Regulatory Positioning of an Innovative Biomaterial for Regenerative Medicine: TissYou Project

Gwenaël Rolin, Gwenaël Rolin, Kenny Pinot, Marilys Blanchy

2023

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 analysis 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.

Paper Citation

in Harvard Style

Rolin G., Pinot K. and Blanchy M. (2023). Regulatory Positioning of an Innovative Biomaterial for Regenerative Medicine: TissYou Project. In Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-631-6, pages 243-249. DOI: 10.5220/0011926300003414

in Bibtex Style

@conference{clinmed23,
author={Gwenaël Rolin and Kenny Pinot and Marilys Blanchy},
title={Regulatory Positioning of an Innovative Biomaterial for Regenerative Medicine: TissYou Project},
booktitle={Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2023},
pages={243-249},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0011926300003414},
isbn={978-989-758-631-6},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - Regulatory Positioning of an Innovative Biomaterial for Regenerative Medicine: TissYou Project
SN - 978-989-758-631-6
AU - Rolin G.
AU - Pinot K.
AU - Blanchy M.
PY - 2023
SP - 243
EP - 249
DO - 10.5220/0011926300003414