New release “Computational Modeling and Simulation of Medical Devices: Verification, Validation, and Uncertainty Quantification”

As computational modeling and simulation (CM&S) continues to transform medical device development, establishing confidence in simulation results has become increasingly important. Computational models are now used throughout the entire product lifecycle—from early-stage design and prototyping to regulatory submissions, in silico clinical trials, and post-market evaluation. A fundamental question remains central across all these applications: can the model be trusted for the decision it is intended to support?

The publication builds upon the ASME V&V 40 standard, introduced in 2018, which established a risk-informed framework for assessing the credibility of computational models used in medical device decision-making. While the standard has gained broad acceptance across industry and regulatory communities, its implementation continues to raise important questions regarding practical application, interpretation, and extension to emerging technologies.

This new volume addresses these challenges by bringing together contributions from leading experts across academia, industry, and regulatory science. The book examines how organisations are implementing ASME V&V 40 in practice, provides guidance that extends beyond the examples presented in the standard itself, and explores how credibility assessment can be adapted to rapidly evolving areas such as data-driven models, in silico clinical trials, and software as a medical device.

The book is organized into four sections:

• Foundations of VVUQ and ASME V&V 40, introducing the principles of verification, validation, uncertainty quantification, and risk-based model credibility.
• Regulatory perspectives, reviewing the evolving acceptance of computational modeling and simulation across the United States and internationally, while drawing lessons from related fields including pharmaceuticals and nuclear engineering.
• Industrial use cases, presenting practical examples from orthopaedic, cardiovascular, and ex vivo medical device applications that demonstrate how V&V 40 is being applied in real-world product development. This section also includes an important discussion of model credibility in the context of litigation.
• Emerging applications, addressing areas where standardized credibility frameworks are still developing, including data-driven models, in silico clinical trials, and simulation as a medical device.

This publication is fully open access, ensuring that researchers, engineers, regulators, clinicians, and patients worldwide can freely benefit from the knowledge it contains. Open access was made possible through the generous support of Prith Banerjee (Synopsys) and Joseph W. Markmann (Johnson & Johnson), who sponsored the publication fees.

The VPH community has long championed and contributed to the development and adoption of credible computational models in healthcare. As digital twins, patient-specific simulations, and AI-enabled medical technologies become increasingly integrated into clinical practice and regulatory science, robust approaches to verification, validation, and uncertainty quantification will remain essential for building trust and enabling innovation.

This book represents an important resource for researchers, developers, regulators, and practitioners working at the intersection of computational modeling, medical devices, and regulatory science.

Read the book:
https://link.springer.com/book/10.1007/978-3-032-09180-2