Modeling the Future: Regulatory Perspectives on In Silico Tools for Medical Devices

Medical device manufacturers have traditionally relied on bench testing, animal testing, and clinical (human) trials to evaluate the safety and effectiveness of medical devices. Computational modeling and simulation (CM&S - aka In Silico) tools are now being adopted to not only accelerate innovation, but also provide additional insights regarding device safety and performance that are difficult/expensive to generate using traditional approaches. And while this may represent a paradigm shift in the development and evaluation of medical devices, these tools have a long history of being used in other regulated industries such as aerospace, nuclear, and automotive.

Questions around the credibility of the CM&S results are critical to establishing trust in this source of evidence. Model validation not only provides confidence during internal decision-making, but also addresses the regulatory risk associated with using models in submissions. This session will provide perspectives on the value of CM&S in the medical device total product life cycle and review current policy, standards, and guidance that support CM&S in regulatory submissions. The goal is to provide information that will facilitate the incorporation of CM&S into the regulatory strategy and submission for medical devices.