This presentation was made at CAASE18, The Conference on Advancing Analysis & Simulation in Engineering. CAASE18 brought together the leading visionaries, developers, and practitioners of CAE-related technologies in an open forum, to share experiences, discuss relevant trends, discover common themes, and explore future issues.

Resource Abstract

ASME’s V&V Standards Committees are responsible for creating V&V best practices, general guidance, a common language, and application-specific guidance documents. Although methods for V&V are well-established, guidance has been lacking on assessing the adequacy of the V&V activities for computational models used to support medical device development and evaluation. The V&V 40 subcommittee is focused on application to medical devices, and the forthcoming V&V 40 standard - Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices – is intended to address the need for guidance in this area.

Computational modeling can be used to provide information that supports decisions related to the technical performance, safety and/or effectiveness of medical devices. Computational models can be used throughout the total product life cycle of medical devices, from initial concept, design and development, to support of nonclinical and clinical activities, to post-market surveillance. Medical device manufacturers may utilize computational models to augment in vitro and in vivo evaluations, or where such evaluations are unjustifiably invasive, prohibitive, and/or deemed unreasonable. Moreover, computational models can also be used to evaluate options not possible experimentally or clinically.

Computational models can also be used to assess aspects of in vivo performance without subjecting patients to potential harm or unnecessary risk. The potential consequence of an incorrect assessment elevates the importance of being able to establish the credibility or trust in the predictive capability of a computational model.

Given the inherent risk of using a computational model as a basis for predicting medical device performance, a risk-informed credibility assessment framework has been developed. The framework centers on establishing that model credibility is commensurate with the risk associated with a decision based in part on the computational model. Thus, the intent of this standard is to provide guidance on how to establish the credibility requirements of computational models based on risk, and then determine and communicate the credibility of computational models used in the evaluation of medical devices through V&V activities.

This presentation will provide a high-level overview of the risk-informed credibility assessment framework, focusing on the new concepts that V&V 40 is introducing into the ASME V&V family of documents.