Health Technology Assessment: Current State of Access to Medical Device Outcomes

Outcome evaluation of medical devices is an increasingly addressed issue. This study compiles publications addressing the issue of how outcomes are approached differently. Current legislation, particularly the MDR and IVDR, places a strong emphasis on the quality, efficacy and safety of medical devices, and some institutions are seeking to include HTA, and specifically medical devices, in their evaluations. However, in the area of outcomes, evaluation is very difficult and completely inconsistent. Several different approaches are used for evaluation. From the use of CoreModel methodologies, to multi-criteria decision making, to the use of patient data and modelling. This article looks at that diversity and the most uniformity of these procedures. The article reviews several studies and their approach to outcomes assessment. The need to unify and properly define the evaluation process methodologically is becoming increasingly apparent.