Impact of in-silico technologies in the development of high-risk medical devices on healthcare

Abstract This study examines the impact of in-silico technologies (IST), such as virtual cohorts and digital twins, on the development of high-risk medical devices within the healthcare sector. An iterative empirical approach combining a literature review, exploratory and in-depth interviews with stakeholders from academia, industry, regulators, healthcare professionals, and focus groups with patients across Europe, Japan, and the USA was employed to gain insight into the implications of IST on healthcare. The findings indicate that IST can reduce the time to market for medical devices, thereby facilitating faster, broader, and more equitable access for patients. The implementation of extensive early testing, optimized study designs and increased sample sizes in trials can facilitate the achievement of enhanced safety. The early identification of adverse effects can enhance the safety of medical devices and improve patient outcomes. Furthermore, IST may facilitate the inclusion of underrepresented groups, such as children, in clinical trials, thereby enhancing their representation in medical research. The reduction in costs associated with IST may facilitate innovation cycles. However, the impact on prices is contingent on competition. Furthermore, IST have the potential to reduce the need for animal testing. Nevertheless, several uncertainties and potential adverse effects have been identified. Physician training on new devices remains a bottleneck, which may limit the benefits of new products. Despite the advancements, a complete replacement of traditional clinical and preclinical trials with IST is not seen to be feasible. From a policy perspective, it is crucial to promote regulatory clarity by providing guidance for the usage of IST, to offer incentives for the adoption of IST, and to foster competition. These findings demonstrate the multifaceted potential benefits and challenges of IST, including enhanced safety, accessibility, and innovation in healthcare. Key messages • In-silico technologies can reduce time-to market of medical devices up medical device and improve safety for patients. • Challenges like physician training and regulatory guidance must be addressed to fully realize benefits of in silico technologies.