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Computational Modeling & Regulatory Science 1:
The ASME V&V 40 Standard: An Introduction and Applications

Tuesday, April 16, 10:30-12:00
Meridian Ballrooms 4, Graduate Minneapolis

Organizer: Marc Horner, ANSYS, Inc.

"An Introduction to the ASME V&V 40 Standard"
Marc Horner, ANSYS, Inc.

"Credibility Assessment Process for Computational Modeling in Regulatory Submissions: A Case Study"
Prasanna Hariharan, U.S. Food and Drug Administration

"Device Success Stories with V&V40"
Jeffrey Bischoff, Director, Biomechanics Research, Zimmer Biomet

"Verification in Computational Modeling of Medical Devices"
Ismail Guler, Research Fellow, Boston Scientific Corporation


Session Abstract:

Medical device manufacturers have traditionally relied on bench testing, animal testing and clinical trials to establish the safety and efficacy of medical devices. This is true both internally, when making decisions about various aspects of a device design, and externally, when applying for regulatory approval. These sources of evidence can be expensive and time-consuming. This has driven sustained interest in the use of computational modeling as a tool to accelerate innovation and provide comprehensive evidence of long-term safety. However, the utilization of computational modeling as evidence in regulatory submissions is lagging in spite of these benefits. One reason is the lack of a well-defined approach for establishing the regulatory bar for acceptance of modeling results as part of a regulatory submission. This session will begin with an overview of the current regulatory pathway for incorporating computational modeling results in device submissions, which will be followed by presentations on model verification best practices and the impact of V&V 40 regulatory interactions.


Session Organizer Bios:

Marc Horner, ANSYS, Inc.
Dr. Marc Horner is a principal engineer focusing on healthcare applications at ANSYS, Inc. Marc joined ANSYS after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc began by providing support and professional services for biomedical and pharmceutical industry clients before transitioning to a healthcare business and technology development role.

Marc has a number of leadership positions in industry. This includes Vice Chair of the ASME V&V40 Sub-Committee - which is establishing V&V best practices for the medical device industry, and the ASME V&V Standards Committee - who oversee the creation of best practices and general guidance on V&V for CM&S. Marc is also an Associate Editor of the ASME Journal of Verification, Validation, and Uncertainty Quantification. Marc also leads the MDIC Blood Damage Working Group, who is aiming to develop regulatory-grade models that can predict some forms of blood damage that occur in blood-contacting devices. Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project who aim to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.


Speaker Bios:

Jeffrey Bischoff, Director, Biomechanics Research, Zimmer Biomet
Dr. Jeffrey Bischoff received his Ph.D. from the University of Michigan in 2001 with a specialization in soft tissue biomechanics. He subsequently held a post-doctoral position at the University of Auckland (New Zealand) and Assistant Professor at the University of South Carolina in Mechanical Engineering, where he developed an experimental and computational laboratory focusing on characterization of cardiovascular and orthopaedic biomaterials, funded through federal research grants. Since 2006, he has been at Zimmer Biomet in various engineering and management roles. During this time he has supported product development efforts in a variety of segments using computational analysis, optimization, and other analytical tools.

Ismail Guler, Research Fellow, Boston Scientific Corporation
Ismail Guler is a research fellow and a member of the Virtual Engineering Team at Boston Scientific Corporation doing computational modeling to help develop medical devices. He is also a lecturer in the Department of Biomedical Engineering at the University of Minnesota teaching a course on the computational modeling of medical devices. He is a member of the ASME V&V 40 subcommittee.


Presentation Abstracts:

"An Introduction to the ASME V&V 40 Standard"
The ASME Standard V&V 40 -- Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices was published in November 2018. Developed through close collaboration between device developers, regulatory agencies, and other device industry stakeholders, V&V 40 provides modelers in the medical device industry with a framework for establishing the credibility requirements for a modeling activity. This talk will provide an overview of the regulatory pathway for computational modeling results in regulatory submissions, including an in-depth look at the ASME V&V 40 standard.

"Credibility Assessment Process for Computational Modeling in Regulatory Submissions: A Case Study"
We will detail a case study where FDA worked closely with a medical device company to apply the credibility assessment principles of the ASME V&V 40 standard in a regulatory submission. We will share the outcomes from the validation study, credibility assessment and its impact on the regulatory decision.  Further, the presentation will also discuss the benefits of V&V 40 in the regulatory process and the potential role of FDA scientists in assisting device industry to apply the risk-informed credibility assessment framework to their computational models.

"Device Success Stories with V&V40"
The newly published ASME V&V40 standard on the use of computational modeling and simulation (CM&S) in support of medical device development provides a framework to guide CM&S practitioners in the medical device space. This talk will present a case study on reducing this framework to practice in direct support of an orthopaedic implant. The technical approach used to address a specific functional aspect of a medical device will be presented; as well as the subsequent interactions with regulators on the model use.

"Verification in Computational Modeling of Medical Devices"
The ASME V&V 40 Verification Working Group focuses on the application of code and calculation (solution) verification best practices in computational modeling of medical devices. The working group is structured into two subgroups, which are currently organizing challenge problems covering code verification for computational fluid dynamics (Womersley flow example) and calculation verification for computational solid mechanics (stent and hip stem examples). The work and results from these challenge problems will be presented.


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