Surgical robotics are amongst the most complex devices entering healthcare, but how should we evaluate them? Published in Nature Medicine, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium outlines the latest guidance to aid researchers evaluating surgical robots.
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.
Led by Mr Hani Marcus (National Hospital for Neurology and Neurosurgery, and UCL Queen Square Institute of Neurology), Dr Pedro Ramirez (Houston Methodist Hospital Neal Cancer Center) and Professor Peter McCulloch (Nuffield Department of Surgical Sciences, University of Oxford), 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 means guidance is provided through the life cycle of a surgical robot.