Computational Modeling and Simulation of Medical Devices
Description
This open access book reflects the growth of computational modeling and simulation (CM&S) in support of medical device development over the past two decades, identifies the opportunities and challenges associated with contemporary CM&S applications, and highlights emerging areas for CM&S in medical devices. The authors provide a springboard for the continued credible use of CM&S in this regulated space, with the belief that such uses will contribute to the development, commercialization, and regulatory review of devices that will positively impact patient health around the globe. Content includes recent developments supporting the use of computational modeling as part of device development and regulatory review, including an overview of governmental policies, relevant standards, and guidance documents. A series of industry-specific examples are also provided by a number of recognized subject-matter experts.
- Provides the fundamental scientific principles of verification, validation, and uncertainty quantification (VVUQ) so that the reader has a baseline understanding;
- Summarizes experience from various sectors regarding the development of CM&S for various regulated industries;
- Includes case studies in the medical device industry and future perspectives on clinical applications and AI/ML;
- This book is open access, which means that you have free and unlimited access.
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Persons
Dr. Marc Horner is a Distinguished Engineer leading technical initiatives for the healthcare industry at Synopsys. Marc joined Synopsys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2002. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME VVUQ 40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Marc is also an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
Dr. Jeffrey Bischoff is Senior Director of Biomechanics Research at Zimmer Biomet, where he has been since 2006. Jeff completed his Ph.D. in Mechanical Engineering at the University of Michigan, served as Lecturer at the University of Auckland (New Zealand) and as Assistant Professor at the University of South Carolina, prior to joining Zimmer Biomet. Over the past two decades, Jeff has supported device development efforts using computational analysis across a wide range of orthopaedic applications, and throughout the total product life cycle from design ideation through regulatory clearance and commercialization. He has been actively involved with the ASME VVUQ 40 Sub-Committee, including as chair of the orthopaedic working group and as vice-chair of the sub-committee. He is currently on his second term as chair of the sub-committee, effective 2022-2025.
Dr. Payman Afshari is a Senior Principal Engineer at Johnson and Johnson MedTech organization with more than two decades of experience leveraging computational modeling and simulation (CM&S) to address complex challenges in spinal implant design and manufacturing. Payman received his PhD in Mechanical Engineering from the University of Illinois at Chicago. Over the past 12 years, he has been advocating for integrating CM&S across the entire medical device product life cycle, with particular emphasis on its role in regulatory evidence generation. Payman currently serves as Vice Chair of the ASME VVUQ 40 Sub-Committee (2019-2025) and as a member of the CM&S Steering Committee of the Medical Device Innovation Consortium (MDIC). His contributions extend internationally, having previously served as an industry advisory board member for EDITH, a coordination and support action funded by the European Commission.
Content
Section 1: Introduction and Fundamentals of Model Credibility.- Ch 1: Introduction.- Ch 2: Verification.- Ch 3: Validation.- Ch 4: Uncertainty Quantification.- Ch 5: An Overview of the ASME V&V 40-2018 Standard.- Section 2: Regulatory Considerations.- Ch 6: Regulatory Perspectives and Considerations on the Use of Computational Modeling.- Ch 7: Regulatory Perspectives and Considerations on Computational Modeling of Medical Devices.- Ch 8: Implementation of a Model Credibility Framework.- Ch 9: A Credibility Assessment Framework Based on the Historical Use of VVUQ in Nuclear Power.- Ch 10: Standardized In Silico Methodologies to Support Medical Device Design and Evaluation.- Section 3: Contemporary Applications of CM&S in Medical Device Development.- Ch 11: Introduction to Computational Modeling and Simulation in Orthopaedics.- Ch 12: Verification, Validation and Uncertainty Quantification of Computational Models.- Ch 13: Applications of Physics-Based in silico Models in Spinal Device Development.- Ch 14: Application of the ASME V&V 40 Standard to Computational Models of Trauma Devices.- Ch 15: Applications of CM&S to Cardiovascular Devices.- Ch 16: Validation for Structural Analyses of Cardiovascular Stents.- Ch 17: Application of the ASME VV40 Standard to Computational Models of Heart Valve Replacement and Repair Devices.- Ch 18: Establishing the Credibility of Computational Models of Blood Pumps.- Ch 19: Verification, Validation and Uncertainty Quantification of Cardiac Electrophysiological Models.- Ch 20: Computational Modeling and Simulation for MR Conditional Safety Assessment.- Ch 21: VVUQ Considerations for in silico Modeling of Ex-Vivo Devices.- Ch 22: Finite Element Analysis in Post-Market Engineering for Medical Devices.- Section 4: Emerging Topics around CM&S in Healthcare.- Ch 23: In Silico Trials.- Ch 24: Simulation as a Medical Device.- Ch 25: Framework for Establishing the Credibility of Data-based Modeling and Simulations.