Background: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. Objective: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. Methods: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for ‘surgical device design in low resource settings’ and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. Results: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. Conclusions: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

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.