title: Organisational impact: Definition and assessment methods for medical devices.
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.
authors.affiliation: 3M France, marchés de la santé, boulevard de l'Oise, 95006 Cergy-Pontoise, France. Electronic address: croussel@mmm.com.
authors.forename: Christophe
authors.initials: C
authors.lastname: Roussel
authors.affiliation: Ministère des affaires sociales, de la santé et des droits des femmes, direction générale de l'offre de soins, 75007 Paris, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Carbonneil
authors.affiliation: Medtronic, 92513 Boulogne-Billancourt cedex, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Audry
mesh_terms: D003362:Cost-Benefit Analysis; D004864:Equipment and Supplies / Q000191:economics / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods*
keywords: Benchmarking; Biomedical; Efficiency; Equipment and supplies; Organisational innovation; Organizational; Technology assessment