Towards Health Technology Assessment for Surgical Robots

Robotics represents a defining megatrend of our era, permeating a wide range of application domains. While over 300 surgical robot prototypes and commercial systems have been developed to date, only a limited number have successfully achieved commercialization and broad clinical adoption, translating into market success. A key barrier to timely market entry and high-quality system deployment has been the complexity of ensuring compliance with applicable regulatory standards. The European Medical Device Regulation (MDR) poses particular challenges for manufacturers, especially in areas involving Artificial Intelligence (AI) and robotics. Among the MDR requirements is the demonstration of clinical benefit or non-inferiority, often necessitating costly clinical trials, comprehensive literature reviews, and rigorous health technology assessments (HTA). This presentation aims to explore the strategies and tools available to navigate the complex certification processes required for both European CE marking and U.S. FDA approval. The paper analyzes various evaluation frameworks to quantify and benchmark current HTA methodologies applied to surgical robotics. The findings emphasize that adherence to established reporting standards is essential for the objective assessment of outcomes. Additionally, the study investigates the potential correlation between financial investment in surgical robot development and the likelihood of regulatory clearance.