Regulatory Applications in Computational Modeling and Simulation
Assessing thrombosis potential is essential to establishing the biocompatibility of blood-contacting medical devices. Computational fluid dynamics (CFD) has proven to be a useful complementary tool for understanding mechanical sources of blood damage such as shear stress, exposure time, and flow recirculation. In an effort to understand the applicability of thrombus modeling for device development and regulatory review, an industry round-robin study was carried out by the MDIC Blood Damage Working Group. This webinar will review the results of this round-robin study and discuss future directions for this work.
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In this webinar, MDIC presented the results of an industry survey measuring the progress of the adoption of CM&S, as well as a comprehensive industry landscape report providing context and identifying a path forward. A panel representing the device industry, technology suppliers, and regulatory agencies provided their input and answered questions. Moderator: Randall Schiestl, Vice President, Research & Development, Global Technology, Boston Scientific Speakers: – David Flynn, PhD, Fellow, CM&S, Global Technology, Boston Scientific – Steven Levine, PhD, Senior Director, Virtual Human Modeling, Dassault Systèmes – Jeffrey E. Bischoff, PhD, Sr Director, Research, Zimmer Biomet – Brent Craven, PhD, Research Scientist & Program Manager (Acting), Credibility of Computational Modeling and Simulation Program, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration – Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, Medical Device Innovation Consortium (MDIC)
