A new report from MDIC's Computational Modeling and Simulation (CM&S) initiative discusses the potential of CM&S to reduce product development costs, accelerate time to market, and better serve patients with safe and effective medical devices.
The more than 40 case studies included in this report demonstrate evidence of the value of CM&S to both industry and regulatory bodies such as the US Food and Drug Administration (FDA). It also investigates current barriers to more widespread adoption and offers recommendations for future actions.
“The use of CM&S, or in silico methods, is well-established and rapidly increasing in the medical product development process, but still lags behind compared to other sectors like aviation or automotive industries. One of the goals for the MDIC CM&S program is to increase confidence in the use of CM&S in regulatory submissions. MDIC aims to generate more discussion on this topic using this report and survey results included in it,” said Jithesh Veetil, Senior Director for Digital & Health Technology portfolio at MDIC.
Featuring insights from experts from industry and regulatory agencies, the report explores the evolution of the use of CM&S in the design and development of medical devices. The report is informed by comparing the results of two surveys that MDIC conducted nearly a decade apart – each of which had input from about 40 small, medium, and large medical device manufacturers, both domestic and international.
“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters,” said Randall Schiestl, vice president, Research & Development, Global Technology, Boston Scientific and Chair of MDIC CM&S steering committee. “The report also highlights the need for continued work to increase both design and regulatory use across small, medium and large device developers.” The CM&S steering committee includes representatives from the FDA, National Institute of Health (NIH), and the medical device and diagnostics industry.
Case studies in this report represent areas such as orthopedics, cardiology, and digital twins, among others, and highlight the benefits of applying these methods in medical device design. Combined with the analysis of the MDIC survey results, these examples help organizations justify utilization of computational modeling and simulation in product development.