ASME debuts organization’s first-ever medical device standard

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In a first for the 140-year-old American Society of Mechanical Engineers (ASME; New York), the organization has introduced a standard focused on the development of 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, said the society in a press release issued yesterday. It hopes that the standard will contribute to lowering the cost of medical device development and accelerate regulatory approvals.

The development of medical devices typically involves physical testing in labs (bench tests, or in vitro testing) and in humans or animals (in vivo testing). These tests provide valuable insights, said ASME, 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,” said Tina Morrison, PhD, Deputy Director of the Division of Applied Mechanics at FDA, Chair of FDA's modeling and simulation working group, and Chair of ASME’s V&V 40 standards committee. “We aimed to develop a risk-based framework to support computational modeling for medical devices, and we accomplished this. 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,” said Morrison.

Dr. Morrison and other committee members will lead a webinar to introduce the new V&V 40 standard on Tuesday, June 4, 2019, at noon EST. For more information about the webinar, 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,” said Ryan Crane, P.E., Director of Standards and Certification Initiatives for ASME. “Ultimately, these standards and engineering processes can help make a real difference in people’s lives.”

Image: Viacheslav Iakobchuk/Adobe Stock

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