Computational modeling and simulation (CM&amp;S) has revolutionized product and process development in industries such as aerospace and automotive over the past several decades, where benefits include predicting performance, assessing design parameter interdependencies, and evaluating real-world use conditions, to name only a few.&nbsp; In contrast, the healthcare industry has traditionally relied on bench testing, animal testing, and clinical trials for medical device development and regulatory approval.&nbsp; The use of computational modeling by the medical device industry is accelerating in various phases of medical device development, especially early design. However, the utilization of computational modeling as evidence in regulatory decision-making is lagging.A primary concern has been the lack of frameworks that can be used to justify that a model has sufficient credibility to be used as a basis for regulatory decision-making.&nbsp; The processes of verification and validation (V&amp;V) provide a framework for establishing the credibility of a numerical solution, where verification establishes the correctness of a numerical solution to a mathematical model and validation establishes whether the mathematical model is an accurate representation of the reality of interest. Put simply, verification answers the question “have I solved the equations correctly?” and validation answers the question “have I solved the correct equations?”&nbsp; The American Society of Mechanical Engineers (ASME) Committee on Verification, Validation, and Uncertainty Quantification in Computational Modeling and Simulation has published the ASME V&amp;V 10 and 20 standards, which outline the processes of verification, validation, and uncertainty quantification for finite element analysis and computational fluid dynamics, respectively.&nbsp; These standards clearly outline how to validate computational models, but don’t provide processes for steering computational model development in the direction of being good enough.&nbsp;The above factors led to the development of the ASME V&amp;V 40 Committee on Verification, Validation, and Uncertainty Quantification in Computational Modeling of Medical Devices, who published the standard “Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices” in 2018.&nbsp; This standard was developed through close collaboration between medical device developers, regulatory agencies, and other device industry stakeholders.&nbsp; The standard describes a “risk-based credibility assessment framework” that establishes an explicit connection between the risk associated with a decision that will be made based on a computational model and the credibility requirements of the model.&nbsp; This presentation will provide an overview of this standard and how it supports the regulatory framework for using computational modeling and simulation results as part of regulatory submissions.

ASME V&V 40: A Risk-Based Framework for Establishing the Credibility of Computational Models of Medical Devices

Paper Proceedings: https://asmedigitalcollection.asme.org/IMECE/IMECE2021/volume/85543

ASME 2021 International Mechanical Engineering Congress and Exposition (IMECE2021)

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