RAIS – Retractor for Abdominal Insufflation-less Surgery
Introduction: To complement our work in developing the Gas Insufflation-Less Laparoscopic Surgery (GILLS) Registry and TARGET training program, the GHRG-ST (in collaboration Pd-m International and partners in India) have developed and evaluated a prototype of an innovative new device to perform abdominal wall lifting during GILLS surgery. By designing a device that is easy for surgeons working in low-resource, remote locations to sterilise, transport, manufacture, maintain and afford, the team aim to make using the GILLS technique and hence minimally invasive surgery a reality for rural surgeons across the country.
Design and Innovation: Our team conducted this work by applying principles of participatory design and frugal innovation to develop the final design: RAIS (Retractor for Abdominal Insufflation-less Surgery). These are both widely recognised approaches for designing high-quality medical devices for low-resource healthcare environments. Participatory design has involved our team working closely with surgeons and other healthcare professionals in India, firstly to understand their needs, then moving to a continual dialogue in which we discussed, evaluated and adapted the design as it developed. Frugal Innovation has helped provide a sustained focus for the project: to innovate a cost-effective solution which focuses on core functionalities while optimising performance and quality.
End-user Evaluation: Our design and development process led to the production of a high-fidelity prototype system. A workshop was convened at the 2019 Association of Rural Surgeons in India Conference to evaluate the system with our surgical and healthcare professional partners from India, together with an international audience of conference delegates and organisers. In the workshop, we worked with the host institution (BVV Sangha’s S. Nijalingappa Medical College, Bagalkot, India) to deliver a series of training, evaluation and feedback sessions to assess the surgical performance of RAIS, using cadaveric models and simulated surgical procedures. As well as considering different aspects of usability and surgical efficacy, rural surgeons were asked to evaluate ease of cleaning, maintaining, repairing and transporting the system in a low-resource environment, from their experience. We also presented the design development work to conference delegates to showcase how this innovative approach to rural surgery can be supported by innovations in engineering and surgical instrument design. A summary of our cadaveric evaluation can be seen here (55sec).
Design Optimisation: The evaluation event highlighted that the RAIS system provides a good surgical experience, with surgeons readily able to setup, adjust and manipulate the system during a variety of surgical scenarios. The design team were present to observe and debrief participants, a process which provided a wealth of information for a second stage of design – ‘optimisation’. The optimisation process focused on incremental improvements to improve usability and robustness, for example ensuring that clamps can be safely operated with gloved hands whilst maintaining sterility. The resultant system, shown below, meets the stringent set of clinical requirements that were developed at the start of the project.
Next Steps: The next phase of our work is to address manufacture – refining the system such that it can be produced cost-effectively, and consistently, by partnering with medical device manufacturing experts in India. The resultant system will be evaluated with healthcare professionals in the UK, India and Africa to ensure it maintains the high standards we require. At this point, we will address aspects of regulatory approval and commercialisation, working with our manufacturing partner, so that the RAIS system can be made commercially available to help global surgeons practising GILLS across the word. Finally, when the device is finalised, we will develop a comprehensive training package tailored for a global audience. This will be achieved in collaboration with both our partners in rural healthcare centres in India and with Medical Aid International, a solutions expert in medical equipment for developing countries. This training package will help ensure that the device is sterilised, used, maintained and stored safely in challenging low-resource environments.