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HTA Guidelines for Medical Devices: What are the Gaps and how can We Address Them?

Health Technology Assessment (HTA) of biomedical devices requires different methods than those usually employed for pharmaceuticals. In fact, there are important differences between medical devices and drugs that can influence the assessment of their cost-effectiveness.

Pecchia and Craven 2012(17) [1] highlighted the main differences between devices and drugs impacting HTA, grouping those into five categories: product lifecycle, clinical evaluation, user issues, costs and economic evaluation, and intellectual property.

In November 2016, as part of the 2015-2018 International Federation of Medical and Biological Engineers (IFMBE)-HTA Division program, a focus group was held at the University of Warwick, aiming to contextualize and extend those differences and:

  1. propose recommendations that address this gap
  2. compare current HTA medical device guidelines with the highlighted gaps, and
  3. to start a project aiming to reach a consensus among the drafted recommendations by means of a modified Delphi survey.

A follow up meeting took place in Finland during the EMBEC conference in June 2017.

 A modified Delphi survey has been designed, piloted and circulated in November 2017 explore the consensus around the recommendations proposed. The survey consists in exploring expert opinion (mainly BMEs and clinical engineers) about the IFMBE HTAD recommendations. This will represent the base for a whitepaper of IFMBE on recommendations on current HTA guidelines limits.

If you would like to know more or to be part in our survey, please contact:


[1] L Pecchia, MP Craven, “Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience”. World Congress on Medical Physics and Biomedical 2012, 26-31 May 2012, Beijing, China.

Fri 10 Nov 2017, 15:25 | Tags: HTA, medical device