Computational Modeling for Medical Devices

The Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of medical devices marketed in the US. For several decades, in a handful of niche applications, medical device industry has used computational modeling to provide evidence for safety or effectiveness, complementing bench, animal, or clinical testing. In recent years, the use of computational modeling in medical device regulatory submissions has grown significantly. FDA’s medical device Center is now tasked with evaluating a wide range of computational models of medical devices, as well as computational models implemented in medical device software (for example, patient-specific model-based software devices, closely related to the concept of a digital twin), and in silico clinical trials. This talk will discuss how computational models are relevant to medical devices, and then delve in model credibility assessment. We will discuss key activities involved in evaluating computational models for medical devices, overview recent FDA-led Standards and Guidances, and summarize recent work expanding these methods to the new frontiers of patient-specific models and in silico clinical trials.