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OBJECTIVES: This study investigated the benefits of and barriers to user involvement in medical device technology development and evaluation. METHODS: A structured review of published literature in peer-reviewed journals was conducted. RESULTS: This literature review revealed that the main benefits of user involvement were an increased access to user needs, experiences, and ideas; improvements in medical device designs and user interfaces; and an increase in the functionality, usability, and quality of the devices. On the other hand, resource issues, particularly those of time and money were found the key impediments to involving users in the development and evaluation of medical device technologies. This study also has categorized both the benefits of and barriers to user involvement. CONCLUSIONS: The involvement of users in medical device technology development and evaluation requires resources, which are limited; however, this involvement is essential from both users and manufacturers perspectives.
Shah et al. (Mon,) studied this question.