让用户参与医疗设备开发的问题与挑战。
Issues and challenges of involving users in medical device development.
作者信息
Bridgelal Ram Mala, Grocott Patricia R, Weir Heather C M
机构信息
King's College London, London, UK.
出版信息
Health Expect. 2008 Mar;11(1):63-71. doi: 10.1111/j.1369-7625.2007.00464.x.
BACKGROUND
User engagement has become a central tenet of health-care policy. This paper reports on a case study in progress that highlights user engagement in the research process in relation to medical device development.
OBJECTIVES
To work with a specific group of medical device users to uncover unmet needs, translating these into design concepts, novel technologies and products. To validate a knowledge transfer model that may be replicated for a range of medical device applications and user groups.
METHODS
In depth qualitative case study to elicit and analyse user needs. The focus is on identifying design concepts for medical device applications from unmet needs, and validating these in an iterative feedback loop to the users.
RESULTS
The case study has highlighted three interrelated challenges: ensuring unmet needs drive new design concepts and technology development; managing user expectations and managing the research process.
CONCLUSION
Despite the challenges, active participation of users is crucial to developing usable and clinically effective devices.
背景
用户参与已成为医疗保健政策的核心原则。本文报告了一项正在进行的案例研究，该研究突出了用户在医疗设备开发研究过程中的参与情况。
目的
与特定的医疗设备用户群体合作，发现未满足的需求，并将其转化为设计概念、新技术和产品。验证一种知识转移模型，该模型可复制用于一系列医疗设备应用和用户群体。
方法
进行深入的定性案例研究，以引出和分析用户需求。重点是从未满足的需求中识别医疗设备应用的设计概念，并在与用户的迭代反馈循环中对这些概念进行验证。
结果
该案例研究突出了三个相互关联的挑战：确保未满足的需求推动新的设计概念和技术开发；管理用户期望以及管理研究过程。
结论
尽管存在挑战，但用户的积极参与对于开发可用且临床有效的设备至关重要。
Zotero 插件