2 Access to surgery ........................................................................................................ 9 2.2.1 Injury as a Priority in Surgery ............................................................................ 10 2.3 Role of Technology in Health Care ........................................................................... 11 2.3.1 Access to Orthopaedic Medical Devices ............................................................ 12 2.4 Barriers to Access ..................................................................................................... 12 2.4.1 High Cost of Equipment and Lack of Budgets ................................................... 13 2.4.2 Intellectual Property .......................................................................................... 13 2.4.3 Failing Donation System ................................................................................... 14 2.5 Design in the Developing World ............................................................................... 15 2.5.1 Appropriate Design of Medical Devices for LMIC ............................................ 15 2.5.2 The 4A Model for Health Technology ............................................................... 15 2.5.3 Innovative Technologies and Success Stories..................................................... 16 2.5.4 Big Industry Focus on Emerging Markets .......................................................... 18 2.5.5 A Model for the Bottom of the Pyramid ............................................................. 19 2.6 Mismatch and Expert User Design ............................................................................ 20 2.6.1 Understanding the Mismatch ............................................................................. 20 2.6.2 Uncovering Assumptions that Guide Traditional Design .................................... 22 viii 2.6.3 The Challenge of Expert Users .......................................................................... 22 2.7 Closing ...................................................................................................................... 24 3 Methods ............................................................................................................................ 25 3.1 Partners ..................................................................................................................... 25 3.1.1 Uganda Sustainable Trauma Orthopaedic Program ............................................ 25 3.1.2 Engineers in Scrubs ........................................................................................... 26 3.2 General Study Approach ........................................................................................... 27 3.3 Grounded Theory Methodology ................................................................................ 28 3.4 Qualitative Design Methods: Cultural Probes ............................................................ 29 3.4.1 Background ....................................................................................................... 29 3.4.2 Study – Mulago Hospital ................................................................................... 32 Disposable cameras (Fujifilm QuickSnap Flash ISO 400 35mm) were given to each of the participants along with an open-ended set of instructions ( ........................................................ 33 3.5 Quantitative Design Methods: Outcome-Driven Innovation ....................................... 34 3.5.1 Background ....................................................................................................... 34 3.5.2 Study – Mulago Hospital ................................................................................... 38 3.6 Ethical Considerations ............................................................................................... 41 3.6.1 Risks and Benefits to Subjects ........................................................................... 41 3.6.2 Compensation and Reimbursement .................................................................... 41 3.6.3 Informed Consent .............................................................................................. 41 ix 3.6.4 Confidentiality Assurances ................................................................................ 42 3.6.5 Conflict of Interest ............................................................................................. 42 3.6.6 Collaborative Agreements ................................................................................. 42 4 Results .............................................................................................................................. 43 4.1 Results of Cultural Probes ......................................................................................... 43 4.1.1 Structure of This Section ................................................................................... 43 4.1.2 Validation of the Method and Analysis .............................................................. 43 4.1.3 Technology Challenges...................................................................................... 43 4.1.4 System ............................................................................................................... 69 4.1.5 People ............................................................................................................... 72 4.1.6 Summary of Themes .......................................................................................... 77 4.2 Results of Outcome Driven Innovation ...................................................................... 80 4.2.1 All Participants .................................................................................................. 81 4.2.2 Comparison Across Professional Background .................................................... 90 4.2.3 Comparison Across Cultural Background .......................................................... 92 5 Discussion ...................................................................................................................... 100 5.1 Comparing Results of Cultural Probes (CP) and Outcome Driven Innovation (ODI) 100 5.1.1 Key Areas of Focus for Impact ........................................................................ 103 5.1.2 Considerations About Users............................................................................. 108 5.2 Putting the Results into the Greater Context ............................................................ 111 x 5.2.1 Cultural Probes Experience Compared to Literature ......................................... 111 5.2.2 Outcome-Driven Innovation Experience Compared to Literature ..................... 114 5.2.3 Combination of CP and ODI ............................................................................ 114 5.3 Improving the Design Process ................................................................................. 115 5.3.1 Successful Collaboration Between Engineers and Clinicians............................ 115 5.3.2 Improved Access to Users and Willingness to Participate ................................ 119 5.3.3 An Easier Alternative for Needs Finding ......................................................... 121 6 Limitations...................................................................................................................... 123 6.1 Researcher’s Bias .................................................................................................... 124 7 Technology Design Project ............................................................................................. 126 7.1 Canadian Workshops ............................................................................................... 126 7.2 Bone Reduction and Alignment Device ................................................................... 130 7.3 Ugandan Feedback .................................................................................................. 132 8 Future Work.................................................................................................................... 135 8.1 On Increasing Access to Safe Surgery Through Technology Focus.......................... 135 8.2 On Participatory Design Methodology in LMIC Healthcare .................................... 136 9 Epilogue: Arbutus Medical Inc. ....................................................................................... 138 9.1 Application of Research Learnings .......................................................................... 139 9.1.1 Integrating Users into the Design Process ........................................................ 139 9.1.2 Designing for LMIC Contexts ......................................................................... 140 xi 9.1.3 Beyond the Technology Innovation ................................................................. 141 10 Conclusion .................................................................................................................. 142 11 Bibliography ............................................................................................................... 145 Appendix A – Camera Instructions ......................................................................................... 156 Appendix B – Journal Questions ............................................................................................. 158 Appendix C – ODI Survey ...................................................................................................... 160 Appendix D – All ODI Opportunites ...................................................................................... 166 Appendix E – ODI Result Categories ...................................................................................... 174 Appendix F – Informed Consent Form .................................................................................... 175 xii List of Tables Table 1 - Top 20 Opportunities across all participants ............................................................... 82 Table 2 - Top 5 Opportunities across all surgeons ..................................................................... 85 Table 3 - Top 5 Opportunities across all nurses ......................................................................... 86 Table 4 - Top 5 Opportunities across all Canadians ................................................................... 87 Table 5 - Top 5 Opportunities across all Ugandans ................................................................... 89 Table 6 - Differences between nurses and surgeons................................................................... 91 Table 7 - Differences between Ugandans and Canadians ........................................................... 94 Table 8 - Differences between Ugandan surgeons and Canadian surgeons ................................ 96 Table 9 - Differences between Ugandan nurses and Canadian nurses ........................................ 98 Table 10 - Comparison of ODI and Cultural Probe themes ...................................................... 102 xiii List of Figures Figure 1 - Shift in Burden of Disease from 2004 to 2030 (Mathers, 2006) ................................... 6 Figure 2 - The ODI process visualized (Ulwick, 2002).............................................................. 36 Figure 3 - The Opportunity Landscape using Outcome Driven Innovation (Ulwick, 2002) ........ 38 Figure 4 - Fracture fixation using plate and screws vs. intramedullary (IM) nailing (Adam Images, 2018) ........................................................................................................................... 39 Figure 5 - Participant working on ODI process ......................................................................... 40 Figure 6 - X-ray displayed in a window rather than a light box ................................................. 44 Figure 7 - Faulty C-arm ............................................................................................................ 45 Figure 8 - Broken traction table ................................................................................................ 50 Figure 9 - Resident maintaining limb position due to lacking traction table ............................... 50 Figure 10 - Dysfunctional battery charging stations from various donated surgical power drills 52 Figure 11 - Poor organization and care for implants mid-surgery .............................................. 55 Figure 12 - Faulty diathermy machine ....................................................................................... 56 Figure 13 - Faulty suction machines.......................................................................................... 58 Figure 14 - Oxygen tank empty ................................................................................................. 59 Figure 15 - Scrub sink, no running water this day ..................................................................... 60 xiv Figure 16 - Faulty sterilizer due to broken door gasket that is out of production ........................ 61 Figure 17 - DIY repair of an operating theatre light................................................................... 68 Figure 18 - Patient waiting in hallway due to lack of recovery room ......................................... 70 Figure 19 - Opportunity Landscape for all participants.............................................................. 82 Figure 20 - Top 25% of Opportunities for all participants ......................................................... 83 Figure 21 – Most common Steps among the top 25% of Opportunities, all participants ............. 84 Figure 22 - Top 25% of Opportunities for all surgeons .............................................................. 85 Figure 23 – Most common Steps among the top 25% of Opportunities, all surgeons ................. 86 Figure 24 - Top 25% of Opportunities for all surgeons .............................................................. 87 Figure 25 – Most common Steps among the top 25% of Opportunities, all nurses ..................... 87 Figure 26 - Top 25% of Opportunities for all Canadians ........................................................... 88 Figure 27 - Most common Steps among the top 25% of Opportunities, all Canadians ............... 88 Figure 28 - Top 25% of Opportunities for all Ugandans ............................................................ 89 Figure 29 - Most common Steps among the top 25% of Opportunities, all Ugandans ................ 90 Figure 30 - Top 25% of Opportunities for all surgeons .............................................................. 90 Figure 31 - Top 25% of Opportunities for all nurses ................................................................. 90 Figure 32 - Top 25% of Opportunities for all Ugandans ............................................................ 93 xv Figure 33 - Top 25% of Opportunities for all Canadians ........................................................... 93 Figure 34 - Top 25% of Opportunities for Ugandan surgeons.................................................... 95 Figure 35 - Top 25% of Opportunities for Canadian surgeons ................................................... 95 Figure 36 - Top 25% of Opportunities for Ugandan nurses ....................................................... 97 Figure 37 - Top 25% of Opportunities for Canadian nurses ....................................................... 97 Figure 38 - Factors that can contribute to the success of cooperation between medical doctors and engineers .......................................................................................................................... 116 Figure 39 - Factors that can contribute to the failure of cooperation between medical doctors and engineers ................................................................................................................................ 118 Figure 40 - Context provided to Canadian participants in design workshops ........................... 127 Figure 41 - Functional steps in the bone reduction and alignment process (Group 1) ............... 128 Figure 42 - Required translation and rotation during reduction and alignment process ............ 129 Figure 43 - Design artefact from innovation workshop ............................................................ 129 Figure 44 - Bone reduction and alignment device (BRAD) ..................................................... 130 Figure 45 - Components of the BRAD .................................................................................... 131 Figure 46 – Bone-tool interface (up close) .............................................................................. 131 Figure 47 – Bone-tool interface (cross-section) ....................................................................... 131 xvi Figure 48 – Various close-up shots of BRAD device sub-components .................................... 132 Figure 49 – The DrillCover device (L) and close-up of the sterile rotary interface (R) ............ 138 xvii Glossary BRAD Bone reduction and alignment device – a prototype device developed as part of this research for easy manipulation of old fractures CAD Canadian Dollars – unless otherwise specified, all currencies in this thesis are in US dollars C-arm An x-ray machine that is C-shaped and used for intraoperative imaging to help guide the placement of orthopaedic implants during surgery CP Cultural Probes – a qualitative research method involving self-guided reflection tools for understanding research participants’ lives and perspectives Disruptive Innovation Describes a process by which a product or service takes root initially in simple applications at the bottom of a market and then relentlessly moves up market, eventually displacing established competitors FDA US Food and Drug Administration IM nail Intramedullary nail – an implant used for longbone fixation, which is inserted down the centre of the bone canal and is secured with inter-locking screws IP Intellectual property, commonly referring to patents, trademarks, or trade secrets K-wire Kirschner wire – a thin metal rod or wire with a threaded tip that is used for temporary or permanent fixation of bone fragments during surgery LMIC Low- and middle-income countries Longbone Bones that are longer than they are wide Malunion Used to indicate that a fracture has healed, but that it has healed in less than an optimal position xviii Medical Device A device intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in man or other animals ODI Outcome-Driven Innovation – a quantitative needs finding and ranking tool Reduction An orthopaedic surgical step of bringing bone fragments back into alignment SIGN Surgical Implant Generation Network, an acronym that included in the name of SIGN Fracture Care, an international non-profit that develops and manufactures low-cost IM nails for LMICs USD United Stated Dollar – unless otherwise specified, all currencies in this thesis are in US dollars USTOP Uganda Sustainable Trauma Orthopaedic Program – a Canadian non-profit focused on improving surgical education in Uganda WHO World Health Organization xix Acknowledgements I would like to thank first and foremost my supervisor Dr. Machiel Van der Loos for his guidance, kind nature, and patience throughout my degree. From early days of proposing this research area he shared my excitement for expanding the field of design research here at UBC. I am grateful for his support and open mindedness as I spent my first year searching for a way to combine my passions for international development, biomedical engineering, design and creativity, and entrepreneurship. From there, I am thankful for his support as I pursued internships, took extended time off for medical leave, and ultimately paused my research for several years as I undertook work with Arbutus Medical Inc. I would like to thank the incredible nurses, surgeons, and other clinicians from the Uganda Sustainable Trauma Orthopaedic Program (USTOP), both in Canada and in Uganda, and other clinical partners and participants from Mulago Hospital in Uganda. This group truly is a family and is committed to improving access to safer surgery for the people of Uganda. I am endlessly inspired by their relentlessness and dedication to this cause in the face of so many challenges. I would like to thank Drs. Piotr Blachut and Peter O’Brien, as well as Nathan O’Hara, who founded and lead the USTOP program, and are an incredible force for change and improvement in the standard of orthopaedic care at Mulago Hospital and across Uganda. Thank you for welcoming me into the USTOP community and enabling this important research. I would like to thank my committee members Moura Quayle and Tony Hodgson, who have been mentors not only in my research ambitions, but in my professional career and beyond. Thank you for being such great role models to try and emulate in your respective fields. I would like to thank Shalaleh Rismani and May Liang for their help in making sense of the CP and ODI data in this research by assisting with my data analysis. I would like to thank my co-founders and colleagues at Arbutus Medical who I’m always grateful to have as teammates, and specifically for their immense support as I stepped away during the last few months to complete this research and graduate. xx I would like to thank my friends and family for their unconditional love and ongoing support as I – as always – try to figure out which crazy direction to take my life next, and who helped endlessly in the completion of this thesis and this degree. And, I would like to thank Peder Sande for being there for me through it all. xxi Dedication I would like to dedicate this thesis and my research to all of the clinical staff and the USTOP team, both in Canada and Uganda, who inspired it. I would especially like to honour Faith Acen, a friend and one of the most inspiring young nurses I met at Mulago who passed away shortly after my trip to Uganda. Her commitment and drive represent for me the potential of the new generation of surgeons and nurses in Uganda who will create incredible change and progress for the neglected surgical patient in the coming years. 1 1 Introduction 1.1 Motivation Orthopaedic injury is set to become one of the top three leading causes globally of disability and death by 2030. Despite the cost-effectiveness and efficacy of orthopaedic surgical interventions, the field of global surgery is still disappointingly low on the priorities of governments, non-profits, and the private sector. Of importance to delivering safe, modern, and timely treatment is access to high quality medical devices that enable surgeons and nurses to prevent, diagnose, and treat disease. This access however is limited by a mismatch between the technology that industry is developing and what is needed in low- and middle-income country (LMIC) contexts. Technology designed for use in the West is often out of reach of affordability for LMIC hospitals, and often inappropriate for use in these contexts due to factors that include lack of maintenance and repair capabilities, lack of appropriate training for users, a mismatch between equipment operating requirements and the available infrastructure. Since affordability is an issue, donors in the West commonly donate used medical equipment to LMIC hospitals, but nearly three quarters of all donated equipment is found to not work within one year of donation, much for the same reasons of lacking reparability, training, and other infrastructure and human issues. While there is an increase in local design and manufacturing of medical equipment in LMICs, much of the global medical device market is still dominated by industry in the West. Therefore, in order to enable clinical staff in LMICs to care for patients through the use of technology, Western designers and engineers must improve the way they approach the design of medical devices for – and with – LMIC end users in the process. This research examines two methods for participatory design of medical devices in LMICs that seek to overcome two gaps in understanding between designers and their target user group: a different cultural background (i.e. Western vs. LMIC), and a different professional background (i.e. engineer/designer vs. clinician), as well as the “Expert User” problem. This study evaluates the use of Cultural Probes (CP) and Outcome-Driven Innovation (ODI) to perform a detailed needs finding and filtering, which is a critical early step of the design process. This research was conducted in a field evaluation at Mulago National Referral Hospital in Kampala, Uganda, in 2 partnership with the Uganda Sustainable Trauma Orthopaedic Program of the University of British Columbia. From the results of these two methods of participatory design, a prototype bone reduction and alignment device was then developed and deployed in Uganda for benchtop feedback. It is the goal of this research to provide a pathway for industry, engineers, and designers to take the lead and leverage these participatory design methods when embarking on medical device innovation projects for LMIC users, and most importantly, include these users in a collaborative design process for a higher likelihood of success. 1.2 Thesis Outline Following this introduction, Chapter 2 provides background on the global health burden of trauma and injury, as well as the role of surgery in reducing death and disability. The current state of access to safe surgery is then addressed, followed by the role of medical devices in providing this access. Barriers to the availability of affordable and appropriate medical technology are discussed, along with the reasons why the Western medical device industry, as well as their designers and engineers, are struggling to design and commercialize medical devices that succeed in LMICs. Chapter 3 details the methods used in this research, namely Cultrual Probes and Outcome-Driven Innovation, evaluating their effectiveness for early stage needs finding in the design process. Chapter 4 describes the results of either methodology, and Chapter 5 is the discussion that ties the results of both methods together. Chapter 6 describes the limitations of the research. Chapter 7 describes a technology design project that arose out of the needs finding exercise in Uganda, resulting in a bone reduction and alignment device (BRAD). Chapter 8 describes future work in this field that could build on the research into participatory design methods and the BRAD device. 3 Chapter 9 is an epilogue to this research and tells the story of the DrillCover technology developed and commercialized by Arbutus Medical Inc. This chapter aims to tie lessons learned from the research in this thesis to a real-world example of medical device design for LMICs. Chapter 10 is the conclusion of the thesis, bringing it all together. 4 2 Background 2.1 Trauma and injury in LMICs The global burden of disease from trauma and injury is estimated at 5 million deaths annually and contributes upwards of 20 million disabilities, with over 90% of those deaths taking place in the developing world (WHO, 2004). One of the most common causes for injury is road traffic accidents, from which it is estimated that over 1 million people die and 10 million are severely injured every year around the world. This global epidemic of orthopaedic trauma and injury is currently the fastest growing cause of morbidity and mortality in the world. It is expected to grow in the coming decades from 9th to 3rd place as leading cause of disability in the world by the year 2030 (Mathers, 2006). Some estimates place this burden even higher. When accounting for all intentional and unintentional injuries, Hofman estimates the total mortality rate is upwards of 16 million people every year, or one in ten deaths (Hofman, 2005). This cost to health care systems and to global society is nearly $500 billion (WHO, 2004). 2.1.1 The Socio-Economic Burden of Disease The burden of disease for orthopaedic trauma is often measured in the Disability-Adjusted Life Year (DALY) statistic, which is a combined index measuring the impact of injuries that lead to death, and also those injuries that will not lead to death but will result in permanent disability (WHO, 2004). The DALY quantifies how many years of productive life are lost in a population due to a particular health burden and is calculated as the sum of Years of Life Lost (YLL) and Years Lost due to Disability (YLD). YLL is calculated as the number of deaths multiplied by the standard life expectancy at the age at which death occurs, while YLD is the number of incident cases in a specified period multiplied by the average duration of a disease and a weight factor based on the severity of the disease on a scale from 0 (perfect health) to 1 (dead). 5 Globally the WHO estimates over 62 million DALYs result from road traffic accidents and violence combined. In Africa it is estimated that 7.2 million DALYs result from traffic accidents. The result of this is a significant impact on the economic and social fabric of society, and of importance to note is that these problems of injury often affect a younger population (McQueen, 2010). A study conducted in Uganda in 2015 showed that the average person injured is a 20-40 year old male, who is otherwise healthy. Of particular economic significance is that young men are three times as likely as women to get injured in traffic accidents (WHO, 2004). Men are most often the breadwinners of households. An injury incurred in the course of daily work (Hofman, 2005), also affects an average of 5 dependents (O'Hara, 2016). Thus, the impact of untreated disability and mortality is much broader and is not limited to the individual. It leaves families, and entire communities, without a source of income and a high risk of sliding further into poverty. O’Hara found that at 12 and 24 month follow-up with injury patients, they faced an average 80% income loss, 25% increase in family debt holding, and the majority of children leaving school. On a global level, it is estimated that 81 million cases of catastrophic expenditure happen from the costs associated with seeking surgical treatment (Lancet, 2015). Furthermore, the impact of stigmatization of people living with disability is staggering to individuals and society (Elkins, 1997). Injury removes people from the workforce and the economically, leading to a drop in socioeconomic status and living conditions. In addition, communities may view a disabled individual as cursed, and further ostracize them. This health burden has a massive impact, not only on the individual and their family and community, but on the ability of a society or country as a whole to develop economically. In Uganda, which is the study site for this thesis and research, and which sees over 325,000 DALYs annually from injury, O’Hara estimates the cost to the Ugandan economy from lower extremity injury alone is over $30 million annually (O'Hara, 2016). Prospects for the future look bleak as the WHO estimates this burden of injury to reach nearly 80 DALYs per 1000 people in Africa in the year 2030 (WHO, 2004). In this time, the Lancet’s Global Surgery 2030 report projects a global GDP loss of $12.3 trillion, reducing annual GDP growth by 2%. In 2010 alone, the report found a loss of $4 trillion in total welfare losses caused by untreated surgical conditions in LMICs (Lancet, 2015) 6 2.1.2 Global Health Trends While communicable diseases (e.g. HIV/AIDS, malaria, tuberculosis) have been the core focus of the global health and international development community for decades, trends show the burden of communicable disease, with the exception of HIV/AIDS, is on the decline. In contrast, a significant increase in burden is arising from injury, pregnancy-related problems, and diseases of wealth such as diabetes and cancer (Mathers, 2006). Figure 1 below shows a predicted shift in burden of disease from the year 2004 to 2030. Of special interest in this thesis is the rise of injury as a percent of total global DALYs from 9th place to 3rd place in the coming decades. Figure 1 - Shift in Burden of Disease from 2004 to 2030 (Mathers, 2006) When it comes to priority, funding, and attention, global surgery often competes with, and falls behind in comparison to, staples of global health such as HIV/AIDS and maternal health, but this prioritization is based on a wrong assumption. Evidence shows that certain surgical procedures, such as male circumcision, can lead to a dramatic drop in transmission rates of HIV between 50- 7 60% (Katz, 2008). Maternal health too is something that depends heavily on emergency surgery and obstetric care to prevent mortality and disabling conditions such as fistula. There is a need to shift perceptions of surgery and to include it as part of a holistic package of treatment for these and other classically accepted global health priorities. Further, investments in treating communicable disease fail to see the long-term gains that are expected if, for example, a child is saved from a malaria-related death but goes on to suffer a life-long disability from an untreated road traffic injury. It is thus imperative that the global health and donor community, as well as governments, include access to surgery in the long-term development of national health systems. Failing to do so would significantly impede welfare gains from other global health and international development initiatives (Lancet, 2015). By investing today in improving surgical capacity for treating near-term and “popular” problems of HIV/AIDS and maternal health through surgery, this builds and strengthens a longer-term capacity for surgical care for more complex diseases such as cancers, cardiovascular disease, and importantly in this thesis, traumatic injury. 2.1.3 An Under-Rated Contributor to the SDGs In 2015 the United Nations established the Sustainable Development Goals (SDGs) as a set of objectives for the international community to strive for in the interest of human betterment. Taking a broader look at the SDGs we can see that injury and trauma plays a significant role in holding back progress across a number of SDGs (UN, 2018). The 17 SDGs are as follows: 1. No poverty 2. Zero hunger 3. Good health and well-being 4. Quality education 5. Gender equality 6. Clean water and sanitation 7. Affordable and clean energy 8. Decent work and economic growth 9. Industry, innovation and infrastructure 8 10. Reduced inequalities 11. Sustainable cities and communities 12. Responsible consumption and production 13. Climate action 14. Life below water 15. Life on land 16. Peace, justice and strong institutions 17. Partnerships for the goals While injury and trauma clearly impact SDG #3 (Good health and well-being), the resulting loss of income for individuals and their families by exiting the workforce has a substantial impact on their ability to achieve SDGs # 1, 2, 4, 5, 6, 8. These are: the ability to rise out of poverty, provide food, quality education, and clean water and sanitation for their families, and to pursue decent work. On a macro level, the burden of trauma and injury affects a community and country’s ability to achieve SDGs 8, 9, and 10, which are the ability to achieve decent work and economic growth, industrial growth, and reduced inequalities. 2.1.4 Cost-Effectiveness of Surgery The greatest argument against surgery is that it is expensive, labour-intensive, individualized, and not cost-effective when compared to population-based programs. However, there is mounting evidence to the contrary. A study found the cost for averting one DALY to be lower for surgical, emergency, and obstetric care ($6 to $409) than for diarrhoeal diseases and treating HIV/AIDS in certain populations ($500 to $6,390) (Laxminarayan, 2006). There is evidence to show additional cost-effectiveness in training lay-people as first responders (Jayaraman, 2009) and in training non-physician clinical officers in the practice of essential surgeries (Saswata, 2005) (Brugha, 2011). Of course, the cost of not providing surgery can often be greater than providing it, both in the long-term cost of disability, but also in the actual cost of alternative procedures. In a Cambodian study, Gosselin found that the total cost of femoral nailing surgery for fracture fixation was actually lower than skeletal traction, which is an outdated and less effective treatment (Gosselin, 2009). 9 2.1.5 Technical vs. Adaptive Challenges In the book The Practice of Adaptive Leadership, Heifetz distinguishes between simple to understand, simple to solve “technical” problems, and very complex, human-based, behaviour-change related “adaptive” problems that are not easily understood or overcome (Heifetz, 2009). One may argue that surgery is a simple and highly understandable solution with predictable results – a technical problem – whereas something as seemingly simple as providing clean water or sanitation is actually an incredibly complex and difficult adaptive problem, and indeed something that the development community has been struggling with for decades. While traditionally interventions in nutrition, communicable disease, and sanitation were thought to be simpler, our ability to intervene in a way that has lasting results is actually entangled in cultural, behavioural, political, social, and other inter-personal barriers that plague these community systems. When comparing difficulty then, one can argue that a scalpel is easier to wield than a village-wide behaviour-change program. An increased focus should then be placed on surgery: a science-based branch of medicine with very well-documented methods and efficacy that are technical rather than adaptive. 2.2 Access to surgery Surgically treatable disease contributes to 30% of the global health burden; however, the role of surgery spans 100% of disease categories (Lancet, 2015). While much of the disability and mortality caused by injury can be prevented through timely access to surgical intervention, there is currently a major gap in provision of surgical care in the developing world. Of the estimated 266 to 360 million operations performed in 2012, only 1 in 20 were in very-low income countries, despite these countries representing over 1/3 of the global population (Weiser, 2016). To meet the total global need for surgery, an additional 143 million operations are required (Lancet, 2015). Unlike many maladies that are preventable or curable using a vaccine or pharmaceutical solution, or a simple intervention like a mosquito net, traumatic orthopaedic injury usually requires complex technical solutions, which are often inaccessible outside of major cities. The complexity is due to the need for sterile surgical environments and equipment reprocessing facilities, water and electricity, and medical devices. To quantify this access in terms of infrastructure, Funk identified 10 that high-income regions of the world all had at least 14 operating theatres per 100,000 population, while the 2.2 billion people in the lowest income regions of the world had fewer than 2 operating theatres for 100,000 (Funk, 2010). Funk further found that over 19% of operating theatres around the world, mostly in lower income regions, were not equipped with basic equipment, such as pulse oximetry, required to perform surgery. Even with proper facilities, however, the system is lacking in the trained medical staff to conduct safe surgery. Uganda, a country with a population of 41 million, had in 2008 a mere 20 orthopaedic surgeons and 10 physician anaesthetists (Ozgediz, 2008). This problem is further exacerbated for 90% of the population who live in rural areas since the majority of trained physicians are located in the capital city, Kampala. 2.2.1 Injury as a Priority in Surgery Despite the recent interest and push for global health improvement, very little of this push is in the direction of surgery. A survey of foreign aid funding in Uganda found that out of 111 health projects, totaling nearly $300 million, only two were specifically aimed at improving surgical facilities at referral hospitals (Angemi, 2007). Not only do donors not invest in surgery, it is often completely omitted as a metric when evaluating the capacity of health systems in developing countries (Backman, 2008). While general advocacy for surgery is necessary to put it on the global health agenda, it would be useful to identify priority areas of focus and give direction of where to start. In 2009, Mock began to categorize three classes of priority in international surgery. He considered a range of surgical procedures and evaluated them on three criteria: cost effectiveness, the significance of the burden of disease, and the level of efficacy of the procedure in treating the disease. The procedures identified as highest priority include low-cost but highly effective trauma, pregnancy-related, as well as congenital diseases and emergent cases (Mock C. C., 2010). This gives clarity for policy makers and funders as to where focus should be placed when evaluating the burden and capacity of surgical care. The factors that Mock used to determine what would classify as a Priority 1 surgical condition are those: 11 • That have a large public health burden, and • For which there is a surgical procedure that is highly successful at treating the condition, and • For which the surgical procedure (and related ancillary services and treatments) is cost-effective and feasible to promote globally Of the 19 Priority 1 surgical conditions, 4 identified were orthopaedic in nature. This gives further impetus for governments, funders, and decision makers to increase their focus on injury and surgical intervention as a global health priority. 2.3 Role of Technology in Health Care The role of surgical technology is vital to the health care system, and the sections that follow will continue to emphasize the interconnectedness between surgery, technology, and the role of designers as they interact with users of the technology. When considering surgery specifically, most, if not all, surgeries are based on a series of technologies that work in concert to help physicians reach a desired outcome. Whether we consider the direct technologies involved in a procedure (e.g. a scalpel, cardiovascular stents, implantable fracture fixation devices), or technologies that are peripheral to the surgery itself, it is impossible to ignore the role of medical devices. Without sterilization facilities and imaging, for example, it would not be possible to perform some of the most common procedures safely and effectively. Finally, we cannot ignore the historical advancements made through the implementation of new technology in healthcare. Whether it is anti-bacterial soap for scrubbing into surgery, or the rapid improvements in cataract surgery that has enabled millions to live more productive and happier lives, technology has always been at the centre of Western medical improvements. This thesis specifically deals with medical devices, which are defined by the United States Food and Drug Administration (FDA) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (FDA, 2018). 12 2.3.1 Access to Orthopaedic Medical Devices The impact on society from orthopaedic trauma, as well as the related morbidity and mortality rates, is very significant. A major factor contributing to the health outcomes of someone suffering from traumatic injury is the ability to access appropriate care, including surgical procedures that require safe and appropriate medical technology. In orthopaedics in particular there is a great need for high-quality implants and fixation devices that allow proper healing of longbones. These various required technologies include devices to directly heal the bone fracture such as plaster, plates and screws, intramedullary nails, and external fixators; however, orthopaedic trauma surgery also depends heavily on a supporting system of technology such as power tools to insert the implants, intra-operative imaging to guide the trajectory of implants, anaesthesia machines and medicines, lighting, and proper sterilization facilities. In recent years the WHO has been encouraging the improvement of surgical care at the District Hospital level in LMICs to aid in expansion of care (WHO, Surgical Care at the District Hospital, 2003); however, the approach taken seems to ignore the extreme shortage of proper equipment and orthopaedic medical devices available. Despite the directives for the use of fixation devices in the WHO’s Instructions to District Hospitals, a study of available trauma services across four countries shows such devices to be non-existent at the District Hospital level. At this level, the results of the study show availability ranging between “absent” to “partly adequate” in each category of internal fixation, external fixation, skeletal traction, and imaging (Mock C. N.-R., 2006). Without appropriate tools, untreated patients can develop improper healing and lifelong disabilities that will affect them and their families. 2.4 Barriers to Access The identified barriers to access for orthopaedic devices are well documented by Bouchard during a study of the Ugandan orthopaedic landscape (Bouchard, 2011). These barriers were composed of four factors: corruption, low human resource capacity, low infrastructure capacity, and high costs of orthopaedic trauma devices. 13 2.4.1 High Cost of Equipment and Lack of Budgets Often the costs of orthopaedic devices can be as high as $1000 for a reusable external fixator and $900 for an intramedullary nail (Bouchard, 2011). Considering that the Ugandan government spends roughly $20 annually per citizen on healthcare (Odaga, 2006), it is hard to imagine how the cost of devices will be covered by the government. It is common for the government to provide a hospital with orthopaedic implants, however they are not sufficient for the full annual need. Hospitals often run out of inventory only a few months after the year has begun (Beyeza, 2012). Because of this, the patient is often asked to pay for the cost of implants up-front in the public healthcare system. In the private healthcare system, insurers often prescribe which devices they are willing to pay for, and very often they will demand that patients accept a generic or inferior quality locally made device (Anonymous, 2012). 2.4.2 Intellectual Property The problem of intellectual property is a major barrier to access to high quality devices in Uganda. Major global companies often hold up to 100,000 patents each on aspects of their technology, which are responsible for the refined product quality and improved patient outcomes (Bouchard, 2011). Since generics struggle to invest in similar research and development and cannot make use of these patented technologies, they end up producing inferior goods. At the same time, for reasons explained above of corruption and insufficient hospital budgets, Western manufacturers are not able or willing to move into these under-penetrated markets, and so the benefit of these patents to developing world patients goes unutilized. Similar challenges faced the HIV/AIDS pandemic for decades, during which expensive patented drugs were not easy for patients across the developing world to access. The global fight for universal access to essential medicines, including appeals against World Trade Organization agreements on intellectual property, has led to tremendous progress in the global pharmaceutical industry and the fight against HIV/AIDS. Access to patents for generic manufacturers at re-negotiated prices has allowed anti-retroviral medications in the developing world to drop from $15,000 annually to only $300 annually for treatment (Bouchard, 2011). A similar global 14 movement could develop in the fight for access to essential medical devices; howeve, the lack of global urgency towards injury, trauma, and surgery makes this very unlikely. 2.4.3 Failing Donation System One approach for closing the gap in health-care that has been employed for decades now is the donation of medical equipment. Due to the rapid turnover of older technology in the West, it is common and convenient for Western medical systems to ship used (and often broken) equipment to the developing world. However, these efforts over the past decades to equip developing world hospitals with donated medical technology have largely failed. In some cases, developing countries depend on foreign donations for up to 95% of their equipment, though studies from 16 countries across Asia, Africa, and South America have found that 80% of these donated technologies fail within the first year (Malkin, 2007). As many as 39% of all donated technology never worked at all once arriving in the recipient country. According to a WHO report and new guidelines on medical equipment donations, as much as 70% of equipment donated around the world is currently being unused (WHO, 2000). The reasons for failure are sometimes technical, as in the case of an inappropriate power supply, but often arise from a lack of foresight into the appropriate design, use, and maintenance of technology (Malkin, 2007). Technology that is designed for use in a highly developed Western medical context simply does not fit that of a developing world hospital. The WHO’s report Medical Device Mismatch identified that, although medical technologies of all sorts are created by industry to treat and manage a wide variety of disease states, a significant mismatch exists between what is needed in the developing world and what is being designed currently for Western markets (WHO, 2010). This gap is one of availability, accessibility, affordability, and appropriateness for local needs of developing world users. This so-called ‘4A’ Model for medical devices is described further later in this thesis. 15 2.5 Design in the Developing World 2.5.1 Appropriate Design of Medical Devices for LMIC The WHO’s Priority Medical Device report showed that there does not exist a gap in technologies for medical care, so much as there is a mismatch. Many medical devices do exist to treat a wide variety of illness, though very few devices are appropriate for low-resource settings. The root of the problem exists in both industry and the education system. Industry has difficulty designing effective technology for LMICs, while the engineering education system does not prepare future designers for the challenges of designing for the Bottom of the Pyramid (BOP) (Prahalad, 2003). Polak argues that a revolution in design is necessary to shift away from the current paradigm, where “90% of designers and engineers are solving problems that affect the 10% richest people on the planet” (Polak, 2008). It is not enough for surgical technology to be designed for low-resource settings if it will never reach the clinicians and patients who need it most. A key recommendation of a 2011 report on medical technology by the global consulting firm Accenture stated that “broader models of innovation that deliver not just break-through innovations, but service and price innovations as well” will be necessary for current players in the medical technology industry to succeed at capturing market share in LMICs (Accenture, 2011). Especially critical at the BOP is the business concept of the “last mile”, which suggests that the greatest delivery challenge may be the final leg of the delivery chain. Our Western models of service and technology delivery break down in this last mile, in the villages and slums where those most in need cannot get their hands on essential equipment and where we do not understand the way that people and the market interact. 2.5.2 The 4A Model for Health Technology The World Health Organization in 2010 launched the Priority Medical Device program to identify the gaps in global health technology. The most significant finding was that the problem didn’t look so much like a gap in innovation, as it did a mismatch between available technologies and ones that would become sustainable solutions for LMICs. The WHO then defined four characteristics of medical device systems to ensure sustainability: medical technology must be affordable, accessible, available, and appropriate (WHO, 2010). 16 Affordability is a clear problem in designing technology for global surgery. Given the limited-resources of such contexts, technology must cost a fraction of what it would in the developed world. Bhatti describes how the aim for affordable technology should be “frugal”, not “cheap”. He suggests that, while poor people need something at perhaps 10% of the traditional cost, they seek and often demand up to 70% of original functionality. In this view, frugal does not mean low quality, but rather it defines a unique price-performance range for highly value-conscious consumers (Bhatti, 2011). Accessible technology means that it is not enough to have the technology in a shop or on hospital shelves, it must be accessible to those who need it. Across the developing world, many of the same devices that we have in Canada exist for those with money or special connections, but sustainable technology needs to be accessible to all. Availability relates to the physical presence of technology. The supply chains, vendors, and logistics must be in place to ensure that when the time comes, the technology is available and ready for use. Finally, appropriateness is key when designing technology for a culture vastly different from our own. Barriers to success of technology can be very subtle and often culturally-based, especially in the field of healthcare, where very close interactions and certain practices between patients, doctors, other health practitioners such as nurses, and technology developers may even be forbidden. 2.5.3 Innovative Technologies and Success Stories There are signs that innovation in developing world medical technologies is starting to take place. There are several examples of designs aimed specifically at this market, driven initially by academic and non-profit groups, but with uptake in the private sector. The Stanford-developed low-cost infant warmer, Embrace, has gathered a lot of attention for its simplicity, usability, and the cost of less than 1% of a traditional incubator (Embrace, 2012). The group has recently partnered with global healthcare giant GE Healthcare to further solve the last 17 mile distribution and accessibility problem that is market driven rather than technology related (GE, 2012). Similarly, the group D-Rev has developed a low-cost device, Brilliance, for treating jaundice in infants at a fraction of the cost and with a design that significantly decreases downtime and the need for repair. The Brilliance device was recently acquired by Phoenix Medical Systems, a company with 70% market share in phototherapy devices in India (D-Rev, 2012). Additional products currently in the process of commercialization include the Shift Labs DripAssist, a low-cost device for automated monitoring of infusion rates, the HemaFuse autotransfusion device by Sisu Global Health, both in the start-up stage and resulting from academic origins (Shift Labs, 2018) (Sisu Global Health, 2018). In orthopaedics, two success stories illustrate the potential for innovation. The SIGN Intramedullary Nail is an FDA-approved device that allows surgeons to complete the procedure without the need for intra-operative imaging through the use of a jig system for guidance (SIGN, 2012). The device has so far been used in over 70,000 surgeries around the world. The improved clinical outcomes and cost-savings afforded by the SIGN Nail are clear when comparing it to alternate procedures such as the use of traction in femoral shaft fracture. In a case study conducted in Cambodia, it was found that, although the cost of SIGN Nail surgery itself is higher, the overall cost to patient is actually lower when taking into account the extended hospital stay, x-ray requirements, and additional physiotherapy required with traction (Gosselin, 2009). In fact, the costs for traction versus SIGN nailing procedure were $941 and $820, respectively. The second innovation in orthopaedics is the Jaipur Knee, a $20 polycentric knee prosthetic that is made from low-cost, locally-sourced parts and self-lubricates (D-Rev, 2012). Both the Jaipur Knee and the SIGN Nail are valuable innovations; however, at this stage neither has been taken to the next level commercially as with the Embrace, Brilliance, DripAssist, or HemaFuse devices. For interest, a number of additional such innovations, mostly growing out of academia, are available in the WHO Compendium of Innovative Health Technologies for Low-Resource Settings (WHO, 2014). 18 A final example of innovative medical device innovation in orthopaedics comes from Arbutus Medical Inc., a Vancouver, Canada based start-up company co-founded by the author of this thesis. The company, its product, as well as the challenges, learnings, failures, and successes in the process of commercialization over the past half-decade will be the subject of a further chapter in this thesis. 2.5.4 Big Industry Focus on Emerging Markets It is encouraging to see that major companies involved in the health care field are beginning a shift towards LMIC markets. In recent years, GE made an announcement of a $6B investment into improving access, quality, and affordability around the world in its devices, and launched this campaign through the introduction of the MAC 400 electrocardiograph (ECG) machine. This $400 ECG intended for the rural Indian market reached its targets by scrapping frivolous extra features and focused on essential functionality, while maintaining a high degree of quality (GE, 2012). Within orthopaedics, the global leader in trauma, Synthes DePuy, shows signs of a similar trajectory. While they hold a 50% market share globally and continue to benefit from a 5% annual growth rate in North America, the growth that Synthes is experiencing in Latin America of over 20%, and in China and India of over 25% in recent years shows both their efforts and resulting success in these emerging markets (Synthes DePuy, 2015). Although the company does not seem to have an immediate focus on African markets, Synthes has shown significant progress in China, which may be a model for Africa’s future. It has invested heavily in local Chinese innovation for the Chinese market, a rapidly expanding sales force in China, and an education program targeted at the local population of surgeons. With a similar trajectory in Latin America, Synthes is on track to pursue its two main goals for the coming years: focus on under-penetrated markets and disruptive innovation in product development (Synthes DePuy, 2015). Having recently been acquired by Johnson & Johnson, Synthes is now better-positioned to use J&J’s extensive distribution, marketing, and sales force to reach consumers across the globe (Thompson, 2011). Similarly, the major medical device company Stryker Corporation has recently announced the development and launch of the Stryker System G orthopaedic power tool (Dandekar, 2016). This device follows in a series of Stryker models named System 5, 6, 7, 8, etc., but with the G said to stand for the Indian city of Gurgaon, where Stryker’s Indian innovation and R&D hub is based. 19 This product is specifically and limited in availability to the Indian market, at a price point said to be 50% that of other Stryker systems. This move by Stryker is with the intent to grow their operations in the massive Indian market, and to do so by filling the gap between very high end Western surgical drills and the low-cost but low-quality local knock-off brands. Similar to Stryker, other major medical device manufacturers, including GE and Johnson & Johnson, have established R&D hubs in India, China, and elsewhere in Asia, with the specific intent for these local engineering teams to develop and commercialize products tailored to those local markets, local needs, and local challenges. 2.5.5 A Model for the Bottom of the Pyramid While companies are beginning to see the market opportunities in emerging markets, it may require a greater shift in perspectives and skills in order to effectively capitalize on those growing markets. Economist and thought leader C.K. Prahalad argues in “The Fortune at the Bottom of the Pyramid” that the next round of global growth will take place at the bottom of the economic pyramid, with those four billion consumers living on $2-$4 a day (Prahalad, 2003). Capitalizing on this opportunity, however, will require a different approach to doing business in this customer base. Some global consumer product companies such as Proctor&Gamble and Unilever have moved into these markets, but have adapted their business model. Rather than selling products at relatively high margins as in the West, these companies have found profitability in very low margins at extremely high volumes. Similar approaches must be employed by companies in the medical device sector, especially if they are to compete for this large economic opportunity with lesser quality but quicker-to-market generics from China and India (Bouchard, 2011). The principles of “design for extreme affordability” are becoming better understood, and in some ways can integrate into the efforts underway by national and international governments and agencies. A common design principle for this kind of innovation is to “disrupt” a system of practice by allowing lower-skilled practitioners to perform the duties that were previously performed by high-skilled but rare professionals. Innovation in technology of this kind, whether it be mobile-phone based diagnostics and emergency management, or low cost first-responder systems, would fit well with programs by the WHO and individual governments to expand quality of care at District levels (WHO, Surgical Care at the District Hospital, 2003). A similar study in Uganda 20 explored the feasibility of training lay-people who are in professions that witness a lot of injury (i.e. taxi drivers, mini-bus operators, commercial truckers), and preparing them with the skills to become “lay-first-responders”, thereby expanding the country’s capacity for pre-hospital care (Jayaraman, 2009). Approaching medical device design from the perspective of “simplifying care” may even lead down a road where complex, thousand-dollar medical implants can be side-stepped in lieu of simpler, more appropriate treatment options that could lead to similar health outcomes. Companies such as GE have capitalized on the unique circumstance of an Indian population with a genetic predisposition to cardiovascular disease with its MAC 400 ECG. It is only a matter of time before the growing epidemic - and cash cow - of global trauma is taken on by a major manufacturer with the proper approach, the vision, and the daring leadership to disrupt the system. 2.6 Mismatch and Expert User Design This thesis argues that there are two major challenges of designing medical technology for international surgery, which we define as taking place in a low-resource, developing world context. Firstly, it is argued that there is a Western bias inherent when models of medical device design are applied in non-traditional markets. This issue arises from assumptions that designers may hold about the design space. Secondly, there is a difficulty in this field of becoming familiar with and understanding the nuances of the problem space, due to the expertise required to understand the field of surgery. This, combined with power dynamics that often accompany cross-cultural projects in low-resource settings, makes for great difficulty in understanding and defining the problem to begin with. A method is proposed for uncovering the assumptions that are inherent in traditional medical device design, validating, and then moving past them to co-create technologies that can benefit international surgical practice. 2.6.1 Understanding the Mismatch It is critical to ask why such a mismatch exists between what the medical device industry is producing and what billions of people around the world need desperately. The Bottom of the Pyramid (BOP) market, defined by Prahalad as the four billion people in the world living on under $2 a day, presents one of the greatest challenges to medical device innovators 21 (Prahalad, 2003). This gap in access to technology-mediated healthcare is not only an opportunity to bring the benefits of modern day technology to underserved populations, but also to gain an economic foothold in some of the fastest growing economies of the world. Although the United States currently makes up 40% of the global market for medical technology, emerging markets, especially the BRIC nations (Brazil, Russia, India, and China), are expected to more than triple their health expenditure between 2010 and 2020 (Holtzman, 2012) (Das, 2012). India and China alone are predicted to increase health spending by a compounded annual growth rate of 15.5% and 14.5% respectively, compared with only 4.0% for the G7 nations during this same period. Though Asian giants have taken the spotlight of emerging market projections, African economies such as Ghana and Rwanda are ranked impressively as the 4th and 13th fastest growing economies in the world, with 2011 estimates of 13.6% and 8.8% annual GDP increase, respectively (CIA, 2012). Medical device manufacturers, like other sectors, are beginning to take note of this trend, with companies such as GE Healthcare, Johnson & Johnson, and most recently Covidien opening R&D centres within these target markets and investing heavily to find appropriate solutions (Covidien, 2012) (GE Healthymagination, 2010) (Johnson & Johnson, 2011). Despite these efforts, many established manufacturers are finding great challenge in reaching the true Bottom of the Pyramid. The socio-economic stratification and geographic separation of the poor majority within developing countries presents two consumer tiers. The wealthiest within these populations are not much different from their Western equivalents. They have access to international standards of healthcare, trained physicians, and cutting-edge technology. For this reason, they are a familiar and welcome sight to Western medical innovators, and have typically been the primary target of companies seeking to enter emerging markets (Deloitte, 2012). In contrast, the poor majority of these populations have little access to healthcare. Despite spending a disproportionately higher percentage of their income on health (Duflo, 2011), the system that serves them is lacking even the most basic of technology. This second tier of consumers is greatly underserved by the medical device industry to date. To understand this problem further, it is necessary to look at the way in which medical device design takes place in the wealthy, developed world. Exploring the basis of these methods that lead to success in the first world may reveal why these steps cannot achieve a similar result in emerging markets. At its root, the problem lies not only in how we approach the design process, but also in 22 how we understand the problem space. It is these two challenges that this thesis will further address. 2.6.2 Uncovering Assumptions that Guide Traditional Design Western biomedical engineers and designers are trained to navigate a rigorous, step-wise process of design for medical technology, based on directives set out by regulating bodies such as the United States FDA (Zenios, 2009). Although there are a number of guidelines and representations of this process, including the waterfall model and the stage-gate model (Pietzsch, 2009), these examples may not deliver successful products in BOP markets. Such models have been developed through the lens of Western designers, and with experience within the complex Western medical device environment. Designers themselves apply these steps and procedures within a particular technology design paradigm, based on a set of expectations and assumptions about the users and context of use that are unique to traditional markets. The paradigm we are designing for in the Western medical world features a different set of characteristics, challenges, and assumptions than those of LMICs. What is needed, then, is a change in how designers and engineers approach the design of medical technology for the developing world. In order for this shift to take place, we must begin to understand and catalogue the differences present in each system, specifically how Western assumptions surrounding technology design may or may no longer apply in a developing world context. Shedding light on our assumptions about the design, delivery, and use of medical technology can also uncover the values and priorities that inform designers on appropriate trade-offs that can be made in the new medical technology paradigm. 2.6.3 The Challenge of Expert Users A further challenge present in medical device design exists in understanding the complex needs of expert users, a task made more difficult than designing in common consumer-focused sectors such as home electronics or kitchenware. There is a distinct asymmetry of information present between user and designer. Expert medical technology users have a depth of understanding of the practice and associated challenges that are 23 rooted in their own experience and education. Designers on the other hand typically have a depth of knowledge in the solution process and method, but have only a common understanding of the problem space. Von Hippel labels this a problem of “sticky information”, which has a high cost of transfer from users to the designers who need it in order to work effectively (Von Hippel, 2005). The information is hard to transfer for a variety of reasons, but primarily due to the complexity and nuances that exist in practice. To the users, the necessary information may seem second nature and obvious among their peer group, thus resulting in their not sharing of certain critical details with designers. Other times the information may not be encoded and the users themselves may not recognize their own habits and needs, such as the manner in which surgeons use bracing strategies to improve manual dexterity and precision during an operation. Suri terms these valuable but unconscious adaptations to one’s environment as “thoughtless acts” (Suri, 2005). Manufacturers try to move past this challenge of understanding the problem space by maintaining close relationships with doctors, nurses, and other medical technology users. Methods borrowed from the field of human centred design are used to understand the user’s context, challenges, and subtle needs. However, applying many of these techniques, such as contextual inquiry, where users are interviewed and use a think-aloud approach to verbalize their decisions, are often not appropriate for the trauma setting, where users are intensely focused on a life or death situation. Some work on developing techniques for needs-finding in trauma surgery has been done. In the field of human factors, Brown presents a process specifically for use in trauma settings consisting of expert interviews, observation, as well as getting feedback on prototypes through usability testing and heuristic evaluation (Brown, 1999). Despite progress made on the development of trauma-specific methods for the early stages of design, this practice within a low-resource setting provides an additional challenge in the power dynamic that exists between designer and user. Evident in international development projects, the dichotomy of the rich, Western donor and a poor, suffering beneficiary intensifies problems in communication, trust, and partnership (Dudley, 1993). A similar perception may exist in a design context where the medical technology users, working in a resource-constrained environment and struggling both personally and professionally, may perceive a designer to be arriving with money, technology solutions, and the significant backing of a foreign entity or company. The real or imagined incentives in this scenario may then become a barrier to hearing truthful comments from 24 users and require a designer to enter with a heightened sense of skepticism and situational awareness. 2.7 Closing As this chapter has highlighted, medical devices are a critical component for health systems capable of dealing with massive global health burdens, notably orthopaedic injury and trauma. While there is a great degree of innovation in this field, the majority takes place in the developed world, and the resulting technologies are designed for use in those same settings. This results in medical devices that do not reach physicians and patients in the developing world where the health burdens are often highest. The channels for reaching these users, either through the market system or through donations, do not often provide great access, and even when they do, the technology is maladapted for these settings and rarely functions sustainably. There is an imperative need for designers around the world to increase their understanding of how to design for and with expert clinical users in the developing world. This involves understanding the unique needs of a local context, gain access to complex information from a unique clinical domain that is otherwise only available to an expert user, and transform this into effective inputs and requirements to begin the design process. The next chapters of this thesis describe how two user-centric design methods are used to bridge the gap between Western designers and expert clinical users in a developing world context. 25 3 Methods To overcome the two challenges in designing appropriate medical devices for low-resource settings, namely 1) the bias of a Western designer not acquainted with the nuances of a local culture and context, and 2) the difficulty in engaging with and understanding problems from the perspective of an expert user, a number of unique research methods were utilized and combined in this research. These methods include Cultural Probes (Gaver, 1999), Outcome Driven Innovation (Ulwick, Turn customer input into innovation, 2002), and an overarching research methodology based in Grounded Theory (Glaser, 1967). This aim of this research is that the insights from the application of such methods provide a guide for future design of medical technology in such contexts that are appropriate for, and in collaboration with, the end user. 3.1 Partners 3.1.1 Uganda Sustainable Trauma Orthopaedic Program In order to make progress on addressing the challenges presented above and identify ways for designers to improve their approaches to design in developing world medical contexts, this research was purposely grounded in a real-world clinical environment with real-world users. Thus it was decided to partner with the Uganda Sustainable Trauma Orthopaedic Program (USTOP). This project of the University of British Columbia in Vancouver, Canada was founded in 2007 by Drs. Piotr Blachut, Peter O’Brien, and Trevor Stone. The group conducts annual trips to Mulago National Referral Hospital in Kampala, Uganda, and often side trips to other smaller hospitals within the country, in order to provide capacity building training for local medical staff. This project is a collaboration between the UBC Faculty of Medicine and Makerere University in Uganda, and thus considers both Canadian and Ugandan surgeons as partners through this collaboration. 26 This partnership provides access for investigators to study the environments, people, and interactions in both a Canadian medical setting at Vancouver General Hospital (VGH), and also in a Ugandan setting at Mulago Hospital. 3.1.2 Engineers in Scrubs A second group that benefitted the research is the Engineers in Scrubs (EiS) Program at UBC (Hodgson, 2014). This program, started in 2011 by Dr. Antony Hodgson, brings together engineering graduate students and clinicians. In the exact spirit of this research and thesis, it is held that clinicians understand well their problems in clinical practice, whereas engineers understand the solution process, but neither understands both, and so by bringing the two groups together it can lead to innovations that would otherwise not have been possible. The EiS program begins with a month-long broad-spectrum Orientation to the Clinical Environment, which is a tour of hospital facilities across Vancouver. Students spend time with stakeholders across the hospital and visit departments that include the operating theatre, sterile processing department, pathology department, the emergency room, and more. Following this orientation, the program makes use of MedTech CAFEs, which are a series of collaborative workshops between the students and clinicians on a bi-weekly schedule. During these workshops clinicians initially pitch a number of ideas and problem areas for the students to research and understand the clinical fundamentals, as well as the existing technology, intellectual property, and market landscape, before selecting one project to focus 8 months on developing. The author of this thesis was fortunate to be part of the first cohort of the EiS Program in 2012, where a number of the qualitative user research methods in this study were introduced, as well as an appreciation for the role of human-centred design in medical innovation. Further, upon completion of the in-situ portion of this research in Uganda at Mulago Hospital, students from future cohorts of the EiS Program were invited to participate alongside surgeons and nurses from the USTOP Program in order to leverage the research results and identify a next step forward for technology development. 27 Lastly, the technology innovation, the Arbutus Medical DrillCover described in the last chapter of this thesis, was a technology developed directly out of the EiS Program. 3.2 General Study Approach This research study began with informal interviews with a number of past, present, and future Canadian members of the USTOP program to get a sense of what to expect and how to frame the in-situ component of this research in Uganda. The main phase of this study took place in the fall of 2012 at Mulago Hospital as the author joined the USTOP surgical team for several weeks, and continued independent research in Uganda for a total of 2 months. At a high level, a Grounded Theory approach was used for conducting this research (Glaser, 1967). In this method, data from various sources including media, observation, and interviews are collected and documented. This information is then coded and interpreted, and becomes the source of emergent patterns in an iterative process of theory building. Perspectives were initially sought on the values and needs of users at Mulago Hospital through the use of Cultural Probes. This technique introduced by Gaver equips users with a reflection toolkit consisting of a journal, questionnaires, and a photo camera (Gaver, 1999). Users are instructed to collect photographs and reflections, and to answer specific questions that serve to inform designers about their life context. Currano demonstrated the value of ‘reflection-out-of-action’, which the cultural probes tools would afford by allowing users a self-guided reflection process without the pressure of a formal interview setting (Currano, 2011). This method is expected to uncover important differences among this user group and perceptions on their environment and challenges as compared to their Western designer counterparts, and will thereby partially address Von Hippel’s sticky information problem and the power dynamics involved. Finally, users were engaged in a creative thinking and imagination exercise in order to co-create locally appropriate solutions. Using the method of Outcome-Driven Innovation (ODI), opportunity areas are mapped as a series of tasks, or jobs, that the user performs, each leading to an overall desired outcome (Ulwick, 2002). Armed with insights about local priorities and acceptable trade- 28 offs, users are engaged to re-imagine how their desired outcomes could be achieved in innovative ways. Such innovations that reduce the need for inaccessible inputs (i.e. consumables, spare parts, knowledge not available locally) or remove steps that do not fit the local context can radically change the face of technology-mediated surgical care in the developing world. 3.3 Grounded Theory Methodology Grounded Theory is a general methodology for conducting research, developed by Glaser and Strauss (Glaser, 1967). The method famously works in contrast to the traditional scientific method. While the scientific method begins with a set of assumptions, which develop into a hypothesis to be tested using a specific scientific experiment, the Grounded Theory methodology consists of no such components. One of the key differentiators of the Grounded Theory method is that researchers must approach a topic area of interest with as few as possible pre-existing assumptions and ideas about what they expect to find. In fact, not even a research question or problem is to be pre-determined, only a general research topic, in order to minimize preconceptions. The researcher is to approach an environment or research context with an open eye for any and all forms of data that emerge. While classical forms of data such as formal interviews and in-situ observations are part of the data collected, so are artefacts and ideas that the researcher unintentionally stumbles upon in the environment. As an example, artefacts such as what may be playing in popular media and even posters or information found on the wall of a building can be considered as data inputs for further categorization, coding, and seeking of emergent patterns. This step of the process is referred to as Theoretical Sampling. The method goes to what some consider an extreme openness to what is considered data in that even the researcher’s own thoughts, perceptions, reflections, and admitted biases can be considered as data for the formation of a Grounded Theory. While this open-ended and open-minded data collection is in progress, the next step is to perform continual coding throughout the process. That is, the researchers must at the end of each day of 29 data collection review the data collected and begin to associate codes or descriptor labels to certain concepts, ideas, themes, and patterns that emerge. As themes emerge over time, additional data that are gathered either build the case for these themes or fail to grow in materiality and thus identify new pathways for thought, trends, patterns, themes, and further data-seeking. This process is continually iterative, and requires the researcher to “suspend his/her preconceptions, remain open, and trust in emergence of concepts from the data" (Grounded Theory Institute, 2018). While there are more specific coding techniques possible, the coding process generally follows these steps: 1) Open Coding is the initial step of attaching codes and categorization of all emergent data. 2) Selective Coding progresses once certain themes emerge that the research wants to build more on. 3) Finally, Theoretical Coding takes place once the emergent themes give clarity to certain phenomena or connective theory between different codes and themes, with the aim of further building an integrative theory out of the data. In addition to ongoing coding, it is essential to engage simultaneously in the iterative step of memoing, which is in essence similar to journaling and documenting of ideas and connections as they happen during the process. This is often done in a free-form and stream-of-consciousness format to allow the researcher to capture any nascent ideas and fleeting concepts before they are gone. Finally, from this process will emerge a theory grounded in the data surrounding a topic of interest. The research in this thesis utilized the Grounded Theory methodology for understanding the data gathered through informal and formal interviews, as well as through the Cultural Probes exercises described in the next section. The data were analyzed using the NVivo for Mac version 12 software by QSR International (Doncaster, Australia). 3.4 Qualitative Design Methods: Cultural Probes 3.4.1 Background As a designer working in any context it can be difficult to see into the lives of users with deep insight. This may be due to not knowing even what to look at, what to look for, or what to be aware of in a particular context. The dual challenges of designing for expert users and of designing for 30 users with a cultural or socioeconomic difference makes it even harder to see, identify, and capture critical information that will define user needs and product requirements. The challenge may be in knowing what to look for and where to look, but it can also be a difficulty in the designer having the ability to access and acquire this information directly, whether due to language or cultural barriers, or even physical access and permission into spaces, environments, and social environments where the information exists. For these reasons and others, traditional forms of data gathering such as observation and interviews may be too intrusive, especially in a more sensitive or taboo setting, or one where special access is required, be that security and privacy access, geographic access, sterile access, or social access. The method of using Cultural Probes can be effective at overcoming these challenges. At its core it allows users to provide information about their context and life in a self-directed manner. People act like a cultural informant regarding their own environment and life. In a cross-cultural setting as is the case in this research, the use of Cultural Probes allows the participants to tell their story on their own terms. They can choose when, where, and how to tell their story. This is important for several reasons in this research. First, allowing users to share information about their lives in a relaxed setting such as the home, rather than within a professional environment such as the hospital, office, or operating theatre, can enable more free thinking and sharing of information without the pressure of work tasks or the distraction of a busy environment. Currano refers to this way of thinking as reflection-out-of-action, and found that designers were often more likely to come up with great ideas when these were generated organically during an unrelated reflective activity such a cooking, showering, or being in nature, as compared to intentionally trying to ideate in a formal setting (Currano, 2011). For this reason, the Cultural Probes allow for a spontaneity of ideas and sharing that may otherwise not happen in a controlled and rigid work environment. This subconscious ideation process benefits from remembering thoughts and concepts related to the subject matter in an ad hoc manner while triggered by completely unrelated stimuli from the environment, and then re-combining these remembered fragments into novel ideas and conceptualizations. Further, there may be some information that is inappropriate to discuss in a work setting, or the user might feel embarrassed or stressed to spend valuable time at work providing an interview 31 when there is a growing list of patients waiting for their care. This may lead to a rushed or incomplete interview, where people are not able to relax and think creatively or openly, or they may not want to let their guard down to be as creative and open as they could be if work pressures were not present. A Cultural Probe project is typically implemented using a kit containing several tools that is given to a participant. This kit may often contain a camera for users to share a visual story, a journal or diary to reflect generally on a topic or to answer specific questions triggered by specific events in their day, an audio recording device that may serve as a diary or can sometimes be auto-triggered in the user’s environment by a certain event, or a map of the user’s environment that is annotated depending on the goal of the research. These are some of the more common tools used as Cultural Probes, but there is no limit to what a design team can put together as a data gathering channel, task, activity, or experience. One additional benefit of a Cultural Probe is that it need not rely on the understanding of a specific language (be it a spoken ethnic language or professional jargon), education or ability such as reading or writing, or even the same conception of the world and frame of thought as the user. For these reasons it is valuable when working with users such as children, seniors, those with various impairments or disabilities, or in this case, individuals from across a cultural and socio-economic and professional divide. Cultural Probes are typically used in the beginning stages of a design process when the design team is working to understand the landscape and values of a user group. The results of the Cultural Probes provide clues and inspiration for the design team to begin forming early conceptions about what is needed by the users, and drive initial design directions. The use of Cultural Probes in an African study is not new, and an informative example comes from Kara Pecknold, who used a number of similar probes as used in this thesis, with the goal of helping a women’s collective in Rwanda to design branding for their business. The use of these probes allowed for a democratization of the design process among a group of participants who do not share the same language and lack a shared understanding of technology (Pecknold, 2009). Pecknold concluded that the use of such tools is an effective way to kick off the design process in these underserved and underrepresented communities, and allow designers to sensitize 32 communities for later stages of the design process. In her research, Pecknold received feedback from local research partners and collaborators in Rwanda that the women in the village who participated in this study “quickly connected that this type of research could be a building block for better days ahead” in terms of development of their community. Despite challenges, the Cultural Probes worked well to convey values and meaning between the researcher and the group of participants who did not speak English, most of whom also had little formal education and no experience with such a design process. With regard to the expert user challenge described earlier, Von Hippel describes “sticky information”, which has a high cost to acquire and transfer from the user and use environment to the designer and design environment (Von Hippel, 2005). This information if often the most critical to inform design and innovation, but is the most challenging to acquire from users who share little in common with the designer, be it socially, economically, culturally, or professionally. Cultural Probes in this case are a tool that can help transfer some of the nuanced, latent ideas and needs that exist for the user but are difficult to share. Of course, along with the benefits of the Cultural Probes come some challenges of this approach. The core risks are that the data returned by the users in the form of photos, journal entries, audio recordings, maps, and so on, may not provide a clear direction for analysis, clear emergent themes, or even valuable in-depth reflections depending on the level of engagement of users. It is also a risk, especially when working with user populations from a different cultural background, that they may not adequately understand the purpose and even what to do with the tools. In her Rwanda experiment, Pecknold found that it was necessary to explain that the disposable cameras were not to be used for taking photographs at family members’ weddings, since the resulting photographic data was pivotal to the researcher’s study success. 3.4.2 Study – Mulago Hospital After initial informal observations in-situ in the operating theatre and surrounding environments at Mulago National Referral Hospital, we equipped clinical users there with cameras and journals to document their daily lives and to tell us something from their perspective. In the spirit of Grounded Theory methodology and not wanting to influence the outcome, the instructions were open-ended for users. 33 3.4.2.1 Participants In total, 16 participants were involved in the Cultural Probes exercise, and all reported back their data by handing in the probes at the end of the study period of two weeks. This included 3 attending orthopaedic surgeons, 7 orthopaedic residents, 1 orthopaedic technician, and 5 operating theatre nurses. All participants provided informed consent. For further details on this please see section 3.6 Ethical Considerations. 3.4.2.2 Disposable Cameras Disposable cameras (Fujifilm QuickSnap Flash ISO 400 35mm) were given to each of the participants along with an open-ended set of instructions (s) that asked them simply to tell a story using the available 24 photos of blank film of the camera. The participants were instructed to show something about their lives that might surprise the researcher who reviews the photos, or that might teach something and inform what an engineer – especially one from Canada – should consider when thinking about designing medical technology. It was emphasized that they as participants had a unique view into their own world, and that it would be highly valuable to give a view into their world, through their eyes, to someone who is a foreigner both to Uganda and also to surgical practice. These cameras were collected at the end of the research period and the film developed in Canada. The photos were then included as data inputs for coding into the Grounded Theory methodology. 3.4.2.3 Journals Participants were also given smal journals to carry around for 14 days. Each page of the journal was populated with two questions per day, and these are available in 34 Appendix B – Journal Questions. Every day the first question on each page was either “What was the most difficult technology interaction today?” or “What was the most challenging part of your day today?” These two questions alternated each day. There was also one additional question every day that was different each day. These are some examples of the questions that changed from day to day: 1. What is an example of a technology that is designed/made outside of Uganda and is not appropriate for use here at Mulago Hospital? 2. How can technology provide value for you in your work? 3. What do you think I should know about your life that would be surprising to me as a Canadian? 4. What aspect or step in surgery takes longer than it should? Participants were asked to fill these out each day for two weeks and to do so in a relaxed setting such as at home, with the intention to follow Currano’s approach of reflection-out-of-action discussed previously. These journals were then returned to the researcher at the end of the time period, who then transcribed the content into a digital format and used the Grounded Theory methodology to analyze, code, and find meaning across this data set. 3.5 Quantitative Design Methods: Outcome-Driven Innovation 3.5.1 Background Outcome-Driven Innovation (ODI) is a process developed by Anthony W. Ulwick, and is now used by the consulting firm Strategyn with Fortune 500 companies across the world (Ulwick, 2002). The process, also known as Jobs-to-be-Done, focuses on what the user is attempting to accomplish, assigns a metric to the goals, and helps designers create solutions that specifically address these goals and are measurable in their value. One of the core reasons Ulwick states that led him to develop the ODI process is that many innovation processes to date are flawed, or simply do not work. Many companies adhere to an “ideas-first” innovation process that includes activities like brainstorming or idea generation, 35 where ideas are created in high volume, and are then assessed for whether they fit the user’s or customer’s needs. He argues that statistically the chance of identifying a winning solution is low, even though the thinking behind brainstorming is to come up with as many ideas as possible. Given that a market typically has between 50-150 unmet needs, according to Ulwick, with the majority of those not being obvious to designers untrained in that market or use context, it is unlikely that designers who approach innovation from an ideas-first approach will have an easy route to success when relying solely on design intuition and creativity (Ulwick, 2010). Similarly, the alternative approach of “needs-first” is structurally flawed. according to Ulwick. While a needs-first approach seems logically superior, it also fails for several reasons. The first of these is the lack of agreement in the design industry about how to even define a need. Secondly, it is difficult for designers to uncover a complete set of needs simply through ethnographic approaches, as many needs may be latent and challenging for a user to verbalize or a designer to see. In contract to the ideas-first or the needs-first approaches, ODI uses “the job” as the unit of analysis. This is because, as is the theory behind ODI, a user or customer buys a product or service so that they can accomplish a particular job. Ulwick defines a job as “fundamental goal customers are trying to accomplish or problem they are trying to solve in a given situation.” These jobs are then further quantified by metrics and assessed for how good of an opportunity they are based on importance and current satisfaction levels with existing solutions. The process begins with the users breaking down a particular process into steps. For demonstrative purposes, the example below considers the process in question to be an orthopaedic surgical procedure. This, along with the following steps, are shown visually in Figure 2 below. 36 Figure 2 - The ODI process visualized (Ulwick, 2002) Typically an activity or process can be broken down to about 8-15 distinct steps for the purpose of an ODI analysis. These are high level steps that may require different tools, actions, environments, or even stakeholders to be present, thus making each distinct from the next. These steps are what ODI refers to as jobs. In the current example of orthopaedic surgery, the jobs can be things like intubating the patient, inserting an arterial line, applying a tourniquet, and so on. Once a process is broken down into high-level steps, or jobs, each job is then further broken down into 8-15 outcomes that are desired. The user is asked to describe what makes that particular job or step work out most effectively by using statements starting with the words “minimize” or “increase” followed by a specific attribute or outcome. In this example, two key outcomes the user is striving for while applying a tourniquet to a limb before surgery are to minimize blood loss, but also to minimize damage to the patient’s soft tissue. As shown here, the two outcomes can sometimes be in tension, since the tourniquet must be applied tightly enough to not allow any bleeding, but not so tight as to damage the neurovascular tissue or muscle at the point where the tourniquet is applied. Given about 8-15 jobs and 8-15 desired outcomes per job, a typical ODI analysis for a particular process can end up with around 150 potential opportunities identified for innovating and resolving a user’s needs. 37 The outcomes that are identified are then quantified in terms of how important each one is, and how well satisfied the user is with the current ability to achieve that outcome, which may be dependent on the current state of available technology, abilities, or other factors. Finally, an Opportunity score is calculated for each of the outcomes using the formula: Opportunity = Importance + max (Importance – Satisfaction, 0) Note that the higher the imbalance between Importance and Satisfaction, the higher the Opportunity score. Note also that, since Importance is always positive, the Opportunity score is always positive. These desired outcomes with scores for Importance and Satisfaction can be plotted on an Opportunity Landscape as in Figure 3. This landscape can be broken down into three critical zones: Appropriately Served, Underserved, and Overserved. Each of the 150 or so outcomes that belong to specific jobs in the process lies somewhere within these three zones, each one presenting an opportunity for innovation. The visualization allows designers to easily see which opportunities to focus on, with potential for disruption and significant gains, and which to ignore. When an opportunity falls within the Appropriately Served zone, the existing technologies and solutions for doing that job with the desired outcomes generally exist, and so there is no need or no room for further improvement, and design resources may not be used efficiently if a designer chose to focus here. On the other hand, when an opportunity lies in the Underserved or Overserved zone, these are ones to be pursued. An opportunity in the Underserved zone will have an Opportunity Score of 10, 12, or even 15 and above, making these outcomes of a particular job both very important and also severely unsatisfied in how well or easily they are achieved. Clearly in such a case there is a gap in available technology, systems, products, or services to allow users to achieve one of their most critical goals. However, there is also significant opportunity on the Overserved side. While the Opportunity Score may not be a high number given Ulwick’s formula, an opportunity that is of low importance but highly satisfied is also one that warrants a designer’s attention. In these cases, the existing state of the art technology and available solutions, products, or services may simply be over-built or over-designed for the given need, and as such as likely over-priced and unnecessary. Here, a job that a user doesn’t see as being too important has a plethora of available solutions that lead to the minimization or increasing of a particular outcome 38 that doesn’t really matter so much. A designer’s focus here can lead to significant disruption to existing technologies and systems, and to entire ecosystems of practice. This aligns well with the concept of frugal innovation, where such an innovation can often achieve a dramatic and radical reduction in price of up to 90%, while still retaining 70% of the function of a technology. This is often due to feature creep of a device, and the design for a market that can afford more and more outputs of the device that may not really be necessary to achieving the most critical jobs for the user. Thus, when designing for resource-constrained settings as in this research, a designer must have a sharp focus on opportunities that are currently underserved, but even more so on those that are overserved for the most basic and critical needs of those with limited resources that they may apply towards such a solution. Figure 3 - The Opportunity Landscape using Outcome-Driven Innovation (Ulwick, 2002) 3.5.2 Study – Mulago Hospital 39 The ODI portion of this research was conducted at Mulago National Referral Hospital in Kampala, Uganda with the same group of participants as the Cultural Probes exercise. Participants were paired off and the first step of identifying jobs and outcomes took place over the period of about one week. Each pair participated in an ODI workshop together that lasted approximately 2 hours. On a large flipchart paper, the participants used Post-it notes to identify each of the steps for a femoral intramedullary nailing procedure. This is a common procedure for fixation of a longbone fracture, where a metallic rod, or nail, is inserted down the intramedullary (IM) canal (i.e. down the middle of the bone). Before inserting the IM nail, the IM canal is reamed out using a power or manual drill in order for the canal to accommodate the nail. After insertion, the IM nail is then held in place with locking screws that are inserted transversely. Figure 4 below shows an implanted IM nail in the tibia. Figure 4 - Fracture fixation using plate and screws vs. intramedullary (IM) nailing (Adam Images, 2018) Figure 5 below shows a participant using yellow Post-its to list out the steps in chronological order from when the patient arrives into the operating theatre to when they leave. These steps of the procedure are the jobs that the user is trying to accomplish during that case. The participant then 40 used blue Post-its to go back and reflect on what characteristics or outcomes they are trying to minimize or increase in order to perform the job as best as possible in their view. Figure 5 - Participant working on ODI process In order to allow greater focus on orthopaedic-specific opportunities for innovation, and partly due to time constraints, participants were instructed to focus only on the jobs in the process that were unique to orthopaedics or to this particular procedure. This means they would ignore more common jobs that would be part of any surgical procedure, such as transferring the patient to the operating theatre, administering anaesthesia, or suturing the surgical site closed at the end. All of these workshops were video and audio recorded. After all of the workshops were complete, the outputs were digitized and turned into a survey that is available in Appendix C – ODI Survey. This survey lists the jobs and outcomes that the participants had come up with in aggregate. The survey was printed out and given back to the participants, who were then asked to rank each of the outcomes of each job in terms of importance and satisfaction. A number of open-ended qualitative questions were also included to probe further at what caused a challenge during specific steps. 41 Once returned and compiled, these surveys resulted in 106 outcomes, which point to 106 opportunities for design and innovation. These were analyzed, with an Opportunity Score calculated for each. 3.6 Ethical Considerations 3.6.1 Risks and Benefits to Subjects There is no risk involved for participants involved in this study. Participants were only be observed to determine how technology is currently used and could best assist them, and were interviewed on their experience in the practice of surgery. Benefits to participants may include a rewarding feeling knowing they are contributing to the improvement of medical capacity in low-resource settings. Participants may also learn new ways of thinking creatively, which could benefit them in their personal and professional lives. The benefits to society more broadly include the advancement of knowledge in the field of medical device design that can improve the way engineering, designers, and manufacturers of medical technology approach innovating for underserved or low-resource communities. 3.6.2 Compensation and Reimbursement There was no cost requirement for participants in this study. There was also no compensation for participants. In some instances, lunch was provided for participants in an interview or focus group discussion. 3.6.3 Informed Consent Consent forms were provided for the surgical staff that are interviewed and observed. Participants were informed that consent is completely voluntary, and any person not wishing to take part had that decision respected. No notes were taken or observations made about those individuals. Consent forms were maintained in a locked cabinet upon return to Canada, and were kept in a locked room during the study in Uganda. 42 Patients were not asked to give consent due to the nature of the study. Firstly, this study did in no way collect information or make any observations about the patients. We are strictly interested in the interactions of medical users and technology. Secondly, because of the urgent and sometimes unpredictable nature of trauma, it is not known whether patients will be conscious at the time of consent. Lastly, since the patient is already suffering from a potentially overwhelming injury, by not approaching them and not bringing them into the study, this removes an additional amount of stress and discomfort on their part. 3.6.4 Confidentiality Assurances There were no identifying or sensitive information gathered about any of the participants throughout this study. All digital data were kept in a password-protected folder on the investigators’ computers. Paper data was kept in a locked room during the study in Uganda, and were subsequently kept in a locked cabinet and access-restricted room once returned to the University of British Columbia. Only the investigators listed in this application have access to the data, and all data will be digitally erased or physically destroyed after the study concludes. 3.6.5 Conflict of Interest There were no expected or known conflicts of interest in this study. 3.6.6 Collaborative Agreements Ethics approval from the University of British Columbia was granted as well as approval by Makerere University and Mulago Hospital Research Ethics Committee. 43 4 Results 4.1 Results of Cultural Probes 4.1.1 Structure of This Section The Cultural Probes identified a number of categories and themes. The core categories that have become apparent in the data relate to Technology, System, and People. Each of these categories and their sub-categories give rise to a number of themes such as Frustration, Patient Outcomes, Delays, the Information Environment, and others. As this chapter progresses, more and more evidence builds to describe and strengthen these and other themes, which are finally presented at the end of the Cultural Probes results section in summary form. 4.1.2 Validation of the Method and Analysis The data was co-coded by the author and an assistant who analyzed 25% of the data to confirm the findings. This was also done using the NVivo software (QSR International, Doncaster, Australia). The primary author provided a pared down list of approximately 30 codes that were the most prominent from the first few rounds of coding, and the assistant was asked to code 5 of the journals using this list, and to add to the codes list if it was warranted. After analysis and comparison of agreement between the two coders using NVivo, an agreement score of 94.9% was found, and a Kappa coefficient of 0.63. This Kappa score falls within the range that indicates substantial agreement (Banerjee, 1999). 4.1.3 Technology Challenges A series of technology challenges were highlighted a number of times throughout the data and across most of the participants. 44 4.1.3.1 Imaging One of the most critical technologies identified by nearly every participant is the need for imaging. This includes a number of modalities such as x-ray, intra-operative fluoroscopy or a C-arm, magnetic resonance imaging (MRI), and computed tomography (CT) scans. In orthopaedic surgery having access to imaging before, during, and after the surgery is critical. Before surgery, x-ray is commonly used to understand the fracture pattern and plan for the surgical approach to fixation. During surgery, intraoperative x-ray or fluoroscopy with a C-arm device is used to continuously check alignment and fixation throughout the procedure as the surgeon implants and secures various screws, plates, intramedullary (IM) nails, or pins. Following the case, the patient is monitored and the desired fixation outcome is confirmed with x-ray. Figure 6 - X-ray displayed in a window rather than a light box While x-ray is available before and after a case, the majority of participants mentioned the lack of intraoperative fluoroscopy. There are a number of reasons that imaging may not be available when needed. The main cause was simply that there was no machine in many operating theatres, as was described by all of the surgeons, residents, and orthopaedic nurses in the Cultural Probes data. Unfortunately, even when technology is available, as there is one C-arm for the department, the device itself may not be accessible to the correct users at the right time. This can be due to people not being familiar with how to use or repair the device, as in “the C-arm in Ward 7 theatre. It’s not appropriate for use here because there is no skilled person to operate it, [and thus] no 45 maintenance work or check can be made. This is an old type of machine which even our technicians are not conversant with” (P10). In the case of another machine, it may not be in a language that the users understand. A donated C-arm described by one nurse had manuals, instructions, and an operating system “written in Dutch … [and] … if there is any problem there is no one to read and understand what it means” (P8). Figure 7 - Faulty C-arm Human errors and systemic inefficiencies caused by lacking or unclear responsibility lead to other headaches with these machines. One participant described that “since we went for a weekend, there was no one to have the C-arm out to charge ready for use on Monday… hence this affected the images it produced” (P4). In some cases, the patients cannot afford or access the pre-surgical x-rays or other required diagnostic tests, and so it is not always available to the patients’ and clinicians’ benefit and may even prevent patients from pursuing surgical treatment. As described by one surgeon, “some of my patients who needed MRI scan had to travel a long distance to a private facility to get it done and this delayed timely investigation. The high cost also means some patients simply cannot afford it.” (P1). The lack of imaging has a number of frustrating and challenging effects on efficiency, clinicians, and patients. These affect the richness of the information environment that the surgeon is able to 46 perform his or her work in, the timeliness with which the surgery can be completed, the potential impact on patient outcomes, and results in improvisations that the clinicians are forced to undertake. 4.1.3.1.1 Theme: Information Environment The severity of the issue of lacking imaging brought to light an interesting theme with regards to the clinicians’ information environment. As will be described later in this Results section, this concept is not limited to just imaging of patients’ anatomy before, during, and after surgery. Indeed, for orthopaedic surgeons the information environment created and facilitated by imaging technology is some of the most critical to their work. With regards to information availability and richness of the environment, the accurate placement of implants is of prime concern, with the implantation of an IM nail being one of the foremost challenges faced by surgeons. Once the nail is inserted down the length of the IM canal, one or more perpendicular inter-locking screws are placed that secure the distal end of the implant to prevent axial rotation or sliding. A number of participants repeatedly indicated that “the most difficult technology interaction was locking [the] distal screw for intramedullary nailing of a fractured femur. It was not easy to locate the hole into the nail itself so if we had C-arm machine it would have been easy to locate the holes” (P16 specifically quoted here but mentioned by P1, 6, 10, 11, 14, 15 and others). In various conversations, participants described that it was not uncommon for the inter-locking screws to miss the locking slot in the IM nail, and be inserted by accident to the side of the IM nail, resting between the cortex of the bone shaft and the exterior of the IM nail within it. Even with mechanical guides, “many times surgeons miss the space where the screws pass despite the fact that there is a jig” (P15). This was reported to cause significant pain for the patient, and is only discovered days later once post-op x-rays are taken, and then requires revision surgery that brings further burden to the system and increased infection risk to the patient. Another concern has to do with the accurate alignment of the fracture reduction. One surgeon described having “two patients who sustained cervical spine injury and are put in traction. However, I was unable to get a mobile x-ray device for them so that I can monitor the progress. I 47 simply had to wait for a few days [for post-op images] and hope that the fracture had achieved the desired results” (P1). Without imaging facilities available, surgeons cannot verify the results and accuracy of the surgery in real-time, requiring them to wait until after surgery to check whether alignment of the bone and positioning of implants is correct. 4.1.3.1.2 Theme: Delays The delays caused when working without the guidance provided by imaging technology lead to longer time that the patient waits both on the ward and on the operating table. It was described as a common occurrence to find “over-crowding of patients on wards and other complications due to overstaying on ward” (P16). The longer the patient is left on the ward, especially with a traumatic open wound, the much higher the risk of infection. “Such problem is always very bad because it delays the patient who should go home quickly and patient with small wound if they delay will get hospital infections which delay their healing. Putting patients together for a long time can cause infection from one patient to another. Patients should not be waiting for so long especially those who have had accidents and compound fracture” (P7). This same clinician then stated that this issue creates a cascading effect as “the bed will also be full for incoming patients, new patients, which let the issues of congestion on the ward and controlling them become difficult and management is not done well” (P7). The increased patient load on the hospital was directly linked to this lacking technology, with one participant stating that “if we had C-arm machine it would have been easy to locate the holes. That would have saved time because of such delays in surgery limits time for other patients to be worked on and at the end of the day some of the patients are not worked on or operated” (P16). Another participant mentioned that “such struggles in the attempts [to lock the IM nail] consumes much time, which is a burden to the patient on the table or the patients waiting from the ward as this can lend to other cases being postponed yet they were meant for this particular day. The only way to minimise such occurrence is by using a well-functioning C-arm” (P4). 48 While the hospital was already significantly under resourced to manage the vast number of cases that presented each day, these imaging-related delays meant that many patients were bumped from one day’s theatre list to the next. 4.1.3.1.3 Theme: Patient Outcomes The lack of imaging adds not only to the burden of time delays and also increased surgical risks to the patient. One significant risk to the patient has already been mentioned, where the implants – such as a locking screw for the IM nail – may be placed incorrectly in the anatomy, leading to painful outcomes and the requirement for revision surgery. The patient is also exposed to a higher infection risk due to the length of time of surgery. “Intramedullary nailing of the femur takes longer because we do not use the image intensifier but rather employ the open approach. This will eventually need addition of time for skin closure” (P10). Different, and often riskier, surgical methods are employed in order to compensate for the lack of imaging technology. “Technology can guide me in the type of surgery I do, i.e. options taken. With the use of an image intensifier I can make minimal incisions on skin [only at the end of the bone for the IM canal access point] and insert an intramedullary nail, rather than making a huge incision to see the nail going in [the different fracture fragments] at the fracture site” (P10). 4.1.3.1.4 Theme: User Improvisation Without available imaging machines, clinicians use their best judgement to try to achieve accurate results. This can include using a second similar implant and laying it externally on the patient’s body to estimate approximately where the locking holes are. This is not only inefficient but it means unwrapping multiple sterile implants so they can use one for reference. This adds to delays if other patients require that implant, and results in additional burden on the sterilization infrastructure to then re-process that implant. “Today I chose to use an AO nailing system for a fractured femur. This was difficult because the locking system does not allow for distal locking. It's designed to be used under imaging and yet the C-arm was not charged the previous night. So 49 we didn’t have any imaging and had to use a nail of similar length to estimate where the distal slot was” (P10). Clinicians are forced to improvise and have to rely on their clinical expertise as well as knowledge of human anatomy for reference points as they operate. “Lack of fluoroscopy to aid my instrumentation most times one had to rely on the knowledge of anatomy and experience which may come with lots of shortcomings” (P14). This can be an issue since “not all humans are perfect, many persons have variable anatomy from the normal and as a clinician you need… to ensure you deliver efficiently with effectiveness.” (P14). While these decisions require intimate knowledge of the anatomy and extensive experience as a surgeon to make certain decisions without all the required information, the unfortunate irony is that the clinicians who are most often forced to make such decisions and operate on incomplete information are in fact the residents with the least experience. These “surgeons find it difficult to exactly locate the space where the screw will pass, especially junior surgeons.” (P15) 4.1.3.2 Traction table A major and recurring issue that surfaced in the data was the reference to a lack of a traction table or fracture table, which is an operating room patient table with specific, built-in limb positioning aids. These limb positioners are critical to hold a limb that is being operated on in a particular position throughout the procedure. The limb positioners can also be used to apply traction to that limb throughout the intervention. The traction table can, for example, include a boot for the patient’s foot. The boot is then pulled along a rail that is attached to the table, while a padded perineal post is placed at the perineum in order to apply traction to the leg. 4.1.3.2.1 Theme: Inefficiencies in Workflow and Staff Issues A common difficulty reported is “fracture reduction at surgery because of lack of fracture tables… in the government hospitals” (P9). Lack of a traction table makes for difficult manual labour or wasting of human resources by making people act as a limb positioner or traction device. Sometimes the surgeon even has to do this, which is very basic manual labour for a highly trained person. “We… rely on human muscle power to apply traction and to hold the fracture fragments in place as we reduce the fractures” (P6). 50 Figure 8 - Broken traction table Figure 9 - Resident maintaining limb position due to lacking traction table 4.1.3.2.2 Theme: Delays The application of traction during surgery is complicated further because “often times the fractures are old (over a month) and there is associated shortening of the muscles because patients were not put on proper skin or skeletal traction” (P6) while on ward. While some patients wait with “improper positioning [on] the ward” (P4) for many on average about 4 weeks (O'Hara, 2016), others do not present with the fracture until weeks or months after the injury, instead, for example “seeking help from a traditional bone setter. The setter was with a mind that the boy was being 51 bewitched. So they delayed to seek professional health care yet if they had done it before, maybe something would be done earlier” (P13). “By the time such patients reach the hospital theatre, their muscles are contracted hence requiring all of man power to apply traction so that the fracture is well aligned” (P4). 4.1.3.3 Power tools Another common technology challenge brought up repeatedly is access to functioning, efficient, and safe power tools. Drills are used in orthopaedics for a number of tasks such as drilling holes in the bone, inserting screws, or reaming the IM canal before inserting a nail. Saws are also used for amputations, osteotomies, and in arthroplasty procedures such as knee and hip replacements. Surgical power drills can be prohibitively expensive however, and even when they are available through donations or the purchase of lower quality or used surgical drills, these present numerous challenges. “In casualty theatre we have 2 [surgical] drill machines. One is as good as dead. So we use one that is also very hard to use… [because the manual drills were unusable] we had to use the other "dead" drill and man, to make a hole in the bone, took out all the energy we had” (P13). Because of these challenges with cost and maintenance of surgical drills, the use of hardware or industrial drills is common. However, unlike the surgical drills, ordinary hardware store drills cannot be sterilized due to the materials of construction and the exposed electronics. “We recently acquired a battery powered industrial drill. This helps to simplify work however we had trouble keeping it sterile as it is not autoclavable” (P6). 52 Figure 10 - Dysfunctional battery charging stations from various donated surgical power drills 4.1.3.3.1 Themes: Frustration, Inefficiencies, and Delays When power drills are not available, some surgeons resort to using manual hand-crank drills, but these come with their own challenges. “[Manual drills] are quite easy to handle and use. They do not require skilled expertise as compared to the power drills. However, they are quite tiresome because they are rusty and often don't revolve spontaneously” (P10). Other participants agreed that use of manual drills “can be both energy and time consuming as the drills are worn out. The ball bearing have fallen out of the gear wheels” (P6). The manual drill to many was used reluctantly as a last resort, with one participant stating that “a power drill makes the work easy but sometimes we have to make do with manual drill because there are very few [power drills] and sometimes they run out of power” (P1). Another participant described going through several options before frustratingly falling back on the manual drill. “The most difficult technology interaction today was having a faulty battery to be used on a drill. Initially we were using a hose drill with nitrogen gas but before we ended the procedure, the gas was used up and the battery drill was brought as an alternative. After failing with the two interventions, we opted to use a manual drill and by the time the procedure ended no one was proposing to go in for another procedure as everyone was exhausted” (P4). The low quality and difficult manual drills can cause other unintended breakdowns and inefficiencies during surgery, such as causing drill bits to break due to the force required to drill 53 through dense bone with manual tools. “We resorted to using the manual drill, the gear system was often getting stuck and drilling was very difficult, the operation took longer than expected… We ended up breaking three drill bits into the patients forearm. Generally frustrating” (P14). It is clear that the surgeon experienced significant frustration during the operation. While the drilling and sawing of bone is critical for orthopaedic surgery, it is clear that clinicians are forced to deal with a myriad of insufficient solutions, and this causes not only delays in the system but also a clear frustration on the morale of the surgical team. These recurring themes of surgeon frustration, inefficiencies, and delays are all highly interlinked and discussed in later sections. 4.1.3.3.2 Theme: Improvisation The power drill challenges faced by users lead into the theme of Improvisation by clinicians who have to make do with the resources available to them and employ ingenious alternate hacks and solutions. This is described by participants in the way they make a non-sterilizable power drill safe and quasi-sterile for use in surgery. “One of us brought a drill [intended] for builders… one person who is not sterile helps make drill holes [while] others insert [sterile implants]” (P13). This practice was often seen during the research trip where a non-sterile clinician would hold the drill while sterile clinicians wearing masks, gloves, and gowns would carefully insert the sterile drill bit into the non-sterile drill. Others described using a surgical glove over top of the non-sterile battery of a power drill to try to reduce infection risk to the patient. “The most difficult technology interaction today was the gloving of an unsterile battery onto a sterile drill to be used in a procedure. This attempt of qualifying the unsterile battery to be used with other sterile equipment requires patience, knowledge, skill with a high degree of time keeping. Otherwise if little or no care is observed, there are high chances of contamination” (P4). 4.1.3.4 Implants Another challenge identified by all participants is access and availability of implants. These include screws and plates, external fixators, hip and knee prosthetics, and IM nails, among others. 54 These are used to fixate a bone fracture by holding different fragments together in the correct alignment as the bone heals over time, and also to provide rigidity that can share the load applied to the bone as the patient starts to regain mobility. Often there are no implants at all, or perhaps not the correct ones. Sometimes though, donated implant sets are incomplete. “I had a number of patients admitted with spinal trauma who need stabilization with pedicle screws and nuts. However, one patient was not operated because of shortage of implants. A few pedicle screws donated are available without nuts. Indeed, the last nuts were used today on patients and the remaining patients in the ward do not have any means of getting implants needed for their surgery” (P1). When the implants run out, it is not clear when and how new implants will arrive for other patients. “There are very many patients who were admitted on ward for booking for total hip replacement, yet we only have two Austin Moores [implants] in the store. It was a challenge because in my practice I don't want to keep many patients on ward, yet I am not sure when the implants would be supplied, and we work on them” (P15). 4.1.3.4.1 Theme: Improvisation, Patient Outcomes, and Delays When implants are unavailable, surgeons often make compromises and improvisations, sometimes at the detriment of patients. “The most challenging work today was opening a dislocated hip prosthesis. The head of the prosthesis was small, but we failed to get [a] prosthesis which could fit well. Finally, we put the one with the bigger head because we could not leave the patient to go out of theatre without any. In such cases we weigh the problems of leaving the patient without any prosthesis and the problems of giving a bigger prosthesis, but ideally we need to fix a fitting prosthesis for better results” (P15). Other cases also required the use of implants that are not perfectly suited to the task. “We had to use the IM nail to immobilise all the bone fragments. Ideally supracondylar fractures are fixed with plates but here plates were not going to be used with an IM nail. We finally fixed all the fragments and there was no discrepancy, though it took us a long time” (P15). 55 While less extreme, compromises are also often made with screws that are used. “We didn't have the right length screws so we had to cut the screws” (P11), a practice which could increase the risk of corrosion, depending on material properties of the screws. The lack and mismatch of available implants can cause delays, both to the patient who is on the table, but also to the system overall when the team is not organized well and it requires them to needlessly open several sterile packs to find the right implants. “Sometimes improper choice of implants causes delays as trials are done and alternatives made” (P4). “It took us a long time than expected opening up different sets and nails so that we can get right tibia nail. It was due to poor preparation of the patients pre-operatively” (P16). Figure 11 - Poor organization and care for implants mid-surgery 4.1.3.5 Diathermy Diathermy, also called electrocautery, is a technique with which several participants faced challenges. An electrocautery machine is a valued piece of equipment that uses an electrical current to seal blood vessels. 56 Figure 12 - Faulty diathermy machine 4.1.3.5.1 Theme: Patient Outcomes For many surgeons, diathermy is a critical piece of technology for keeping patients from bleeding out during surgery. “My favourite medical technology I use is diathermy. This is extremely useful in minimizing bleeding. Most of my patients sustained trauma and already present with low blood. To avoid unnecessary blood transfusion the use of diathermy is very important” (P1). 4.1.3.5.2 Theme: Flexibility The data identified an interesting theme of Flexibility as something that clinicians value in their practice, and in the technology they use. In particular, diathermy was described as being of high value because “diathermy use is applicable in most body parts unlike tourniquet which is used mainly on limbs” (P4). Moreover, this theme extends to the idea of allowing clinicians to maximize the resources available to them and to allow them to leverage technology in their favour despite the myriad challenges faced in their operating environment. One such example is that diathermy allows for safely prolonging the surgery, as “there is no time limitation in the use unlike tourniquet that needs maximum speed during surgery (1 hour to 1.5 hours). In case the most surgery is to run for more hours, tourniquet use is inappropriate and this calls for diathermy use” (P4). As has been shown previously, there are a number of different causes for delays across the clinical system and especially during the surgery itself. For this reason, diathermy allows surgeons to mitigate the fact 57 that delays are inevitable and safely extend the surgery time and complete the case safely despite all of the challenges. 4.1.3.5.3 Theme: Information Environment Diathermy as a technology also contributes to the theme of Information Environment. “[The] lack of diathermy machine [was] making surgery bloody” (P2), and thus makes operating difficult for the clinician who needs to have a clear view into the surgical field as they dissect, suture, and perform other critical tasks mid surgery. “Once the surgery began and bleeding started, I needed to coagulate the bleeding vessels, but the diathermy failed to work. I then had to resort to using suture to ligate vessels and mop away excess blood” (P10). 4.1.3.6 Suction Another technology often highlighted by clinicians was the availability of a suction device. These can be electrical or manual powered and are used for removing fluids and gases from the operating field to increase visibility (Theme: Information Environment), or to reduce surgical risks to the patient such as aspiration or inhalation of a foreign body before or during surgery while under anaesthesia. “If there is inhalation which is not detected very fast and if there is poor suction machine, by this inhalation it means either the patient did not follow the pre-op advice or he has not been prepared properly” (P8). This is common as was described by another participant also. Patient had an aspiration pneumonia but I had very poor manual foot suction machine that could not delivery adequate suction” (P14). Unfortunately, as with other technologies, in some cases the breakdown of the device is often not known until it is too late. “The vacuum suction was not working… [and we] only realized it mid surgery” (P9). This can add to the delays experienced and also add to risks the patient faces mid-surgery. It is likely caused by technologies that are not repaired with sufficient frequency, either due to the lacking spare parts, the lacking biomedical engineering capacity, or poor planning and inefficiencies in the maintenance scheduling. 58 Figure 13 - Faulty suction machines The themes that this technology contribute to include Information Environment, Delays, risks to Patient Outcomes, and Frustration among the surgical team. 4.1.3.7 Infrastructure 4.1.3.7.1 Oxygen Oxygen is critical to the safe delivery of anaesthesia, as well as many other surgical functions, however it is not always easily available. On several days “surgery was supposed to be postponed today due to lack of wall oxygen” (P5), which is the centralized supply within the building that comes from the hospital’s oxygen plant. Other times, the oxygen is brought in from a vendor in cylinders, but this is not reliable either. “There was not enough oxygen to operate in all my patients. Here oxygen is delivered by cylinders and sometimes runs out. The cylinders are brought all the way from Nairobi, Kenya” (P1). The lack of oxygen contributes to a number of the identified themes, including delays and frustration for the working staff, and has an impact on the patients being treated with timely and safe surgery. “There [are] a lot of patients waiting and… when oxygen is not there it makes work very difficult because you cannot put patients under general anesthesia, [and] you definitely will have no oxygen support for your patient. At least oxygen should be constant so as to avoid patient suffering, yet they have right to treatment” (P7). 59 Figure 14 - Oxygen tank empty 4.1.3.7.2 Power Similar to the lack of oxygen, the intermittent availability of electricity and power made it difficult for surgery to take place. On many days and across different theatres the participants reported that they “had all the operating lights off. It made it very difficult to see inside the operated part” (P8). 4.1.3.7.3 Water Another common cause for delays that was seen across participants was the intermittent access to running water, which affects the ability to prepare both the equipment and the clinicians for surgery. “Today I had 3 patients on my theatre list. I did 2 and 1 missed surgery. Part of the reason was because time was over and also there was no running water. Today we scrub for surgery using water from a container as running tap was off” (P1). 60 Figure 15 - Scrub sink, no running water this day 4.1.3.7.4 Sterilization Aseptic technique, the careful practice of reducing any contamination to the sterile field, is critical to performing modern surgery and preventing infection in the patient. However, there are a number of challenges that affect the ability of the hospital team to re-process and sterilize equipment before surgery. These include the aforementioned issues with electricity and water availability, but the machines themselves were observed to be old and experiencing frequent breakdowns. Staff reported having to traverse the hospital campus to use a sterilizer located a 15-minute walk at the bottom of the Mulago hospital hill, “moving from one place to another looking for [a working] sterilizer that makes work delay and time wasted” (P7). 61 Figure 16 - Faulty sterilizer due to broken door gasket that is out of production This often was the case without any warning, adding to the frustration experienced and the delays to the patient list. One participant “woke up and went to hospital like any other normal day. Getting to spinal ward I was told we were not going to operate today because there were no sterile instruments as the autoclave (main one in the hospital) was down and not working” (P13). As the machines came back online after weeks of breakdown, hospital departments then had to compete for access to the machine. “The central sterilizing machine was eventually repaired after two weeks of breakdown. Since we had a back log of patients in the hospital wards, each theatre was struggling to sterilize their equipment to use during operations and yet the theatre lists also became so long. Sterilizing and working at the same time was a challenge because of shortage of instruments and yet you had to wait for some time as they sterilize for other theatres too. This cause a bit of delay between cases” (P5). In addition to the autoclaves, standard washing machines are used for reprocessing certain linens and scrubs, and these too posed a challenge. “The washing machine broke down therefore we has no clothes for wrapping drapes for surgery” (P16). 4.1.3.8 Bringing it all together While these technology challenges are each uniquely frustrating for users, each technologically related problem that a user encounters is highly related as medical devices are often interdependent 62 in their function. A clear example of this is described by P6 when asked to describe some of the technology challenges experienced that day: “Locking of the nails. Especially locking at the distal slots. This is because we don't have accurate target arms for to estimate the location of the slot in the nail. The lack of power tools to simply reaming and drilling of bone. The lack of fracture table for proper positioning of the patient and for flexibility while maneuvering the image intensifier around the patient while ensuring sterility. The lack of radio-lucent operation table. This complicates work with the image intensifier.” The delays, frustrations, and safety issues posed by a single technology can be significant; however, when combined, the different technology challenges faced at Mulago Hospital amplify the impact to the patients, workflow, burden on the hospital system, and the clinical team’s morale. 4.1.3.9 Appropriate Technology Two of the major discussion points across most questions in the journals had to do with either technology challenges the participants faced, as described in previous sections, or with what they value in technology and what they see as being appropriate technology. 4.1.3.9.1 Ease of Use and Efficiency Across participants it was common for them to describe ease of use of the product, and a gain in efficiency provided by the technology. “Technology that I am comfortable with in using it, knowledgeable about its mode of operation. Efficiency… automated one switch button without complexity in its use. [It should be] portable, not very cumbersome, efficient in the context that one does not have to spend a lot of energy A medical equipment should be easy to be used by any person” (P14). Another participant desired to have technology provide “better time utilization, less energy expended” (P9). 63 4.1.3.9.2 Increased Safety Improvements in efficiency and time saved was often linked with the safety results of such time savings. “Technology can provide good quality outcomes in especially reconstruction surgery. Reduced operating time reduces chances of wound infection due to prolonged wound exposure. Good technology reduces the surgical accidents” (P14). Indeed, for several participants, a large component of their definition of appropriate technology had to do with the technology affording “safety for the patient and surgeon” (P14), as well as giving “confidence in perioperative and post-operative outcomes” (P9). 4.1.3.9.3 Reliability, Durability, Repairability “Reliability, durability” (P14) and the ability to repair the product made the technology appropriate in the eyes of the participants as well. This ability to repair was based on both the availability of spare parts, and the availability of local knowledge, or training, on how to fix equipment. “We need machines with re-usable parts because it is difficult to come by spare parts in Uganda. Once an essential component of a machine breaks down and is difficult to replace, often times the machine is discarded despite other parts being fully functional” (P6). 4.1.3.9.4 Appropriate for Local Context One of the best examples of technologies designed specifically for LMIC and resource-constrained contexts is the SIGN nail. This device is globally seen as a significant aid to surgeons in resource-constrained environments due to its design that relies on a mechanical jig rather than imaging technology to lock the nail in place. This device is designed, manufactured, and distributed by SIGN Fracture Care International (Richland, WA, USA) specifically for use in such environments. The device is quite popular with a number of the participants. “The SIGN nail locking system is my favourite. It quickens the work and allows for distal slot locking. The best part when using it is after you have drilled in your screw hole then you use the step drill to locate the screw slot. The step drill locks and you know that you are in the right slot” (P10). Similarly, P11 described “the 64 SIGN intramedullary nail which is locked without use of c-arm” as a “uniquely appropriate device for Mulago Hospital”. 4.1.3.9.5 Frugal Innovations Not Always Preferred Despite the intended design of the SIGN nail to specifically reduce the need for imaging in order to achieve a successful outcome, many other participants also described the SIGN nail as challenging to use without imaging. “Locking distal end of SIGN nail intramedullary nail. It took long time looking for distal holes so that we can lock it. Therefore, we needed C-arm for easy locking” (P16). Similarly, P4 described their most challenging technology interaction one day being “locating the distal hole in an attempt to lock an intramedullary nail without a C-arm (SIGN nail). Such struggles in the attempts consumes much time which is a burden to the patient on the table or the patients waiting from the ward as this can lead to other cases being postponed yet they were meant for this particular day. The only way to minimise such occurrence is by using a well-functioning C-arm”. This shows that even though the device is well-intentioned and for the most part achieves its design objective, it can still fall short in terms of usability and in helping the maximize efficiency in achieving the user’s clinical goals. Some surgeons however expressed a strong preference for Western brands of surgical implants, even when products were made available to them that were designed specifically for LMIC contexts, and were designated (often by Westerners) as appropriate technology. Surgeons expressed a preference for Synthes (Raynham, Massachusetts, USA) brand implants, despite these costing several thousands of dollars apiece, compared to the SIGN nail, which is available for free. A big part of what they preferred is the flexibility afforded by the device, allowing them to use the instrumentation set and implants for any number of fracture types that may present on a given day. “The Synthes instrumentation for intramedullary nailing. It is easy to assemble since it comprises of a few detachable parts. It is easy to handle since it has a good design. The target arm for locking 65 the nail is very accurate. Its components are durable. It provides several options for locking the IM nails so it can be used for fixing different fracture patterns and fracture locations” (P6) It is clear also that the surgeons valued the improved design of these expensive Western products that were easy to assemble and handle, were highly accurate, and were designed with robustness and reliability. While frugal innovations like the SIGN nail are often thought to be the best for these LMIC settings, the user base still prefers the precision, quality, and flexibility of the products that are also most preferred in the West. 4.1.3.9.6 Flexibility As described in the previous section, flexibility was one of the reasons some users preferred Western products like the Synthes instruments and implants, which allow for a wider variety of procedures to be performed with the same set of equipment. Similarly, flexibility afforded by the technology was indicated by other participants, such as in the case of a skin graft machine that allowed a small piece of skin to be harvested and then applied across a wider area of the body. “The favourite medical technology is the mesher that widens the skin during skin graft. It is a very good machine because first of all helps you to harvest little skin from a patient and you widen it using the machine making work easy for everyone” (P7). This touches on a theme where the technology allows surgeons to stretch their available resources across more patients or to perform more work. This flexibility was also afforded by diathermy technology as described in previous sections, which not only allowed for operating on more diverse areas of the body than just limbs (as compared to tourniquets), but also allowed the user to stretch out the time of the case by not giving an upper limit to how long the bleeding could be stopped (again, as compared to a tourniquet). The flexibility afforded by the device can buy time, reverse mistakes, and allow the clinical team to generally reverse some of the negative effects of the local environment, context, user issues, and errors. 66 4.1.3.9.7 Low Function is Sometimes Most Appropriate For some participants, the definition of appropriate technology was limited by their perceived capacity of the system, their peers, and themselves. Lower quality, less efficient, and less effective devices were often claimed to be more appropriate for the Mulago Hospital environment, which itself is perceived to be of lower quality, efficiency, and effectiveness. “In the casualty theatre, we use manual drills. These are quite easy to handle and use. They do not require skilled expertise as compared to the power drills. However, they are quite tiresome because they are rusty and often don't revolve spontaneously. It's appropriate here because they are cheap and any surgeon or resident can use them” (P10). “There is lots of equipment out there in the world that has been bettered over the years especially in the West. It has eased work and now better outcome is seen using these. For the West and European and American countries, that is appropriate technology. Such technology wouldn't be appropriate in Africa since there are no people equipped to handle it, maintain it, or the cost would make it serve a few people and so is not appropriate for Africa” (P13). Thus, participants’ definition, perception, and perspective on appropriate technology was grounded in their perception of people and place. Modern, high-end technology may not be compatible with the kind of environment they practice in, and with their lived experience. 4.1.3.10 Donations Participants were all asked to reflect in the journals about their perspective and advice when it comes to donations of medical equipment. 4.1.3.10.1 Matching Local Needs The most common theme among the responses had to do with donations actually matching the local needs where the donation is made. “Technology donations can work better if technologists would first come and find out how best their donations are working before they continue supplying them” (P15). Another participant stated that, “I think donations should match the requirement of the hospital and the personnel available to operate it” (P10). 67 At times, even basic requirements were not met, causing frustration among participants, such as the machines coming from the West not being designed for the 240V electrical circuits of Uganda. The donations were described as “very sensitive to power instability and yet power may be unreliable in most of our places [i.e. the Ugandan context]” (P14). 4.1.3.10.2 Donations of Unusable Implants Other issues identified regarding donations had to do with the implant sizing and whether it was a correct fit for the local population. “[Donors and designers should] design sizes which can fit medium-sized Ugandans. For example, we received supracondylar plates in March which were very big compared to the size of medium-sized individuals in Uganda. This means this supply was a waste because it is rare to get a person where they will fit. Generally, most Ugandans are small” (P15). Part of the reason this was believed to be such a problem is that Western donors would typically donate the products that were left over in their inventory and close to expiry, and so the sizes of implants less frequently used in the West were donated, thus leaving Ugandan surgeons with the extremes in size availability. 4.1.3.10.3 Training, Spare Parts, and Serviceability A common theme among participants also had to do with the ability of the recipients to use, repair, and maintain technology that was donated to them. “Technology donations can work better only with basic information about the donation being offered to whoever is to interact with the appliance. Cases of trial and error [when users are guessing how to use the technology correctly] are avoided that can lead to the machine breaking down. Usually knowledge of how to repair and the costs incurred are unbearable” (P4). Training on repairs and availability of spare parts was a specific concern as the service contracts provided by vendors of technology in the West were not accessible and available locally. “Donors should train the technicians on how to carry out maintenance checks and repairs. They should have access to spare parts” (P10). 68 Figure 17 - DIY repair of an operating theatre light Other participants shared frustration at donations that are not well thought out and provide more burden than benefit. “Donating something but not leaving measures in place to keep it working is useless. If this breaks down, then who repairs it. Also, train a few natives who will repair and teach staff how to use these technologies” (P13). “They are good but not sustainable, they are often single use equipment. Some of them when they break down, they are not replaceable due to lack of spare parts. Some of them are used equipment (second hand) and don't come with operation manuals. These donations should come when they are brand new, recyclable, durable operation manuals and less bulky” (P14). Participants appeared frustrated that even basic requirements for appropriate donation were not met, such as an anaesthesia machine that was donated and completely unusable as the instruction manual and operating system functioned only in Dutch. “Our machine written instruction is not in English but it is written in Dutch. It makes it difficult if there is any problem with the machine. There is no one to read and understand what it means” (P8). 4.1.3.10.4 Overall Perception and Message to Donors Despite challenges, participants were clearly appreciative of the intent and benefit that many donated technologies provide in an environment where there is little to no money for procurement. “I think technology donations are good in that there are instances where we cannot afford the price of a particular technology appliance yet with the help of donors, appliances are made accessible” (P4). 69 However, the messaging to donors was also clear that “donors should first acknowledge that what works best at theirs may not work here. They should first understand and appreciate the dynamics of our culture and [environment]. Before they criticize what we are doing they should first appreciate the [conditions] we are working in” (P13). Ultimately, participants also shared their frustrations that donations did not lead to a sustainable solution, and that capacity building at a higher level was preferred so that they could ultimately become self-sufficient in their technology needs and as a whole. "We should be helped to sustain ourselves instead of spoiling us with free donations which in the end are abused" (P9). The ongoing reliance on donations was of concern as it did not build a level of ownership and personal investment among the clinical staff to care for the equipment. 4.1.4 System Besides technology challenges, there are a number of systemic issues that contribute to the same themes of frustration among the staff, delays, and impacts of the patient outcomes and the already overburdened system. 4.1.4.1 Transfer and Management of Equipment The transfer and management of both equipment and patients is often described as significant challenges experienced by participants. Oftentimes it was reported that participants had to travel across the hospital to acquire blood. “Our laboratories are on the third floor so if you need blood you have to leave theatre [and] change to go and get blood for your patient, which is difficult because sometimes you don’t even get the blood at that time (P7). Beyond the inefficiency and time wasted to cross the hospital campus for the necessary products and equipment, sometimes the needed item is not even available, and there is no management system that would have informed them of this. “I sent a nurse to get blood for a patient who I was working on and there was no blood at the blood bank. We had re-fractured a femur bone which had malunited and it was bleeding so much” (P15). Availability of sterile linens and equipment also required participants to travel across the hospital, taking up valuable time and limited human resources from other more important tasks. “I had to 70 wait several hours for the sterile instruments to be brought from lower Mulago central sterilizer unit. This adversely affected my work output and some patients missed surgery” (P1). 4.1.4.2 Transfer and Management of Patients The movement of patients between departments, the wards, and the operating theatre was also reported to be a challenge. This is partly due to lacking equipment such as stretchers that bring patients from one room to another and patient sliders for transferring patients between beds, as well as other insufficient facilities to handle and process the patients through the hospital. “There is only one way in and out of theatre. That means one patient after surgery has to get out of theatre before the next one is prepared to come in using the same patient stretcher. This results in approximately 1 hour time wasted between cases. Also lack of recovery ward means patients has to recover up to some point in theatre before going to the ward” (P1). Figure 18 - Patient waiting in hallway due to lack of recovery room Other participants described a lack of organization as the cause for difficulties and delays arising from patient management. “Patients should not be waiting for so long especially those who have had accidents and compound fracture. There should be a system whereby if they arrived they are immediately taken for x-ray without waiting and the team concerned should be preparing for the patient either to go for theatre for surgery and right away emergency theatre in charge nurse is informed of the emergency coming such that pain is reduced in the patient and they are comfortable” (P7). Another participant described the lack of an effective communication system. 71 “The reason for time delay in between cases, there is no easy communication system linking theatre and ward” (P1). The lacking information management within the hospital is a significant barrier to productivity and a major source of frustration for participants. “Most challenging situation today was to extract some information from the operation log register manually analysing each patient one at a time. Challenging in the sense that so many cases to explore and analyze. Worst of it, the recording procedure was hand written and yet some persons have very bad hand writing. There is a need for data synchronization and uniform case reporting for future use” (P14). In some cases, the patient was not prepared properly for surgery, either because of staff not conducting an appropriate intake, or because the patient was unwilling or unable to perform the required tasks. One such example is that the patient must not eat before surgery, however some patients did not listen to instructions, while others arrived unconscious and it was unknown whether they had eaten or not but required immediate surgery. “Preparing the patient because most of them do eat food even when they tell them not to do so. Another thing can be that some patients are not counselled for theatre and not well prepared emotionally and physically and physiologically which makes surgery become very difficult to perform. Another one can be patient who came in as emergencies when they have already eaten food but yet you have to go ahead and continue to do their surgery that alone make it difficult for the team” (P7). 4.1.4.3 Poor Preparation and Planning At times the delays and safety hazards they faced seemed to be caused by poor planning and preparation for the cases. For example, the right implants were often not selected before the case based on the patient’s anatomy and fracture pattern as shown on the x-ray, and so the participants had to open numerous sterile implant packs in order to find the right one. “Opening fracture of right tibia without the right nail to fix the fracture. It took us a long time than expected opening up different sets and nails so that we can get right tibia nail. It was due to poor preparation of the patients pre-operatively” (P16). This meant that patients were delayed while on the operating table with an 72 exposed wound, and also that all of the unwrapped implants now had to go through the lengthy sterilization cycle again. The lack of planning and communication among the surgical team also led to major issues during surgery, such as bone grafts being wasted due to improper care. “By the time the chief surgeon realized the need for bone piece, it had dried up and he suspected the tissues were dead by then, so we had to reach for another site to obtain a bone graft” (P4). 4.1.4.4 Work and Environment are Physically Taxing The amount of work, as well as the operating and working environment itself left participants feeling tired, frustrated, and made work much more challenging. “The theatre got really hot and everyone was sweating. I tried to switch on the AC but I realized that it had formed a layer of ice over its fan so cool air was not circulating” (P10). “We work up to late because patients were very many on the list and we were very tired” (P8). 4.1.5 People 4.1.5.1 Staff Issues 4.1.5.1.1 Ownership of Responsibility and General Management Difficulties with staff and resource management were reported as causing unnecessary delays. “Since we went for a weekend, there was no one to have the C-arm out to charge ready for use on Monday. All in all, there was inadequate time allocated to the C-arm to charge on Monday hence this affected the images it produced” (P4). This lack of ownership for the product among the team led to delays and contributed to the poor information environment they had to work in. 4.1.5.1.2 Power Dynamics and Unsafe Decisions Other frustrations were identified by nurses who felt that senior attending surgeons were not taking basic steps to ensure safety of the patient, and the power dynamics prevented participants from making any change with regards to this. One particular nurse identified on multiple occasions this issue: 73 “The most challenging part of my work today was the time-out briefing which was neglected by the team of surgeons yet it is right clear on the chart to have the surgeon participate in the briefing to have a safe surgery. Such a negative attitude towards a proposed positive change left me close lipped and down hearted as I thought that my effort to enact a positive change is not being considered. ‘Please my surgeons, forget about the yesterday's rigidity and move with today's and tomorrow's flexibility so that we practice safe surgery as a team’” (P4). “The surgical safety checklist is the most difficult to perform. Team members are usually not willing to perform the briefing yet it requires very little time. The briefing is only easier with the residents, yet they are temporary but the permanent senior people make it difficult to perform” (P4). “The most challenging part of my work today was using an unsterile pack (doubted sterility) to carry out a procedure. After having explained to the team about the doubted sterility of that particular pack, the response I got from the team had demonstrated ignorance from an educated person. He went ahead saying, if we are to go by what books say, we shall not be able to work and from history, patients on whom such doubted packs have been used have never reported to have gotten infected. I was advised to wait the awesome time when we (Mulago Hospital) met the levels of those hospitals practicing such recommendations saying ‘any pack with doubted sterility should not considered unsterile hence not be used’" (P4). 4.1.5.1.3 Lacking Anaesthetists and Other Specialists Delays were also caused by the limitations of available anaesthesia technicians and other specially-skilled stakeholders. “I had two spinal surgery cases who were cancelled because of lack of anesthesia. All the anesthetists had gone away for a conference leaving the hospital paralyzed. All theatres did virtually no work and even some emergencies in the casualty could not be worked upon. More anesthetists are needed in the hospital” (P1). “We couldn't do surgery because the anaesthetist we had couldn't operate the anesthetic machine. You know, I am now rotating on the spinal ward. Recently we had a spinal surgical camp and when the American donors were leaving they left us this high tech anaesthetic machine. Only one doctor, a Russian, knows how to use it. Today he is sick and so they have sent us another anesthetist 74 who looks like they have no idea what they are doing. The theatre list is cancelled while the doctor who knows how to operate the machine is back” (P13). 4.1.5.1.4 Concerns About Residents’ Errors and Delays With Mulago Hospital being a teaching institution, some participants expressed concern about the delays and errors caused by students still learning to operate. “This being a teaching institution, residents are to be showed the techniques of how to reduce fractures by the senior person. They are also offered chances to apply the acquired knowledge. This sometimes leads to misalignment hence revision” (P4). “The most challenging part of my work today was working with residents who are for their first rotation on the unit. We had no senior person among us and the challenge here was, how has the fracture been reduced, will the check x-ray show a perfect reduction or not. If not, shall I need to be part of the team revising the surgery” (P4). 4.1.5.1.5 Corruption Finally, some participants expressed clear concern and frustration for what they perceived to be the root cause of their difficulty in providing safe, timely surgery to all of the patients in need: corruption. “We live in a country of thieves (corruption) It hurts within” (P9). 4.1.5.1.6 Bringing It All Together As with technology issues, the staff and systemic challenges experienced have a multiplier effect on the inefficiency of the whole system, the delays caused, and the resulting impact on patient outcomes and staff frustration levels. “I make a list of my patients to operate on. Leave a list on the ward and carry the other one to theatre. I instruct the nurse to prepare patients so that when I call the ward, the patient is brought to theatre. Calling to theatre the anaesthetist has not yet come. It's 3 hours past the time of reporting. The phone here doesn't work, so I have to change from theatre gown to my ordinary clothes and go fetch the patient. Because when I get to the ward the nurse is alone many on 75 emergency ward have over 50 patients. God, this is crazy, can she really give medications to all and monitor all???? I ask myself” (P13). 4.1.5.2 Patients 4.1.5.2.1 Priorities of Staff Participants often mentioned their primary goal as clinicians is to operate as safely as possible on patients while trying to reduce the burden on the system caused by so many patients and few resources. “The priority is to ensure that the work done is properly done so it is better to work on a few patients but properly than to work on many patients with poor outcomes” (P11). Others described children, patients with comorbidities such as diabetes, and emergency cases taking priority for them: “Children are a priority just because they are the future generation and besides their metabolism demands are higher. In Africa when a child is sick many family members are affected and many attendants come to the hospital” (P14). “Our priorities as surgery is concerned, children and diabetic patients are operated first then follows other patients. Children can’t starve for a long time and even diabetic patients because their medical conditions and potential complications” (P16). 4.1.5.2.2 Negative Impacts on Patient Outcomes The delays caused across the system, and as described previously, have a number of negative effects on orthopaedic patients. These can include an increased risk of infection while waiting on the ward with open injuries for long, or due to the prolonged exposure of open wounds while in surgery. “Intramedullary nailing of the femur takes longer because we do not use the image intensifier but rather employ the open approach. This will eventually need addition of time for skin closure” (P10). These delays not only lead to infection, but also to poor healing of the bone cause by malunions as the bone begins to heal improperly while waiting. Often the patients are kept on ward without adequate traction and so muscle contractures are common, which then create extra burden on the 76 tissue and on the clinical team as they work to resolve the contractures. Participant P4 explained the challenges with “proper fracture alignment and fixation. This comes as a result of improper positioning of the patients from the ward or delays by the patients to come to the hospital early enough, predisposing them to muscle contraction and malunion.” Ultimately, some users even reported severe injury or death due to the delays and challenges faced across technology and the system. “Plating the tibia and intramedullary nail, it took long time of about 4 hours and even the patient went into shock due to bleeding” (P16). Another participant explained losing a patient that otherwise might have been preventable with appropriate facilities. “Lack of patient monitoring and life supporting equipment (ATLS). No functioning ICU in the hospital. Patient died just because I couldn’t support his respiration due to severe [unreadable] and injury” (P14). 4.1.5.2.3 Emotional Response of Staff Often participants discussed the personal emotional challenge they feel as they empathize with patients that are struggling. “It is painful to see such a patient in pain they take quite a long time on the ward to heal they get so depressed and refuses to eat sometimes also some of them loses both eyes making life more difficult for them and they go under a lot of surgery to help them recover. They need a lot of nutrition and a lot of counselling to keep them calm. Some of them are also abandoned in the hospital by their relatives because of that they develop attitude of not eating that they can die because think the world is does not need them any more. For that reason it make my work so challenging seeing them suffering while others are enjoying life while for them developing a lot of complication as they heal” (P7). 4.1.5.2.4 Emotional Impact on Patients As previously described, participants shared deep concern about the emotional well-being and mental health of their patients, some of whom were at risk for depression and even suicide. “Our theatre is leaking and the list is cancelled. That is so bad because [it] keeps the patient depressed and also make them feel tired of waiting” (P7). 77 4.1.6 Summary of Themes 4.1.6.1 Theme: Information Environment A major theme that emerged throughout the data has to do with the richness of the information environment within which the participants work, make decisions, and treat patients. The main contributor to a poor information environment is the lack of imaging equipment, most notably a C-arm for intraoperative orthopaedic imaging. Without this device, surgeons cannot accurately confirm that the fracture had been properly aligned and fixated, nor that the implants have been properly secured. They must wait until days after surgery for confirmation through post-operative x-ray, at which point they may discover a need for revision surgery, which impacts the patient’s outcomes and adds to the burden of the hospital. In other cases the lack of information is because of a lack of diathermy to keep the surgical field clear of blood, or the fact that patients cannot afford the necessary tests prescribed to them. This lack of information requires the clinical team to make decisions and operate blindly to some degree. It requires careful judgement and navigation of the human body, relying on their experience and intimate knowledge of anatomy. Ironically however the people most likely to need to make such decisions blindly based on gut feel, experience, and knowledge, are in fact the residents who often operate alone and are only at the start of their careers. For the patient, this again results in an increased risk of errors and poor outcomes. 4.1.6.2 Theme: Delays, Workflow Challenges, and the Impact on Patient Outcomes It was clear from the data that patient suffer directly as a result of the delays and gaps in practice caused by the technological, systemic, and human challenges faced. Unfortunately, at Mulago Hospital there are many difficulties that are a cause for poor patient outcomes, and many of these difficulties have a multiplier effect in their negative impact. From the time patients arrive to hospital, they may be placed for a very long time on the ward to wait for their turn for surgery. This often leads to additional complications, infections, and often to malunions and muscle contractures as patients are not appropriately held waiting in traction. 78 This then makes surgery more difficult and more risky, further adding to the likelihood of a bad outcome. The lack of blood, equipment, infrastructure, staff, and facilities for proper care even has led to deaths reported in the data by the participants on the day they were responding to journal questions. This is a major theme and of significant importance as it can be seen that for many patients the core objective of the healthcare system – that is, to provide safe and timely care – is failing them. 4.1.6.3 Theme: Improvisations and Jugaad Innovation An interesting theme that arose from the data was that when faced with difficulties or without a necessary piece of equipment, many surgeons and nurses exhibited a strong sense of improvisation and what is known as Jugaad Innovation or Frugal Innovation (Bhatti, 2011). This was evident in the approach to decision-making that users took when they had to fix complex fractures without access to imaging and information, or when they had to substitute – or even modify and manually cut – a different implant than the one they needed because of lack of availability. In more extreme cases, such as when using a non-sterile hardware drill in place of the expensive surgical drill, the clinical team had to use their best judgement and mitigate the infection risk as much as possible by involving multiple sterile and non-sterile persons in the handling of the drill, drill bits, and screws. This theme shows the resiliency of clinical users of technology when facing constraints, and their motivation to resolve problems that arise. Even under the most challenging conditions, they would rather improvise and adapt than fall victim to and contribute further to the increasing surgical burden of the hospital. Their duty to the patients was also evident in their willingness to find a solution, regardless of challenges before them. 4.1.6.4 Theme: Frustration Nearly all of the participants described deep frustrations with the environment and constraints they encountered. 79 The challenges faced often left participants feeling powerless, especially in the case of nurses having to try to advocate for the patient’s safety and facing resistance from attending surgeons due to power dynamics within the hospital. For some, the frustration was due to their self-perception as being highly skilled and highly trained, and yet their output being limited by the system they were operating within. Not being able to perform to their fullest abilities, as well as the low pay that participants faced, was also a major source of frustration. 4.1.6.5 Theme: Flexibility While assessing the participants’ perception of how technology provides value for them, the most unique and surprising common answer was that of flexibility. Examples of this included the diathermy machine that enabled the surgical team to operate for longer periods of time and provide more options for which areas of the body could be operated on while preventing bleeding. Flexibility was also preferred in the participants’ choice on implants, with some indicating that they preferred the Western branded products due to the numerous procedures and configurations afforded by the instruments, rather than the SIGN nail that was designed specifically for this LMIC context but was limited in the options afforded to the team in terms of fracture patterns and types that could be fixed. The skin grafting machine that allowed them to turn a small piece of skin into a stretched out larger piece was a favourite of some participants as it allowed them to literally stretch their resources further and provide treatment to more patients. Flexibility seems to be critical in an environment where so much can and does go wrong on a daily basis, and the clinical team needs to be able to adapt. When technology provides and affords them flexibility, the users need to improvise less and thus take fewer risks. Designers should then put an emphasis in the design process on how technology can support users and help make up for the unpredictability of the system they work within, where on any given day a patient may present 80 with a wide range of unique medical problems, and the system around them is one on which clinicians cannot readily rely. 4.2 Results of Outcome Driven Innovation The data from the Outcome Driven Innovation workshops was analyzed and the results are presented in this section. As described in the Methods section, participants were asked to identify the Steps in a typical orthopaedic procedure, namely the IM nailing of a tibia or femur. From these workshops, the following aggregate list of 20 Steps was identified: 1. Pre-op splinting 2. Patient Transport 3. Anaesthesia 4. Patient Positioning 5. Surgeon/Nurse Scrubbing 6. Tourniquet 7. Draping 8. Skin and Limb Preparation 9. Debridement and Irrigation 10. Incision, Dissection, and Cleaning the Fracture 11. General Mid-Surgery Goals 12. Reduction 13. Alignment 14. Drilling 15. Shantz Pin Insertion and Frame Assembly (for External Fixation Procedures) 16. Awl Insertion and Reaming (for Nailing) 17. Nail Insertion 18. Nail Locking 19. Confirm Alignment During Surgery 20. Closure 81 After participants in the workshops identified these Steps, they were asked to go back through this list and assign 5-8 Goals per step, phrased either as “minimizing” or “increasing” a certain attribute. The data from all of the workshops was aggregated again and these Goals were tallied into a list of 106 specific Goals. These Goals are listed in Appendix C – ODI Survey. Towards the end of the Uganda field research trip, this ODI Survey document was given to all participants in order to rank the Importance and Satisfaction with each Goal, and then calculate the Opportunity score. Once tallied and given an Opportunity score, this document gave rise to 106 ranked opportunities for design and innovation, with the potential for disruption and impact in the Ugandan orthopaedic environment. The following sections show the top Opportunities in table format, as well as pie charts that show the top 25% of Opportunities organized by category or topic. Further, the top 25% of Opportunities were analyzed to determine which Steps they mostly fall within, and this data is also shown in pie charts in the following sections. Results are shown in the following sections by participant type. As well, comparisons are made between participants across cultural and professional divides. 4.2.1 All Participants Figure 19 below shows the Opportunity Landscape for all participants across all 106 Goals. The Opportunity Landscape also shows that the majority of data points fall in the “Underserved” lower right segment of the chart, while no data points fall in the upper left “Overserved” segment. The data shows a total of 28 Opportunities (26%) that have an Opportunity Score of 15 and above, which Ulwick defines as “Extreme Opportunities” for innovation. It is clear that the majority of the Goals identified and ranked by participants would provide great opportunities for innovation, design, and improvements not only in clinical efficiency and patient outcomes, but in clinician satisfaction. 82 Figure 19 - Opportunity Landscape for all participants The top 20 Opportunities across all participants are shown in Table 1 below. Table 1 - Top 20 Opportunities across all participants 0.001.002.003.004.005.006.007.008.009.0010.000.00 2.00 4.00 6.00 8.00 10.00Satisfaction ImportanceNursesSurgeonsStep Goal Opportunity Patient Positioning Maintain a sterile environment 16.9 Nail Locking Minimize risk of missing the slot with screw 16.7 Debridement and Irrigation Minimize bacterial contamination 16.5 Draping Minimize risk of contamination 16.3 Nail Locking Minimize risk of rotation 16.3 Surgeon/Nurse Scrubbing Minimize chance of re-contamination after scrub 16.1 Surgeon/Nurse Scrubbing Appropriate scrubbing facilities 15.9 Pre-Op Splinting Rule out associated injuries 15.9 Incision, Dissection, Cleaning Fracture Minimize soft tissue, neuro/vascular damage 15.9 Anaesthesia Minimize injury to patient during intubation 15.8 Awl Insertion & Reaming (for Nailing) Minimize fracturing of bone 15.8 83 From reviewing this list, it is clear that Opportunities are present across the surgical process in many Steps and among many Goals within those. The majority of these Opportunities lie within three categories: 1) decreasing the risk of contamination to the sterile field or the patient, minimizing soft tissue and further bone injury to the patients, and 3) improving accuracy and stability of the bone alignment, reduction, or fixation. To better understand trends among the Opportunities, each was tagged with a category label. The list of categories used to tag each of the Opportunities emerged from the Steps and Goals themselves as keywords or short-hand for that type of activity or issue. The top 25% of Opportunities across all participants are shown in Figure 20 below by category. Figure 20 - Top 25% of Opportunities for all participants 25%16%16%43%ContaminationAlignment and stabilityInformation andvisualizationOther Confirm Alignment During Surgery Confirm stability of fixation construct 15.6 Pre-Op Splinting Minimize further damage to soft tissues/ injury 15.6 Surgeon/Nurse Scrubbing Minimize bacterial load on hands 15.6 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase stability of construct 15.5 Debridement and Irrigation Minimize bleeding 15.4 Confirm Alignment During Surgery Confirm alignment of bone after reduction 15.4 Drilling Minimize thermal necrosis of bone 15.4 Skin and Limb Preparation Minimize bacterial load on skin 15.4 Alignment Verify and confirm accuracy in alignment 15.3 84 It is notable from the above that contamination of the sterile field of patient is the number one concern across all participants, regardless of cultural of professional background. The categories that make up second and third place in the list of top Opportunities – alignment and stability, and information and visualization – are both unique but more often than not these tags were applied to Opportunities having to do with alignment, accuracy, and stability while reducing, aligning, and fixating the bone and implant construct. The “Other” category is made up of a number of other categories that each was less than 5% in volume, and are listed in Appendix E. The top 25% of Opportunities were analyzed further to determine which Steps in the surgical process these Opportunities would most commonly fall within, thus showing the Steps where the Goals were most important and least satisfied. Figure 21 below shows this for all participants. Note that the “Other” Step consists of a number of other Steps that each fell below a 5-10% threshold. All Steps are listed above in Section 0. Figure 21 – Most common Steps among the top 25% of Opportunities, all participants From this information we can see, for example, that Steps such as locking of the IM nail or confirmation of alignment of the bone and implants are areas where a number of the clinical team’s Goals are important but are not being achieved in a satisfactory fashion. The results here are consistent with the main categories of Opportunity, notably reducing contamination and improving alignment and stability of the fixation. 11%9%9%9%9%9%44%STEP: Nail LockingSTEP: Confirm Alignment DuringSurgerySTEP: Debridement and IrrigationSTEP: Surgeon/Nurse ScrubbingSTEP: Incision, Dissection,Cleaning FractureSTEP: Patient PositioningOther 85 The following sections follow the same structure for how the data and results were analyzed and how they are presented. 4.2.1.1 All Surgeons The top five Opportunities for innovation as described by all surgeons are presented below in Table 2. Table 2 - Top 5 Opportunities across all surgeons Step Goal Opportunity Nail Locking Minimize risk of missing the slot with screw 17.6 Debridement and Irrigation Minimize bacterial contamination 17.5 Pre-Op Splinting Rule out associated injuries 17.4 Nail Locking Minimize risk of rotation 17.4 Surgeon/Nurse Scrubbing Appropriate scrubbing facilities 17.3 The top 25% of Opportunities as described by all surgeons are presented by category in Figure 22 below. Figure 22 - Top 25% of Opportunities for all surgeons Figure 23 below shows the most common Steps of the surgical process where the top 25% of Opportunities fall within, as described by all surgeons. 21%16%13%8%8%34%ContaminationAlignment and stabilityInformation andvisualizationSoft tissue damagePatient positioningOther 86 Figure 23 – Most common Steps among the top 25% of Opportunities, all surgeons 4.2.1.2 All Nurses The top five Opportunities for innovation as described by all surgeons are presented below in Table 3. Table 3 - Top 5 Opportunities across all nurses Step Goal Opportunity Debridement and Irrigation Minimize bacterial contamination 17.4 Alignment Verify and confirm accuracy in alignment 17.1 Skin and Limb Preparation Minimize re-introduction of flora into site 16.9 Surgeon/Nurse Scrubbing Minimize bacterial load on hands 16.9 Pre-Op Splinting Minimize bleeding 16.9 The top 25% of Opportunities as described by all nurses are presented by category in Figure 24 below. 12%12%9%9%9%49%STEP: Nail LockingSTEP: Patient PositioningSTEP: Confirm AlignmentDuring SurgerySTEP: DrapingSTEP: Skin and LimbPreparationOther 87 Figure 24 - Top 25% of Opportunities for all surgeons Figure 25 below shows the most common Steps of the surgical process where the top 25% of Opportunities fall within, as described by all nurses. Figure 25 – Most common Steps among the top 25% of Opportunities, all nurses 4.2.1.3 All Canadian Participants The top five Opportunities for innovation as described by all Canadian participants are presented below in Table 4. Table 4 - Top 5 Opportunities across all Canadians Step Goal Opportunity Debridement and Irrigation Minimize bacterial contamination 20.0 22%16%13%8%41%Information andvisualizationContaminationAlignment and stabilityDebridementOther17%14%8%8%9%9%9%26%STEP: Debridement and IrrigationSTEP: Skin and Limb PreparationSTEP: Confirm Alignment During SurgerySTEP: Incision, Dissection, Cleaning FractureSTEP: Patient PositioningSTEP: Pre-Op SplintingSTEP: Surgeon/Nurse ScrubbingOther 88 Draping Minimize risk of contamination 20.0 Pre-Op Splinting Rule out associated injuries 20.0 Patient Positioning Maintain a sterile environment 20.0 Shantz Pin Insertion & Frame Increase stability of construct 20.0 The top 25% of Opportunities as described by all Canadian participants are presented by category in Figure 26 below. Figure 26 - Top 25% of Opportunities for all Canadians Figure 27 below shows the most common Steps of the surgical process where the top 25% of Opportunities fall within, as described by all Canadian participants. Figure 27 - Most common Steps among the top 25% of Opportunities, all Canadians 26%14%11%8%9%6%6%20%ContaminationInformation andvisualizationAlignment and stabilitySoft tissue damageDebridementPatient positioningAirwayOther15%11%11%11%52%STEP: Pre-Op SplintingSTEP: Debridement andIrrigationSTEP: Patient PositioningSTEP: Surgeon/NurseScrubbingOther 89 4.2.1.4 All Ugandan Participants The top five Opportunities for innovation as described by all Ugandan participants are presented below in Table 5. Table 5 - Top 5 Opportunities across all Ugandans Step Goal Opportunity Nail Locking Minimize risk of missing the slot with screw 16.6 Nail Locking Minimize risk of rotation 16.1 Patient Positioning Maintain a sterile environment 16.0 Confirm Alignment During Surgery Confirm alignment of bone after reduction 15.7 Debridement and Irrigation Minimize bacterial contamination 15.7 The top 25% of Opportunities as described by all Canadian participants are presented by category in Figure 28 below. Figure 28 - Top 25% of Opportunities for all Ugandans Figure 29 below shows the most common Steps of the surgical process where the top 25% of Opportunities fall within, as described by all Ugandans. 19%16%13%13%39%Information andvisualizationAlignment and stabilityContaminationSoft tissue damageOther 90 Figure 29 - Most common Steps among the top 25% of Opportunities, all Ugandans 4.2.2 Comparison Across Professional Background The top 25% of Opportunities as described by all surgeons and all nurses are presented by category in Figure 30 and Figure 31 respectively below. Figure 30 - Top 25% of Opportunities for all surgeons Figure 31 - Top 25% of Opportunities for all nurses Interestingly, both the nurses’ and surgeons’ results showed the same Opportunity types among the top three. This is not surprising since these two groups of professionals have similar training and emphasis on how to measure and strive for key patient outcomes through their practice, including things like aseptic technique and creating accurate fracture fixation constructs. Both 14%11%8%8%59%STEP: Nail LockingSTEP: DrillingSTEP: Confirm AlignmentDuring SurgerySTEP: Incision, Dissection,Cleaning FractureOther21%16%13%8%8%34%ContaminationAlignment andstabilityInformation andvisualizationSoft tissuedamagePatientpositioningOther22%16%13%8%41%Information andvisualizationContaminationAlignment andstabilityDebridementOther 91 groups are also strongly impacted by the lack of information provided to them in their working environment by technology such as imaging and diathermy. The results are also consistent to the key technology gaps and themes arising from the Cultural Probes method discussed previously. For example, the Opportunities linked to information and visualization, as well as alignment and stability, most often had to do with the lack of intraoperative imaging technology and a lack of a traction table. These top Opportunities also reaffirm the theme of the Information Environment from the Cultural Probes work. However, it is notable that the majority of Opportunities within those top three categories in the figures above all do have an Opportunity Score above 15, showing Extreme Opportunities for innovation. Because of the nature of the Mulago Hospital environment being so resource constrained, a number of the top Opportunities resulted in very high Opportunity Scores, and so the ranking of top Opportunities may not have significant meaning of their relative importance to one another since they all are seen as very important in this particular clinical context. A more useful comparison then is where these two groups’ views differed. The following Table 6 shows a comparison between how surgeons and nurses viewed particular Goals differently. The Opportunity score for each goal is listed for either group of participants, and the delta column shows the difference between the two. In the table are presented the Opportunities with the highest and lowest delta. The first ten Opportunities shown in the table are those where surgeons’ responses ranked highly in Opportunity score and nurses ranked low, whereas the bottom ten Opportunities show the opposite. Table 6 - Differences between nurses and surgeons Step Goal Surgeons Nurses Delta Reduction Minimize damage to soft tissues 17.1 10.5 6.7 Nail Locking Minimize risk of missing the slot with screw 17.6 11.8 5.8 Nail Locking Minimize bone alignment changes 15.5 10.0 5.5 Drilling Minimize effort in drilling 13.6 8.1 5.5 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase stability of construct 16.7 11.8 4.8 Drilling Minimize thermal necrosis of bone 16.0 11.2 4.8 92 Drilling Minimize time of drilling 14.5 9.8 4.7 Pre-Op Splinting Minimize further damage to soft tissues/ injury 16.4 11.7 4.7 Nail Locking Increase double cortex fixation 14.2 10.0 4.2 Drilling Minimize slipping of drill 12.8 8.7 4.2 Pre-Op Splinting Minimize bleeding 14.9 16.9 -2.1 Debridement and Irrigation Increase exposure to bone edges 12.8 15.0 -2.2 Alignment Increase accuracy of leg length 11.3 13.6 -2.4 Alignment Verify and confirm accuracy in alignment 14.6 17.1 -2.6 Incision, Dissection, Cleaning Fracture Minimize size of incision 10.8 13.3 -2.6 Awl Insertion & Reaming (for Nailing) Minimize under reaming 10.6 13.2 -2.6 Tourniquet Increase visualization of operating site 11.3 14.3 -3.0 Reduction Increase anatomic accuracy of reduction 10.9 14.5 -3.7 Incision, Dissection, Cleaning Fracture Minimize soft tissue, neuro/vascular damage 12.8 16.7 -3.9 Skin and Limb Preparation Minimize cuts on skin due to shaving 10.5 16.2 -5.6 One insight from the above table is that the Opportunities that only surgeons ranked highest are more often dealing with specific technology use, such as drilling or nail locking, whereas the Opportunities ranking higher only with nurses were more related to the patient and minimizing negative outcomes such as bleeding or soft tissue damage. The Opportunities ranked higher only by nurses also took place more often at Steps that had to do with preparing the patient and limb for surgery in the first few stages of surgery. Thus we can say from this data that surgeons’ views of importance had more to do with the technical nature of the procedure, whereas the nurses were more concerned with the softer human aspects of the case. 4.2.3 Comparison Across Cultural Background 4.2.3.1 All Ugandan Participants vs. All Canadian Participants The top 25% of Opportunities as described by all Ugandans and all Canadians are presented by category in Figure 32 and Figure 33 respectively below. 93 Figure 32 - Top 25% of Opportunities for all Ugandans Figure 33 - Top 25% of Opportunities for all Canadians As with the comparison between nurses and surgeons, we again find that the top four categories when comparing Canadian to Ugandan participants are the same, albeit in a different order of importance. There does appear to be a difference in the relative ranking of contamination, which is first place for the Canadian participants but comes in only third for Ugandans. One possible explanation for this is that Canadian participants are used to a higher standard of aeseptic practice in Canada at their home hospitals than in Uganda. Ugandans on the other hand ranked Opportunities having to do with information, visualization, alignment, and stability higher than Canadians, perhaps pointing to a greater frustration that is sensed on a daily basis by these participants in their work, thus ranking these challenges that affect their personal technical performance ability during surgery above the challenges having to do with contamination, which impact the patient further down the road beyond the OR. Similar to the previous section comparing differences among nurses and surgeons, the following Table 7 shows a comparison between how Ugandans and Canadians viewed particular Goals differently. The Opportunity score for each goal is listed for either group of participants, and the delta column shows the difference between the two. In the table are presented the Opportunities with the highest and lowest delta. The first ten Opportunities shown in the table are those where 19%16%13%13%39%InformationandvisualizationAlignment andstabilityContaminationSoft tissuedamageOther26%14%11%8%9%6%6%20%ContaminationInformation andvisualizationAlignment andstabilitySoft tissuedamageDebridementPatientpositioningAirwayOther 94 Canadians’ responses ranked highly in Opportunity score and Ugandans’ ranked low, whereas the bottom ten Opportunities show the opposite. Table 7 - Differences between Ugandans and Canadians Step Goal UG All CA All Delta Pre-Op Splinting Identify the fracture pattern 11.7 20.0 8.3 Shantz Pin Insertion & Frame A Minimize chance of losing reduction 12.0 20.0 8.0 Closure Increase wound healing 12.0 20.0 8.0 Debridement and Irrigation Minimize amount of dead tissue 12.7 20.0 7.3 Awl Insertion & Reaming (for Nailing) Increase accuracy of reamer insertion point 12.8 20.0 7.2 Draping Increase sterile isolation of the limb 13.2 20.0 6.8 Patient Positioning Minimize injury to patient 13.2 20.0 6.8 Anaesthesia Minimize risk of aspiration 13.2 20.0 6.8 Pre-Op Splinting Minimize bleeding 13.6 20.0 6.4 Debridement and Irrigation Minimize debris present 13.8 20.0 6.2 Nail Locking Minimize bone alignment changes 14.6 11.4 -3.2 Drilling Increase user stability during drilling 11.8 8.6 -3.2 Drilling Minimize effort in drilling 12.0 8.6 -3.4 Patient Transport Minimize difficulty in patient transport from ward 12.4 8.8 -3.6 Drilling Minimize time of drilling 12.6 8.6 -4.0 Incision, Dissection, Cleaning Increase accuracy of incision location 12.7 8.6 -4.2 Incision, Dissection, Cleaning Minimize operating time 14.2 10.0 -4.2 Drilling Minimize soft tissue injury 15.7 11.4 -4.2 Reduction Minimize time to achieve reduction 13.1 8.6 -4.5 Incision, Dissection, Cleaning Minimize soft tissue interposition 14.6 8.6 -6.1 The most notable difference from the above table is that Canadians’ priorities focused around Goals that had an impact on longer-term outcomes, such as reducing injury to the patient and reducing contamination that could lead to infection, whereas Ugandan participants’ priorities focused more around technical objectives such as reducing time and effort of drilling while increasing the surgeon’s stability during that Step, or increasing accuracy of where the incision should be made. 95 4.2.3.2 Ugandan Surgeons vs. Canadian Surgeons The top 25% of Opportunities as described by Ugandan surgeons and Canadian surgeons are presented by category in Figure 34 and Figure 35 respectively below. Figure 34 - Top 25% of Opportunities for Ugandan surgeons Figure 35 - Top 25% of Opportunities for Canadian surgeons The data above shows that the top Opportunities for Ugandans fall into the category of contamination, followed by alignment and stability. In contrast, the top Opportunities for Canadian surgeons had to do with information and visualization, followed closely by alignment and stability, both of which generally had to do with the accuracy of the fracture fixation, given available enabling technologies. The following Table 8 shows a comparison between how Ugandan surgeons and Canadian surgeons viewed particular Goals differently. The Opportunity score for each goal is listed for either group of participants, and the delta column shows the difference between the two. In the table are presented the Opportunities with the highest and lowest delta. The first ten Opportunities shown in the table are those where Canadian surgeons’ responses ranked highly in Opportunity score and Ugandan surgeons’ ranked low, whereas the bottom ten Opportunities show the opposite. 25%16%10%9%6%6%28%ContaminationAlignment andstabilitySoft tissuedamageNail lockingDebridementPatientpositioningOther23%18%11%10%10%28%Information andvisualizationAlignment andstabilityContaminationSoft tissuedamageAccuracyOther 96 Table 8 - Differences between Ugandan surgeons and Canadian surgeons Step Goal UG Surgeon CA Surgeon Delta Closure Minimize bone exposure after closure 12.2 20.0 7.8 Pre-Op Splinting Identify the fracture pattern 12.8 20.0 7.2 Awl Insertion & Reaming (for Nailing) Minimize over reaming 11.7 18.8 7.1 Drilling Minimize slipping of drill 11.8 18.8 7.0 Closure Increase wound healing 12.2 18.8 6.5 Incision, Dissection, Cleaning Fracture Increase accuracy of incision location 12.2 18.8 6.5 Alignment Increase accuracy of alignment 13.7 20.0 6.3 Debridement and Irrigation Increase exposure to bone edges 12.2 18.3 6.1 Closure Minimize instrument retention inside patient 12.8 18.8 6.0 Reduction Identify the fracture pattern 14.2 20.0 5.8 Alignment Increase accuracy of rotation alignment 14.4 5.4 -9.0 Incision, Dissection, Cleaning Fracture Minimize soft tissue interposition 14.4 5.4 -9.0 Drilling Minimize soft tissue injury 15.0 5.4 -9.6 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy in depth of pin insertion 15.0 5.4 -9.6 Drilling Minimize effort in drilling 15.0 5.4 -9.6 Incision, Dissection, Cleaning Fracture Minimize operating time 15.3 5.4 -9.9 Patient Transport Minimize difficulty in patient transfer to OR table 14.1 4.2 -10.0 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize chance of pin pull-out 15.6 5.4 -10.1 Mid-Surgery General Goals Increase usability of instruments 16.0 5.4 -10.6 Patient Transport Minimize patient injury in transfer to OR table 17.2 5.4 -11.8 An interesting trend to note is that for the more positive delta numbers, the Ugandan Opportunity scores, although much lower than the Canadian surgeons’, were still between 10-15, thus showing relative agreement between the two groups. However, the most negative delta numbers showed 97 high Opportunity scores as ranked by Ugandans but only in the range of 4-6 for Canadians, showing significant disagreement in the relative importance and satisfaction. One reason that this might be the case is that the high positive delta Opportunities are Goals that might generally be easy to agree on, such as “increase wound healing”, however the most negative delta Opportunities may be overlooked by the Canadian surgeons as these are not issues they deal with on a daily basis. For example, the greatest disparity is for the Opportunity of “minimizing patient injury in transfer to the OR table”, which could be a common way that patients get injured in Uganda due to the lack of adjustable beds, tables, stretchers, and other patient transfer technology – as identified in the Cultural Probes results. The safe transfer of patients from one bed to another maybe something that is taken for granted in a Canadian context where patient transport and transfer is done using adjustable, electrically controlled beds. 4.2.3.3 Ugandan Nurses vs. Canadian Nurses The top 25% of Opportunities as described by Ugandan nurses and Canadian nurses are presented by category in Figure 36 and Figure 37 respectively below. Figure 36 - Top 25% of Opportunities for Ugandan nurses Figure 37 - Top 25% of Opportunities for Canadian nurses When comparing the differences between what Ugandan nurses and Canadian nurses see as the top Opportunities, the top three most pressing items are the same, however the order indicates a 16%14%14%8%8%8%32%ContaminationAlignment andstabilityInformation andvisualizationSoft tissuedamageDebridementBleedingOther21%18%16%13%32%Alignment andstabilityInformationandvisualizationContaminationAccuracyOther 98 difference in priority. While contamination is the top Opportunity area of concern for Ugandan nurses, it takes third place for the Canadian nurses. Conversely, the Canadian nurses prioritized alignment and stability, and information and visualization, while these come in second and third place respectively for the Ugandan nurses. The following Table 9 shows a comparison between how Ugandan nurses and Canadian nurses viewed particular Goals differently. The Opportunity score for each goal is listed for either group of participants, and the delta column shows the difference between the two. In the table are presented the Opportunities with the highest and lowest delta. The first ten Opportunities shown in the table are those where Canadian nurses’ responses ranked highly in Opportunity score and Ugandan nurses’ ranked low, whereas the bottom ten Opportunities show the opposite. Table 9 - Differences between Ugandan nurses and Canadian nurses Step Goal UG Nurse CA Nurse Delta Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy in bone alignment 8.2 20.0 11.8 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize chance of losing reduction 8.2 20.0 11.8 Patient Positioning Minimize pressure on identified pressure points 8.8 20.0 11.3 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize chance of pin pull-out 9.3 20.0 10.7 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy of rotation alignment 9.3 20.0 10.7 Nail Locking Minimize bone length changes 9.6 20.0 10.4 Patient Positioning Minimize risk of limbs falling off table 10.0 20.0 10.0 Alignment Increase accuracy of leg length 10.0 20.0 10.0 Incision, Dissection, Cleaning Fracture Minimize size of incision 10.0 20.0 10.0 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase bone contact in reduction 10.7 20.0 9.3 Drilling Minimize thermal necrosis of bone 11.8 10.0 -1.8 Patient Transport Other: 15.0 13.0 -2.0 Awl Insertion & Reaming (for Nailing) Minimize thermal necrosis of bone 12.1 10.0 -2.1 99 Incision, Dissection, Cleaning Fracture Minimize operating time 12.5 10.0 -2.5 Drilling Minimize slipping of drill 9.6 6.7 -2.9 Drilling Minimize risk of inaccurate drill hole placement 13.2 10.0 -3.2 Incision, Dissection, Cleaning Fracture Minimize soft tissue interposition 13.8 10.0 -3.8 Patient Transport Minimize difficulty in patient transfer to OR table 11.3 7.5 -3.8 Drilling Increase user stability during drilling 14.2 10.0 -4.2 Drilling Minimize soft tissue injury 15.7 10.0 -5.7 The above data shows a mix of technical and patient-related Goals across both Ugandan and Canadian nurses. Interestingly, five of the ten responses with a high positive delta were for the Step “Shantz Pin Insertion and Frame Assembly”, whereas five of the ten most negative delta Opportunities has to do with the Step “Drilling”. Both of these Steps are ones undertaken solely by the surgeon and is not the responsibility of the nurse during surgery. This perhaps shows that the areas of disagreement for Canadian and Ugandan nurses took place during Steps that neither would have considered critical for their roles, and the above pie charts in fact do show agreement among the critical aspects of surgery where the nurses do have more of an impact, such as maintaining the sterile field and proper aseptic technique so as to minimize contamination. 100 5 Discussion The main aim of this study and this research overall was to understand how to better approach medical device design in LMICs, specifically by engaging local users in the innovation process. According to Ramachandran, “the needs and conditions of developing regions have been relatively less explored for the purpose of technology design” (Ramachandran, 2007). Among a number of reasons for this, this thesis specifically highlights the challenges faced by Western designers both in “expert user design”, and due to the cultural gaps relative to the end users of technology. This section reviews some of the key findings about surgery in Uganda, as well as opportunity areas for designers to make an impact. The Cultural Probes and Outcome Driven Innovation methodology is then evaluated for its effectiveness in overcoming the challenges of designing in this context, and what designers may learn and keep in mind about participatory design of medical technology when working across professional and cultural divides. 5.1 Comparing Results of Cultural Probes (CP) and Outcome Driven Innovation (ODI) Using the two methods in this research, namely CP and ODI, allowed us to not only see the emergent patterns and needs from each method, but to use these two approaches to triangulate the most pressing challenges and opportunities for designers to focus on. 101 Table 10 below shows a list of the emergent ODI categories and compares these to the themes and specific technology challenges identified in the CP method. 102 Table 10 - Comparison of ODI and Cultural Probe themes ODI Categories Cultural Probe Themes Cultural Probe Technologies Information and visualization Information environment Imaging, Diathermy, Traction table Alignment and stability Information environment Traction table, Imaging Accuracy Information environment Imaging Contamination Patient outcomes, Sterility Soft tissue damage Patient outcomes Debridement Implants Implants Bone damage Patient outcomes Reduction Traction table Bleeding Patient outcomes Diathermy Ease of use Ease of use Time Time delays Patient positioning Traction table Tourniquet Nail locking Information environment Imaging Prep Wound healing Patient outcomes Patient transfer Patient management Airway Reaming Drills Instrument care Staff issues Instrument retention Patient outcomes Necrosis Patient outcomes Occupational hazards Staff issues Pressure sores Patient outcomes Scrubbing Sterility Understand the injury Information environment Imaging Incision Nail insertion Information environment Imaging From reviewing the above data, it is evident that there is significant overlap in concepts that arose between the two methods. The use of both methods, CP and ODI, in conjunction not only helps validate and triangulate on key themes of importance, but may actually help participants in the research to provide stronger data by encouraging different thinking styles. Privitera suggests that “data collection tools should include still and video recordings… [which] allow the [research] team to complete further analysis of the user and device interactions at a more in-depth level and effective pace… [and 103 that] the use of preliminary diaries by users can be helpful and can ‘prime’ users prior to an interview” (Privitera, 2009). In the case of this Uganda research, it is likely that participation in daily reflection journaling and the use of disposable cameras to capture their story helped to prime high quality contributions during the ODI stage of the research which followed. 5.1.1 Key Areas of Focus for Impact 5.1.1.1 Information Environment One of the core themes across both methodologies had to do with the richness of the information environment that users are working in. This is a challenge that was created by the lack of various technology, but the main cause for an information poor environment in the Ugandan surgical setting is the lack of imaging technology. Orthopaedics is especially reliant on pre- and post-operative x-ray, as well as intraoperative imaging using a C-arm, in order to properly understand the fracture pattern and then to re-align, reduce, and fixate the fracture by insert implants at correct locations, angles, and depths. The low information environment leads users to take actions blindly and hampers decision making. When designers look at innovating in LMIC environments, especially in the health space, it is critical to consider how access to information affects the ability for clinicians to perform their role, and what impacts this has on patients’ outcomes. When evaluating opportunities for innovation, designers might reflect on questions such as: • How might we improve access to information for the user during this particular task? • How might the user achieve their objective despite an information poor environment? • How might information be made available to the user through an alternative means in an LMIC context relative to how it might be provided in the West? • How might we empower the clinical team to make better decisions? 5.1.1.2 Sterile Practice A second major theme that emerged across both CP results and for all participants in the ODI method is around contamination and sterility. This theme had to do with both technology availability, such as functioning sterilizers, but also with practices among the clinical team such as 104 the reluctance to discard and replace instruments of unknown sterility status. This heightened risk of contamination is very wide spread throughout the care continuum of the hospital, and poses severe short and long term risks of infection, ultimately leading to potential amputation, sepsis, or even death. When designing for improved healthcare in LMICs, designers might consider questions such as: • How might a new technology encourage or effortlessly force correct aeseptic technique among users? • How might a technology reduce the risk of contamination to the patient? • How might we innovate the workflow of people and equipment within the hospital in such a way to encourage mindfulness of sterility with regards to their equipment use? 5.1.1.3 Alignment and Reduction of Fractures in the LMIC Context A recurring theme among participants had to do with the ability to mechanically reduce, align, and fixate fractures. Due in part to the lack of a traction table in the operating theatre, the maneuvering and positioning of limbs was challenging, often requiring highly skilled nurses or other surgeons to stand-in as limb positioners for hours at a time during surgery in order to provide the right visibility and access to the surgical site for the operating surgeon. This problem was compounded by the fact that most patients presented with injuries that were weeks or even months old, often incorrectly healed with malunions, scarred bone and soft tissue, and significant muscle contractures that made manipulation of the limbs and bone fragments extremely physically challenging. When approaching the design process, designers may consider questions such as: • How might we reduce the physical and mechanical labour associated with positioning and aligning limbs and bone fragments? • How might we help the clinical team better manage and prevent further injury and complications caused by long delayed treatment? • How might technology be designed differently for treating old vs. new fractures and injuries? 105 5.1.1.4 Flexibility and Improvisation One of the most important values that was uncovered in both the ODI and CP data has to do with the flexibility that technology offers a user. This was evident in the preference for implant sets that allowed them to treat a range of potential fracture patterns, or with diathermy technology that enabled them to stop unexpected bleeding and prolong surgery beyond what the use of a tourniquet would allow. The flexibility inherent in a technology, and the user’s aptitude at improvisation in their work when faced with an unexpected challenge, are especially important in an LMIC context where so many challenges exist and unexpected issues arise constantly throughout the day. Designers innovating in an LMIC healthcare context may ask questions during the design process such as: • How might we design technology with flexibility as a core attribute of the device? • How might a technology enable users to improvise further as they use it, given that unique cases and situations may arise in the future which are difficult to predict? • How might we enable users to stretch their resources further and apply them across more patients? 5.1.1.5 Interdependence of Challenges A major take-away from the data is that there are a myriad of challenges: technological, systemic, personnel related, and patient related, and that these challenges are all highly interdependent. The difficulties at Mulago Hospital impact one another often as positive feedback loops that result in more delay, more frustration, more bottlenecks, and a worsening impact on patient outcomes. As an example: 1) patients often present with very old and badly healed injuries, 2) they are again delayed with a long wait on the ward, likely without the limb being placed in traction, 3) communication and management issues lead to inefficiencies and so not all patients on the day’s operating list are worked on, leading to greater delays, 4) further delays during surgery are caused by poor planning of which implants are needed and brought to theatre, requiring nurses to open up and dig through multiple sterile packs to find and fit the right implant, 5) the lack of a traction table results in difficult access to the desired surgical site, while some surgical team members are relegated to “limb positioner” duty, 6) a lack of a working diathermy machine leads to excessive 106 blood loss and obscuring of the surgical field of view, 7) lack of imaging means that a larger incision is required to expose more of the fracture site, resulting in a higher risk of infection, 8) dull drill bits and underpowered drills are used to make holes in the bone, which are placed incorrectly relative to the slots in the implant due to the lack of imaging, and 9) all of these factors make for a very frustrated and demoralized clinical team that may not choose to start another case after this patient, thus resulting in yet further delays. The resulting ODI insight that the vast majority of the Opportunities identified had an Opportunity Score indicating high, very high, or extreme opportunities for innovation shows just how many overlapping challenges exist, and the awareness of the clinical team to their existence. Designers working in this context may wish to consider questions such as: • What is the relation of this technology to staff, patients, infrastructure, and other technology? • How might we develop technology that functions independently to other technologies and factors in the system, and thereby reduce cascading effects when a problem arises? • How might we leverage the negative feedback loops and delays in the system to enhance the value and usefulness of a new technological innovation? 5.1.1.6 Perspectives on Technology: Donations, Appropriate Technology, and Frugal Innovation Participants shared valuable insights about technology across a number of areas of interest, including technology donations, their views on appropriate technology, and the concept frugal innovations that are designed specifically for LMICs. With regards to donations, the main takeaway from participants across the group was that donors should consult with recipients and ensure that technology not only meets the needs of the beneficiary, but is transferred in a way that ensures appropriate training, and sustainability through access to spare parts and maintenance as required. On the topic of appropriate technology, multiple perspectives were shared. Many of the users preferred devices such as the SIGN nail, which is designed specifically with the considerations of 107 the local environment (e.g. no access to intraoperative imaging) in an LMIC. Some users however also showed a preference for very low tech devices such as manual drills, stating that these are appropriate for Mulago Hospital because of the existing low quality of infrastructure, multitude of challenges, and staff skill level. This fatalist view is surprising as the manual drill is acknowledged by participants to be of inferior quality, time and energy intensive to use, and often result in additional injury to the patient. This view may be related to the frustration felt by staff working in this environment, and thus a reluctance to seek and adopt technology that is above what their system and peers can handle. The design community and even the WHO generally tend to agree with this sentiment of frugal, locally appropriate technology being the best for these settings: “the types of technologies seen as potentially appropriate for low-resource settings are quite different from the PET scans and implantables seen in wealthy countries. Low-cost infant warmers, point-of-use water purifiers, portable low-cost ventilators, self-contained parasite-detection systems, low-technology child-restraint seats, and reusable newborn suction devices are examples of health technologies that the WHO has indicated are needed for low-resource settings and are worthy of investigation” (Sinha, 2011). Some users however did show a preference for top Western implant and instrumentation brands, above and beyond products like the SIGN nail. The reasons for this were primarily due to the robustness, reliability, high quality construction, and flexibility in the types of cases a surgeon can perform with Western systems, as compared to the SIGN nail that is limited to a more specific application. The reasoning given behind this reinforced the perception that, despite their challenging environmental circumstances, clinical staff in Uganda is equally trained and capable as a surgeon anywhere in the world, and should have access to the same standard of technology as in Canada or elsewhere. This tendency towards Western products is similar to results from Krista Donaldson’s study into product design in Kenya. She found that people generally had “West is best” product bias, having a strong preference for Western designed and manufactured products because of the implicit assumption that it must be better (Donaldson, 2006). Designers approaching innovation in LMIC healthcare must then keep these different ideas in mind when considering what appropriate technology means to and for users. While low-cost and frugal innovations are often a good fit in such contexts, designers must stay attuned to the emotional and perceptual aspects of introducing new technologies. Neither should design be limited by fatalist 108 views of users who do not see a way out of their current situation, nor should designers ignore the importance of professional pride among users and aspirations for equivalency in stature with their counterparts across the globe. 5.1.2 Considerations About Users It is important to consider not only the information gathered about the environment of use and needs that arise, but also how the users themselves take part in the needs finding process, and how they may be leveraged for greater success. 5.1.2.1 Variance in Perspectives of Users and Implications for Designers The ODI process found a general agreement across user types and background. Across most user groups, the top Opportunities identified fell into the categories of contamination and sterility, information and visualization, and alignment and stability. This is a sign that despite being educated in different contexts, clinical staff hold similar values in terms of their priorities and key objectives, namely improved efficiency in clinical practice and improved patient outcomes. Ultimately, in the field of orthopaedic surgery the similarities in terms of anatomy, physiology, clinical indications, clinical team training and curriculum, and desired outcomes outweigh the differences that both culture and East vs. West socioeconomic divergence might suggest. Designers in this field then can expect that users’ perspectives on clinical practice and objectives to be similar both in the West and in an LMIC setting. Since embedding oneself long term in an LMIC medical context can be expensive and restricted, designers may thus cautiously consider the more easily available Western clinicians at home as a reasonably representative user group at various staged of the design process – so long as conclusions and design decisions are also periodically validated with the actual intended LMIC users in situ. A difference that was identified in the ODI results between surgeons and nurses was the surgeons’ tendency to prioritize technical goals, while nurses prioritized softer patient-centric goals. This was evident as well from the CP results which showed surgeons focusing on specific technical steps that must be performed on the patient (e.g. drilling, nail locking), while nurses’ responses were much broader, often focusing on the systemic challenges they faced, their role in ensuring the operating runs smoothly and on time, concern for macro level issues that may affect the 109 patient’s outcomes and how they might mitigate these for and with the rest of the clinical team in theatre (e.g. consistent implementation of the WHO Safe Surgery Checklist). Designers may keep this in mind when approaching different hospital stakeholders for design inputs in the needs finding process, and consider adding extra emphasis during ethnography and interviews accordingly with different user types based on their tendency towards technical or people-centric thinking. Between Ugandan and Canadian users, while there was significant agreement on challenges, it is noteworthy that a majority of Uganda’s top ODI Opportunities had to do with specific technical challenges they faced mid-surgery, while Canadians seemed to take a more long-term and patient-centric view with Opportunities that focused more on outcomes. Among Western clinical teams involved in a similar design exercise, Martin similarly found that “the well-being of their patients was the primary concern of all of the health professionals interviewed, with any difficulties or inconveniences they experienced being seen as very much of secondary importance. This goal-driven culture that is characteristic of the healthcare industry has important implications for device developers” (Martin, 2012). While this is consistent with the sentiments of Canadian clinicians in the ODI results, we believe there is however value for designers to keep in mind that while Western clinicians may give high priority to longer-term positive outcomes of the surgery, their brief exposure – typically on surgical missions, some of who only travel abroad to teach and not practice – to the LMIC healthcare context may be too limited for them to have fully understood the burdens of day to day surgical practice that are faced by local LMIC clinical staff. Designers should not overlook potential improvements on the technical frustrations faced and highlighted by LMIC end users, since these have a direct impact on the longer-term objectives that a Western clinician may focus on. As we have seen, the many small technical challenges faced at every step of surgery have a significant compounding effect on efficiency, safety, time delays, patient throughput, and staff morale, and are thus worthwhile difficulties to mitigate through design. In picking which problems to focus on, there needs to be a balance between higher level objectives of the clinical work, such as improved patient outcomes and reduction in complications, and the more basic and functional requirements of day to day work, which impede and frustrate a clinician trying to perform their most basic tasks. 110 In some instances, relying on expert users who are foreign to the desired use context can be misleading, or may leave out key insights about what the actual intended users may value and need. This was evident in the comparison between Ugandan and Canadian surgeons’ ODI responses, and specifically with certain objectives that Ugandans rated with a high Opportunity Score, whereas Canadians did not. An example of this is the difficulty of transferring patients between different hospital beds, stretchers, and the operating table. This was ranked by Ugandans as having an Opportunity Score of 14.1, whereas Canadians ranked it with only 4.2. The hypothesis here is that this is a challenge that gets overlooked by foreign clinical teams when visiting Uganda because they are coming from an environment that is resource rich, and these small impedances to day-to-day work, productivity, and safety are taken for granted. This should be taken under consideration for Western designers who use a Western clinical user group in early focus groups or testing of ideas since their perspectives, while aligning more often than not with LMIC users on general good clinical practice and goals, may lack some of the nuance that an LMIC user has repeated daily exposure to in their own environment of work. A final interesting insight was that according to the ODI results, surgeons seemed to view Opportunities as more important, and to be less satisfied, than their nursing counterparts. This is worth exploring further in a future study, and something for designers to keep in mind as they leverage different hospital stakeholders in the needs finding process. 5.1.2.2 Design as a Means of Improving Healthcare Worker Morale Frustration was a theme that emerged throughout the Cultural Probes data and was caused by a multitude of ongoing technical and systemic challenges, frustrations with corrupt and unsafe practices by their peers, and emotional burden from observing patients suffering due to delays that are beyond their control. In a study by Delobelle, the majority of South African nurses surveyed (n=143) reported dissatisfaction with working conditions and pay, with half considering leaving their post within two years (Delobelle, 2010). What the Cultural Probe research showed was a high level of engagement and positive response from nurses, surgeons, and residents, which is an indicator that engaging clinical users in a participatory co-design process has the potential to reduce this risk of attrition. Inclusion of clinicians in the early stages of innovation can help frustrated staff feel heard, give an outlet for sharing their challenges, and for feeling valued and 111 appreciated and empowered to be a part of the problem-solving team. Not only does inclusion promote these positive feelings, further expanded upon in the next section, but seeing that initiatives for innovation are underway at their institution may naturally lead to an increased sense of hope and optimism. 5.2 Putting the Results into the Greater Context It is important to understand how these results fit into the greater context of the literature, what can be learned from others’ experiences, and what insights this study can provide to researchers in the future. The surgical and clinical results, such as technology gaps and systemic issues that were identified, are consistent with gaps reported in various previous studies by Bouchard, Malkin, and the WHO Mismatch of Medical Devices report. As these clinical results were discussed in the previous section, this section will instead focus on how the use and success of the CP and ODI results fit into the broader literature. Since the main purpose of this research is to understand whether the methodology is effective, we can contrast the experience in this research with that of other studies in the field. A number of lessons can be learned as we compare this research study with the literature. 5.2.1 Cultural Probes Experience Compared to Literature Similarities and insights can be drawn from Crabtree’s research using Cultural Probes in a clinical environment working with patients in a care home. While Gaver’s intention for use of Cultural Probes was to inspire design (Gaver, 1999), Crabtree took a more conservative approach. Acknowledging the sensitive and challenging environment of data collection in a clinical setting, he aimed instead to collect data to inform and shape design (Crabtree, 2003). Rather than treating the Cultural Probes as a source of complex reflections, they were instead treated only as analytical and factual resources. In the case of the Ugandan research in this thesis, the results are a mix between deep reflections and insights provided by some users through journaling, and more basic journal entries submitted with more literal descriptions of the procedure types performed in a given day and nothing else. Interestingly, the more insightful and lengthy reflections came from younger 112 clinical staff and those with lower stature, while senior surgeons provided less rich and more literal information. This indicates a higher likelihood for younger, less powerful hospital stakeholders to be more valuable cultural informants. This is likely due to their opinions often being undervalued by administrators and senior colleagues, while this research provided them a unique channel to be heard. In a study of 31 seniors living in their homes, Wherton also found similar engagement results to those from the Ugandan study. Those findings saw a high level of engagement from some participants, while others used the Probes minimally due to limited literacy, time, and other factors (Wherton, 2012). Wherton found the method specifically useful when having conversations with non-English speakers through an interpreter. With regards to the usefulness and ease of understanding of the results, Pecknold (Pecknold, 2009) and Crabtree both found that the photos resulting from the disposable cameras were difficult to interpret, and the results were considered “trivial” rather than filled with deep meaning. This is consistent to the experience of the photos retrieved from the Ugandan clinicians. Despite the challenges with the Cultural Probe method, both Crabtree and Pecknold consider their use successful “as a means of including unusual and often ignored groups of users in collaborative analysis of the design domain”. Both researchers in their separate studies acknowledge as well that “it is undoubtedly the case that our respondents have enjoyed using - and misusing - the probe packs” These sentiments and experience of misuse were found to be the case with Ugandan clinical participants as well who reported enjoyment and gratefulness for the opportunity to participate in the research, and felt empowered by it, while also misusing the probes by taking personal photos with some of the available exposures on the cameras. Soro suggested that the Cultural Probe process may produce better results if led by researchers through collaborative workshops, rather than the users left to their own interpretations of how to use Cultural Probe packs. He referred to this alternative guided approach as “manned cultural probes” (Soro, 2016). In the case of the Ugandan surgery research, such a “manned” approach may have been more valuable for the disposable cameras, as they may be more likely to be used correctly had a researcher walked through the hospital with the participant to experience “a day in their life” while the photos were taken and narrated by the clinician. The journals however are 113 thought to have been executed effectively as done in this study, and a “manned” approach would have perhaps removed some of the intimacy and vulnerability afforded to the participant by their ability to fill out the journals at home without immediate judgement by the researcher. A key benefit identified in this research was the less intrusive nature of Cultural Probes as compared to ethnography or in-person video recording and observation, which was echoed by other researchers using this method in the healthcare field such as Hassling (Hassling, 2005). In her study, the family of a boy with diabetes were given a Cultural Probes pack to better understand life with the disease. Hassling’s results reinforce an explicit decision made in this Ugandan research, which was to not give specific instructions to participants for the cameras, but rather provide them high-level guidance. Unlike Pecknold who created custom-made packaging for the disposable cameras that listed exactly what each photo should be composed of (e.g. “This is what I wear on my feet”, or “this is my favourite drink”), Ugandan participants were asked to “show me what you value, what you think might surprise me as a Canadian or as an engineer.” Hassling concluded similarly that “in order to get data from processes that in an observational setting would not be initiated, we found that the subjects should not be given detailed instructions on what to document.” In other words, participants might do certain things in their regular day-to-day work that, when given too much instruction in an observational setting, they might intentionally or unintentionally omit or change. Wherton provides a summary of many of the critiques of the CP method, calling it a superficial tool that can “distract the research gaze from the complex social and political determinants that structure and constrain human action. For example, the collection of image-rich and evocative data from an individual using Cultural Probes may inspire the creative imagination to produce new technologies, but this approach allegedly ignores the fact that the individual could never afford to buy the technology whose design they have inspired” (Wherton, 2012). This may especially be relevant in an LMIC context where the complexity of the socioeconomic, political, and cultural landscape is very different from that of the designer’s. In general, the literature has many examples of Cultural Probe use with patients and caregivers, but far fewer examples of the method used with clinicians and hospital staff. Wherton confirms 114 that to be the case, that Cultural Probes in general have had limited use to date in the healthcare field (Wherton, 2012). Thus, the research in Ugandan surgery focusing specifically on clinicians adds a valuable perspective to the literature on how these methods can be expected to be implemented, to be received, and ultimately how to derive a rich data set and insights from its application with such a demographic. 5.2.2 Outcome-Driven Innovation Experience Compared to Literature The literature around the use of ODI, and specifically case studies and research papers describing its use appear quite limited. Instead, there are a number of whitepapers on the topic, but these are mainly descriptive and marketing pieces for the methodology and the company behind it. This may have to do with the nature of ODI as a methodology that grew out of a consulting practice at the company Strategyn (San Francisco, California), with its application primarily for corporate clients in industry who likely do not publish the results of such consulting engagements. Because of this lack of literature on how ODI has been used in the field, a more valuable discussion can be had in the following section that considers the value of similar mixed methods approaches (i.e. CP and ODI). 5.2.3 Combination of CP and ODI There is no specific reference in the literature to anyone having used CP and ODI together in the past, however we can still draw conclusions from other research that uses a mixed-methods qualitative and quantitative approach. Hassling concluded in her work that using self-documentary material with participants (i.e. Cultural Probes) was insufficient for comprehensive requirements elicitation. She suggested future work to include also interviews, workshops, task analysis, and goal directed design that could add more richness and a goal-specific rigor to the results. This points exactly to the value of ODI as a supplementary method to CP, as its focus is specifically on the participants’ goals. In contrast, however, Sale argues that qualitative and quantitative methods cannot and should not be combined for useful cross-validation or triangulation, but should be limited to consideration as 115 complementary methods (Sale, 2002). Sale even argues that the two cannot be considered to enrich the understanding of the same phenomenon, because by nature, the two methods cannot study the same phenomenon. Further, she argues that by attempting to combine the two, there is a strong risk of misrepresenting and losing the data and information, since the attempt to unite the two paradigms “promotes the selective search for similarities in data.” Reflecting on this concern with regards to the Uganda research and results, the loss of information did not seem to be an issue. The most prominent ODI categories and Opportunities, and the most prominent CP themes were all considered carefully and described at length in this thesis, irrespective to whether or not each had a counterpart across methods. 5.3 Improving the Design Process 5.3.1 Successful Collaboration Between Engineers and Clinicians In a study across three different countries, Yoda identified a number of factors that clinicians and engineers both saw as important for successful collaborative projects between them, and also identified factors that would be a hindrance to success (Yoda, 2011). These positive and negative factors are presented in Figure 38 and Figure 39 below: 116 Figure 38 - Factors that can contribute to the success of cooperation between medical doctors and engineers While this data from Yoda comes from across the globe in Asia, Europe, and North America, all three of these are highly developed and industrialized countries, unlike Uganda. Despite this, evidence from the CP and ODI results points to similar experiences and perspectives. Among the key factors for success that were highlighted by Yoda among both clinicians and engineers are 1) availability of funding, 2) a mutual recognition between engineer and clinician that they need each other’s knowledge and experience, and 3) a personality match between engineers and clinicians. While funding for innovation was not a topic of relevance or discussion in the CP or ODI process, the other two items are certainly applicable. This was evidenced in a general sense of positivity and optimism among participants with regards to their participation in this research and in the innovation process. Unprompted, participants openly shared positive sentiments towards the research and the desire for mutual learning in their CP journals: “You should know that I am someone who likes visitors at my country and welcomes any person that I meet in life because life is like a circle, you never know where I will meet you again after and its good to meet new friends because then you can share new ideas with others and help each 117 other so that we are able to make better the working environment for ourselves and for the visitors. We are even able to share and relate changes that will learn from each other” (P7). Another resident remarked in their journal reflection that “what Florin is doing of first understanding the system here and seeing how to design technology that suits it is the best. But Florin, don't forget to get feedback from us” (P13). This is encouraging and gives optimism to designers who want to innovate for and with these end users, as there appears to be a strong willingness among clinicians in such contexts to collaborate, share their perspectives, and learn from Western designers too. The personality match also is hypothesized to be a key factor in the richness of the data collected in this study and the vulnerability shown by participants in their data reporting, which is further described in the next section. 118 Figure 39 - Factors that can contribute to the failure of cooperation between medical doctors and engineers The key negative factors that contributed to the failure of collaborations between engineers and clinicians according to Yoda are 1) lack of funding, 2) a personality mismatch between engineer and clinician, 3) a lack of commitment from the engineers and clinicians for the innovation project, 4) a knowledge gap among both engineers and clinicians for the other’s field, and thereby being unable to understand each other, and 5) a difference in the culture and value systems of the engineers and clinicians. It is believed that issues 2-5 were mitigated through the nature of how this study was conducted, and it is recommended that future designers take a similar approach. In particular, there was a strong commitment held by the primary author for complete and long-term immersion in the end users’ environment. That, paired with a background in biomedical engineering and experience shadowing and innovating in the operating theatre context in Canada, led to overcoming the knowledge gap, as well as demonstrating to participants the level of commitment by the author to this research. 119 Secondly, there was a strong commitment to the development of personal relationships between the author and participants, which was inherent to the nature of the surgical mission that this research was a part of. By forging strong social connections with end users through shared meals and informal experiences outside of the operating theatre, this helped mitigate the potential personality, culture, and values mismatch between the author and clinicians. Lastly, the author maintained transparency with regards to the research objective as being to help improve the delivery of surgical care in Uganda, to approach the problem space with “beginner’s eyes” and maintain openness to learning from and with the clinical staff, and ultimately hoping to help improve the day-to-day productivity and ease with which participants could do their job. This was well received by participants, and is evidenced in their praises for this type of research taking place at their institution. 5.3.2 Improved Access to Users and Willingness to Participate A common problem faced in design for clinical users is access to the participants, who may be reluctant to participate, whether due to lack of time or ability given their busy and unpredictable profession. Common needs finding approaches such as contextual inquiry or asking users to think-aloud while performing their tasks may be challenging in an emergency situation, where the human and medical drama unfolds and pressure is high (Brown, 1999). The findings from the combined methods of CP and ODI are that these “reflection-out-of-action” exercises (Currano, 2011) give flexibility to participants to contribute on their own time and to the best of their ability. For example, some participants found it easy to answer just one or two quick journal questions in the evenings without the pressure of work, while other participants did not have the time for journaling – especially the attending surgeons – but were able to make sure of the disposable cameras to tell their story through that medium. Some of the most committed participants were willing to even sit through ODI workshops lasting on average 2-3 hours. The advice to designers is to leverage the multiple data collection mediums of the CP and ODI methodology to present a multitude of options to participants for participation, allowing each user to contribute in ways that suits their time and preferred means of sharing. 120 It was indeed surprising when analyzing the data just how much the majority of participants contributed, and the generosity with their time and knowledge. The journal reflections by most participants were very detailed and comprehensive, and often participants showed a surprising level of candour and vulnerability in their responses. The strength of the relationship with the designer or researcher is also believed to be a strong factor in the wealth of data collected and shared by participants. Trust-building among Ugandan and Canadian colleagues is a core goal of the Uganda Sustainable Trauma Orthopaedic Program that facilitated this research at Mulago Hospital, and so there was great opportunity to connect with participants in social and informal setting on numerous occasions during dinners and social events. The continuation of personal relationships with participants beyond the scope of the research is an indicator of the level of trust and collegiality between researcher and subject, and surely this played a strong role in the richness of data collection. Given the nature of power dynamics common in the international development community between “donor” and “beneficiary”, designers should make every effort to connect and build trust among the user population in order to create a safe environment for users to share their views and needs candidly. There was a tendency for some participants to share more and participate to a greater degree than others. Nurses and residents were found to share much more nuanced reports in the journals as compared with attending surgeons who might only write a sentence or a few words about their experience that day. In contract to the attending surgeons, nurses and residents often shared deeply emotional and personal details of their work and how it impacted their personal life and perspectives. Being of lower stature and power in the hospital, the nurse and resident participants may have taken this rare opportunity to be heard and to share in a relatively anonymous fashion some of their deepest concerns with the work, their colleagues, and the challenges that frustrate them. For the designer, these types of users may become some of the best advocates for the innovation process at their institution, and prove to be very valuable cultural informants that not only provide rich data but help the designer to navigate the complexities of the clinical system, stakeholders, and cultural barriers. 121 5.3.3 An Easier Alternative for Needs Finding Needs finding is a key step during early stages of design and immersion of designers and engineers in the use environment is critical to spotting and identifying both problems and new opportunities (Martin, 2012). However ,this task is not easy, especially for novice designers and students. In the Stanford BioDesign program, students spend months shadowing and observing a variety of clinical stakeholders in various environments, ultimately required to come up with at least 200 needs based on this direct observation (Brinton, 2013). Ethnography, however, is a challenging skill to learn, especially as it is a skill more common in the humanities than in the engineering design curriculum. The ODI methodology then presents a more structured, replicable, and easy to administer process for needs finding. In a LMIC environment, designers may be exposed to a context, people, and culture that are vastly different from their home environment, if not dauntingly so. In such a case, it may be especially beneficial to apply greater structure to needs finding in order to limit the variables and bring control to a potentially overwhelming process. Furthermore, the BioDesign program as described by Brinton involved a number of iterative cycles of validation and filtering of needs that arise, which could also be accelerated through the application of ODI in this environment since the filtering and validation is done by the users themselves by nature of the ODI process (Brinton, 2013). In a cross-cultural design project in LMICs, the length of time of a trip and thus exposure to the use environment and users may be limited. In such a situation, the integrated nature of filtering and validation of needs within the ODI process is again of benefit, since one or two rounds of interviews and ODI workshops with users is sufficient to produce what countless hours of observation and more traditional validation exercises would. According to Privitera, another challenge with basic ethnography is the tendency, especially for novices, towards “two observational mentalities: the ‘write everything’ mentality, in which the observer will ‘write down everything, putting them into a situation where data analysis becomes a futile effort’ due to quantity; and the ‘write what’s interesting’ mentality, in which the observer will ‘write only what they find interesting,’ whereby filtering the data with their own personal bias” (Privitera, 2009). While personal bias with CP and the Grounded Theory analysis 122 methodology used in this research can be an issue, the use of CP and ODI methods by definition relies on users to self-report their needs, rather than relying on the designer to collect data and potentially fall into one of Privitera’s two observational mentalities. 123 6 Limitations A particular challenge of the CP method was the interpretation and usefulness of the disposable camera photos. Once the films were developed, a number of the photographs were simply photos of the environment or a particular activity mid-surgery. It was often challenging to identify the intended meaning or specific object that the participant was trying to draw attention to. There is also the possibility that some participants did not understand the purpose or use of the cameras, or they ran out of time and patience to complete the task usefully with all 24 available exposures. A similar experience was described by Pecknold when using disposable cameras with women in a village in Rwanda (Pecknold, 2009). It is thus recommended that future researchers do use cameras as probes, but that they be relied on as supplementary data to support other more reliable and robust means of communicating from the users to the designer. A challenge with applying the ODI methodology in a low resource environment such as this was that the vast majority of the Opportunities identified had been ranked with an Opportunity Score that is deemed as high, very high, or extremely high opportunities for innovation. Almost none of the potential Opportunities were ranked with low Importance or low Satisfaction by participants. This is an artefact of the context of the research study where there are many challenges that users face in their work on a daily basis, as covered in this thesis. With so many Opportunities ranking so highly, it makes it difficult for designers to understand relative importance of the Opportunities, and where one might dedicate further time to develop solutions for the top Opportunities. Another limitation of this study is due to the single site that was evaluated, namely Mulago Hospital. The scope of this research was limited due to time, funding, and access to alternative LMIC clinical groups beyond what was facilitated through the Uganda Sustainable Trauma Orthopaedic Program. The results in this study are therefore difficult to extend to other hospitals in Uganda or across other LMICs globally, though based on anecdotal stories from participants about their time in other institutions, similar themes could be expected to be found elsewhere. Furthermore, due to the complex and institution-specific culture and function of healthcare, it may be wise for designers to use this similar methodology at any site they wish to innovate at, and not 124 simply assume that the way surgery is performed and the barriers to efficacy and efficiency from one hospital are the same as those at another. 6.1 Researcher’s Bias Before beginning to share the results, and even before analyzing the data, it is important that the audience and the researcher both take into account the existing biases of the person conducting the study. These biases can include a person’s background, such as cultural, professional, education, and personal experience. It can also include beliefs and biases that are resultant from these experiences. Interests, perspectives, and ways of seeing the world are all part of this. By acknowledging these, it gives transparency to what and where the resultant emergent theories’ and concepts’ grounding. In this case, the author of this research thesis is a 30 year old Canadian male born in Romania, with an educational background in mechanical and biomedical engineering. Professionally, the author has spent the past 5 years working on developing and commercializing medical devices that are radically affordable and intended for use in low-resource settings, with a specific focus on orthopaedic surgical power tools. Prior experience has been in the field of medical device design and innovation, as well as international development in East, Southern, and West Africa. While there may be a number of conscious and sub-conscious biases arising from this profile, the key ones are likely as follows: First, this research and analysis is done through the lens of a Westerner, who, despite years of clinical and non-clinical work across Africa, cannot have the nuanced understanding and perspective of a local clinician in the Ugandan context. The analysis will be driven by the value system of someone from North America. Second, the analysis is done through the eyes of an engineer and designer. This means there is a bias towards looking deeply at the technology more so than the people, patients, anatomy, physiology, or pathology. The bias is to looking at how users interact with devices more so than each other or with the body, and how technology works or doesn’t work for the user to accomplish their technical or clinical goal. 125 Third, the analysis is done through the eyes of someone who has been developing and commercializing medical technology for use in orthopaedic surgery in a place like Uganda for the last half a decade, meaning there is a great deal of intimate knowledge of the design space, the industry, and the use environment, as well as many of the challenges present in designing medical equipment for these settings. It is challenging to look at this with completely fresh eyes given the depth of exposure to this area already, and to ignore the biases from having learned, failed, and succeeded at innovation in this space. Lastly, this analysis comes with the bias of someone working in international development for several years, both in healthcare and beyond. The bias this brings is one of having pre-conceived notions of how development works or doesn’t work, how systems are broken due to local corruption, lack of resources, and also the failure of the international donor community. This thesis is also written with an appreciation for how the resilience and strength of the “beneficiaries” of development projects – often the poor that we as Westerners are trying to help – can and are actively improving their lives in ways foreigners with good intentions cannot. 126 7 Technology Design Project The previous chapters were successful at identifying a number of key opportunities for innovation. Many of these could have a significant impact on the efficiency, safety, and satisfaction of various stakeholders across the healthcare continuum at Mulago Hospital, and likely beyond that in orthopaedic surgery in LMICs. In addition to the ODI results that directly identified these target focus areas, the CP results helped to paint a nuanced picture of the context for these innovation opportunities. While the main portion of this research was complete, it was decided that a technology development project would be undertaken in order to see how the next steps of the design process would unfold as a result of the inputs provided by CP and ODI methods, and out of an entrepreneurial spirit, to see if a solution could be found to one of the most critical challenges identified. 7.1 Canadian Workshops Upon return to Canada and initial analysis of the data from the CP and ODI methods, one of the key issues that stood out and was re-affirmed repeatedly by participants was the difficulty they had in managing old fractures. Since patients on average wait a month for surgery at Mulago Hospital (O'Hara, 2016), the bone tissue begins to heal in a malunion, while the muscles and soft tissue contract, making it difficult for surgeons to re-break the bone, reduce, and align the bone fragments. This is made worse by the lack of a traction table for placing the limb into traction and using the mechanical advantage afforded by the table to lengthen the limb. For this reason, a technology design project was embarked upon by the author. Two groups of 4-6 biomedical engineering students and orthopaedic surgeons each were brought together for ideation workshops. Participants were led through some of the findings from ODI and CP work in Uganda, and familiarized with the problem and context. Figure 40 below is an artefact from the introduction phase of the workshops. 127 Figure 40 - Context provided to Canadian participants in design workshops Participants were also introduced to the two current methods as witnessed and used by Ugandan surgeons to deal with these cases, namely 1) applying manual brute force by several of the clinical staff to distract the tissue, and 2) stripping a significant amount of soft tissue and periosteal tissue from around the bone in order to allow greater manipulation of the two bone fragments, allowing them to be brought into contact at an angle and the bones levered into a parallel position. This second method is particularly damaging to the patient since it 1) results in a significantly larger exposed wound that increases the risk of infection, 2) strips away critical periosteal tissue from the bone, reducing blood flow to the bone tissue, and 3) places a tremendous amount of pressure and 128 force on the bones at the fulcrum where they are levered against each other, often causing the bone to splinter or fracture further. Participants were then led through an activity to break down the process of reducing and aligning the bone fragments into functional steps. These are shown in Figure 41 below. Figure 41 - Functional steps in the bone reduction and alignment process (Group 1) This process also led to the development of a series of Problem Statements to guide the further brainstorming of solutions: 1. Delayed treatment of fractures results in significant muscle contractures, making reduction difficult 2. Existing techniques are inadequate for overcoming muscle contracture forces to re-gain length 3. Existing devices (e.g. femoral distractor) are limiting for easily manipulating fragments in 6 degrees of freedom, while holding length 129 Figure 42 - Required translation and rotation during reduction and alignment process The groups then spent some time discussion possible design solutions for this problem statement, which are shown in part in Figure 43 as a design artefact from the activity. Figure 43 - Design artefact from innovation workshop The ideas from these workshops, and specifically the critical function diagrams, were used to inform a further design step by the author to create a prototype solution. 130 7.2 Bone Reduction and Alignment Device Using the insights from the workshops with students and surgeons, as well as the ODI, CP, and ethnographic observations in Uganda, a bone reduction and alignment device (BRAD) was developed, as shown in Figure 44 below. Figure 44 - Bone reduction and alignment device (BRAD) 131 Figure 45 - Components of the BRAD The device consists of forceps-like handles (D, H) on each side that are used to grasp and lock on to the bone fragments (E). To these handles are attached a series of lockable U-joints for angulation (C), lead-screws (B, F) for translation across different axes, and an additional lockable rotation arm (A) for rotating the construct and providing translation in the third axis. Figure 46 – Bone-tool interface (up close) Figure 47 – Bone-tool interface (cross-section) At the bone-tool interface, a hole in the forceps tip allows for insertion of an inter-locking K-wire that prevents the forceps from rotating, sliding, or coming loose when external forces are applied 132 to the device and construct. The placement of the hole in the forceps tip allows for insertion of the inter-locking K-wire into a single cortex of the bone. This keeps the IM canal clear for insertion of an IM nail after reduction, if required. The following images in Figure 48 show close-up views of the device components: Figure 48 – Various close-up shots of BRAD device sub-components 7.3 Ugandan Feedback The BRAD device was sent to Uganda on the next available USTOP trip with Canadian surgeons who were trained on its assembly and use. During the trip, the USTOP team was able to perform several individual and group interviews, which were audio and video recorded. Despite training and a detailed instruction set, it was evident in the recordings that USTOP team members still had a hard time with assembling and demonstrating the device. This also became one of the core pieces of feedback from Ugandan surgeons, that the device was too cumbersome, 133 difficult to use, and also quite big and heavy. They reported that they mostly would not like to use such a device in their practice. This feedback in itself is interesting for reasons beyond just understanding that the device appeared too cumbersome and bulky. First, it is surprising that despite how big of a challenge it is to reduce and align old fractures, both in terms of the physical and time burden on staff members, and also the significant increase in risk of infection and secondary fracture to the patient, the BRAD device proved to be not worth the hassle. Surgeons showed a willingness to “brute force” their way through the problem. This is an indication to designers that user preference, perception of usability can often trump potential safety improvements. Furthermore, some burdens faced by users that would otherwise seem of great importance through the designer’s eyes may not be great enough to motivate change. Second, it is the experience anecdotally of the author both in Canada and Uganda that clinicians and engineers/designers tend to hold quite different perspectives on the role of prototypes. Engineers and designers are aware that prototypes can exist in various levels of fidelity and finish, and that different kinds of prototypes serve different aims and learning objectives. For example, a critical function prototype may be visually unappealing, focus solely on proving the technical objective, or even an isolated function within the overall technology concept. Conversely, a look and feel prototype may have zero functionality, aside from testing ergonomics or perception of the form factor. This kind of language and understanding of the role of different kinds of prototypes does not exist in the medical field as it does in the product design field, and so it is important for designers to be aware of how early prototypes will be viewed. In the experience of the author, critical function prototypes, that otherwise performed very efficaciously, may be given immediate negative reviews from clinicians who envision how well this crude prototype, in its current form with all its usability and ergonomic flaws, would fit into their busy and complex workflow. This was also the experience of seeking and receiving feedback on the BRAD device. One surgeon gave an insightful view on the usefulness of such a device in Uganda. “In the Western medical world, everything is aimed at reducing the number of assistants. Here in the developing world, we have no shortage of manpower.” This is an interesting consideration for designers, that tools which optimize efficiency, especially of human resources, may not be perceived with equal value or importance by an LMIC user or administrator. Put another way, a technology whose main 134 benefit is an increase of human resource or workflow efficiency may not be something seen as worth spending precious procurement budget dollars on. There was positive feedback on the device as well, with surgeons liking the way the bone-tool interface locked onto the bone through a K-wire placement into the single cortex. This was very positively seen since forceps that are commonly used for manipulating the bone fragments were reported to slip off the bone due to the high forces applied manually. This is a design feature that may prove useful in other technology where a bone-tool interface is required to withstand greater application of forces. Finally, one of the most senior surgeons interviewed was open to the technology, recognizing the positive change something like this could bring. There was a willingness shown to try it clinically, even in a rough prototype format, since “only by putting it into use will we know whether it can prove useful or not.” 135 8 Future Work 8.1 On Increasing Access to Safe Surgery Through Technology Focus With regards to further research and work towards making an impact on the efficacy, efficiency, and safety of orthopaedic surgery in LMICs, it is the opinion of the author that efforts focused on technological design are misplaced. Rather, innovation efforts should be directed towards business model innovation, as well as innovation in holistic programmatic delivery of healthcare interventions. This perspective is formed not only on the research in this thesis, which shows technology challenges to make up only a portion of the overall concerns of participants, but also based on real-world experience of building and running a medical device company focused on commercialization of medical devices in LMICs (detailed in the final chapter of this thesis). From the research data, it is evident that a number of technology challenges are amplified by a system lacking in effective management of technology, human resources, and patients; systems for timely communication; and appropriate planning and organization before, during, and after surgery. From the past 5 years of work at Arbutus Medical Inc. a continual challenge has been no with the technology, but with sustainable commercialization and large-scale roll-out of the DrillCover product. While the device, a radically affordable alternative to surgical drills, is a great fit for user needs and is often lauded by surgeons across LMICs for its innovativeness, reaching scale has proven difficult. This has been due to difficulties in finding reliable distribution partners and sales channels, the complexities surrounding local regulatory requirements, and the willingness and ability of end users or their hospital administrators to pay for the technology. Some of the greatest success stories for global health impact made through medical devices has come from innovative companies and non-profits that look beyond the technology itself, to instead 136 focus on achieving scale in the delivery of a healthcare intervention, while doing so in a way that is financially viable across all stakeholders. An example of this is Medtronic’s Shruti program currently being implemented in India (Medtronic, 2018). In order to combat hearing loss, Shruti uses a low-cost endoscope device, the ENTraview, for inner ear monitoring as part of a larger community healthcare effort that bridges the gap between the community and high quality specialist care. In the field, community health workers (CHWs) are trained to recruit community members to screening events in the area. These CHWs are then trained to perform basic information gathering through patient interviews and through the use of the device for diagnostic purposes. The ENTraview uses algorithms to identify patients who are likely in need of further care, and sends their diagnostic images to a cloud platform that is accessible by physicians across the country. Patients deemed to be in further need are referred to an even higher level of specialist or surgeon. In this program the technology is a small part of a broader community initiative that works across many level of the care continuum to efficiently bring the patients most in need to specialists who are in high demand. There is a need for similar programmatic approaches to delivering improved orthopaedic surgical care, and so the recommendation of this thesis that further study into how access to care may be improved take a focus that is at a higher level than just technical innovation. 8.2 On Participatory Design Methodology in LMIC Healthcare In terms of future work on improving the process of participatory design in healthcare in LMICs by Western designers, there is certainly room for continued learning. One key insight from the ODI methodology was that in a low resource environment where many challenges exist across the system, the majority of Opportunities as described and ranked by participants may result in high, very high, or extremely high Opportunity Scores. This makes it difficult for the researcher or designer to identify which Opportunity to focus on and devote efforts to solving, as they all appear to be of very high criticality. Further research is warranted on how to 137 appropriately apply the ODI process, perhaps modified, to an LMIC context such that it produces results that give clearer direction for next steps to the design team. With a list of over 100 Opportunities resulting from the ODI method, a natural next step would be to continue filtering and refining the list in collaboration with end users in order to collaboratively identify the most valuable areas of focus for the design team, and document that filtering process as it evolves. The winnowing down of Opportunities was not included as part of the scope of this research, but it would be valuable to map out how this should be done in an LMIC context together with users. Future work is also possible on further refinement and validation of the bone alignment device designed as part of this research, as there were insufficient time and funds to include this as a larger and more comprehensive part of this research. 138 9 Epilogue: Arbutus Medical Inc. This research was started in 2011 and evolved through 2012 and 2013 with the support of the USTOP program to bring it to life in the field in Uganda. From 2014 through the better part of 2018, the author took a step back from the research in order to focus on a related technology start-up venture, Arbutus Medical Inc. This experience, and lessons learned as they apply to this research, are presented in this section. Through the Engineers in Scrubs program at the University of British Columbia, a group of graduate biomedical engineering students worked with the same group of Canadian and Ugandan USTOP surgeons to develop a more affordable surgical power tool solution. These students built on previous similar concepts to develop the DrillCover product. This is a sterilisable, reusable, pathogen and liquid resistant barrier that envelops a non-sterile hardware drill and allows the rotary motion of the power tool to pass through a fully-sealed bearing interface in the bag in order to drive screws and pins, and make holes in a sterile surgical environment. The product is shown in Figure 49 below. The key benefit to clinicians, aside from the cost that is less than 10% that of Western surgical drills, is the efficiency gain and increased surgical uptime provided by when having a hardware drill with a number of pre-sterilized DrillCovers that can be used back-to-back. Figure 49 – The DrillCover device (L) and close-up of the sterile rotary interface (R) Following the completion of the Engineers in Scrubs academic program, the student group continued on. At this time, the author joined the team as an advisor, and became increasingly involved as the project sought funding through Grand Challenges Canada, and ultimately 139 incorporated as Arbutus Medical Inc. with the aim of commercializing the technology globally. Since then, the company has raised close to CAD $3 million, launched a number of additional products including an oscillating saw and a cannulated drill with various attachments, all with US FDA and Health Canada approvals. The company has achieved sales in 2017 of over CAD $200,000, with penetration in over a dozen markets across Africa, Central America, Asia, the Middle East, and also in the military and veterinary markets in Canada, Europe, and the US. 9.1 Application of Research Learnings 9.1.1 Integrating Users into the Design Process Dr. Thomas Fogarty famously commented that, when seeking to understand users’ needs, “you’ve got to learn the difference between what they say, what they want, what they’ll pay for, [and] what they actually do” (Fogarty, 2003). For designers this is especially important as clinicians may find technology to be interesting, even just for the science behind it or the novelty factor, but it may not be something they or their hospital would actually pay for, nor be willing to integrate into their workflow. This was the case for the DrillCover product in the market there it originated, Uganda, and even in the hospital where the product was conceived, Mulago Hospital. For the majority of surgeons it turns out, despite the praise for the device and it being a marked improvement over existing technology, the technology was lacking in certain features as compared to Western surgical drills, and so this stalled adoption. This was the case even when the standard of practice at a particular hospital was to use a non-sterile drill, a manual drill, or just to not be able to do any surgery because of lack of power tools! This experience is rooted in the ODI finding that Canadian and Ugandan surgeons prioritized goals on different timescales and with different considerations. The feedback from the Canadian USTOP surgeons was always very positive, saying that the DrillCover is revolutionary in its improvement to sterile practice and increased patient throughput in a place like Mulago where the burden of trauma is overwhelming. The LMIC surgeons on the other hand, with few resources to invest in new technology, would only invest in a power tool that would be a workhorse for them across any kind of procedure they needed it for. Surgeons could not predict the type of case that may present, and thus wanted a tool (and they could only afford to buy one) that could be utilized on any patient, with any fracture pattern, and with any implant. This also reflects on the CP theme of flexibility as a core value of technology, and the requirement 140 for that technology to afford the treatment of many patients with limited resources. For this reason, Arbutus Medical has since grown the product line to include the oscillating saw and cannulated drill with all of the attachments of any major Western brand. It is notable that the need for flexibility for the unexpected was also paired with two related requirements: 1) the prestige associated with owning a product seen as being of high quality, and thus requiring full functionality, and 2) the need for a product that could perform well not only in trauma surgery, but in the hip and knee replacements that made up the majority of the income of many surgeons in the private sector during their off hours from Mulago. This is only one example, and a core challenge experienced by the company, but it is evident that many of the ODI and CP results are interweaved into this example. From the need for drills as a critical piece of equipment, to the values of flexibility, improvisation, and maximizing utility, to the differences in perception of Western vs. LMIC users, many of the learnings from the research are applicable as key insights and warnings for designers. 9.1.2 Designing for LMIC Contexts We have learned that designing for LMIC contexts sometimes means fool proofing the device against the unexpected. As designers have had to expect misuse of the product against the official Instructions For Use (IFU), and mitigate these as best as possible. One such example is that most medical devices should not be decontaminated or washed with a chlorine-based solution such as bleach, as it will quickly degrade textiles and plastics, and corrode metals. Despite an ongoing training campaign and warnings on all of the training materials and IFU, many hospitals where the DrillCover is in use today still use bleach for washing devices. While not completely resistant, our engineering team worked hard to find materials and suppliers for sub-components of the DrillCover that were more resistive to corrosion caused by chlorine-based solutions. A high degree of care and thought was also put into the usability of the device to ensure that even with little training and prior exposure to the DrillCover IFU, users could safely assemble and use the product. As much as possible, we have tried to be cognizant of errors that a user could make which could introduce contamination to the sterile DrillCover. This was learned as we observed inaccurate use and assembly of the product in the field even following extensive training, and is a measure taken by the company in anticipation that extensive training may not always take place 141 given the multiple levels of distribution between Arbutus Medical and the end user and a reluctance for some sales people and clinicians to accept training. Another consideration for the DrillCover is that, while it is a reusable product, it too has a finite lifetime. At Mulago Hospital the re-use of single-use disposable products was a common practice, which meant a high likelihood of the DrillCover being used far beyond its designated lifetime. Unfortunately, this continues to be a challenge despite customer education about the need to discard damaged DrillCovers, the implementation of a manual tracking grid on the product itself, and attempts to financially incentivize replacement. For this challenge, the company is exploring the option to roll-out a single-use version of the DrillCover that is designed to prevent repeat use, thereby ensuring that every use of the DrillCover technology is a sterile one. 9.1.3 Beyond the Technology Innovation Reiterating the comments in the Future Work section, the biggest challenge when innovating for impact in global surgery is not necessarily with the technology. While the device has likely gone through over one hundred iterations in design, a number of clinical evaluations, and is a highly engineered technology, the biggest challenge for the company has been since the beginning the ability to scale commercially and sustainably. As we worked to commercialize the DrillCover in the past five years, we had naively failed to understand just how challenging LMIC markets are, which is evidenced by the failure of Western surgical power tool companies to get a foothold in many of these markets. In several markets we learned this lesson as we tried, and failed, to build and maintain effective sales and distribution channels with partners that we can rely on to pay and do the required sales work. Another significant challenge is understanding and navigating the very opaque procurement process of public and private hospitals in LMICs, where funds are difficult to identify and secure as a vendor, despite money clearly flowing through the system as evidenced by major tenders and government contracts. Today the company has learned and adapted to these challenges, and we continue to navigate the nuances of bringing this product to scale sustainably. Sinha wisely stated that, “to create solutions for developing countries that reflect their needs and value systems requires multidisciplinary needs-finding research, as well as financial and design modeling and business-implementation plans” (Sinha, 2011). 142 10 Conclusion Orthopaedic injury is set to become one of the top three leading causes globally of disability and death in the coming years. Despite the cost-effectiveness and efficaciousness of orthopaedic surgical interventions, the field of global surgery is still disappointingly low on the priorities of governments, non-profits, and the private sector. Of importance to delivering safe, modern, and timely treatment is access to high quality medical devices that enable surgeons and nurses to prevent, diagnose, and treat disease. This access however is limited by a mismatch between the technology that industry is developing and what is needed in LMIC contexts. Technology designed for use in the West is often out of reach of affordability for LMIC hospitals, and often inappropriate for use in these contexts due to factors that include lack of maintenance and repair capabilities, lack of appropriate training for users, a mismatch between equipment operating requirements and the available infrastructure. Since affordability is an issue, donors in the West commonly donate used medical equipment to LMIC hospitals, but nearly three quarters of all donated equipment is found to not work within one year of donation, much for the same reasons of lacking reparability, training, and other infrastructure and human issues. While there is an increase in local design and manufacturing of medical equipment in LMICs, much of the global medical device market is still fed by industry in the West. Therefore, in order to enable clinical staff in LMICs to care for patients through the use of technology, Western designers and engineers must improve the way they approach the design of medical devices for – and with – LMIC end users in the process. This research has examined two methods for participatory design of medical devices in LMICs that seek to overcome two gaps in understanding between designers and their target user group: a different cultural background (i.e. Western vs. LMIC), and a different professional background (i.e. engineer/designer vs. clinician), also referred to as the “Expert User” problem. The use of Cultural Probes (CP) and Outcome-Driven Innovation (ODI) has enabled the author to easily perform a detailed needs finding and filtering, which is a critical early step of the design process. These two methods brought structure to an otherwise ambiguous process that typically relies on more open-ended and ambiguous ethnography and observations. Furthermore, unlike needs 143 finding through ethnography, which results in a list of opportunity areas defined by the designer, the methods applied in this research led to a vast range of opportunities defined and ranked by users themselves. The methods of CP and ODI are ideally used together as they help triangulate and identify the most important areas for innovation. Designers are encouraged to use these methods in LMIC innovation exercises, and continue to build the knowledge base on how these are applied across different fields, from med-tech to the fin-tech to ag-tech and beyond. It is clear from the results of this research that LMIC healthcare workers face a myriad of challenges across all domains: technology, systemic, infrastructure, staff, and patients all contribute to difficulty in providing timely, safe surgery. Some of the key technologies that were highlighted time and again by end users as lacking or not meeting their needs are: imaging devices, adjustable traction operating tables, power tools, the implants themselves, and many more. The users’ perspectives shared in this research inform both future technology donations, and how the design of technologies should match the users’ value system when it comes to technology. Among the aspects valued by end users is the flexibility afforded by technology in their unpredictable context of use, as well as the affordance for users to improvise and stretch their resources across as many patients as they can. Another top theme identified is the richness of the information environment afforded by technology, which enables users to work efficiently, safely, and make evidence-based decisions. These results give designers insight into which technology areas are the most underserved at present, and which attributes of technology might warrant special consideration in the design process. From the ODI results, the top opportunities for innovation were identified to fall in categories of 1) reducing contamination risk, 2) improving information availability and visualization, and 3) improving alignment, stability, and accuracy in the process of reduction and fixation of a bone fracture. The detailed list of Opportunities gives over 100 needs as starting points for designers to innovate in this field. Through the ODI process it was also valuable seeing how different groups of participants (i.e. surgeons vs. nurses, Canadians vs. Ugandans) responded to and ranked the Opportunities through their own unique lens, giving designers insight into how to leverage both Western and LMIC clinical users, and which hospital stakeholders might prove to be invaluable cultural informants. 144 From these results, the design of a bone reduction and alignment device was prototyped. The resulting feedback from users gave insight into the perceptual differences between designers and clinicians when it comes to prototypes of varying fidelity levels. As well, it gave insight into the importance of usability and the significant barrier to changes in workflow and practice, even when the current practice is acknowledged to be physically taxing for users and pose serious safety risks for the patient. The many lessons from this research have been applied in the past five years to the development and commercialization of the DrillCover portfolio of products through Arbutus Medical. While not perfect, it is encouraging to see these many design insights being applied towards the aim of appropriate medical device design, and it is hoped that they may inspire and empower the greater medical device industry to similarly increase their focus on designing medical technology that fits the needs and budgets of LMIC clinicians and patients. It is our hope that industry, engineers, and designers take the lead by leveraging these participatory design methods when embarking on medical device innovation projects for LMIC users, and most importantly, include these users in a collaborative design process for a higher likelihood of success. 145 11 Bibliography Accenture. (2011). Achieving high performance: Reinventing medical technology for a dramatically different future. Adam Images. (2018, August 30). Retrieved from Adam Images: http://www.adamimages.com/ Adams, J. (2001). Conceptual Blockbusting: A Guide to Better Ideas. Cambridge: Perseus Publishing. Adu, P. (2018, July 12). Qualitative analysis coding and categorizing. Retrieved from Slideshare: https://www.slideshare.net/kontorphilip/qualitative-analysis-coding-and-categorizing Anonymous. (2012, January 27). Industry Representative. (F. Gheorghe, Interviewer) Backman, G. (2008). Health systems and the right to health: An assessement of 194 countries. Lancet, 372(9655), 2047-2085. Banerjee, M. (1999). Beyond kappa: A review of interrater agreement measures. Can. J. Stat., 3-23. Beyeza, D. T. (2012, October 2). Interview about orthopaedic practice at Mulago Hospital. (F. Gheorghe, Interviewer) Bhatti, Y. (2011). What is frugal? What is innovation? Towards a theory of frugal innovation. Working Paper. Said Business School. 146 Bouchard, M. (2011). Responding to the Global Injury Burden by Improving Access to Orthopaedic Medical Devices: A qualitative case study of orthopaedic services in Uganda. Thesis. Brinton, T. e. (2013). Outcomes from a Postgraduate Biomedical Technology Innovation Training Program: The First 12 Years of Stanford Biodesign. Annals of Biomedical Engineering, 1803–1810. Brown, D. M. (1999). Device design methodology for trauma applications. Computer Human Interaction (CHI), (pp. 590-594). Brugha, R. (2011). Training non-physician clinicians to deliver surgical care in Africa. Conference of the College of Surgeons of East, Central and Southern Africa (COSECSA). London: Royal Society of Medicine. CIA. (2012). CIA World Factbook. Covidien. (2012, August 12). Covidien opens US$45 million R&D facility in China. Retrieved from http://investor.covidien.com Crabtree, A. e. (2003). Designing with Care: Adapting Cultural Probes to Inform Design in Sensitive Settings . OzCHI (pp. 4-13). Brisbane: Ergonomics Society of Australia. Currano, R. S. (2011). Characterizing reflective practice in design: What about those ideas you get in the shower. International Conference on Engineering Design (ICED11). Dandekar, V. (2016, April 9). US Firm Stryker banks on India R&D to gain edge in emerging markets. The Economic Times of India. 147 Das, R. (2012). Asia pacific healthcare outlook 2012-2015. Frost & Sullivan. DCP2. (2006). Financing Health Systems: Severe challenges exist for low-income countries in setting health priorities and financing health systems. Disease Control Priorities Project. Delobelle, P. e. (2010). Job satisfaction and turnover intent of primary healthcare nurses in rural South Africa: a questionnaire survey. JAN, 371-383. Deloitte. (2012). Securing the next level of growth: Second tier emerging markets. Retrieved from http://www.deloitte.com Donaldson, K. (2006). Product design in less industrialized economies: constraints and opportunities in Kenya. In Res Eng Design. London: Springer-Verlang. D-Rev. (2012, January 29). Brilliance: World-class jaundice treatment for low resource settings. Retrieved from Design Revolution: http://d-rev.org/projects/brilliance/need.html D-Rev. (2012, January 28). Jaipur knee: A high-performance knee joint for developing world amputees. Retrieved from Design Revolution: http://www.d-rev.org/projects/remotion.html Dudley, E. (1993). The Critical Villager: Beyond Community Participation. London: Routledge. Duflo, E. B. (2011). Poor Economics: A Radical Rethinking of the Way to Fight Global Poverty. New York: Public Affairs. Elkins, T. (1997). Fistula surgery: Past, present, and future directions. Int Urogynecol Journal, 30-35. 148 Embrace. (2012, January 28). Embrace, a Low Cost Infant Warmer. Retrieved from http://embraceglobal.org/ FDA. (2018, June 29). Medical Device Overview. Retrieved from Food and Drug Administration: https://www.fda.gov/forindustry/importprogram/importbasics/regulatedproducts/ucm510630.htm Fogarty, T. (2003, January 27). From the Innovators Workbench: Medical Technology Innovation Series. (D. Cassak, Interviewer) Funk, L. e. (2010). Global operating theatre distribution and pulse oximetry supply: an estimation from reported data. Lancet, 1055-1061. Gaver, B. D. (1999). Design: Cultural probes. Interactions, 6(1), 21-29. GE. (2012, January 29). Embrace Infant Warmer. Retrieved from Healthymagination: http://www.healthymagination.com/progress/technology/embrace/ GE. (2012, January 29). MAC 400 Resting ECG System. Retrieved from http://www.gehealthcare.com/euen/cardiology/products/diagnostic_ecg/resting_stress/mac_400/index.html GE Healthymagination. (2010). 2010 Annual report. General Electric. Gennari, J. R. (2000). Participatory Design and an Eligibility Screening Tool. 290-294. Glaser, B. S. (1967). The Discovery of Grounded Theory: Strategies for Qualitative Research. New Jersey: Transaction Publishers. 149 Glassman, A. (2012, March 30). Healthization of Development. Retrieved from Center for Global Development: http://blogs.cgdev.org/globalhealth/2012/03/healthization-of-development.php Gosselin, R. e. (2009). Cost-effectiveness of replacing skeletal traction by interlocked intramedullary nailing for femoral shaft fractures in a provincial trauma hospital in Cambodia. International Oprthopaedics, 1445-1448. Grounded Theory Institute. (2018, July 3). What is Grounded Theory. Retrieved from Grounded Theory Institute: http://www.groundedtheory.com/what-is-gt.aspx Harsanyi, J. (1953). Cardinal utility in welfare economics and in the theory of risk-taking. J. Polit. Economy, 61, 434-435. Hassling, L. (2005). Use of cultural probes for representation of chronic disease experience: Exploration of an innovative method for design of supportive technologies . Technology and health care , 87. Heifetz, R. (2009). The Practice of Adaptive Leadership. Harvard Business Pres. Hodgson, A. e. (2014). “Engineers in Scrubs”—A New Graduate Training Program for Biomedical Engineers at the University of British Columbia. J. Med. Devices, 030912-030913. Hofman, K. P. (2005). Addressing the growing burden of trauma and injury in low- and middle-income countries. American journal of public health, 95(1), 13-17. 150 Holtzman, Y. (2012). The U.S. medical device industry in 2012: Challenges at home and abroad. Medical Device and Diagnostic Industry. Jayaraman, S. e. (2009). Current patterns of pre-hospital trauma care in Kampala, Uganda and the feasibility of a la-first-responder training program. World Journal of Surgery, 2512-2521. Johnson & Johnson. (2011). 2011 Annual report. Katz, I. (2008). Circumcision — A Surgical Strategy for HIV Prevention in Africa. N Engl J Med, 359, 2412-2415. Lancet. (2015). Global Surgery 2030. The Lancet Commission on Global Surgery. Laxminarayan, R. (2006). Advancement of global health: key messages from the Disease Control Priorities Project. Lancet, 1193-1208. Malkin, R. (2007). Barriers for medical devices for the developing world. Expert Review of Medical Devices, 4(6), 759-763. Malkin, R. (2007). Design of health care technologies for the developing world. Annual Review of Biomedical Engineering, 567-587. Martin, J. e. (2012). A user-centred approach to requirements elicitation in medical device development: A case study from an industry perspective. Applied Ergonomics, 184-190. Mathers, C. L. (2006). Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med, 3(11), e442. 151 McQueen, K. e. (2010). Essential surgery: Integral to the right to health. Health and Human Rights, 12(1), 137-152. Medtronic. (2018, August 25). Shruti. Retrieved from Medtronic: http://www.medtronic.com/in-en/about/shruti.html Mock, C. C. (2010). Developing priorities for addressing surgical conditions globally: Furthering the link between surgery and public health policy. World Journal of Surgery, 34(3), 381-385. Mock, C. J.-A.-K. (1998). Trauma mortality patterns in three nations at different economic levels: Implications for global trauma system development. The Journal of Trauma, 44(5), 804-814. Mock, C. N.-R. (2006). Evaluation of Trauma Care capabilities in four countries using the WHO-IATSIC Guidelines for Essential Trauma Care. World Journal of Surgery, 30(6), 946-956. Mutto, M. K. (2002). The effect of an overpass on pedestrian injuries on a major highway in Kampala - Uganda. African health sciences, 2(3), 89-93. Odaga, J. &. (2006). Budget ceilings and health in Uganda. World Health Organization & Caritas. O'Hara, N. e. (2016). Economic loss due to traumatic injury in Uganda: The patient's perspective. Injury, 47(5), 1098-1103. Ozgediz, D. e. (2008). Afria's negelcted surgical workforce crisis. Lancet, 627-628. 152 PATH. (2012, April 17). PATH. Retrieved from http://www.path.org Pecknold, K. (2009). Dialogue through design: visual communication across the cultural divide. C&C '09 Proceedings of the seventh ACM conference on Creativity and cognition, (pp. 239-244). Berkeley. Penn Anthropology. (2009, April 21). Penn Arts and Sciences. Retrieved from http://www.sas.upenn.edu/anthro/anthro/whatisethnography Pietzsch, J. (2009). Stage-gate process for the development of medical devices. Journal of Medical Devices, 3(2). Polak, P. (2008). Out of poverty: What works when traditional methods fail. San Francisco: Berrett-Koehler Publishers. Prahalad, C. (2003). The Fortune at the Bottom of the Pyramid: Eradicating Poverty Through Profit. Upper Saddle River, NJ: Wharton School Publishing. Privitera, M. (2009). Applied Ergonomics: Determining User Needs in Medical Device Design. IEEE EMBS, (pp. 5606-5608). Minneapolis. Ramachandran, D. (2007). Social Dynamics of Early Stage Co-Design in Developing Regions. CHI 2007. San Jose. Ronsmans, C. G. (2006). Maternal mortality: Who, when, where, and why? Lancet, 368(9542), 1189-1200. Saldana, J. (2013). The coding manual for qualitative researchers. London: Sage. 153 Sale, J. e. (2002). Revisiting the Quantitative-Qualitative Debate: Implications for Mixed-Methods Research. Quality & Quantity, 43-53. Saswata, B. e. (2005). Bridging the health gap in Uganda: the surgical role of the clinical officer. African Health Sciences, 5(1), 86-89. Sehgal, V. D. (2010). The importance of frugal engineering. Strategy + Business(59). Sekimpi, P. O. (2011). Femoral fracture fixation in developing countries: An evaluation of the SIGN Intramedullary Nail. Journal of Bone and Joint Surgery, 93(19), 1811-1818. Shift Labs. (2018, June 29). DripAssist. Retrieved from http://www.shiftlabs.com/ SIGN. (2012, January 29). Surgical Implant Generation Network. Retrieved from http://www.sign-post.org/ Sinha, S. B. (2011). Health Technologies and Innovation in the Global Health Arena . New England Journal of Medicine, 779-782. Sisu Global Health. (2018, June 29). The Hemafuse. Retrieved from https://sisuglobal.health/products/ Soro, A. e. (2016). Cross-Cultural Dialogical Probes. AfriCHI'16 Proceedings of the First African Conference on Human Computer Interaction (pp. 114-125). Nairobi: ACM. Stefik, M. S. (2005, Winter). The prepared mind versus the beginner’s mind. Design Management Review, pp. 10-16. Suri, J. (2005). Thoughtless Acts? San Francisco: Chronicle Books. 154 Synthes. (2010). Annual Report 2010. Synthes DePuy. (2015). Annual Report 2015. Tannen, R. (2009, April 20). 5 Guidelines for Ergonomic Observation. Retrieved from Designing *for Humans: http://www.designingforhumans.com/idsa/2008/07/five-principles-of-ergonomic-observation.html Thompson, H. (2011). MD+DI's Manufacturer of the Year: Johnson&Johnson. Medical Device and Diagnostic Industry, 33(11). Ulwick, A. (2002). Turn customer input into innovation. Harvard Business Review, 80(1), 91-97. Ulwick, A. (2010). What is Outcome Driven Innovation (ODI)? Cambridge: Strategyn. UN. (1948). Universal Declaration of Human Rights. United Nations. UN. (2018, June 28). Sustainable Development Goals. Retrieved from United Nations: https://www.un.org/sustainabledevelopment/sustainable-development-goals/ Vados, C. (2012, March 25). Acumen Fund Employee. (F. Gheorghe, Interviewer) Von Hippel, E. (2005). Democratizing Innovation. Massachusetts: MIT Press. Wassuna, A. (1987). Surgical Manpower in Africa. Bull Am Coll Surg, 72(6), 18-19. Weiser, T. e. (2016). Size and distribution of the global volume of surgery in 2012. Bulletin of the World Health Organization, 201-209. 155 Wherton, J. e. (2012). Designing assisted living technologies ‘in the wild’: preliminary experiences with cultural probe methodology. BMC Medical Research Methodology. WHO. (2000). Guidelines for Health Care Equipment Donations. World Health Organization. WHO. (2003). Surgical Care at the District Hospital. World Health Organization. WHO. (2004). The global burden of disease: 2004 update. World Health Organization. WHO. (2007). Alcohol and Injury. World Health Organization. WHO. (2007). Factsheet: Spending on Health: A Global Overview. World Health Organization. WHO. (2010). Medical devices: Managing the mismatch. World Health Organization. WHO. (2014). Copendium of innovative technologies for low-resource settings. World Health Organization. World Bank. (2010). Health worker attitudes toward rural service in India: Results from qualitative research. Health, Nutrition, and Population Discussion Paper. World Bank. (2018, July 2). World Bank Country and Lending Groups . Retrieved from World Bank: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups Yoda, T. (2011). Cooperation between medical doctors and engineers for developing advanced medical devices. Tokyo: Institute for Future Technology. Zenios, S. M. (2009). Biodesign: The Process of Innovating Medical Technologies. Cambridge University Press. 156 Appendix A – Camera Instructions Department of Mechanical Engineering 2054-6250 Applied Science Lane Vancouver, B.C., Canada V6T 1Z4 Tel: (604) 822-2781 Fax: (604) 822-2403 www.mech.ubc.ca Design Innovation / Version: September 1, 2012 Page 1 of 1 Instructions for Photos Participatory Design for Surgical Innovation in the Developing World Dear Participant, Thank you in advance for supporting this important and unique research taking place at Mulago Hospital. I truly am grateful for your help as this will allow us to prioritize, and then design solutions for some of the biggest challenges in orthopaedic surgery in Uganda. In this package you will find a disposable camera that you can use to take up to 24 photos. Before you take a photo, you must rewind the film using the plastic wheel on the top right on the back of the camera until it stops rotating. Look through the viewing window in the camera to make sure the camera will capture what you want to show me, and then press the large button on top of the camera to take a snap. Repeat this again up to 24 times to take all the available photos. Please be careful with this camera near water or x-ray machines since that can damage the photos. Please feel free to take pictures that show me what you value, what challenges you face, and what your world looks like as a medical professional in Uganda, through your eyes. In addition to the journals, I wanted you to tell me a story about what matters to you as you see it, and since photography is visual, it helps to tell the story in a different way than just writing it down. It helps you think differently, express differently, and it helps me look at the information differently too. I understand you are pressed for time, and I am also asking that you complete the reflection journals. If your time is too limited to complete both, then I ask that you prioritize the journals over this photo task, as it is more important to my research. Please submit all items to Nathan O’Hara or Florin Gheorghe within two weeks after receiving this package. Thank you again for your contribution to innovating new solutions to the challenges faced in orthopedics in Uganda. Yours sincerely, Florin Gheorghe MASc Candidate, Biomedical Engineering Design University of British Columbia Principal Investigator: H.F. Machiel Van der Loos, PhD, P.Eng. Associate Professor Dept. of Mechanical Engineering University of British Columbia Co-Investigator: Dr. Piotr Blachut, MD, FRCSC Orthopaedic Surgeon Department of Orthopaedics University of British Columbia Co-Investigator: Florin Gheorghe, M.A.Sc. Candidate Design Researcher Dept. of Mechanical Engineering, University of British Columbia 158 Appendix B – Journal Questions Day 1 • Q1: What was the most difficult technology interaction today? • Q2: What is an example of a technology in the OR that is designed/made outside of Uganda, and is not appropriate for use here at Mulago Hospital? Day 2 • Q3: What was the most challenging part of your day today? • Q4: What do you think I should know about your life that would be surprising to me as a Canadian? (that I don't already know). Day 3 • Q5: What was the most difficult technology interaction today? • Q6: What does appropriate technology mean to you? Day 4 • Q7: What was the most challenging part of your work today? • Q8: What do you value in medical technology? Day 5 • Q9: What was the most difficult technology interaction today? • Q10: What are your priorities at work? How do you balance these? Which is prioritized over another? Day 6 • Q11: What was the most challenging part of your work today? • Q12: Describe a medical technology that you use often that is uniquely appropriate for your context and use at Mulago. 159 Day 7 • Q13: What was the most difficult technology interaction today? • Q14: What aspect or step in surgery takes longer than it should? Day 8 • Q15: What was the most challenging part of your work today? • Q16: How can technology provide value for you in your work? Day 9 • Q17: What was the most difficult technology interaction today? • Q18: What step in surgery requires the most manpower? Is the greatest burden on human resources? Day 10 • Q19: What was the most challenging part of your work today? • Q20: What step in surgery is the most difficult to perform? Why? Day 11 • Q21: What was the most difficult technology interaction today? • Q22: What do you think about technology donations? How could they work better? Day 12 • Q23: What was the most challenging part of your work today? • Q24: Describe your favourite medical technology that you use. 160 Appendix C – ODI Survey Innovations)in)Orthopaedics)Surgery)5)Research)of)the)University)of)British)ColumbiaNo. Step,)Task,)or)GoalNot)At)All)ImportantSomewhat)ImportantImportantVery)ImportantExtremely)ImportantNot)At)All)SatisfiedSomewhat)SatisfiedSatisfiedVery)SatisfiedExtremely)Satisfied1 STEP:)Pre5Op)Splinting 1 2 3 4 5 1 2 3 4 52 Identify)the)fracture)pattern 1 2 3 4 5 1 2 3 4 52 Increase)accuracy)in)alignment)of)bone)fragments 1 2 3 4 5 1 2 3 4 53 Minimize)further)damage)to)soft)tissues/)injury 1 2 3 4 5 1 2 3 4 54 Minimize)bleeding 1 2 3 4 5 1 2 3 4 55 Rule)out)associated)injuries 1 2 3 4 5 1 2 3 4 56 Other: 1 2 3 4 5 1 2 3 4 57 STEP:)Patient)Transport 1 2 3 4 5 1 2 3 4 58 Minimize)difficulty)in)patient)transport)from)ward 1 2 3 4 5 1 2 3 4 59 Minimize)difficulty)in)patient)transfer)to)OR)table 1 2 3 4 5 1 2 3 4 510 Minimize)patient)injury)in)transfer)to)OR)table 1 2 3 4 5 1 2 3 4 511 Other: 1 2 3 4 5 1 2 3 4 512 STEP:)Anaesthesia 1 2 3 4 5 1 2 3 4 513 Minimize)risk)of)aspiration 1 2 3 4 5 1 2 3 4 514 Minimize)injury)to)patient)during)intubation 1 2 3 4 5 1 2 3 4 515 Other: 1 2 3 4 5 1 2 3 4 516 STEP:)Patient)Positioning 1 2 3 4 5 1 2 3 4 517 Increase)access)to)operating)site 1 2 3 4 5 1 2 3 4 518 Minimize)risk)of)limbs)falling)off)table 1 2 3 4 5 1 2 3 4 519 Minimize)injury)to)patient 1 2 3 4 5 1 2 3 4 520 Minimize)contamination)of)operating)site 1 2 3 4 5 1 2 3 4 521 Minimize)pressure)on)identified)pressure)points 1 2 3 4 5 1 2 3 4 5How)important)is)it)that)you)are)able)to…? How)satisfied)are)you)with)your)ability)to…?Thank)you)for)taking)the)time)to)fill)out)this)survery,)a)continuation)of)research)conducted)at)Mulago)Hospital)in)October)of)2012.)Whether)you)have)taken)part)in)this)research)previously)or)not,)your)completion)of)this)updated)survery)is)very)highly)appreciated,)and)will)greatly)support)the)work)of)engineers)at)the)University)of)British)Columbia,)Canada,)in)designing)technology)appropriate)for)the)needs)of)orthopaedic)staff)at)Mulago)Hospital.)Already)there)are)two)projects)underway)for)an)improved)sterilizer)and)improved)orthopaedic)drilling)solutions,)and)this)survey)will)allow)further)innovations.)If)you)would)prefer)to)do)this)survey)online:)))))http://bit.ly/16eefGzIn)the)first)section,)please)rank)the)IMPORTANCE)of)each)step,)task,)and)goal)described.)Then,)rank)how)SATISFIED)you)are)with)your)ability)to)perform)that)task/goal)with)currently)available)technology,)resources,)and)methods.)For)'SATISFIED',)please)rank)both)Uganda)and)Canada)to)provide)a)comparison.)Use)an)X)or)a)check)mark)for)Uganda,)and)then)circle)your)answer)for)Canada.)The)second)section)of)this)survey)features)open_ended)questions)on)pressing)topics)in)orthopaedic)surgery)at)Mulago)Hospital.No. Step,)Task,)or)GoalNot)At)All)ImportantSomewhat)ImportantImportantVery)ImportantExtremely)ImportantNot)At)All)SatisfiedSomewhat)SatisfiedSatisfiedVery)SatisfiedExtremely)Satisfied22 Maintain)a)sterile)environment 1 2 3 4 5 1 2 3 4 523 Other: 1 2 3 4 5 1 2 3 4 524 STEP:)Surgeon/Nurse)Scrubbing 1 2 3 4 5 1 2 3 4 525 Minimize)bacterial)load)on)hands 1 2 3 4 5 1 2 3 4 526 Minimize)chance)of)re_contamination)after)scrub 1 2 3 4 5 1 2 3 4 527 Appropriate)scrubbing)facilities 1 2 3 4 5 1 2 3 4 528 Other: 1 2 3 4 5 1 2 3 4 529 STEP:)Tourniquet 1 2 3 4 5 1 2 3 4 530 Minimize)blood)loss)during)surgery 1 2 3 4 5 1 2 3 4 531 Increase)visualization)of)operating)site 1 2 3 4 5 1 2 3 4 532 Minimize)damage)to)soft)tissue)when)applying 1 2 3 4 5 1 2 3 4 533 Minimize)time)under)use)of)tourniquet 1 2 3 4 5 1 2 3 4 533 Increase)awareness)about)length)of)time)under)use 1 2 3 4 5 1 2 3 4 534 Other: 1 2 3 4 5 1 2 3 4 535 STEP:)Draping 1 2 3 4 5 1 2 3 4 536 Increase)sterile)isolation)of)the)limb 1 2 3 4 5 1 2 3 4 537 Minimize)tearing)drapes)while)attaching 1 2 3 4 5 1 2 3 4 538 Minimize)risk)of)contamination 1 2 3 4 5 1 2 3 4 540 Other: 1 2 3 4 5 1 2 3 4 541 STEP:)Skin)and)Limb)Preparation 1 2 3 4 5 1 2 3 4 542 Minimize)cuts)on)skin)due)to)shaving 1 2 3 4 5 1 2 3 4 543 Minimize)bacterial)load)on)skin 1 2 3 4 5 1 2 3 4 544 Minimize)debris)on)skin 1 2 3 4 5 1 2 3 4 545 Minimize)re_introduction)of)flora)into)site 1 2 3 4 5 1 2 3 4 546 Other: 1 2 3 4 5 1 2 3 4 547 STEP:)Debridement)and)Irrigation 1 2 3 4 5 1 2 3 4 548 Minimize)bacterial)contamination 1 2 3 4 5 1 2 3 4 549 Minimize)amount)of)dead)tissue 1 2 3 4 5 1 2 3 4 550 Increase)exposure)to)bone)edges 1 2 3 4 5 1 2 3 4 551 Increse)visualization)of)important)structures 1 2 3 4 5 1 2 3 4 552 Minimize)presence)of)free)bone)fragments 1 2 3 4 5 1 2 3 4 5How)important)is)it)that)you)are)able)to…? How)satisfied)are)you)with)your)ability)to…?No. Step,)Task,)or)GoalNot)At)All)ImportantSomewhat)ImportantImportantVery)ImportantExtremely)ImportantNot)At)All)SatisfiedSomewhat)SatisfiedSatisfiedVery)SatisfiedExtremely)Satisfied53 Minimize)debris)present 1 2 3 4 5 1 2 3 4 554 Minimize)skin)and)tissue)loss 1 2 3 4 5 1 2 3 4 555 Increase)fresh)skin)margins 1 2 3 4 5 1 2 3 4 556 Minimize)bleeding 1 2 3 4 5 1 2 3 4 557 Other: 1 2 3 4 5 1 2 3 4 558 STEP:)Incision,)Dissection,)Cleaning)Fracture 1 2 3 4 5 1 2 3 4 559 Minimize)bleeding 1 2 3 4 5 1 2 3 4 560 Minimize)size)of)incision 1 2 3 4 5 1 2 3 4 561 Increase)visualization)of)injury/surgical)site 1 2 3 4 5 1 2 3 4 562 Minimize)soft)tissue,)neuro/vascular)damage 1 2 3 4 5 1 2 3 4 563 Increase)accuracy)of)incision)location 1 2 3 4 5 1 2 3 4 564 Minimize)soft)tissue)interposition 1 2 3 4 5 1 2 3 4 565 Minimize)operating)time 1 2 3 4 5 1 2 3 4 566 Allow)for)good)cleaning)of)fracture)site 1 2 3 4 5 1 2 3 4 567 Other: 1 2 3 4 5 1 2 3 4 568 STEP:)Mid5Surgery)General)Goals 1 2 3 4 5 1 2 3 4 569 Minimize)occuprational)hazards/injury)to)staff 1 2 3 4 5 1 2 3 4 570 Minimize)damage)to)instruments 1 2 3 4 5 1 2 3 4 571 Increase)usability)of)instruments 1 2 3 4 5 1 2 3 4 573 Other: 1 2 3 4 5 1 2 3 4 574 STEP:)Reduction 1 2 3 4 5 1 2 3 4 575 Identify)the)fracture)pattern 1 2 3 4 5 1 2 3 4 576 Minimize)further)fracture)or)splitting)of)the)bone 1 2 3 4 5 1 2 3 4 577 Increase)anatomic)accuracy)of)reduction 1 2 3 4 5 1 2 3 4 578 Minimize)periosteal)stripping 1 2 3 4 5 1 2 3 4 579 Minimize)damage)to)soft)tissues 1 2 3 4 5 1 2 3 4 580 Minimize)time)to)achieve)reduction 1 2 3 4 5 1 2 3 4 581 Reduction)of)old)(delayed)treatment))fractures 1 2 3 4 5 1 2 3 4 582 Other: 1 2 3 4 5 1 2 3 4 583 STEP:)Alignment 1 2 3 4 5 1 2 3 4 584 Increase)accuracy)of)alignment 1 2 3 4 5 1 2 3 4 5How)important)is)it)that)you)are)able)to…? How)satisfied)are)you)with)your)ability)to…?No. Step,)Task,)or)GoalNot)At)All)ImportantSomewhat)ImportantImportantVery)ImportantExtremely)ImportantNot)At)All)SatisfiedSomewhat)SatisfiedSatisfiedVery)SatisfiedExtremely)Satisfied85 Increase)accuracy)of)leg)length 1 2 3 4 5 1 2 3 4 586 Increase)accuracy)of)rotation)alignment 1 2 3 4 5 1 2 3 4 587 Verify)and)confirm)accuracy)in)alignment 1 2 3 4 5 1 2 3 4 588 Other: 1 2 3 4 5 1 2 3 4 589 STEP:)Drilling 1 2 3 4 5 1 2 3 4 590 Increase)accuracy)of)drilling)through)both)cortices 1 2 3 4 5 1 2 3 4 591 Minimize)toggling)and)widening)of)holes 1 2 3 4 5 1 2 3 4 592 Minimize)time)of)drilling 1 2 3 4 5 1 2 3 4 593 Minimize)effort)in)drilling 1 2 3 4 5 1 2 3 4 594 Minimize)soft)tissue)injury 1 2 3 4 5 1 2 3 4 595 Minimize)risk)of)inaccurate)drill)hole)placement 1 2 3 4 5 1 2 3 4 596 Minimize)thermal)necrosis)of)bone 1 2 3 4 5 1 2 3 4 597 Minimize)other)bone)trauma 1 2 3 4 5 1 2 3 4 598 Minimize)slipping)of)drill 1 2 3 4 5 1 2 3 4 599 Increase)user)stability)during)drilling 1 2 3 4 5 1 2 3 4 5100 Other: 1 2 3 4 5 1 2 3 4 5101 STEP:)Shantz)Pin)Insertion)&)Frame)Assembly)(Ex5Fix) 1 2 3 4 5 1 2 3 4 5102 Minimize)toggling)when)inserting)pins 1 2 3 4 5 1 2 3 4 5103 Increase)accuracy)in)depth)of)pin)insertion 1 2 3 4 5 1 2 3 4 5104 Increase)pin)concentricity)with)drilled)hole 1 2 3 4 5 1 2 3 4 5105 Increase)stability)of)construct 1 2 3 4 5 1 2 3 4 5106 Increase)accuracy)in)bone)alignment 1 2 3 4 5 1 2 3 4 5107 Increase)accuracy)of)rotation)alignment 1 2 3 4 5 1 2 3 4 5108 Increase)bone)contact)in)reduction 1 2 3 4 5 1 2 3 4 5109 Minimize)chance)of)pin)pull_out 1 2 3 4 5 1 2 3 4 5110 Minimize)chance)of)losing)reduction 1 2 3 4 5 1 2 3 4 5111 Other: 1 2 3 4 5 1 2 3 4 5112 STEP:)Awl)Insertion)&)Reaming)(for)Nailing) 1 2 3 4 5 1 2 3 4 5113 Increase)ease)of)entry)for)reamer)and)nail 1 2 3 4 5 1 2 3 4 5114 Increase)accuracy)of)awl)placement)on)first)try 1 2 3 4 5 1 2 3 4 5115 Increase)accuracy)of)reamer)insertion)point 1 2 3 4 5 1 2 3 4 5How)important)is)it)that)you)are)able)to…? How)satisfied)are)you)with)your)ability)to…?No. Step,)Task,)or)GoalNot)At)All)ImportantSomewhat)ImportantImportantVery)ImportantExtremely)ImportantNot)At)All)SatisfiedSomewhat)SatisfiedSatisfiedVery)SatisfiedExtremely)Satisfied116 Minimize)over)reaming 1 2 3 4 5 1 2 3 4 5117 Minimize)under)reaming 1 2 3 4 5 1 2 3 4 5118 Minimize)thermal)necrosis)of)bone 1 2 3 4 5 1 2 3 4 5119 Minimize)fracturing)of)bone 1 2 3 4 5 1 2 3 4 5120 Other: 1 2 3 4 5 1 2 3 4 5121 STEP:)Nail)Insertion 1 2 3 4 5 1 2 3 4 5122 Minimize)additional)fracture)during)insertion 1 2 3 4 5 1 2 3 4 5123 Increase)accuracy)in)nail)orientation 1 2 3 4 5 1 2 3 4 5124 Increase)accuracy)of)depth)placement)of)nail 1 2 3 4 5 1 2 3 4 5125 Minimize)nail)rotation)during)insertion 1 2 3 4 5 1 2 3 4 5127 Other: 1 2 3 4 5 1 2 3 4 5128 STEP:)Nail)Locking 1 2 3 4 5 1 2 3 4 5129 Minimize)risk)of)missing)the)slot)with)screw 1 2 3 4 5 1 2 3 4 5130 Minimize)risk)of)rotation 1 2 3 4 5 1 2 3 4 5131 Minimize)nail)mobility 1 2 3 4 5 1 2 3 4 5132 Minimize)bone)length)changes 1 2 3 4 5 1 2 3 4 5133 Minimize)bone)alignment)changes 1 2 3 4 5 1 2 3 4 5134 Increase)double)cortex)fixation 1 2 3 4 5 1 2 3 4 5135 Minimize)soft)tissue)damage)with)too)long)screw 1 2 3 4 5 1 2 3 4 5136 Other: 1 2 3 4 5 1 2 3 4 5137 STEP:)Confirm)Alignment)During)Surgery 1 2 3 4 5 1 2 3 4 5138 Confirm)alignment)of)bone)after)reduction 1 2 3 4 5 1 2 3 4 5139 Confirm)alignment)of)bone)after)fixation 1 2 3 4 5 1 2 3 4 5147 Confirm)stability)of)fixation)construct 1 2 3 4 5 1 2 3 4 5140 Other: 1 2 3 4 5 1 2 3 4 5141 STEP:)Closure 1 2 3 4 5 1 2 3 4 5142 Minimize)bone)exposure)after)closure 1 2 3 4 5 1 2 3 4 5143 Minimize)breakdown)of)wound)after)closure 1 2 3 4 5 1 2 3 4 5144 Minimize)instrument)retention)inside)patient 1 2 3 4 5 1 2 3 4 5145 Increase)wound)healing 1 2 3 4 5 1 2 3 4 5148 Other: 1 2 3 4 5 1 2 3 4 5How)important)is)it)that)you)are)able)to…? How)satisfied)are)you)with)your)ability)to…? 166 Appendix D – All ODI Opportunites Step Goal All All Surg All Nurs UG Surg UG Nurs UG All CA Surg CA Nurs CA All Patient Positioning Maintain a sterile environment 16.9 16.2 14.2 16.7 13.8 16.0 12.1 15.0 20.0 Nail Locking Minimize risk of missing the slot with screw 16.7 17.6 11.8 18.3 11.8 16.6 13.3 0.0 17.1 Debridement and Irrigation Minimize bacterial contamination 16.5 17.5 17.4 17.2 15.7 15.7 20.0 20.0 20.0 Draping Minimize risk of contamination 16.3 16.3 13.8 17.2 12.5 15.4 8.3 16.0 20.0 Nail Locking Minimize risk of rotation 16.3 17.4 15.5 17.1 15.7 16.1 18.8 15.0 17.1 Surgeon/Nurse Scrubbing Minimize chance of re-contamination after scrub 16.1 16.3 16.2 16.1 13.8 15.0 18.3 20.0 20.0 Surgeon/Nurse Scrubbing Appropriate scrubbing facilities 15.9 17.3 15.8 17.2 12.9 15.6 18.3 20.0 17.1 Pre-Op Splinting Rule out associated injuries 15.9 17.4 15.8 17.2 13.8 15.0 18.6 20.0 20.0 Incision, Dissection, Cleaning Fracture Minimize soft tissue, neuro/vascular damage 15.9 12.8 16.7 14.1 15.0 14.8 5.4 20.0 20.0 Anaesthesia Minimize injury to patient during intubation 15.8 16.5 16.5 16.1 14.3 14.5 18.8 20.0 20.0 Awl Insertion & Reaming (for Nailing) Minimize fracturing of bone 15.8 15.7 15.0 15.4 15.0 15.5 17.5 15.0 17.1 Confirm Alignment During Surgery Confirm stability of fixation construct 15.6 16.5 13.3 16.1 12.5 15.3 18.8 15.0 17.1 Pre-Op Splinting Minimize further damage to soft tissues/ injury 15.6 16.4 11.7 16.1 10.0 14.7 18.6 15.0 20.0 167 Surgeon/Nurse Scrubbing Minimize bacterial load on hands 15.6 15.0 16.9 14.4 15.0 14.3 20.0 20.0 20.0 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase stability of construct 15.5 16.7 11.8 16.7 10.0 14.2 0.0 15.0 20.0 Debridement and Irrigation Minimize bleeding 15.4 14.4 15.0 14.4 15.0 15.0 0.0 15.0 17.1 Confirm Alignment During Surgery Confirm alignment of bone after reduction 15.4 16.0 15.0 15.6 15.0 15.7 18.8 0.0 14.3 Drilling Minimize thermal necrosis of bone 15.4 16.0 11.2 16.7 11.8 15.6 12.1 10.0 14.3 Skin and Limb Preparation Minimize bacterial load on skin 15.4 14.8 14.2 14.8 14.3 14.4 0.0 14.0 20.0 Alignment Verify and confirm accuracy in alignment 15.3 14.6 17.1 15.0 15.7 14.9 12.1 20.0 17.1 Confirm Alignment During Surgery Confirm alignment of bone after fixation 15.3 14.1 15.0 14.4 15.0 14.9 12.1 15.0 17.1 Patient Positioning Minimize contamination of operating site 15.2 16.4 14.9 16.1 11.8 13.9 18.8 20.0 20.0 Tourniquet Minimize time under use of tourniquet 15.1 16.3 13.8 17.2 12.5 15.4 8.3 16.0 14.3 Debridement and Irrigation Minimize debris present 15.0 16.1 12.7 16.1 11.4 13.8 0.0 15.0 20.0 Incision, Dissection, Cleaning Fracture Allow for good cleaning of fracture site 15.0 12.7 13.1 13.9 13.8 14.4 5.4 12.0 17.5 Nail Locking Minimize nail mobility 15.0 15.2 14.5 15.6 11.8 14.7 12.1 20.0 16.7 Skin and Limb Preparation Minimize re-introduction of flora into site 15.0 15.0 16.9 15.0 15.0 14.6 0.0 20.0 16.7 Drilling Minimize other bone trauma 15.0 14.6 14.5 15.0 14.3 15.3 12.1 15.0 13.3 168 Patient Positioning Minimize injury to patient 14.9 14.6 13.8 15.0 12.5 13.2 12.1 16.0 20.0 Anaesthesia Minimize risk of aspiration 14.9 15.0 16.2 14.4 13.8 13.2 18.6 20.0 20.0 Pre-Op Splinting Minimize bleeding 14.9 14.9 16.9 14.4 15.0 13.6 18.6 20.0 20.0 Drilling Minimize soft tissue injury 14.8 13.6 13.8 15.0 15.7 15.7 5.4 10.0 11.4 Mid-Surgery General Goals Minimize occuprational hazards/injury to staff 14.8 13.6 12.5 14.8 12.5 14.5 6.7 0.0 15.9 Reduction Minimize further fracture or splitting of the bone 14.8 13.9 13.3 14.2 12.5 14.2 12.1 15.0 17.1 Tourniquet Minimize blood loss during surgery 14.6 15.0 13.8 15.6 13.8 14.0 10.0 0.0 17.1 Incision, Dissection, Cleaning Fracture Minimize bleeding 14.6 13.3 13.8 13.3 13.8 14.0 13.3 0.0 17.1 Reduction Minimize damage to soft tissues 14.5 17.1 10.5 16.9 10.7 14.6 18.8 10.0 14.3 Tourniquet Minimize damage to soft tissue when applying 14.5 16.1 13.8 17.1 12.1 14.6 8.3 16.0 14.3 Draping Increase sterile isolation of the limb 14.5 16.0 12.9 15.6 12.9 13.2 20.0 0.0 20.0 Alignment Increase accuracy of rotation alignment 14.5 13.2 13.8 14.4 10.7 13.8 5.4 20.0 17.1 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase bone contact in reduction 14.4 15.1 13.8 15.6 10.7 14.4 12.1 20.0 14.3 Skin and Limb Preparation Minimize debris on skin 14.3 16.0 15.4 15.9 12.5 13.8 18.3 20.0 16.7 Tourniquet Increase awareness about length of time under use 14.3 14.3 15.4 15.0 15.0 14.0 8.3 16.0 15.5 169 Awl Insertion & Reaming (for Nailing) Increase accuracy of reamer insertion point 14.3 13.6 10.6 13.9 11.0 12.8 12.1 10.0 20.0 Pre-Op Splinting Increase accuracy in alignment of bone fragments 14.2 14.9 15.0 14.4 12.5 13.7 18.6 20.0 16.7 Awl Insertion & Reaming (for Nailing) Increase ease of entry for reamer and nail 14.2 14.6 13.8 14.8 13.8 14.1 13.3 0.0 14.3 Alignment Increase accuracy of alignment 14.1 14.6 13.2 13.7 13.2 13.4 20.0 0.0 17.1 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy in bone alignment 14.1 15.5 12.1 15.0 8.2 13.3 18.8 20.0 17.1 Debridement and Irrigation Minimize skin and tissue loss 14.1 15.5 16.7 15.0 15.0 14.0 18.8 20.0 14.3 Debridement and Irrigation Minimize amount of dead tissue 14.0 14.8 16.4 14.4 14.6 12.7 18.3 20.0 20.0 Nail Insertion Increase accuracy in nail orientation 13.9 14.6 12.1 15.0 10.7 13.1 12.1 15.0 17.1 Nail Locking Minimize bone alignment changes 13.9 15.5 10.0 16.1 10.0 14.6 12.1 10.0 11.4 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize chance of pin pull-out 13.9 14.1 12.2 15.6 9.3 13.4 5.4 20.0 16.7 Mid-Surgery General Goals Increase usability of instruments 13.9 14.5 12.7 16.0 11.4 14.5 5.4 15.0 11.4 Patient Transport Minimize patient injury in transfer to OR table 13.9 16.0 12.3 17.2 12.5 14.1 5.4 12.0 13.0 Mid-Surgery General Goals Minimize damage to instruments 13.8 14.8 14.3 15.4 12.5 14.3 10.8 18.0 11.4 Nail Insertion Increase accuracy of depth placement of nail 13.7 15.1 13.8 15.6 10.7 13.6 12.1 20.0 14.3 Awl Insertion & Reaming (for Nailing) Minimize thermal necrosis of bone 13.7 13.9 11.4 14.4 12.1 13.2 10.8 10.0 15.5 170 Closure Minimize breakdown of wound after closure 13.7 13.6 11.2 13.9 9.3 12.8 12.1 15.0 17.1 Closure Increase wound healing 13.7 13.2 12.1 12.2 10.7 12.0 18.8 15.0 20.0 Reduction Minimize periosteal stripping 13.7 14.8 11.8 15.3 10.0 13.5 12.1 15.0 14.3 Patient Positioning Increase access to operating site 13.6 15.0 14.6 15.6 11.3 12.6 11.9 20.0 16.7 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy in depth of pin insertion 13.6 13.6 11.7 15.0 10.0 13.4 5.4 15.0 14.3 Nail Insertion Minimize nail rotation during insertion 13.5 13.0 14.0 14.2 11.8 13.5 5.4 20.0 13.3 Nail Locking Increase double cortex fixation 13.4 14.2 10.0 14.4 10.0 13.5 12.1 10.0 13.3 Incision, Dissection, Cleaning Fracture Minimize soft tissue interposition 13.4 13.2 12.5 14.4 13.8 14.6 5.4 10.0 8.6 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize chance of losing reduction 13.4 13.8 11.4 14.1 8.2 12.0 12.1 20.0 20.0 Nail Insertion Minimize additional fracture during insertion 13.4 13.2 14.5 13.3 11.8 13.2 12.1 20.0 14.3 Reduction Identify the fracture pattern 13.4 15.0 11.4 14.2 11.4 13.2 20.0 0.0 14.3 Closure Minimize instrument retention inside patient 13.3 13.6 11.9 12.8 10.4 12.4 18.8 15.0 17.1 Incision, Dissection, Cleaning Fracture Minimize operating time 13.3 13.8 11.5 15.3 12.5 14.2 5.4 10.0 10.0 Draping Minimize tearing drapes while attaching 13.2 16.2 14.6 15.9 11.3 12.9 18.3 20.0 14.3 171 Drilling Minimize risk of inaccurate drill hole placement 13.2 13.6 12.1 13.9 13.2 13.6 12.1 10.0 11.4 Pre-Op Splinting Identify the fracture pattern 13.2 13.5 12.1 12.8 12.1 11.7 20.0 0.0 20.0 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase accuracy of rotation alignment 13.1 14.1 13.2 14.4 9.3 12.0 12.1 20.0 17.1 Awl Insertion & Reaming (for Nailing) Increase accuracy of awl placement on first try 13.1 13.6 12.0 13.9 10.3 13.5 12.1 15.0 11.4 Closure Minimize bone exposure after closure 13.0 13.3 12.9 12.2 12.9 12.7 20.0 0.0 14.3 Patient Positioning Minimize pressure on identified pressure points 13.0 16.0 12.5 15.6 8.8 12.7 18.3 20.0 14.3 Patient Positioning Minimize risk of limbs falling off table 13.0 13.9 13.8 14.2 10.0 12.2 12.1 20.0 15.6 Drilling Increase accuracy of drilling through both cortices 12.6 12.9 9.6 13.3 9.6 12.2 10.0 0.0 14.3 Debridement and Irrigation Minimize presence of free bone fragments 12.5 12.8 14.5 12.8 14.3 13.1 0.0 15.0 10.0 Nail Locking Minimize bone length changes 12.3 12.6 13.1 13.3 9.6 12.5 8.3 20.0 11.4 Nail Locking Minimize soft tissue damage with too long screw 12.3 12.6 11.2 13.3 9.3 12.5 8.3 15.0 11.4 Debridement and Irrigation Increase fresh skin margins 12.2 14.2 14.5 14.4 14.3 12.7 12.1 15.0 10.0 Reduction Minimize time to achieve reduction 12.2 15.0 10.8 14.3 11.3 13.1 18.8 10.0 8.6 Reduction Increase anatomic accuracy of reduction 12.1 10.9 14.5 10.7 11.4 11.6 12.1 20.0 14.3 Patient Transport Minimize difficulty in 12.1 12.6 9.8 14.1 11.3 12.4 4.2 7.5 11.1 172 patient transfer to OR table Drilling Minimize toggling and widening of holes 12.1 13.6 12.1 13.9 10.7 12.3 12.1 15.0 11.4 Debridement and Irrigation Increse visualization of important structures 11.9 12.8 13.6 13.3 12.9 12.3 8.3 15.0 10.0 Incision, Dissection, Cleaning Fracture Increase accuracy of incision location 11.9 13.2 14.5 12.2 11.4 12.7 18.8 20.0 8.6 Debridement and Irrigation Increase exposure to bone edges 11.8 12.8 15.0 12.2 12.1 11.5 18.3 20.0 13.3 Drilling Minimize time of drilling 11.8 14.5 9.8 14.9 9.6 12.6 12.1 10.0 8.6 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Increase pin concentricity with drilled hole 11.7 13.7 10.6 13.9 8.1 12.1 12.1 15.0 10.0 Shantz Pin Insertion & Frame Assembly (Ex-Fix) Minimize toggling when inserting pins 11.7 12.9 12.5 12.8 12.5 11.8 13.3 0.0 11.4 Awl Insertion & Reaming (for Nailing) Minimize under reaming 11.6 10.6 13.2 11.7 12.1 12.2 4.2 15.0 9.8 Patient Transport Minimize difficulty in patient transport from ward 11.6 14.3 13.8 14.4 13.8 12.4 13.3 0.0 8.8 Awl Insertion & Reaming (for Nailing) Minimize over reaming 11.4 12.7 13.8 11.7 10.7 11.9 18.8 20.0 9.8 Tourniquet Increase visualization of operating site 11.4 11.3 14.3 11.7 10.7 10.7 8.3 20.0 14.3 Drilling Minimize effort in drilling 11.3 13.6 8.1 15.0 7.1 12.0 5.4 10.0 8.6 Drilling Minimize slipping of drill 11.3 12.8 8.7 11.8 9.6 11.2 18.8 6.7 11.4 173 Drilling Increase user stability during drilling 11.2 11.8 12.8 11.8 14.2 11.8 12.1 10.0 8.6 Skin and Limb Preparation Minimize cuts on skin due to shaving 11.1 10.5 16.2 10.6 13.8 10.9 10.0 20.0 11.9 Alignment Increase accuracy of leg length 11.0 11.3 13.6 11.1 10.0 10.2 12.1 20.0 14.3 Incision, Dissection, Cleaning Fracture Minimize size of incision 10.6 10.8 13.3 10.6 10.0 11.1 12.1 20.0 8.6 Incision, Dissection, Cleaning Fracture Increase visualization of injury/surgical site 10.1 8.9 10.0 9.4 10.0 9.1 5.4 10.0 14.3 Reduction Reduction of old (delayed treatment) fractures 10.1 10.5 7.0 11.5 5.2 9.7 5.4 10.0 11.4 174 Appendix E – ODI Result Categories Information and visualization Alignment and stability Accuracy Contamination Soft tissue damage Debridement Implants Bone damage Reduction Bleeding Ease of use Time Patient positioning Tourniquet Nail locking Prep Wound healing Patient transfer Airway Reaming Instrument care Instrument retention Necrosis Occupational hazards Pressure sores Scrubbing Understand the injury Incision Nail insertion 175 Appendix F – Informed Consent Form Department of Mechanical Engineering 2054-6250 Applied Science Lane Vancouver, B.C., Canada V6T 1Z4 Tel: (604) 822-2781 Fax: (604) 822-2403 www.mech.ubc.ca Design Innovation / Version: September 1, 2012 Page 1 of 2 Consent Form Participatory Design for Surgical Innovation in the Developing World Purpose: The purpose of this research is to explore ways in which surgical care staff can be engaged in the design of medical technology for surgery in the developing world. Methods will be tested for creative thinking, re-framing surgical challenges, and seeking opportunities for innovation. This research will inform how engineers, designers, and medical device manufacturers can engage surgical staff in the design of appropriate technology. Study Procedures: The research will be qualitative in nature, focusing on the Uganda Sustainable Trauma Orthopaedic Program (USTOP) members’ experiences and practice, as well as those of surgical staff at Mulago Hospital. The research team will observe the surgical process as well as interactions between participants and technology during surgery. The research team will conduct one semi-structured focus group, which is aimed at testing various design strategies and will take no longer than two hours. The research team may interview participants individually to discuss the results and methods used in the focus group, taking no more than thirty minutes. This is an optional secondary engagement and would explore the same questions as the focus group in further detail. Self-guided reflection kits will be distributed to participants to record ideas and reflections on surgical challenges. This may include a journal, audio recorder, or photo camera. Time required is approximately 10 minutes a day for one to two weeks, and is optional. Potential Risks: The physical, emotional or psychological risks associated with this project are minimal. The participants will only be asked questions regarding their experience providing surgical care in Canada and Uganda. Potential Benefits: Participants could benefit from learning about design strategies to increase their capacity for innovative ideas and approaches in their work. An indirect benefit is that the outcomes of this research will inform the development of improved surgical technology for developing world practice. Confidentiality: All data will be kept in a locked cabinet, and computer files password protected, participants will not be identified by name in any reports of the completed study; only the research team will have access to this information. Participants are able to seek attribution if they wish to. Principal Investigator: H.F. Machiel Van der Loos, PhD, P.Eng. Associate Professor Dept. of Mechanical Engineering University of British Columbia Co-Investigator: Dr. Piotr Blachut, MD, FRCSC Orthopaedic Surgeon Department of Orthopaedics University of British Columbia Co-Investigator: Florin Gheorghe, M.A.Sc. Candidate Design Researcher Dept. of Mechanical Engineering, University of British Columbia Department of Mechanical Engineering 2054-6250 Applied Science Lane Vancouver, B.C., Canada V6T 1Z4 Tel: (604) 822-2781 Fax: (604) 822-2403 www.mech.ubc.ca Design Innovation / Version: September 1, 2012 Page 2 of 2 Contact for information about the study: If you have any questions or desire further information with respect to this study, you may contact Florin Gheorghe (gheorghe.florin@gmail.com) at _________________. Contact for concerns about the rights of research subjects: If you have any concerns about your treatment or rights as a research subject, you may contact the Research Subject Information Line in the UBC Office of Research Services at 604-822-8598 or if long distance e-mail to RSIL@ors.ubc.ca. In Uganda you may contact the Chairperson, School of Health Sciences Institutional Review Board (MakSHS-IRB) or Uganda National Council of Sciences and Technology. Tel: (+256) 772-404970 or (+256)-41-250431. Consent: Your participation in this study is entirely voluntary and you may refuse to participate or withdraw from the study at any time without jeopardy to your work or participation in any future design oriented activities. Initial here if you are providing consent for surgical observation ___________ Initial here if you are providing consent for interview/focus group discussion ___________ Initial here if you are providing consent for use of a self-guided reflection kit ___________ Your signature below indicates that you have received a copy of this consent form for your own records. Your signature indicates that you consent to participate in this study. ______________________________________________________________________ Subject Name (print) Signature ________________ Date In addition and separately, I agree to allow my comments to be quoted in reports or publications. If a quote were used, there would be nothing in the quote that could identify me, or any of my clients. ______________________________________________________________________ Subject Name (print) Signature ________________ Date
Thesis/Dissertation
eng
Biomedical Engineering
Vancouver : University of British Columbia Library
Attribution-NonCommercial-NoDerivatives 4.0 International
Graduate
Participatory design methods for medical device innovation in Uganda
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