The US Food and Drug Administration (FDA) must clear or approve new medical devices before they can be sold within the USA. This interactive workshop will begin with a brief introduction containing basic information describing how commercial products are developed and the additional requirements needed for evaluation by the FDA. Next, model risk will be discussed in the context of how computational modeling and simulation can be used as part of an FDA submission. This will be followed by a small group activity to practice the principles of model risk evaluation. The second FDA presentation will be on calibration evidence and followed by another small group activity on this topic. The workshop will conclude with a question-and-answer session to address issues raised/discovered in the group activities with the entire group. We anticipate about 60-100 people to participate in the workshop including engineers and entrepreneurs that work in industry, graduate and undergraduate students, and university faculty.
Workshop Chair & Presenters:
- Martin Tanaka, Western Carolina University
- Pras Pathmanathan, US Food & Drug Administration
Click on the drop downs below for additional information.
Presentation Details
Martin Tanaka, PhD
Professor of Mechanical Engineering
Western Carolina University
Bio: Martin has a PhD in Biomedical Engineering, and his research includes computational modeling, medical device development, biomechanics, and human subject experiments. For three summers he worked as a Scholar in Residence at the FDA. Dr. Tanaka has 11 years of experience designing commercial products in industry and 17 years in academia. He is a licensed professional engineer, a fellow of ASME, and a veteran of the US Armed Forces.
Martin Tanaka's WCU profile.
Pras Pathmanathan, PhD
Senior Research Scientist
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)
US Food & Drug Administration
Bio: I am a senior scientist at the FDA's medical device Center specializing in computational modeling, with a focus on model credibility, i.e., how do we know when models are reliable? I've led the development of FDA Guidance on model credibility, published extensively on this topic and created FDA Regulatory Science Tools. I've led or been a key contributor to numerous initiatives advancing computational modeling in healthcare and digital health, including co-founding and co-Chairing FDA’s Modeling and Simulation Working Group, and previously leading OSEL’s regulatory science program on Credibility of Computational Models.
Pulled from LinkedIn Profile.