医疗器械的多维准备评估

IF 1.4 Q4 ERGONOMICS
R. Seva, Angela Li Sin Tan, L. Tejero, M. Salvacion
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引用次数: 1

摘要

医疗器械(MD)开发人员目前使用技术就绪水平(trl)来确定技术的状态。然而,每个级别的广泛定义使得难以确定MDs的准备情况。TRL对md的严格监管要求、对人类系统集成的要求和市场竞争也漠不关心。本文提出了一个技术准备框架,用于沟通和规划第三类医疗器械的发展,称为医疗器械准备水平(mdrl)。五个退出标准在框架内按有意义的顺序进行:安全性,临床有效性,可用性,舒适性和情感反应。它也纳入了持份者的观点,并考虑到用户在操纵决策过程中的不同需求。参与决策发展的专业人士肯定了该框架的有用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Multi-dimensional readiness assessment of medical devices
Abstract Medical device (MD) developers currently use the Technology Readiness Levels (TRLs) to determine the status of technology. However, the broad definition of each level makes it difficult to ascertain readiness of MDs. The TRL is also indifferent to the strict regulatory requirements for MDs, requirements for human systems integration, and market competition. This paper proposes a technology readiness framework for communicating and planning the development of Class III MDs called the Medical Device Readiness Levels (MDRLs). Five exit criteria were staged in a meaningful sequence within the framework: safety, clinical effectiveness, usability, comfort, and affective response. It also incorporates the stakeholders’ perspectives, mindful of the users’ varying needs in manipulating the MD. The usefulness of the framework was affirmed by professionals involved in MD development.
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来源期刊
CiteScore
4.10
自引率
6.20%
发文量
38
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