Math Modeling Seminar: Computational Modeling for Medical Devices

Math Modeling Seminar
Computational Modeling for Medical Devices: Applications in Regulatory Submissions and Credibility Assessment

Dr. Pras Pathmanathan
Senior Scientist
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
US Food and Drug Administration

You may attend this lecture in person at 2305 Gosnell Hall or virtually via Zoom.
If you’d like to attend virtually, you may register here for Zoom link.

Abstract:
Computational modeling and simulation (M&S) have a myriad of applications in medical devices, from virtual testing of new devices during either internal development or for regulatory review, to M&S algorithms being implemented within medical device software. An enormous range of M&S disciplines are relevant to medical devices, from traditional solid mechanics models to predict fracture risk of implanted devices, electromagnetic models to predict MRI-induced heating of metallic implants, to physiological patients models used to evaluate physiologic closed loop control devices such as automated mechanic ventilators. The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medical devices on the US market. A key question that CDRH has been faced with in recent years, as M&S has become increasingly used in medical device regulatory submissions, is when can M&S be trusted, that is, when is M&S credible? This talk will begin with an overview of M&S at FDA, following by an overview of M&S applications for medical devices. We will then discuss model credibility assessment, including frameworks for assessing models that have recently been developed by the medical devices community, and presenting research and results of assessment of models of the electrical activity in the heart.

Speaker Bio:
Dr. Pras Pathmanathan is a senior scientist at the Office of Science and Engineering Laboratories (OSEL), the regulatory science research Office within FDA’s Center for Devices and Radiological Health (CDRH). His research focuses on methods for establishing the credibility of computational models, covering the wide range of models relevant to medical devices, with a focus on physiological models including computational cardiac models. He leads or collaborates in numerous initiatives advancing computational modeling in healthcare, including co-founding and co-chairing FDA’s Modeling and Simulation Working Group, and leading OSEL’s regulatory science program on Credibility of Computational Models. He received a BA in mathematics from Cambridge University and an MSc and PhD in computational cardiology from Oxford University. Read more here.

Intended Audience:
Undergraduates, graduates, and experts. Those with interest in the topic.

The Math Modeling Seminar will recur each week throughout the semester on the same day and time. Find out more about upcoming speakers on the Mathematical Modeling Seminar Series webpage.
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