The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

• Published in: IEEE journal of translational engineering in health and medicine 2022-01, Vol.10, p.1-12
• Main Authors: Webb, M. Marriott, Bridges, P., Aruparayil, N., Chugh, C., Beacon, T., Singh, T., Sawhney, S. S., Bains, L., Hall, R., Jayne, D., Gnanaraj, J., Mishra, A., Culmer, P. R.
• Format: Article
• Language: English
• Subjects: Commercialization; Context; Embedding; frugal engineering; global health; Instruments; medical device design; Medical devices; Medical equipment; Medical services; participatory design; Performance evaluation; Prototypes; Public health; Regulatory approval; Stakeholders; Surgeons; Surgery; Surgical instruments; surgical technology; Systems development; User requirements
• ISSN: 2168-2372; 2168-2372
• DOI: 10.1109/JTEHM.2022.3177313

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.