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

M Marriott Webb1, P Bridges2, N Aruparayil3

  • 1School of Mechanical EngineeringUniversity of Leeds Leeds LS2 9JT U.K.

IEEE Journal of Translational Engineering in Health and Medicine
|July 22, 2022
PubMed
Summary

A new surgical retractor was developed for Gas Insufflation-Less Laparoscopic Surgery (GILLS), addressing the inequity in surgical access for over 5 billion people globally. This context-appropriate innovation is now clinically validated for use in low-resource settings.

Keywords:
frugal engineeringglobal healthmedical device designparticipatory designsurgical technology

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Area of Science:

  • Global Health
  • Surgical Innovation
  • Medical Device Design

Background:

  • Over 5 billion people lack access to essential surgical care, primarily in low-resource settings.
  • Gas Insufflation-Less Laparoscopic Surgery (GILLS) offers a potential solution to improve surgical access.
  • Current GILLS instrumentation requires enhancement to meet modern surgical standards.

Purpose of the Study:

  • To develop and translate a novel Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical practice.
  • To establish a context-appropriate system for advancing GILLS surgery in underserved regions.
  • To address the global inequity in surgical treatment access.

Main Methods:

  • A multidisciplinary UK-India team collaborated with local stakeholders and industry partners.
  • Frugal and participatory design principles were employed in an iterative development process.
  • The RAIS system underwent rigorous evaluation through cadaveric simulations and clinical validation with rural surgeons.

Main Results:

  • User needs and contextual requirements were defined, leading to a refined RAIS design through five iterations.
  • A commercial RAIS system received Indian regulatory approval and was successfully used in 12 GILLS procedures.
  • Clinical feedback confirmed the RAIS system as a valuable, usable, and context-appropriate surgical instrument.

Conclusions:

  • Context-specific development and stakeholder engagement were critical for the RAIS system's success.
  • The RAIS system represents a successful translation of a global health need into a commercialized surgical instrument.
  • This innovation enables surgeons in low-resource regions across India to perform GILLS procedures effectively.