Does assessing the value for money of therapeutic medical devices require a flexible approach?

Regulation criteria for licensing pharmaceuticals and medical devices (MDs) are asymmetric. This has affected the type, quantity and quality of the evidence produced in support of MDs. This paper has three objectives: to examine the reasons behind the current licensing criteria for MDs; to identify key methodological challenges associated with pre- and post-market evaluation of MDs and to assess the extent to which existing methods for the economic evaluation of pharmaceuticals can be applied to the evaluation of MDs. The belief that MDs cannot be properly evaluated stems from a combination of historical events and complexities in implementing rigorous RCTs in this field. Existing challenges to conduct sound economic evaluation of MDs have begun to be addressed in medical research using mixed research methods. While more challenging to implement, robust evaluations of therapeutic MDs can and need to be carried out to safeguard individual's wellbeing.