Keynote

Presentation Title: Computer Modeling and Simulation as a Source of Regulatory Evidence at FDA

Biography: Brent Craven is a Research Scientist and Principal Investigator in the Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH) at the U.S. FDA. He received his PhD in Mechanical Engineering from the Pennsylvania State University in 2008. His areas of expertise include computational fluid dynamics (CFD), fluid-structure interaction (FSI), multiphysics modeling, patient-specific modeling, and verification and validation (V&V) of computer modeling applied to medical devices such as mechanical circulatory support devices, artificial heart valves, intravascular blood clot filters, and inhalers. His research at the FDA primarily focuses on (i) advancing the use of V&V for physics-based computational modeling of medical devices, and (ii) developing improved models for reliably predicting flow-induced blood damage in cardiovascular devices. He has authored 49 refereed journal papers and more than 100 conference proceedings and abstracts. He is currently an Associate Editor for the Journal of Verification, Validation and Uncertainty Quantification. In addition to research, he regularly serves as a subject matter expert and technical consulting reviewer on regulatory submissions to CDRH. He was a recipient of an FDA CDRH COVID-19 award in 2020 for his regulatory contributions in the technical review of emergency use ventilators, the FDA CDRH Excellence in Scientific Research Award in 2018, the American Society for Artificial Internal Organs (ASAIO) Kolff Award in 2016, and his research was featured in the 2015-2016 FDA Regulatory Science Progress Report to Congress.