Key recommendations published in Nature Medicine set out guidelines for the evaluation of surgical robotics.
The IDEAL Robotics Colloquium outlines its new recommendations published in Nature Medicine, providing practical guidance for the evaluation of surgical robotics throughout their life cycle. Led by Mr Hani Marcus, Dr Pedro Ramirez & Professor Peter McCulloch, the IDEAL Robotics Colloquium affords researchers and innovators recommendations to consider when evaluating surgical robots, structured according to the IDEAL Stages: “Preclinical Development and Early Clinical Evaluation” (IDEAL Stages 0 – 2a), “Comparative Evaluation” (IDEAL Stages 2b – 3) and the “Long-term Monitoring and Technological Evolution” (IDEAL Stage 4). This paper is an important milestone in the maturation of surgical robotics research, bringing key perspectives together to improve how surgical robots are evaluated.
Surgical robots are poised to significantly alter the healthcare landscape, with expansion of the field of robotics increasingly permeating health systems. This is an exciting time for both patients and surgeons – but is not without risk. Lessons from the past showcase the harms of innovating without evaluating, and as the diffusion of surgical robots increases, thoughtful and robust evaluation methods must be established. Whilst they pose the same traditional challenges seen when evaluating medical devices, they are amongst the most complex systems entering contemporary health systems, and are, by their nature, a disruptive innovation, obligating major changes in the way work is done and in the business model of surgery. This warrants bespoke analysis and careful evaluation.
Surgical robots present novel challenges for evaluation, and the paper tackles them through the four key stakeholder perspectives described in the IDEAL-D framework – the device, the clinician, the patient and the system. When evaluating the device, for example, the potential for inclusion of artificial intelligence (AI) in the robot, and for increasing autonomy, means that our current static methods of evaluation are redundant, and future evaluation will need to be continuous. . Claims surrounding robots’ ergonomic benefit for clinicians require validation, and the impact of the learning curve of surgeons must be considered. From the perspective of the patient, robots introduce new ethical challenges relating to equitable access to care, and to determining who is accountable for errors where systems have a degree of autonomy. In terms of health systems, the financial cost of robotic systems is high and there are questions surrounding their carbon footprint, requiring analysis of their economic viability and sustainability. These must be viewed both with respect to the specific organisation or health system, but also as part of the global conversation relating to their environmental impact.
It becomes apparent that the range of issues evaluators should consider is significant, something which this paper addresses by orienting the reader to IDEAL stage specific recommendations across the four stakeholder perspectives outlined. These are some examples amongst the many raised in the IDEAL Robotics Colloquium guidelines, and they demonstrate the need for a broad and comprehensive analysis to identify the challenges of evaluation and provide recommendations to address the range of impacts surgical robots have on health systems and society in general. The Colloquium expert panel system has allowed us to integrate many previously disparate voices, raising the issues discussed in this paper, and offering some solutions to the challenges surgical robotics present. Bringing these together provides a robust starting point for developing future evaluations.
The paper does not claim to be definitive, and there is certainly more work to be done to improve how we evaluate surgical robots. However, the Collaboration is excited to share their recommendations and hope they assist their safe translation to improve the outcomes for patients.
Access this through Nature Medicine.
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