Stakeholders, Prototypes, and Settings of Front-End Medical Device Design Activities

IF 0.8 4区医学 Q4 ENGINEERING, BIOMEDICAL

Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-03-29 DOI:10.1115/1.4054207

Marianna J. Coulentianos, Ilka Rodriguez-Calero, S. Daly, Jocelyn Burridge, K. Sienko

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引用次数: 3

Abstract

Successful medical device design entails an understanding of stakeholder-driven requirements early in the process to assure device safety and usability and support successful and positive patient experiences. Prototypes can be used during stakeholder engagement in the design front end to gather information to inform design decisions. However, an understanding of medical device industry practices of front-end stakeholder engagement with prototypes is lacking. Through interviews with medical device design practitioners, this study explored the variety of stakeholder groups engaged by design practitioners, prototype types used during stakeholder engagements, and settings in which engagements took place during front-end design activities. This study describes the 14 types of stakeholders, 14 types of prototypes, and six types of settings described by practitioners as well as patterns across engagement strategies, stakeholders, prototypes, and/or settings in front-end activities. These outcomes can contribute to broadening designers' stakeholder engagement planning and practices.

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前端医疗器械设计活动的利益相关者、原型和设置

成功的医疗器械设计需要在过程的早期了解利益相关者驱动的需求，以确保器械的安全性和可用性，并支持成功和积极的患者体验。原型可以在利益相关者参与设计前端的过程中使用，以收集信息，为设计决策提供信息。然而，对医疗器械行业前端利益相关者参与原型的实践缺乏了解。通过对医疗器械设计从业者的访谈，本研究探讨了设计从业者参与的各种利益相关者群体、利益相关者参与过程中使用的原型类型，以及前端设计活动中参与的环境。本研究描述了从业者描述的14种类型的利益相关者、14种类型原型和6种类型的环境，以及前端活动中参与策略、利益相关者和/或环境的模式。这些成果有助于扩大设计师的利益相关者参与规划和实践。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Medical Devices-Transactions of the Asme ENGINEERING, BIOMEDICAL-

CiteScore

1.80

自引率

11.10%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.