Introduction to Computational Modeling in Medical Device Development

Bench testing, animal testing, and clinical trials have long been recognized by the medical device industry and global regulatory bodies as the “three pillars” of product development and pre-market evaluation. Multiple sources of information are required since each has its own strengths (and weaknesses) when predicting the safety and effectiveness of a device. Computational modeling and simulation (CM&S) can provide additional, and often complementary, information to the traditional sources of evidence and is now recognized by the US FDA as the fourth pillar of pre-market evaluation. As a result, the medical device industry is now rapidly adopting CM&S to reduce the time, costs, and risks associated with developing and approving new devices.

This presentation will begin with an overview of the use of CM&S in the healthcare industry. The current regulatory position on computational modeling as part of the regulatory review process will then be covered. Case studies illustrating the application of computational modeling to a variety of applications will also be presented.