Full 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.
Contents
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.
