Organisational impact: Definition and assessment methods for medical devices

Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine; Burtey, Stéphane; Fare, Sandrine; Langevin, François; Laroche, Stéphane; Luigi, Emmanuel; Martelli, Nicolas; Méchin, Hubert; Mercier, Grégoire; Rupprecht, F.C.; Szwarcensztein, Karine; Tanti, André; Woynar, Sébastien; Zaidman, Catherine

doi:10.1016/j.therap.2016.01.003

Cited by 12 publications

(12 citation statements)

References 4 publications

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“…This approach considers a wide range of aspects, including the medical, social, ethical, and economic implications of the development, diffusion, and use of health technologies . Several authors highlight that, to capture their overall impact, nonclinical criteria must be integrated into the assessment of MDs . At a hospital level, organizational impacts (OIs) need to be evaluated to fully understand the potential value of an MD .…”

Section: Introductionmentioning

confidence: 99%

“…Several authors highlight that, to capture their overall impact, nonclinical criteria must be integrated into the assessment of MDs . At a hospital level, organizational impacts (OIs) need to be evaluated to fully understand the potential value of an MD . Roussel et al state that examples of such evaluations are still too scarce because of absence of any tested methodology .…”

Section: Introductionmentioning

confidence: 99%

“…[3][4][5][6] At a hospital level, organizational impacts (OIs) need to be evaluated to fully understand the potential value of an MD. 4 Roussel et al state that examples of such evaluations are still too scarce because of absence of any tested methodology. 4 However, recent research shows that innovative methodologies for assessing MDs can be applied at a hospital level.…”

mentioning

confidence: 99%

“…4 Roussel et al state that examples of such evaluations are still too scarce because of absence of any tested methodology. 4 However, recent research shows that innovative methodologies for assessing MDs can be applied at a hospital level. 7 The single-use flexible bronchoscope (FB) represents a novel health technology.…”

mentioning

confidence: 99%

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Single‐use flexible bronchoscopes compared with reusable bronchoscopes: Positive organizational impact but a costly solution

Châteauvieux

Farah

Guérot

et al. 2018

Evaluation Clinical Practice

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Single‐use flexible bronchoscopes compared with reusable bronchoscopes: Positive organizational impact but a costly solution

Châteauvieux

Farah

Guérot

et al. 2018

Evaluation Clinical Practice

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“…Nevertheless, it is crucial to evaluate impact of changes induced [36]. That is why, the description of organisational impact benefits from an increasing interest [37]. If the organisational dimension still remains currently poorly studied, it is promoted by hospital decision-makers and should being developed in the nearly future [38].…”

Section: Key Opportunities and Challenges Of Medical Innovation Assesmentioning

confidence: 99%

Assessment and diffusion of medical innovations in France: an overview

Dubromel

Geffroy

Aulagner

et al. 2018

Journal of Market Access & Health Policy

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Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. Method: The data are extracted from French authorities or organisations websites and documents and from French legislative texts. In addition, regarding discussion, a search in MEDLINE database was carried out. Results: An overview of the assessment and diffusion of medical innovation in France is given by presenting the different types of medical innovations according to French health system definition (I); introducing French authorities participating to health technology assessment and describe assessment procedures of medical innovations (II); and giving details about market access process of innovative health product in France (III). Key opportunities and challenges of medical innovation assessment and diffusion in France are discussed at the end of this article. Conclusion: In France, medical innovation is considered as a crucial component for quality of care and performance of healthcare system. The aim of health technology assessment is to promote a secure and timely access to innovation for patients. Nevertheless, it appears necessary to improve regulatory mechanisms.

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