Introduction to ASME V&V 40 Standard – Medical device evaluation using computational modeling

At this webinar ASME will introduce its first verification and validation standard for specific application to medical devices. Understand this new standardized approach for determining the credibility evidence needed to support use of a computational model and how such a model can impact medical device lifecycles.

Medical device development traditionally has involved physical testing in labs using human or animal models. Performing computational modeling and simulation can decrease the number of physical tests necessary for product development if the modeling approach is supported with appropriate credibility evidence, which typically comes from V&V activities. Verification is done to determine if the computational model fits the mathematical description. Validation is a direct comparison between the computational model output and data from a real-world experience. In this way, variables in the computer model can quickly be adjusted to experiment with different scenarios. Computational models also enable evaluations that are not possible to conduct experimentally or clinically. The ASME V&V 40 standard builds on the foundations of ASME's V&V 10 and V&V 20 standards.

Webinar attendees will gain an understanding of this new standard and how it can be applied to modern medical device design and healthcare. Join innovative leaders in this rapidly evolving field as they discuss the many possibilities of computational modeling and simulation for medical devices.

Key Takeaways

• Gain understanding of a conceptual framework for implementing verification and validation for computational modeling to medical devices.
• Unite the engineering and scientific communities with a common language, advancing innovative design and testing.
• Learn about risk-based approach to gathering credibility evidence to support a computational model.
• Obtain insights into the current regulatory perspective on modeling and simulation for medical devices.
• Find out about the new V&V 40 standard and how it can help bring time and cost efficiencies to medical device development.

Speakers

Tina M. Morrison, Ph.D., Deputy Director, Division of Applied Mechanics, FDA’s Office of Science and Engineering Laboratories

Dr. Morrison is a mechanical engineer who received her PhD in Theoretical & Applied Mechanics from Cornell University. Over the decade working at the FDA, she has advanced the role of computer modeling and simulation in medical device design and product evaluation. The FDA Office of the Chief Scientist entrusted her with forming and leading an agency-wide working group on modeling and simulation, whose first workshop attracted hundreds of FDA participants. She also headed the drafting of FDA's breakthrough guidance for modeling: Reporting of Computational Modeling studies in Medical Device Submissions, attracting international recognition. Because of these efforts, Dr. Morrison was selected as the 2019 Federal Engineer of the Year for FDA. She is the Deputy Director of the Division of Applied Mechanics in FDA's Office of Science and Engineering Laboratories.

Marc Horner, Ph.D., Principal Engineer, ANSYS, Inc.

Dr. Horner earned his Ph.D. in Chemical Engineering from Northwestern University in 2001, and is the principal engineer at ANSYS, Inc. Dr. Horner is Vice Chair of the ASME V&V40 Sub-Committee, which establishes V&V best practices for the medical device industry, and the ASME V&V Standards Committee, which oversees the creation of best practices and general guidance on V&V for CM&S. He is an Associate Editor of the ASME Journal of Verification, Validation, and Uncertainty Quantification, and also leads the MDIC Blood Damage Working Group, which is charged with developing regulatory-grade models that can predict some forms of blood damage that occur in blood-contacting devices. Marc also is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.

Jeffrey Bischoff, Ph.D., Director of Biomechanics, Zimmer Biomet

Dr. Bischoff completed his Ph.D. in Mechanical Engineering at the University of Michigan and is the Director of Biomechanics at Zimmer Biomet. He previously served as Lecturer at the University of Auckland (New Zealand) and as Assistant Professor at the University of South Carolina, where he pursued federally funded research in various aspects of computational biomechanics and was instrumental in forming a biomedical engineering degree program. Over the past 10 years, Jeff has supported device development efforts using computational analysis across a wide range of orthopedic applications, and throughout the total product life cycle from design ideation through regulatory clearance and commercialization. Dr. Bischoff is actively involved with the ASME V&V40 Sub-Committee, including serving as chair of the orthopedic working group and as vice-chair of the sub-committee. He was recently appointed to chair the sub-committee, effective 2019-2022.

Full information on the webinar can be found here