Session Organizer: Marc Horner, Ansys
Introduction to the ASME VVUQ 40.1 Technical Report
Brandon Lurie, BS, MS
Modeling and Simulation Engineer, W. L. Gore & Associates
Abstract: ASME VVUQ 40.1 is a new technical report expected to be issued by the VVUQ 40 subcommittee this winter or early spring. It applies the ASME V&V 40-2018 standard to a computational model that has a role in assessing the durability of a fictional tibial tray. While the standard already includes several limited examples of risk-informed validation and verification activities, the technical report walks through the planning and execution of every activity. Additionally, it provides a discussion section for each credibility factor that proposes work that could be done if greater credibility is needed. This talk will highlight the process of identifying a continuum of validation and verification activities for each credibility factor appropriate for the computational model and context of use instead of simply adopting the gradations listed in the V&V 40 standard. Strategies for defining general gradations to apply to multiple scenarios and rationalizing selecting an activity tied to a model risk lower than what was assessed will also be discussed.
Bio: Brandon Lurie is a Modeling & Simulation Engineer at W. L. Gore & Associates. He has spent over 15 years applying FEA to stents and other implantable medical devices. Brandon has led multiple standard writing groups, including the working group for ASTM F2514, Standard Guide for FEA of Metallic Vascular Stents Subject to Uniform Radial Loading, which was published in 2021, and ASME VVUQ 40.1, An Example of Assessing Model Credibility Using the ASME V&V 40 Risk-Based Framework: Tibial Tray Component Worst-Case Size Identification for Fatigue Testing, which is on track to publish in the first half of 2025. His current focus is on developing in-house tools, processes, and technology that aid the development of implantable medical devices. Though a graduate of the University of Michigan, Brandon cannot help the University of Minnesota obtain the Little Brown Jug.
Session Organizer
Marc Horner
Distinguished Engineer, Ansys
Dr. Marc Horner is a Distinguished Engineer leading technical initiatives for the healthcare industry at Ansys. Marc joined Ansys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME VVUQ-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Marc is also 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. Lastly, Marc helped to found the ASME VVUQ-80 Sub-Committee focused on computational modeling and simulation for pharma/biuopharma manufacturing,