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Journal Articles Thérapie Year : 2016

Organisational impact: Definition and assessment methods for medical devices

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Christophe Roussel
  • Function : Author
Cédric Carbonneil
  • Function : Author
Antoine Audry
  • Function : Author
Stéphane Burtey
Sandrine Faré
  • Function : Author
François Langevin
  • Function : Author
Stéphane Laroche
  • Function : Author
Emmanuel Luigi
  • Function : Author
Hubert Méchin
  • Function : Author
Grégoire Mercier
  • Function : Author
Frédéric Rupprecht
  • Function : Author
Karine Szwarcensztein
  • Function : Author
André Tanti
  • Function : Author
Sébastien Woynar
  • Function : Author
Catherine Zaidman
  • Function : Author


Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.
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Dates and versions

hal-03396892 , version 1 (22-10-2021)



Christophe Roussel, Cédric Carbonneil, Antoine Audry, Stéphane Burtey, Sandrine Faré, et al.. Organisational impact: Definition and assessment methods for medical devices. Thérapie, 2016, 71 (1), pp.83-96. ⟨10.1016/j.therap.2016.01.003⟩. ⟨hal-03396892⟩
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