Issues and challenges of involving users in medical device development.

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.