Computational Modeling and Simulation of Medical Devices: Verification, Validation, and Uncertainty Quantification
暫譯: 醫療設備的計算模型與模擬：驗證、確認與不確定性量化

Horner, Marc, Bischoff, Jeffrey E., Afshari, Payman

Computational Modeling and Simulation of Medical Devices: Verification, Validation, and Uncertainty Quantification
  • 出版商: Springer
  • 出版日期: 2026-07-22
  • 售價: $2,740
  • 貴賓價: 9.5 折 $2,603
  • 語言: 英文
  • 頁數: 671
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 3032091799
  • ISBN-13: 9783032091796
  • 相關分類: 控制系統 Control-systems

    • 海外代購書籍(需單獨結帳)

相關主題

商品描述

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.

商品描述(中文翻譯)

這本開放存取的書籍反映了計算建模與模擬（CM&S）在過去二十年中對醫療器材開發的支持成長，識別當代CM&S應用所面臨的機會與挑戰，並突顯醫療器材中CM&S的新興領域。作者提供了一個基礎，以促進在這個受監管領域中CM&S的持續可信使用，並相信這些用途將有助於設備的開發、商業化及監管審查，從而對全球患者健康產生積極影響。內容包括支持計算建模作為設備開發和監管審查一部分的最新發展，包括政府政策、相關標準和指導文件的概述。還提供了一系列由多位公認的主題專家提供的行業特定範例。

- 提供驗證、確認和不確定性量化（VVUQ）的基本科學原則，以便讀者具備基礎理解；
- 總結來自各個行業在開發CM&S方面的經驗，針對各種受監管行業；
- 包括醫療器材行業的案例研究以及對臨床應用和AI/ML的未來展望；
- 本書為開放存取，這意味著您可以免費且無限制地訪問。

作者簡介

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.

作者簡介(中文翻譯)

馬克·霍納博士（Dr. Marc Horner）是Synopsys的傑出工程師，負責推動醫療保健行業的技術倡議。馬克於2002年在西北大學獲得化學工程博士學位後加入Synopsys。馬克目前擔任多個行業領導職位，專注於模型可信度框架、監管科學和臨床應用。其中包括ASME VVUQ 40小組委員會的副主席以及Avicenna Alliance全球協調任務小組的領導者。馬克還是IMAG/MSM醫療保健建模與模擬可信實踐項目的執行委員會成員，該項目旨在建立一個以任務為導向的協作平台，概述基於模擬的醫學可信實踐。

傑佛瑞·比肖夫博士（Dr. Jeffrey Bischoff）是Zimmer Biomet的生物力學研究高級總監，自2006年以來一直在該公司工作。傑夫在密西根大學獲得機械工程博士學位，曾在奧克蘭大學（新西蘭）擔任講師，並在南卡羅來納大學擔任助理教授，然後加入Zimmer Biomet。在過去的二十年中，傑夫支持使用計算分析進行設備開發，涵蓋廣泛的骨科應用，並貫穿整個產品生命週期，從設計構思到監管批准和商業化。他積極參與ASME VVUQ 40小組委員會，包括擔任骨科工作組的主席和小組委員會的副主席。他目前正處於小組委員會主席的第二任期，任期為2022年至2025年。

佩曼·阿夫沙里博士（Dr. Payman Afshari）是強生醫療科技組織的高級首席工程師，擁有超過二十年的經驗，利用計算建模和模擬（CM&S）來解決脊椎植入物設計和製造中的複雜挑戰。佩曼在伊利諾伊大學芝加哥分校獲得機械工程博士學位。在過去的12年中，他一直倡導在整個醫療設備產品生命週期中整合CM&S，特別強調其在監管證據生成中的作用。佩曼目前擔任ASME VVUQ 40小組委員會的副主席（2019-2025），並且是醫療設備創新聯盟（MDIC）CM&S指導委員會的成員。他的貢獻具有國際影響力，曾擔任由歐洲委員會資助的協調和支持行動EDITH的行業諮詢委員會成員。

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