Authors:
Thomas Lihoreau
1
;
Brice Chatelain
2
;
Gwenaël Rolin
1
;
3
;
Chrystelle Vidal
1
;
Nadia Butterlin
4
;
Emmanuelle Jacquet
5
;
Aflah Elouneg
5
;
Jérôme Chambert
5
;
Xavier Bertrand
6
;
Christophe Meyer
2
;
7
and
Aurélien Louvrier
2
;
3
Affiliations:
1
CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, Besançon, France
;
2
CHU Besançon, Department of Maxillo-Facial Surgery, Besançon, France
;
3
Univ. Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Besançon, France
;
4
Univ. Bourgogne Franche-Comté, Institut Supérieur d'Ingénieurs de Franche-Comté ISIFC, Besançon, France
;
5
Univ. Bourgogne Franche-Comté, FEMTO-ST Department of Applied Mechanics, CNRS/UFC/ENSMM/UTBM, Besançon, France
;
6
CHU Besançon, Hygiène Hospitalière, UMR 6249 Chrono-Environnement, Université de Bourgogne-Franche-Comté, Besançon, France
;
7
Univ. Bourgogne Franche-Comté, Nanomedicine Lab EA 4662, Besançon, France
Keyword(s):
User-need, Keloid Scars, Medical Device, Innovation Cycle, Clinical Investigation.
Abstract:
Scar is a common visible mark of human tissue healing. Sometimes pathological phenomena lead to abnormal hypertrophic or keloid scars, with evolutions varying depending on different conditions: origin of the tissue barrier disruption, concerned body area, or ethnic origin. Based on these statements, care procedures have been developed to avoid aesthetical or functional impairments: drugs injection, surgery, cryotherapy or mechanical compression. The story will relate the matching of a multi-disciplinary team that focused on covering an unmet need for ear lobe keloid treatment, providing patients an optimal and holistic care. The benefits researched lied in improving the understanding of the disorder, avoiding the recidivism of the scars, diminishing the frequency and duration of care, and in end improving patients’ quality of life. The paper will not only narrate the building of a health innovation, on technological, clinical, user points of view, but will also try to detail the eval
uations planned at the different stages of development, as well as the challenges, conditions and prerequisites allowing to produce concrete solution.
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