How to improve user access to innovative medical devices: what is needed?

General methods of health technology assessment (HTA) are well-established, however their detailed application can often raise methodological challenges. Most international guidelines have been written with pharmaceuticals in mind frequently overlooking that HTA of medical devices (MDs) raises a number of challenges. MDs have peculiar characteristics that need to be taken into consideration when their assessment is at stake. To cite only a few of these challenges, clinical evidence for MDs can not always be drawn from experimental studies because they are often impossible to conduct. Observational longitudinal studies can instead be often useful to provide analysts with a good insight of MDs’ clinical performance. This would also make data more relevant to policy-makers who are struggling with looking for real world data on which to base their decisions at to priorities. It also has to be considered that devices frequently undergo product modifications (incremental innovation) usually aimed at improving performance. For certain categories of MDs, performance is also dependent from end-users. This leads to consideration of learning curve and how this should be correctly assessed in an HTA report. Moreover, a closer interaction with manufacturers of MDs can help understanding the specificities of MDs. HTA can be an important tool for allocating resources efficiently in the healthcare sector. However its methods would need to be consistent with the kind of technologies that are assessed and can not be transposed to MDs without a deep understanding of their peculiar characteristics