Physician-researcher Develops Framework for Evaluating New Surgical Technologies

“Unfortunately, there hasn't been a formal entity that has provided guidance on how to evaluate and incorporate new technology, specifically robots and AI, into surgery,” Ramirez explained. “So, I joined the IDEAL Collaboration to help implement a robotics colloquium to address this need.” Founded in 2007-2008 at the University of Oxford, the IDEAL Collaboration is comprised of a group of research methodologists and surgeons with a common goal of improving surgical innovation research. While the group has already established an IDEAL Framework to evaluate surgical innovation and devices, the nature of surgical robots and AI pose new questions and concerns that go beyond the IDEAL Framework and the boundaries of classical evidence-based medicine.

“We felt that robotics needed its own evaluation framework because it is a technology that is growing so quickly and being integrated so fast,” Ramirez explained. “We need to become more critical of robotic technology as it is introduced to the field, especially when AI is involved and there’s potential for increasing device autonomy.” Using the existing IDEAL Framework as guidance, Ramirez and a team of diverse experts— surgeons, engineers, economists, patient representatives, and social scientists—began developing the IDEAL Robotics Colloquium in 2022. Dividing into panels, these experts participated in a series of virtual discussions focusing on key concerns regarding surgical robotics: AI, technical evaluation, clinical evaluation, human factors, health economics, ethics and surgical training. Through these discussions, significant questions emerged. For instance, what is the patient consent process and legal implications if a surgical robot performs most of a surgery? If surgical robots gain autonomy due to AI, will surgeons begin questioning their own intuition? If so, what are the implications of this? “We’re moving toward a technology where the surgeon can potentially be on autopilot or standby,” Ramirez said. “These types of advancements come with ramifications if the technology is not evaluated and used properly.” Taking these concerns into account, Ramirez and his team published the IDEAL Robotics Colloquium in Nature Medicine in 2024. The new framework outlines recommendations for surgical robot evaluation during development, comparative study and clinical monitoring. This framework also provides practical recommendations for developers, clinicians, patients and healthcare systems while considering multiple perspectives, including economics, surgical training, human factors, ethics, patient perspectives and sustainability.