The RAIS device for low-resource laparoscopic surgery: development, evaluation and future perspectives

The RAIS device for low-resource laparoscopic surgery: development, evaluation and future perspectives

Millie M Webb, Philippa Bridges, Noel Aruparayil, Tim Ho, Tim Beacon, Anurag Mishra, Tamandeep Singh, Sundeep S Sawhney, Lovenish Bains, Richard Hall, David Jayne, Jesudian Gnanaraj, Peter Culmer
University of Leeds, Leeds, United Kingdom; Maulana Azad Medical College, New Delhi, India

Background: Over 5 billion people have no access to safe or affordable surgery, despite it being the primary life-saving treatment for many common conditions. Access is worst in resource-scarce regions, exaggerating this inequity in healthcare. Gas Insufflation-Less Laparoscopic Surgery (GILLS) is a technique which can address this inequity, bringing the advantages of laparoscopic surgery with low resource use. Unfortunately, extant GILLS instrumentation does not meet modern standards, limiting wider use. Accordingly, our aim was to address the clinical need for contextappropriate GILLS instrumentation by developing RAIS: the Retractor for Abdominal Insufflationless Surgery (RAIS).

Methods: Employing participatory design principles, we assembled a multidisciplinary team of engineers, designers, surgeons and healthcare experts from the UK and India, clinical stakeholders and a commercial partner. We used a combination of medical-device design methodologies, with an iterative development process featuring regular stakeholder evaluation, to address the unique challenges of designing for resource-scarce environments. A final commercialisation phase was then conducted, led by our surgical and commercial partners in consultation with regulatory and clinical bodies in India.

Results: The design approach proved an effective means of integrating stakeholders within the development process. A series of prototypes were produced and tested, concluding with a candidate system meeting all major clinical requirements. This was evaluated in workshops with rural surgeons using RAIS with cadaveric models. Feedback informed revisions to optimise surgical performance, cleaning, maintenance and transportation. A commercial version of RAIS was then produced (XLO Ortho) obtaining regulatory approval for use in India. Our clinical team used this in patient cases at GILLS training workshops across India. Surgeon feedback revealed it provides a high-quality surgical experience and enabled new teams to perform GILLS independently in resource-scarce environments.

Conclusions: Using participatory design principles with a motivated multidisciplinary team was crucial to achieving a successful commercial version of RAIS. This surgical instrument is being used by an expanding team of surgeons in resource-scarce regions of India; realising our ambition of moving from clinical need to clinical use. Our focus is now to use RAIS to support translation of GILLS to other world-regions which can benefit from this approach.