January 31, 2023

ARLINGTON, Va., January 31, 2022The Medical Device Innovation Consortium (MDIC) released the “Landscape Report & Industry Survey on the Use of Computational modeling and Simulation (CM&S) in Medical Device Development”.  This new report from MDIC discusses the potential of CM&S to reduce product development costs, speed up time to market, and better serve patients with safe and effective medical devices. Case studies included in this report demonstrate tangible evidence of the value of CM&S to both industry and regulatory bodies such as the US Food and Drug Administration (FDA). The report also discusses 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.

Steven Levin, Sr. Director, Virtual Human Modeling, Executive Director, Living Heart Project agrees. “The MDIC survey shows the business impact of modeling and simulation is now well established and the FDA is recognized as a strong supporter. The landscape report adds important context and is a call to action for companies holding onto old R&D processes, highlighting MDIC’s important role as we enter the era of digital health.”

In addition to this landscape report on CM&S, MDIC’s CM&S program focuses on topics such as (1)  Augmenting clinical trials with virtual patients and external evidence methods to reduce the burden on human subjects;  (2) Translational research to bridge the gap between NIH and other publicly funded academic research human models – like blood damaging model, orthopedic models – with the aim to assess the credibility of simulation models for industry contexts of use and develop models with sufficient credibility into a Medical Device Development Tool (MDDT); and (3) Bootcamps specifically focusing on medical device CM&S for device manufacturers and regulatory professionals. A collection of MDIC resources across the total product lifecycle of medical devices that highlights the dynamic and evolving technology advancements in healthcare is available in the MDIC online Resource Library.

About MDIC:
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.

Todd West