MEDTECHTA · Methods for Health Technology Assessment of Medical Devices: a European Perspective

Health Technology Assessment (HTA) is widely accepted as a multidisciplinary approach studying the clinical, economic, social and ethical implications of development, diffusion and use of health technologies and its role in policy making is increasingly established in EU countries. However, the currently adopted methodological framework for HTA doesn’t fully encounter the challenges rising from intrinsic differences between different types of health technologies, and in particular medical devices. The general objective of MedtecHTA project is to investigate improvement of HTA methods to allow for more comprehensive evaluation of medical devices by acknowledging complexities rising from their integration into clinical practice. The MedtecHTA project will provide more than 280 person- months of scientific research effort to: (i) explore current differences in methods used for HTA of medical devices in EU countries; (ii) investigate within- and between country variations in utilization of innovative medical devices (e.g implantable devices in cardiology) that have important implications on equity; iii) develop improved methods for satisfying three main pillars of HTA: comparative effectiveness, economic evaluation and organizational impact of medical devices and (iv) investigate uncertainty surrounding the development of new devices and investments in research. The essence of the MedtecHTA research methodology is a cross-disciplinary consortium with outstanding track record in health services research including health economics, healthcare management, health policy and also public health, epidemiology and clinical research. The MedtecHTA is expected to make a substantial contribution to the development of methodologies and practices of HTA for medical devices for a wide range of key stakeholders: policy makers, scientific community, HTA agencies, healthcare providers, medical device industry and patients, which in turn will impact on public health in the Region.