The handbook, developed under the editorial direction of the ASME VVUQ 40 subcommittee, provides a framework for assessing the credibility of computational models used in the medical device industry. Funding for the open-access publication was provided by Ansys, now part of Synopsys, and Johnson & Johnson, ensuring the material remains accessible to engineers developing everything from artificial hearts to dialysis equipment.

Goodin and Taskin’s contribution explores the lifecycle of medical device design, emphasizing that the rigor required for computational modeling scales with the reliance placed on that data. While physical testing often serves as the primary evidence for regulatory submissions, simulation becomes essential when test data is limited. The authors argue that because these devices directly impact human health, engineers must integrate simulation and experimentation to build a comprehensive evidence base for every stage of development. To discuss these findings, the engineers will host a live webinar on September 10, 2026, at 1:00 p.m. ET.