Multi-Criteria Decision Making for Medical Device Development

IF 1.9 4区 管理学 Q3 ENGINEERING, INDUSTRIAL Engineering Management Journal Pub Date : 2023-04-03 DOI:10.1080/10429247.2022.2040267
H. Barkaoui, Helmi Ben Rejeb, A. Barkaoui, J. Tavares
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Abstract

Abstract The development of a new product is a complicated multi-stakeholder process with a significant risk of failure. This is particularly true in the medical device sector, where there are strict therapeutic, psychological, and normative constraints. This article presents a multi-criteria decision making process called “Define, Prioritize, Measure, and Aggregate” (DPMA). DPMA is designed to help engineering managers in decision making during the development process of new medical devices. The model is based on two sets of criteria linked to business and customer satisfaction. These criteria are weighted using the analytic hierarchy process (AHP) and group decision making (GDM) process. The performance of a medical device is measured according to each criterion. Furthermore, the final score of GO/NO GO alternatives are calculated with the simple additive weighting (SAW) method. A case study for the development of a new kind of femoral implant is presented to demonstrate the implementation of the DPMA process. This study shows that the application of the DPMA process during the design of a 3D printed femoral prosthesis provided engineering managers the key elements and green light to go ahead with the development of this medical device.
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医疗器械开发的多准则决策
摘要新产品的开发是一个复杂的多利益相关者过程,具有重大的失败风险。医疗器械行业尤其如此,那里有严格的治疗、心理和规范约束。本文介绍了一个名为“定义、确定优先级、测量和聚合”(DPMA)的多标准决策过程。DPMA旨在帮助工程管理人员在新医疗器械开发过程中做出决策。该模型基于两组与业务和客户满意度相关的标准。这些标准使用层次分析法(AHP)和群体决策(GDM)过程进行加权。医疗器械的性能是根据每个标准来衡量的。此外,采用简单加性加权(SAW)方法计算了GO/NO-GO备选方案的最终得分。介绍了一种新型股骨植入物的开发案例,以证明DPMA工艺的实施。这项研究表明,DPMA工艺在3D打印股骨假体设计过程中的应用为工程管理人员提供了关键要素,并为该医疗设备的开发开了绿灯。
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来源期刊
Engineering Management Journal
Engineering Management Journal 工程技术-工程:工业
CiteScore
5.60
自引率
12.00%
发文量
27
审稿时长
>12 weeks
期刊介绍: EMJ is designed to provide practical, pertinent knowledge on the management of technology, technical professionals, and technical organizations. EMJ strives to provide value to the practice of engineering management and engineering managers. EMJ is an archival journal that facilitates both practitioners and university faculty in publishing useful articles. The primary focus is on articles that improve the practice of engineering management. To support the practice of engineering management, EMJ publishes papers within key engineering management content areas. EMJ Editors will continue to refine these areas to ensure they are aligned with the challenges faced by technical organizations and technical managers.
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