CASE STUDY DESIGN ETHNOGRAPHY AS AN ENGINEERING TOOL 02 Currently the design, development, and implementation of medical devices insufficiently address health care needs in low-resource settings. Most existing medical devices are simple adaptations of devices designed for high-resource 01 settings. However, the spectrum of needs in low-resource 01 settings is often beyond the scope of such simple adaptations, resulting in products with limited impact. AMIR SABET SARVESTANI is a PhD candidate in the design science program at the University of Michigan, Ann Arbor. He is pursuing his graduate work at the Laboratory o develop medical devices that address the complex challenges of for Innovation in Global Health global health, we have studied how conventional engineering design Technology. He has been a consultant processes can be supplemented by methods derived from social to the Medical Devices Unit at the science fields such as anthropology. Design ethnography, which World Health Organization. encompasses processes for gaining a complete understanding of Tstakeholders’ actions, behaviors, words, and thoughts, provides a framework for acquiring tacit information from stakeholders that would not be obtained through commonly used methodologies in engineering design and market re- search. ¶ Although this technique is applicable to a broad range of global health technologies, we chose to highlight its application to traditional adult male cir- cumcision given the unique design context and constraints. This study, among KATHLEEN SIENKO is a Miller Faculty others performed to date, indicates the need for engineers to understand the Scholar and an associate professor broader context in which a medical device will be used, as well as the need for in the departments of mechanical and biomedical engineering at the global health design decision-making processes based on rigorous studies that University of Michigan in Ann Arbor. generate quantitative outcomes rather than anecdotal evidence. She directs the Sensory Augmentation and Rehabilitation Laboratory (SARL) and the Laboratory for Innovation in Global Health Technology (LIGHT). Male circumcision is a culturally significant Traditional adult male circumcision is not procedure in many parts of the world. For without risks. Cutters and their assistants, instance, traditional adult male circumcision typically with limited or no formal clinical UGANDA (TMC) is an important cultural practice in parts training, perform TMC in non-clinical settings. of sub-Saharan Africa, and a rite of passage for While evidence supports TMC’s effectiveness boys between the ages of 10 and 18. against HIV transmission when adequate Recently, several randomized clini- foreskin is removed, rates of life-threatening cal trials have shown that clinical adult risks and health complications for this practice male circumcision is an effective medical are as high as 48 percent [5]. Infection, intervention for the prevention of sexually delayed wound healing, glans amputation transmitted HIV, reducing the rate of trans- and injury, bleeding, loss of penile sensitivity, mission by 60 percent among heterosexual excessive removal of foreskin, and even death men [2, 3, 4]. This is an important result for are the major complications reported [6]. sub-Saharan Africa, where more than two- There are medical devices that accommo- thirds of the 22.5 million people in the world date clinical adult male circumcision (AMC), DEMAND | ASME GLOBAL DEVELOPMENT REVIEW living with HIV reside [1]. but none of them are suitable for TMC due UGANDA KENYA DEMOCRATIC REPUBLIC OF CONGO 95% APPROXIMATELY 95% of medical • Kapchorwa (Sebei | 63) devices used in low- and middle- income settings are imported. • Bundibugyo (Baamba | 38) • Mbale (Bagisu | 46) 40% - 70% • Kampala OF IMPORTED DEVICES are • Kasese (Bakonzo | 61) dysfunctional (Howitt, 2012). • Capital of Uganda • Locations of Focus Group Discussions (Associated ethnic group | Total number of participants) 80% MORE THAN 80% of health technologies in developing settings are acquired 25,000,000 by donation. HIV/AIDS HAS TAKEN OVER 25 MILLION LIVES IN THE LAST THREE DECADES and remains a major health challenge throughout the world, especially in sub-Saharan Africa, where about 68% of global HIV 68% infection cases (22.5 million) reside. 22.5 MILLION The African context: HIV/AIDS rates, medical devices and region of investigation to their cultural inappropriateness, high cost, identified, would it be accepted? What is and Manufacturing course during the Winter and complexity. the process associated with designing such 2009 semester. The students assigned to Based on a conversation with Family a device, given that we have no firsthand the unusual project—the course had never Health International 360’s (FHI 360) Dr. experience with the procedure or context? seen the likes of such a topic before—began David Sokal, with whom we partnered Since funding wasn’t initially available to work in a similar way to other academic on this project, we raised the following tackle these questions through field-based design projects. They consulted the literature questions: Was there a need for a culturally studies, the project was offered to a team and interviewed clinical experts. We were appropriate device to improve the likelihood of undergraduate students within a section surprised at the lack of data on traditional of a safe outcome during traditional of the University of Michigan’s Department circumcision practice, which made the design adult male circumcision? If a solution was of Mechanical Engineering Capstone Design of such a device extremely challenging. By CASE STUDY | DESIGN ETHNOGRAPHY AS AN ENGINEERING TOOL 04 the end of the course, the students had gen- staff of international and national organiza- erated a preliminary list of user requirements Design ethnography tions promoting and implementing clinical and associated engineering specifications, a male circumcision. concept solution and physical prototype, and provides a framework for We conducted 10 interviews with various preliminary validation results that enabled us experts during this initial visit, and held to apply for external funding. acquiring tacit in formation 12 FGDs with about 100 participants with After applying for funding and receiving a the four ethnic groups that practice TMC in Gates Grand Challenges Explorations Grant, we from stakeholders, which Uganda—the Sebei, Bagisu, Baamba, and formed a multidisciplinary team that included Bakonzo. While the circumcision rate in engineers, clinicians, sociologists, and public would not be obtained Baamba and Bakonzo men is unknown, it health and business experts to further pursue is estimated that 80 percent of Sebei and the design. The funding enabled additional through commonly Bagisu men are circumcised. engineering analyses on the original prototype Each FGD consisted of 6 to 12 participants developed by the student design team, includ- used methodologies in and was run by trained American and Ugan- ing fit and grip studies performed on cadavers dan study team members, who remained at the University of Michigan’s Anatomical Lab. engineering design and the same across the focus groups, with Qualitative and quantitative measures were the assistance of translators, who varied. used in cadaver studies to assess the time market research. Predetermined themes, such as TMC’s cul- required to apply and remove the device, the tural importance, logistics of the practice, ease of application, the degree of glans protec- It was obvious that stakeholder input was cutters’ training procedures, and tools used tion, and the length of foreskin cut. required to establish the need for such an in- during TMC were selected prior to holding Most importantly, to gain much needed tervention and to generate the data necessary the FGDs. insight, we conducted fieldwork in Uganda, for informing key design decisions. With the The FGDs were recorded, and we tran- because of the country’s multiple eth- input of social scientists skilled in qualitative scribed all the files verbatim and cross- nic groups known to practice TMC, and research, we used principles of design eth- checked the transcription results with because FHI 360 had a field office there nography that focus on the broad patterns of research assistants to ensure accuracy. Tran- with established relationships with the daily life that pertain to the conception, devel- scripts were reviewed, and reoccurring themes ethnic groups. In Uganda, as in many other opment, and implementation of new products based on the five topics were identified to sub-Saharan African countries, TMC has in a given society. Design ethnography, which develop a codebook. After an in-depth review been practiced for centuries, particularly as encompasses processes for gaining a com- of the transcriptions and cross-analyses of the an initiation ritual and rite of passage into plete understanding of stakeholders’ actions, four ethnic groups and different participants, manhood. Uganda’s HIV prevalence rate is behaviors, words, and thoughts, provides a additional codes were derived for further 6.5 percent, and approximately 10 percent framework for acquiring tacit information characterization. Hence our codebook, which (3.5 million) of the population belongs to from stakeholders that would not be obtained was initially based on predetermined codes, ethnic groups that practice TMC [7]. through commonly used methodologies in evolved through an iterative process with the engineering