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Computational Modeling and Simulation of Medical Devices - Book Release
27/07/2026
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The medical device industry is increasingly adopting computational modeling and simulation (CM&S) throughout the product life cycle—from early-stage design and prototyping to regulatory submissions and post-market performance evaluation. A key challenge across all these applications is establishing whether a model is sufficiently credible to support (regulatory) decision-making. The ASME V&V 40 standard, published in 2018, introduced a risk-based framework for assessing model credibility and has gained broad acceptance across the industry.
Since its publication, however, important questions have emerged:
- How are organizations implementing ASME V&V 40 in practice?
- What resources are available to help new users move beyond the examples provided in the standard?
- And how can the framework be adapted to emerging applications such as data-driven models, in silico clinical trials, and software as a medical device (SaMD)?
To address these questions, the editors—Marc Horner (Synopsys), Jeff Bischoff (Zimmer Biomet), and Payman Afshari (Johnson & Johnson)—recently announced the release of the open-access Springer book Computational Modeling and Simulation of Medical Devices: Verification, Validation, and Uncertainty Quantification.
The book is grounded in the ASME V&V 40 standard and begins with an introduction to verification, validation, and uncertainty quantification (VVUQ), along with an overview of risk-based model credibility assessment. It then examines the evolving regulatory landscape for CM&S in the United States and internationally, including perspectives from the pharmaceutical and nuclear sectors. A central section presents practical case studies spanning orthopaedic, cardiovascular, and ex vivo applications, illustrating how industry practitioners apply V&V 40 to support model development and decision-making. Additional chapters explore the role of model credibility in litigation and discuss emerging areas where standardized credibility frameworks are still evolving, including data-driven models, in silico clinical trials, and simulation as a medical device.
We are proud that numerous members of the Avicenna Alliance contributed as co-authors to this book.
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