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.

摘要

新产品的开发是一个复杂的多利益相关者过程，存在很大的失败风险。在医疗器械领域尤其如此，该领域存在严格的治疗、心理和规范限制。本文介绍了一个名为“定义、优先级、测量和聚合”(DPMA) 的多标准决策过程。DPMA 旨在帮助工程经理在新医疗器械的开发过程中做出决策。该模型基于与业务和客户满意度相关的两组标准。这些标准使用层次分析法 (AHP) 和群体决策 (GDM) 流程进行加权。医疗器械的性能是根据每个标准来衡量的。此外，GO/NO GO 替代方案的最终得分通过简单加性加权 (SAW) 方法计算。本文通过一个开发新型股骨植入物的案例研究来展示 DPMA 流程的实施。这项研究表明，在 3D 打印股骨假体设计过程中应用 DPMA 工艺，为工程经理提供了关键要素，并为继续开发该医疗设备开了绿灯。