Emerging Risks and Epistemic Uncertainty in Medtech Industry Innovation

s Innovation is an intrinsic characteristic of the medical technology (MedTech) industry and a major driver of improved healthcare outcomes. Recent advances in digitalization, artificial intelligence (AI), telemedicine, and advanced robotics are drastically transforming diagnostics, treatment, and care delivery. At the same time, these innovations challenge established safety and risk management paradigms, as novel technologies are often introduced into clinical practice before sufficient knowledge is available to fully characterize their risks. This situation creates a structural mismatch between the innovation speed and the maturity of regulatory frameworks. This paper analyses innovation in healthcare and MedTech from an engineering perspective, with a particular focus on emerging risks and epistemic uncertainty. It argues that traditional risk assessment approaches, largely developed for mature technologies, are inadequate to address the complexity, adaptiveness, and interconnection of modern medical systems. To address this limitation, an epistemic risk assessment model is proposed that explicitly distinguishes between known and unknown risks and emphasizes the uncertainty associated with risk estimates at market entry and throughout the product lifecycle. The applicability of the proposed model is presented through representative examples, including digital healthcare systems, telemedicine and personalized healthcare, AI-based medical devices, and advanced robotics, with explicit reference to Medical Device Regulation risk classes. These examples demonstrate that, while innovation delivers clear benefits, it also amplifies uncertainty in risk estimation, increases exposure to unknown risks, and challenges conventional post-market surveillance strategies. The paper concludes that the explicit integration of epistemic uncertainty into benefit-risk analysis, and its transparent communication, are essential to support informed decision-making, responsible innovation, and sustained trust in healthcare and MedTech technologies.

Keywords: MedTech, innovation, risk assessment, AI, surgical robots, medical device.