Current Applications and Future Developments of the ASME V&V 40 Standard

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.
 

Jeff Bodner, MS
Distinguished Scientist
Medtronic

Abstract: An emerging idea called an "In Silico Clinical Trial" (ISCT) has received a lot of interest by the medical device industry, but is still immature in terms of methods and practice.   In ISCT, simulated patients are used to augment or replace results from real human patients in order to reduce trial costs and duration, while improving the overall quality of the information generated.   For a simulation to be used in such a high consequence application, the credibility of the model must be well-established in the eyes of the diverse set of stakeholders who are impacted by the trial's outcome.  Performing validation of these models is a non-trivial problem, given the limitations of bench or animal model studies as comparators, while direct validation against human data is rarely possible for a number of practical reasons.    In this talk, the presenter will discuss the unique credibility demands of ISCT, and how credibility frameworks like ASME V&V40 can be utilized.   An overview of the relevant literature will be provided.

Bio: Jeff Bodner is a Distinguished Scientist and Technical Fellow at Medtronic in Minneapolis, MN. During his 18 years at Medtronic, his work has supported several products included implantable drug pumps and neuromodulation devices. He is currently focused on advancing the practice of computational modeling and simulation across the enterprise. Jeff is an active member of the ASME verification and validation standards community, having served previously on the ASME V&V40 sub-committee and currently on the V&V10 sub-committee. Prior to Medtronic, he held positions at Boston Scientific, Guidant, and BAE Systems. 

Jeff has a Bachelor's and Master's degree in Mechanical Engineering from Case Western Reserve University and a Master's degree in Biomedical Engineering from the University of Minnesota, Twin Cities.  He is an inventor on over 25 US patents related to medical device design. 

Julien Clin, PhD, MS
Scientific Director
Numalogics

Abstract: The ASME VVUQ 40 Sub-Committee is exploring credibility best practices when utilizing patient-specific data as part of computational modeling and simulation (CM&S) activities. More specifically, the patient-specific modeling working group is writing a new ASME technical report where the ASME V&V 40 standard is applied to a patient-specific application (femur-fracture prediction).  The goal of this report effort is to identify any potential modifications to the ASME V&V 40 standard framework to provide better alignment with patient-specific models.  Additionally, the working group is developing a classification framework for comparators that can be used to assess the credibility of patient-specific computational models. The goal is to define, classify, and compare these different types of comparators, highlight the strengths and weaknesses of each comparator type, and provide rationale for using each type of comparator. This presentation will review this classification system as well as current progress on the new report.

Bio:  Julien Clin got his Bachelor of Engineering degree from École Polytechnique de Paris (France). He then specialized in biomedical engineering in École Polytechnique of Montréal (Canada) where he received a Master of Applied Sciences and a Ph.D.

During his career, he specialized notably in spine biomechanics and in the development of high-end computational models and simulations (CM&S).  He particularly focused on the development of automated CM&S engines and in their embedment in clinical software. As a member of the VVUQ40 committee, he also contributes to the improvement of the CM&S verification and validation processes.
He is currently the scientific director of the biomechanical simulation team at Numalogics Inc. (Montréal, Canada).

Travis Schauer, MS
Associate Senior R&D Fellow
Boston Scientific

Abstract: Grid convergence studies are at the heart of both code and calculation verification. The way a grid or mesh is refined can significantly influence the conclusions drawn from a grid convergence study. In this presentation, we will show an example of code verification for a blood hemolysis model, highlighting how misleading results can arise when systematic mesh refinement is not applied. Furthermore, we will discuss key considerations for maintaining systematic mesh refinement on unstructured meshes with nonuniform element sizes, including one important aspect that is often overlooked in the literature.

Bio: Travis is an R&D engineer in the Computational Modeling & Simulation group at Boston Scientific. He has spent the past 20 years developing computational models for a wide range of products/problems in the medical device field including blood pumps, coating processes, drug transport, biological fluid mechanics, vascular stents, and radiofrequency ablation of tissue.  Previously, he worked 5 years at Goodrich Sensor Systems where he carried out wind tunnel testing and computational analysis of air data probes. He received a B.S. and M.S. in Aerospace Engineering & Mechanics along with a minor in Mathematics from the University of Minnesota – Twin Cities.  His graduate research focused on experimental studies of supercavitating torpedoes

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,