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Authors: K. Charrière 1 ; C. Azzopardi 2 ; M. Nicolier 1 ; 3 ; T. Lihoreau 1 ; F. Bellivier 4 ; 5 ; 6 ; 7 ; E. Haffen 1 ; 3 ; 8 and B. Wacogne 1 ; 2

Affiliations: 1 Centre Hospitalier Universitaire de Besançon, Centre d’Investigation Clinique, INSERM CIC 1431, 25030, Besançon Cedex, France ; 2 FEMTO-ST Institute, Univ. Bourgogne Franche-Comte, CNRS, 15B avenue des Montboucons, 25030 Besancon Cedex, France ; 3 Department of Clinical Psychiatry, CHU de Besançon, EA 481 Neurosciences, University Bourgogne Franche-Comté, 25030, Besançon Cedex, France ; 4 AP-HP, GH Saint-Louis, Lariboisière, F. Widal, Department of Psychiatry and Addiction Medicine, 75475 Paris cedex 10, France ; 5 Inserm, U1144, Paris, F-75006, France ; 6 Université Paris Descartes, UMR-S 1144, Paris, F-75006, France ; 7 Université Paris Diderot, Sorbonne Paris Cité, UMR-S 1144, Paris, F-75013, France ; 8 FondaMental Foundation, Creteil, Hôpital Albert Chenevier, Pôle Psychiatrie, 40 rue de Mesly, 94000 Créteil, France

Keyword(s): Functional Analysis, Medical Device, Lithium Monitoring.

Abstract: Medical device development is often understood as a linear process with design stages occurring sequentially. First stages are usually performed in order to specify the future device definition through interviews/meetings of the end-users, researchers and manufacturers. Because the medical device is original, these first stages mainly involve end-users and researcher. However, regulation constraints and economic reality sometimes makes manufacturers hesitant to base the industrial development on this initial basis. Functional analysis, well known by manufacturers, is a method used to accurately define the final functions of a medical device. In this conference, we estimate that the functional analysis can be put to profit in a more efficient way if researchers and end-users get familiar with it prior to the interview/meeting stages. Although the results of such knowledge democratisation is not demonstrated here, we present the function analysis conducted on a lithium monitoring devic e according to this multidisciplinary approach. We also show that function analysis can be used not only to drive research actions but also to identify regulation requirements. (More)

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Paper citation in several formats:
Charrière, K.; Azzopardi, C.; Nicolier, M.; Lihoreau, T.; Bellivier, F.; Haffen, E. and Wacogne, B. (2021). Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device. In Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed, ISBN 978-989-758-490-9; ISSN 2184-4305, pages 300-307. DOI: 10.5220/0010382503000307

@conference{clinmed21,
author={K. Charrière. and C. Azzopardi. and M. Nicolier. and T. Lihoreau. and F. Bellivier. and E. Haffen. and B. Wacogne.},
title={Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device},
booktitle={Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed,},
year={2021},
pages={300-307},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010382503000307},
isbn={978-989-758-490-9},
issn={2184-4305},
}

TY - CONF

JO - Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies - ClinMed,
TI - Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device
SN - 978-989-758-490-9
IS - 2184-4305
AU - Charrière, K.
AU - Azzopardi, C.
AU - Nicolier, M.
AU - Lihoreau, T.
AU - Bellivier, F.
AU - Haffen, E.
AU - Wacogne, B.
PY - 2021
SP - 300
EP - 307
DO - 10.5220/0010382503000307

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