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Organisational impact: Definition and assessment methods for medical devices

Christophe Roussel 1 Cédric Carbonneil Antoine Audry Stéphane Burtey 2, 3 Sandrine Fare François Langevin 4, 5 Stephane Laroche Emmanuel Luigi Nicolas Martelli 6 Hubert Mechin Grégoire Mercier Frederic Rupprecht Karine Szwarcensztein Andre Tanti Sebastien Woynar Catherine Zaidman
1 ISM2 - Institut des Sciences Moléculaires de Marseille
2 Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM]
3 VRCM - Vascular research center of Marseille
4 EHESP - École des Hautes Études en Santé Publique [EHESP]
5 IDM - Institut du Management
6 HEGP - Hôpital Européen Georges Pompidou [APHP]
Abstract : 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.
Keywords : Technology assessment Biomedical Equipment and supplies Efficiency Organizational Organisational innovation Benchmarking
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Journal articles
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https://hal-amu.archives-ouvertes.fr/hal-01464976
Contributor : Françoise Dignat-George <>
Submitted on : Friday, February 10, 2017 - 4:38:13 PM
Last modification on : Thursday, May 27, 2021 - 3:11:05 AM

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UNIV-AMU | CNRS | EC-MARSEILLE | INC-CNRS | EHESP | USPC | ISM2 | EHESP-IDM

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Christophe Roussel, Cédric Carbonneil, Antoine Audry, Stéphane Burtey, Sandrine Fare, et al.. Organisational impact: Definition and assessment methods for medical devices. Thérapie, EDP Sciences, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩. ⟨hal-01464976⟩

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