June 2021 – Virtual Technical Forum & Networking Event

Computational Modeling for Medical Device Regulatory Submissions per ASME V&V40

Abstract:

There is a growing acceptance and reliance on computational modeling and simulation as scientific evidence for regulatory submissions. The FDA has included this in its strategic plan for regulatory science through several specific initiatives. With growing use of computational modeling and simulation for medical device submissions, there is a critical need to ensure that the models represent an appropriate approximation of reality. The ASME V&V 40 (2018) standard provides a risk-informed credibility assessment framework for computational modeling, specifically intended for medical devices. The credibility assessment is performed through a series of verification and validation activities for the computational model. The presentation will provide an overview of the ASME V&V 40 process along with a few case studies.

Speaker & Bio:

Nilesh Billade, PhD.

Senior Associate, Stress Engineering Services, Inc.

Dr. Billade is a Senior Associate at Stress Engineering Services. He earned his M.S. and Ph.D. degrees in mechanical engineering from the University of Cincinnati. His primary areas of interest include mechanical testing and numerical characterization of linear and non-linear engineering materials and biomaterials, and advanced nonlinear computational modeling techniques, such as the finite element analyses (FEA). He has 12 years of engineering work experience in the use of these techniques for innovation, product design and development, and optimization of a variety of products in the medical device and consumer products industries. Relevant experience includes: (a) Shipping and distribution simulation of a sterile barrier system and verification and validation of the computational model under the framework provided by ASME V&V40 Standard (b) Product integrity evaluation of a drug delivery system through its shelf life, using computational modeling and testing.

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