User Requirement Guide
This guide provides help and advice on the issues that should be considered when developing medical devices to ensure that the device meets the requirements of its users. The guide discusses each stage of product development and the user issues that should be considered at each of these.
The guide describes in detail the process of planning a user requirements study and covers issues of sampling, access to users, applying for ethical approval, and the role of user data in medical device standards and regulations. A number of examples of successful user involvement in medical device development are provided, and a glossary is included, providing information on how research methods can be applied in a medical environment.
The guide is aimed at medical device designers, developers and marketing personnel. It is not prescriptive: rather, it provides generic advice which developers can customise to fit the needs of their particular device.