Inspiring Practice Project

MedtecHTA - Methods for Health Technology Assessment of medical devices: a European perspective

Uploaded by RRI Tools on 11 January 2017

MedtecHTA aims to improve the existing methodological framework within the paradigm of Health Technology Assessment (HTA) for the assessment of medical devices (MDs), and to develop this framework into a tool that provides structured, evidence-based input into health policies. Medical devices are different from drugs but are currently assessed using the same methods. This poses risks for decision-makers and they may generate biased recommendations that prevent patients from accessing cost-effective procedures.

The research team has involved several stakeholders at various stages in the research. The continuous and open exchange of views and perspectives has greatly helped to improve the project and, more importantly, to make its findings relevant and useful for society as a whole

Development, Exploration, Implementation, Monitorization & Evaluation, Dissemination
Besides academics, MedtecHTA has involved relevant stakeholders: clinicians, policymakers,
providers, regulators and the industry. These actors have different backgrounds and different
objectives, sometimes with opposing goals. Given the ultimate aim of MedtecHTA (i.e. to recommend a methodological framework to assess medical devices), it was fundamental to gather
stakeholders’ opinions to ensure that all possible aspects that might impact the way in which MDs are assessed are taken into account. The rationale is that research can translate into policy action only if shared and agreed by relevant stakeholders. The stakeholders were involved at several points during the study period. Regulators and policymakers were interviewed several times in order to elicit their preferences in terms of process and procedures for assessing MDs but also to understand their difficulties and perplexities. Clinicians have been part of a large European survey aimed at investigating the key motivational factors that predict diffusion of MDs and equality of access for patients. Hospitals have been compared to measure their performance in providing MDs and identify key success factors. The industry has been consulted in order to fully understand how MDs are developed and the challenges in carrying out clinical studies.
Target groups were involved in the research project from the start of MedtecHTA through an
Advisory Board, composed of people from industry, policymakers, the scientific community,
EUnetHTA and clinicians. The objectives and methods were shared with them and feedback was
gathered in order to better shape the research proposal and improve the methods and materials.
A website was developed on which key milestones were posted and circulated via a newsletter
sent to all subscribers. Preliminary results have been presented as soon as they were ready to
several conferences and workshops covering different target groups (e.g. HTAi which is widely
attended by regulators, policy-makers and payers; iHEA at which academics are well represented;
ISPOR with a strong industry presence; HAS-Haute Autorité de la Santé which is attended by
many patients’ organisations, industry, regulators and payers). The final results were presented
to a large audience consisting of patients, clinicians, payers, hospital managers and the industry
and discussed with HTA Agencies, Scientific Associations, the Department of Health and EunetHTA.

The MedtecHTA project made a substantial contribution towards the development of HTA methodologies and practices for medical devices for a wide range of key stakeholders and towards
informing policy in the European Union, which in turn will impact on public health in the Region.
The objective of the MedtecHTA project was to bring the research to the attention of various
target audiences interested in methodological developments in health technology assessment:
these include researchers, policymakers, the industry, and patients’ associations. It aimed to
demonstrate the ways in which research is contributing to a European ‘Innovation Union’ and
to show its openness. This was done by providing tangible proof that collaborative research
adds value by showing how European collaboration has achieved more than would have otherwise
been possible in helping to solve the challenges facing society


From 01/01/2013 to 31/12/2015
Leading organisation: 
  • Università Commerciale Luigi Bocconi, Milan, Italy

Cooperation partners:

  • Hamburg Centre for Health Economics of the University of Hamburg;
  • University of York Centre for Health Economics;
  • Technology Assessment Group of the Peninsula College of Medicine & Dentistry University of Exeter;
  • Institute of Public Health, Medical Decision Making and Health Technology Assessment of the University for Health Sciences, Medical Informatics and Technology in Austria;
  • Institute for Economic Research in Slovenia and the European Society of Cardiology of the European Heart Rhythm Association in France

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