Authors:
K. Charrière
1
;
C. L. 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.
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