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

M Marriott Webb; P Bridges; N Aruparayil; C Chugh; T Beacon; T Singh; S S Sawhney; L Bains; R Hall; D Jayne; J Gnanaraj; A Mishra; P R Culmer

doi:10.1109/JTEHM.2022.3177313

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

IEEE J Transl Eng Health Med. 2022 May 23:10:3700212. doi: 10.1109/JTEHM.2022.3177313. eCollection 2022.

Authors

M Marriott Webb¹, P Bridges², N Aruparayil³, C Chugh⁴, T Beacon⁵, T Singh⁶, S S Sawhney⁶, L Bains⁴, R Hall², D Jayne⁷, J Gnanaraj⁸, A Mishra⁴, P R Culmer¹

Affiliations

¹ School of Mechanical EngineeringUniversity of Leeds Leeds LS2 9JT U.K.
² Pd-m International Thirsk YO7 1DA U.K.
³ Leeds Institute of Medical Research, University of Leeds Leeds LS2 9JT U.K.
⁴ Department of SurgeryMaulana Azad Medical College New Delhi 110002 India.
⁵ Medical Aid International Bedford MK43 8TW U.K.
⁶ XLO Ortho Life Systems New Delhi 110020 India.
⁷ Department of Academic SurgeryUniversity of Leeds Leeds LS2 9JT U.K.
⁸ Department of Electronics and Instrumentation EngineeringKarunya University Coimbatore 641114 India.

Abstract

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.

Keywords: frugal engineering; global health; medical device design; participatory design; surgical technology.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Feedback
Humans
Insufflation*
Stakeholder Participation
Surgeons*
Surveys and Questionnaires

Grants and funding

This work was supported in part by the National Institute for Health Research (NIHR) using U.K. Aid from the U.K. Government to support global health research under Grant 16/137/44 and in part by the UK Global Challenges Research Fund (GCRF) allocation to the University of Leeds.