Dec 12, 2011

In a new joint position paper, European medical technology associations are arguing for greater industry participation in the health technology assessment (HTA) process to promote more efficient decision-making and resource allocation.

Associations including Eucomed, COCIR and EDMA argue that increased health care industry involvement in HTA processes used to assess safety, effectiveness and value of medical devices would facilitate system and method improvements. Managing scale, costs and predictability of HTAs requires more substantial input from manufacturers to support regulatory agencies, according to the associations. Medical technology developers have also gained substantial understanding of local and international HTA systems through their compliance efforts; as such, including industry perspectives going forward would make for more robust HTA processes, argue Eucomed and its cohorts.

Medical technology manufacturers produce or sponsor most evidence used to inform HTA processes, according to the position paper, and their “sophisticated” understanding of their products enables them to more effectively interpret clinical evidence crucial to HTAs as well.

The paper furthermore identifies the following stages of the HTA process where industry can play a larger role: overall agency governance of the HTA process; specific technology assessments including data gathering and evaluation of evidence; and reviews of new clinical evidence as it emerges.

Industry desires to affect International Medical Device Regulators’ Forum and reduce input from industry representatives. European regulators may show similar inclinations.


  • Stewart Eisenhart