The American Society of Mechanical Engineers (ASME) has launched its first standard with application to medical devices. ASME’s new V&V 40 standard assesses the credibility of computational modeling through verification and validation with application to medical devices, including endovascular and orthopedic devices, heart valves and stents.
V&V 40 builds on the foundation of other widely adopted ASME standards for computational (predictive) modeling techniques and performance simulation that have helped to streamline the development of new technologies for advanced manufacturing, to safely study the impact of fluid dynamics and heat transfer in nuclear energy systems, etc.
Traditionally, the development of medical devices has involved physical testing in labs (bench tests, or in vitro testing) and in humans or animals (in vivo testing). These tests provide valuable insights, but the use of computational models and simulation provides another, more efficient avenue for looking at medical devices. Companies can build models of devices and the body’s systems and run simulations of how the device will perform when deployed. They can quickly adjust variables to model different scenarios, making it possible to run through a large number of possibilities in a relatively short time and find the optimal result.
“The FDA was pleased to participate in and help lead this ASME subcommittee. We aimed to develop a risk-based framework to support computational modeling for medical devices, and we accomplished this,” notes Tina Morrison, PhD, deputy director of the division of applied mechanics of the FDA, chair of its modeling and simulation working group, and chair of ASME’s V&V 40 standards committee. “We believe that standardized computational modeling techniques will aid in the design, testing, and regulatory review of medical devices or components that will ultimately lead to a more efficient and lower cost way of evaluating devices throughout their total product life cycle.”
Morrison and other committee members will lead a webinar to introduce the new V&V 40 standard on Tuesday, June 4, at 12 p.m. EST. For more information about the webinar and its presenters, visit go.asme.org/vv40webinar.
“With credible computational modeling, the medical device industry can meet many challenges, streamline processes, reduce costs and scale the development of new technologies for wider use,” adds Ryan Crane, PE, director of standards and certification initiatives for ASME. “Ultimately, these standards and engineering processes can help make a real difference is people’s lives.”