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Organisational impact: Definition and assessment methods for medical devices
- Source :
- Thérapie, Thérapie, EDP Sciences, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩, Thérapie, EDP Sciences, 2016, 71 (1), pp.83-96. ⟨10.1016/j.therap.2016.01.003⟩, Thérapie, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩
- Publication Year :
- 2016
- Publisher :
- HAL CCSD, 2016.
-
Abstract
- International audience; 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.
- Subjects :
- Value (ethics)
Technology Assessment, Biomedical
Organisational innovation
Biomedical
Computer science
Process (engineering)
Cost-Benefit Analysis
[SDV]Life Sciences [q-bio]
Guidelines as Topic
Efficiency
Technology assessment
030226 pharmacology & pharmacy
Organizational
03 medical and health sciences
0302 clinical medicine
MESH: Technology Assessment, Biomedical
Humans
Pharmacology (medical)
MESH: Humans
Cost–benefit analysis
030503 health policy & services
MESH: Guidelines as Topic
Health technology
MESH: Equipment and Supplies
Benchmarking
Risk analysis (engineering)
Work (electrical)
Equipment and supplies
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
0305 other medical science
Medical literature
MESH: Cost-Benefit Analysis
Subjects
Details
- Language :
- English
- ISSN :
- 00405957 and 19585578
- Database :
- OpenAIRE
- Journal :
- Thérapie, Thérapie, EDP Sciences, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩, Thérapie, EDP Sciences, 2016, 71 (1), pp.83-96. ⟨10.1016/j.therap.2016.01.003⟩, Thérapie, 2016, 71, pp.69-96. ⟨10.1016/j.therap.2016.01.003⟩
- Accession number :
- edsair.doi.dedup.....e251290120c63557e1428c4ead5ecfd1