医疗器械的用户定义和用户需求确定

Indentify the Users and Users’ Requirements of Medical Devices

定义用户和确定用户的需求是医疗器械设计开发中最基本的要求,是医疗器械设计开发必需的,因为设计开发过程中纳入用户需求可以带来很多价值。医疗器械的用户也并非通常认为的医生,而是复杂很多。情景调查法是最常用的确定医疗器械用户需求的方法,在纳入真实用户困难的时候可以适当地选择用户代理人,在时间和金钱有限情况下应该平衡运用各种方法确定用户需求。

It is necessary and basic to define the users and indentify their requirements when you design and develop a medical device. The result always benefits very much. Usually the users of the medical devices are larger than you think. In fact, indentifying users is a difficult matter. Context inquiry is the most common means used to indentify the users’ requirements. Choose the suitable proxies when you find it is difficult to involve the real end-users. Integrate the different means in indentifying users’ requirements of medical devices with the limit of time and money.