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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

ISBN: 978-989-758-490-9

ISSN: 2184-4305

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 device 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.; Nicolier, M.; Lihoreau, T.; Bellivier, F.; Bellivier, F.; Bellivier, F.; Bellivier, F.; Haffen, E.; Haffen, E.; Haffen, E.; Wacogne, B. 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 - Volume 1: 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 M. Nicolier. and T. Lihoreau. and F. Bellivier. and F. Bellivier. and F. Bellivier. and F. Bellivier. and E. Haffen. and E. Haffen. and E. Haffen. and B. Wacogne. 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 - Volume 1: 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 - Volume 1: 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 - Nicolier, M.
AU - Lihoreau, T.
AU - Bellivier, F.
AU - Bellivier, F.
AU - Bellivier, F.
AU - Bellivier, F.
AU - Haffen, E.
AU - Haffen, E.
AU - Haffen, E.
AU - Wacogne, B.
AU - Wacogne, B.
PY - 2021
SP - 300
EP - 307
DO - 10.5220/0010382503000307

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