title: Issues and challenges of involving users in medical device development.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Despite the challenges, active participation of users is crucial to developing usable and clinically effective devices.
authors.affiliation: King's College London, London, UK.
authors.forename: Mala
authors.initials: M
authors.lastname: Bridgelal Ram
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Grocott
authors.forename: Heather C M
authors.initials: HC
authors.lastname: Weir
mesh_terms: D004059:Diffusion of Innovation; D004820:Epidermolysis Bullosa / Q000628:therapy*; D004867:Equipment Design / Q000379:methods*; D004864:Equipment and Supplies; D006801:Humans; D008962:Models, Theoretical; D020380:Needs Assessment; D009723:Nurse-Patient Relations; D019982:Organizational Case Studies; D010358:Patient Participation / Q000379:methods*; D018794:Problem-Based Learning; D013673:Technology Assessment, Biomedical / Q000379:methods*; D006113:United Kingdom; D014945:Wound Healing; D014947:Wounds and Injuries / Q000628:therapy*