User involvement in healthcare technology development and assessment: structured literature review.

PURPOSE: Medical device users are one of the principal medical device technology stakeholders. The involvement of users in medical device technology development and assessment is central to meet their needs. This study aims to examine this issue. DESIGN/METHODOLOGY/APPROACH: A structured review of the literature published from 1980 to 2005 in peer-reviewed journals was carried out from a social science perspective to investigate user involvement practice in the development and assessment of medical device technologies. This was followed by a qualitative thematic analysis.
FINDINGS: Medical device users include clinicians, patients, carers and others. Different kinds of medical devices are developed and assessed by user involvement. The user involvement occurs at different stages of the medical device technology lifecycle and the degree of user involvement is in the order of: design > testing and trials > deployment > concept stages. The methods most commonly used for capturing users' perspectives are usability tests, interviews and questionnaire surveys. RESEARCH LIMITATIONS/IMPLICATIONS: The relevant engineering, medical and nursing literature, which might have been useful, was not reviewed. However, useful findings emerge that apply to health care generally. ORIGINALITY/VALUE: This study shows that medical device users are not homogeneous but heterogeneous in several aspects, such as needs, skills and working environments. This is an important consideration for incorporating users' perspectives in medical device technologies.