In Silico: Virtual Patients, Real Evidence: The Current Use of In Silico Regulatory Evidence

Description: The Medical Device Regulation (MDR) places a strong emphasis on clinical data. Clinical investigations are time-intensive, costly and demand specialized expertise, thereby creating significant hurdles for manufacturers. The impact of MDR on the MedTech landscape is already evident: reduced innovation, disappearance of niche products, supply challenges, and even company closures. Recent pivotal moments have further highlighted the need for alternative approaches: orphan medical devices often face insurmountable challenges due to low patient populations, while the COVID-19 pandemic has illustrated how alternative data such as in silico models could have enabled faster access to critical technologies. Such virtual physiological human models can also provide evidence for aspects that cannot be measured experimentally.

This session will explore the role of in silico models as alternatives or complements to clinical investigations, from the perspectives of a Notified Body, manufacturer, scientist and consultant. We will highlight the potential of such models to reduce reliance on in vivo clinical data generation throughout the life cycle of medical devices and how validation requirements can be scaled according to the different contexts of use. Specifically, we will show how in silico approaches are already well-established in support of device development and contribute to the overall body of evidence required for CE marking, and how they may further add value to a lean post-market clinical follow-up PMCF strategy. Finally, a real-world case study will demonstrate how a world-leading joint replacement manufacturer is applying physic-informed in silico approaches across design optimization, preclinical verification, and clinical evaluation. Advanced anatomical and physiological musculoskeletal human models will also be presented, which are used for realistic evaluations of joint implants. These cutting-edge in silico technologies have the potential to transform product design, clinical evidence and regulatory processes

The presentation will also address limitations of in silico models - both technical/clinical and regulatory.