Who are the right users to be involved in the design process of health products

Gustavo Michelini, Carina Campese, Janaina Mascarenhas
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Abstract

The misuse of medical products can cause harm to the health of patients and other users. Many international standards are practiced in the medical product development industry to ensure quality and safety, including guides and models with various ways to engage the user in the development process. There are methods that can be performed at any stage of development, which hampers the project-planning phase. Nevertheless, there is a lack of information that helps companies select the most appropriate users, according to a particular profile or attribute. In order to demystify how users can be involved in the development of the product for health and using case studies in the literature as a basis, this research aims to present the recurrent activities that users perform when involved in development of medical devices. The main contribution of this word is the model of user tasks crossed with users characteristics developed.
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谁是参与健康产品设计过程的合适用户
滥用医疗产品会对患者和其他使用者的健康造成危害。医疗产品开发行业采用了许多国际标准,以确保质量和安全,包括以各种方式让用户参与开发过程的指南和模型。有些方法可以在开发的任何阶段执行,这妨碍了项目规划阶段。然而,缺乏帮助公司根据特定的配置文件或属性选择最合适的用户的信息。为了揭开用户如何参与健康产品开发的神秘面纱,并以文献中的案例研究为基础,本研究旨在介绍用户在参与医疗设备开发时所进行的经常性活动。这个词的主要贡献是将用户任务与用户特征交叉的模型开发出来。
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