New ASME V&V 40 Standard for Medical Devices Released
The American Society of Mechanical Engineering (ASME) released the new Verification & Validation (V&V 40) standard for Computational Modeling of Medical Devices on November 15, 2018. This is big news for companies in the biomedical industry, particularly those using simulation to support the design and development of their medical devices.
The ASME V&V 40 standard isn’t intended as step-by-step guide. Instead, it aims to provide a framework for identifying and establishing the risk-informed credibility of a computational model.
“The ASME V&V 40 standard provides guidance on how to communicate your simulation verification and validation efforts within your own organization and also with a regulatory agency as part of your regulatory submission,” says Mark Goodin, SimuTech Group CFD Consulting Engineer and V&V 40 Subcommittee member. “Following this methodology, you use the simulation verification and validation results to help answer a specific question of interest. The goal is to determine the level of credibility needed with your simulation so that you can use the simulation results to support a decision that may influence the safety or health of a patient.”
Verification addresses whether your code is correctly solving the mathematical equations you’ve modeled and the accuracy with which you’ve solved those equations. Validation addresses how well the simulation results compare with what happens in the real world, such as in vitro or in vivo test data. In addition to model verification and validation, the ASME V&V 40 standard also discusses model applicability which considers the relevance of the validation activities to a specific context of use. The standard includes 13 credibility factors associated with the verification, validation, and model applicability activities, which are very helpful when establishing the credibility of your computational model.
Used in conjunction with the Food and Drug Administration’s guidance on “Reporting of Computational Modeling Studies in Medical Device Submissions,” the new ASME V&V40 standard will play a significant role in both establishing and demonstrating the level of rigor needed for computational modeling used in support of a regulatory submission. “It’s very exciting to be part of this journey and to help in clarifying the expectations and demonstrating the important role that computational modeling can play in advancing patient health,” says Goodin.
Read more about the FDA’s current thinking in its document “Reporting of Computational Modeling Studies in Medical Device Submissions.”
To order a copy of the new ASME V&V 40 standard, visit the ASME website; digital copies are available immediately.
The ASAIO Journal recently published an article "Assessing Computational Model Credibility Using a Risk-Based Framework" that includes the application of the ASME V&V 40 standard to hemolysis in centrifugal blood pumps, an ANSYS CFX model developed by SimuTech’s Mark Goodin, Principal CFD Consulting Engineer. Mark collaborated with authors from the US Food & Drug Administration, Baxter Healthcare, DePuy Synthes Spine, Johnson & Johnson, and ANSYS, Inc. on this article.