Computational Modeling and Simulation (CM&S) for Medical Devices

MDIC continues to play a central role in advancing the use of digital evidence to support regulatory decision-making for medical devices. As FDA Modernization Act 3.0 advances through Congress, the legislative push to replace animal testing with human-relevant methods is accelerating. This newly published manuscript translates these goals into regulatory reality and provides a definitive status report on how Computational Modeling and Simulation (CM&S) is evolving from an engineering tool into a primary source of regulatory evidence aligned with recent modernization efforts.  

This manuscript offers insights into:

• Proof of Credibility: Details a landmark “End-to-End” collaboration between the FDA and industry that applied the ASME V&V 40 standard to a spinal pedicle screw system. This successful mock submission serves as a blueprint for manufacturers to validate digital evidence in lieu of physical testing.
• Clinical Realism: Highlights the move toward in silico Clinical Trials (iSCT), the paper showcases real-world successes, such as Boston Children’s Hospital using patient-specific digital twins to plan complex congenital heart surgeries. These examples demonstrate that simulations can often predict outcomes more accurately than animal models.
• Industry Momentum: The 2024 FDA/MDIC Symposium, where MDIC successfully convened 229 global experts to solidify Computational Modeling and Simulation (CM&S) as key regulatory evidence. The experts survey revealed that 65.7% of attendees believe CM&S adoption in regulatory submissions has grown significantly over the last five years.