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.