Authors:
Gwenaël Rolin
1
;
2
;
Kenny Pinot
1
and
Marilys Blanchy
3
Affiliations:
1
INSERM CIC-1431, CHU Besançon, F-25000 Besançon, France
;
2
Univ. Franche-Comté, INSERM, EFS BFC, UMR1098, RIGHT Interactions Greffon-Hôte-Tumeur/ Ingénierie Cellulaire et Génique, F-25000, Besançon, France
;
3
Rescoll®, Pessac, France
Keyword(s):
Biomaterial, Electrospining, Implantable Device, European Regulation.
Abstract:
New technologies make it possible to industrialize objects that can reconstruct in-vivo like extracellular matrices. Actually, these scaffolds exhibit properties mimicking physiological tissue. The project presented here aims at the industrial production of a new bicomposite biomaterial for skin regeneration. This “TissYou” matrix is produced by electrospining two polymers, silk fibroin and polycaproclactone, using an innovative process. The state of progress of the project leads us today to have in our hands a functional prototype on the way to becoming a finished product. In order to ensure the transition of this product from R&D to a possible medical device, the regulatory roadmap that awaits the future product should be prepared as soon as possible. Consequently, and relying on the European regulation and its annexes, our main objective is to demonstrate that the product meets the definition of a medical device, to precisely define the class to which it belongs, to start a risk a
nalysis process and definition of the standards that should be applied in the subsequent qualification of the product. In order to stabilize the perimeter of the future indication of the product, we will also present a questionnaire deployed among professionals in order to collect their user needs.
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