Designing devices for global surgery: evaluation of participatory and frugal design methods

Abstract

Introduction: Most people living in low- and middle-income countries have no access to surgical care. Equipping under-resourced health care contexts with appropriate surgical equipment is thus critical. “Global” technologies must be designed specifically for these contexts. But while models, approaches and methods have been developed for the design of equipment for global surgery, few studies describe their implementation or evaluate their adequacy for this purpose. Methods: A multidisciplinary team applied participatory and frugal design methods to design a surgical device for gasless laparoscopy. The team employed a formal roadmap, devised to guide the development of global surgical equipment, to structure the design process into phases. Phases 0–1 comprised primary research with surgeons working in low-resource settings and forming collaborative partnerships with key stakeholders. These participated in phases 2–3 through design workshops and video events. To conclude, surgical stakeholders (n=13) evaluated a high-fidelity prototype in a cadaveric study. Results: The resulting design, “RAIS” (Retractor for Abdominal Insufflation-less Surgery), received positive feedback from rural surgeons keen to embrace and champion innovation as a result of the close collaboration and participatory design methods employed. The roadmap provided a valuable means to structure the design process but this evaluation highlighted the need for further development to detail specific methodology. The project outcomes were used to develop recommendations for innovators designing global surgical equipment. To inform early phases in the design roadmap, engaging a variety of stakeholders to provide regular input is crucial. Effective communication is vital to elucidate clear functional design requirements and hence reveal opportunities for frugal innovation. Finally, responsible innovation must be embedded within the process of designing devices for global surgery. Conclusion: A community-wide effort is required to formally evaluate and optimize processes for designing global surgical devices and hence accelerate adoption of frugal surgical technologies in low-resource settings.

Systematic literature review of the barriers and facilitators of frugal innovation for surgical care in low-income and middle-income countries

“…This is important because frugal innovation may offer a cost-effective option to bridge the current gap in access to surgical care 32. Thus, this review can potentially contribute to developing more effective frugal innovations in surgical care for LMICs in the future 33. However, these findings only represent partial explanations about the complex nature of implementing frugal surgical innovations and must be considered helpful but incomplete understandings of the topic as they cannot be generalised in every LMIC setting 34.…”

Design of a syringe extension device (Chloe SED®) for low-resource settings in sub-Saharan Africa: a circular economy approach

“…The starting point for designing a medical device to support PCB during gynaecological procedures in LRS was to understand the context of use ( 51 , 59 ). This included, for example, the device users (healthcare workers), their needs, tasks involved in administering PCB, why and how these tasks are performed, and barriers encountered by the patients in accessing PCB.…”

“…Phase 3 comprised activities necessary to move from specified design requirements into physical and tangible design artefacts. Using the established design requirements (see Table 2 ), design ideas and prototypes were developed through a Waterfall Design Process ( 59 , 63 ). This process allowed for structuring iterative design activities from early conceptual designs through analysis and testing ( 63 ) while enabling stakeholders from the five partner healthcare facilities in Kenya to evaluate designs and contribute ideas throughout the process.…”