ASME V&V 40 Workshop


Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices was published in 2018 to support the credible use of modeling and simulation within the medical device industry. This standard was developed through close collaboration between medical device developers, regulatory agencies, and other device industry stakeholders, and provides modelers in the medical device industry with a framework for establishing model credibility requirements. This introductory course will provide an overview of the standard and highlight its key tenets through a few medical device examples and active discussions.

2023 Organizers and speakers are the officers of the ASME VVUQ Subcommittee 40:

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Jeffrey Bischoff, Sr Director, Research, Zimmer Biomet

Jeffrey Bischoff - 2023 DMD VV40 Speaker

Jeffrey Bischoff
Sr Director, Research, Zimmer Biomet

Dr. Jeffrey Bischoff is the Director of Biomechanics at Zimmer Biomet, where he has been since 2006. Prior to joining the medical device industry, he completed his Ph.D. in Mechanical Engineering at the University of Michigan, served as Assistant Professor at the University of South Carolina. Over the past ten years, Jeff has supported device development efforts using computational analysis across a wide range of orthopaedic applications, and throughout the total product life cycle from design ideation through regulatory clearance and commercialization. He has been actively involved with the ASME V&V40 Sub-Committee, including as chair of the orthopaedic working group and as vice-chair of the sub-committee. He recently was appointed to chair of the sub-committee, effective 2019-2022.

Marc Horner, ANSYS

Marc Horner - 2023 DMD VV40 Speaker

Marc Horner
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 V&V-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Lastly, Marc 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.

Fredric Constantino, The American Society of Mechanical Engineers

Fredric Constantino - 2023 V&V Speaker

Fredric Constantino
Project Engineering Advisor, The American Society of Mechanical Engineers

Fredric Constantino earned a dual Bachelor of Science in Aerospace/Mechanical Engineering from the University at Buffalo. He received his Master of Science from Columbia University in Mechanical Engineering with a concentration in control systems. Fredric is a licensed Project Management Professional (PMP) working as a Project Engineering Advisor for the American Society of Mechanical Engineers (ASME). He manages the development and revision of various engineering codes and standards related to product design and manufacturing as well as digital engineering. In addition to his work with ASME, Fredric volunteered with Engineers Without Boarders (EWB) for several years designing a water treatment and wastewater treatment system for a health clinic in Peru.

Payman Afshari, Sr. Principal Engineer DePuy Synthes, Johnson and Johnson

Payman Afshari - 2023 DMD VV40 Speaker

Payman Afshari, Ph.D
Sr. Principal Engineer DePuy Synthes, Johnson and Johnson

Dr. Payman Afshari is a Sr. principal engineer at the DePuy Synthes, Johnson and Johnson. He has more than 15 years of experience in applying computaitonal modeling asimulaiton (M&S) to address challenging problems in design and manufacturig of spinal implans. For the past 10 years, he has been involved in promoing the use of M&S across product life cycle including regualtory evidence generation. Currently, he is vice-chair of ASME V&V40 subcommttee, an active member of ASTM, the Avicenna Alliance, A European predictive medicine organizaiton, Medical Device Innovation Consortium (MDIC) and InSilcioUK initiative. He has co-authored several publicaiton in the area of verification, validation and uncertainty quantification of models in medical device development and regualtory applicaitons.

Kenneth Aycock, U.S. Food and Drug Administration

Kenneth Aycock - 2023 V&V 40 Speaker

Kenneth Aycock
U.S. Food and Drug Administration

Dr. Aycock performs experimental and computational continuum mechanics research at the U.S. Food and Drug Administration. Specific areas of interest include patient-specific mechanics and hemodynamics, implantable cardiovascular devices, fatigue failure, and nonlinear materials including superelastic nitinol. His current research focuses on demonstrating best practices in verification, validation, and uncertainty quantification of physics-based computational models following FDA guidance and ASME V&V standards. 

Pre‐Event Reading Materials: Obtain and familiarize yourself with the V&V 40 Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation Standard prior to the Workshop, a copy of the V&V 40 standard does not come with your registration. The document is available for purchase online at: ASME Store_V&V 40 - 2018

Location
American Society of Mechanical Engineers (ASME)

This workshop is being held in conjunction with the Design of Medical Devices 2023 Conference and the Institute for Engineering in Medicine's Innovation Week.

Separate Registration from DMD will be required for this workshop. Additional information about pricing will be available soon.