Defining the role and impact of the clinician in the early medical device innovation process using early health technology assessment- An action research-based approach

The clinician’s function in early health technology assessment (EHTA) is one which is unclear in terms of their role; their interactions with the process; and their subsequent impact on medical device innovation process (MDI) through participation. Using action research, these roles were clarified and a framework was developed for clinician participation during EHTA. These findings were then utilised in 3 different case-studies, which demonstrated the ability to the framework to be applied, individualised and inform on the clinical, technical and commercial aspects of the venture. Resultantly, this was shown to improve clinician direction, participation and impact during the MDI.