ClinMed 2023 Abstracts

Area 1 - ClinMed
Full Papers

Area 1 - ClinMed

Full Papers
Paper Nr: 5
Title:

Medical Devices Used in Extreme Conditions in Pre-Hospital Emergency Medicine: Overview of the Issue, Use Case Regarding Mechanical Ventilation at Altitude and Advice
Authors:

Carine Malle, Alban De Luca and Thierry Chevallier
Abstract: Pre-hospital emergency medicine sometimes involves taking care of patients in environments far different from the hospital. Cold, heat, humidity, altitude, wind, etc. put human beings and equipment to a severe test. What are the extreme conditions to which pre-hospital emergency medicine professionals are exposed? What types of medical devices are particularly concerned? What are the regulations and standards in force? What are the impacts of exposure to extreme conditions on medical devices? To answer these questions, we rely on an analysis of the regulatory and normative context, on a scientific literature review and on a case study involving mechanical ventilation at altitude. Finally, we share some thoughts and advice intended for health facilities and users, in order to improve practices in terms of selection, use and monitoring of medical devices exposed to extreme conditions. This document is illustrated with examples concerning the French defence health service, but our approach can be applied to any entity concerned with pre-hospital emergency medicine.
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Paper Nr: 6
Title:

How to Create a Biological Sample Collection: Requirements and Tips from an Academic Research Example in France
Authors:

M. Medina Calderon, C. Viennet, Y. Pellequer, F. Aubin, P. Guillem, K. Mouyabi-Nkombo, T. Lihoreau and G. Rolin
Abstract: This short paper examines the regulatory needs behind the creation of a biological sample collection in France. Many research projects, including for medical devices development and evaluation, need biological sample collections, this article’s ambition is to provide a clear view of the requirements to create such collections. Numerous laws from the Public Health Code frame research in the health sector in France, starting with the definition of the research type, and going through the various documents needed, especially securing patient safety (in link with Good Clinical Practices –GCPs) and data protection. To have a better insight into the requirements to create a biological sample collection, the use of an on-going academic research will help illustrate our purpose. This research did not involve human subjects, and therefore had a “simplified” path regarding national competent authority approval, and what is called “reference methodologies”. Even though the procedure was labelled “simplified”, numerous interactions are required such as with clinicians, researchers, the clinical investigation center, the hospital research department, and different public administrations including the Hospital, the Minister of Higher Education, Research and Innovation, the National Commission for Data Processing and Liberty (CNIL), and the University of Franche-Comté.
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Paper Nr: 7
Title:

Shaping User-Centered Health Innovation Through Assessment
Authors:

Arthur Trognon, David Servais, Islem Habibi, Robert Picard, Thomas Lihoreau, Lionel Pazart, Sylvia Pelayo, Thierry Chevallier, Kathryn Ernecq, Anaïs Garin, Mathias Béjean and Denis Abraham
Abstract: Historically, evaluation methods for innovative projects have focused mainly on technological development aspects. However, recent research suggests that, in the context of consumption by the general public, the decision parameters for acceptance seem to be based more on characteristics extrinsic to technological maturity. In the present work, we present a model for the evaluation of innovative projects, the Concept Maturity Level Santé France model, inspired by the CML model developed by the National Aeronautics and Space Administration and specified in the context of MedTech project development, and placing co-design with the end-user and its ecosystem on the same level of importance as the regulatory and technological development aspects, and giving it a theoretical and fundamental basis.
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Paper Nr: 8
Title:

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

Gwenaël Rolin, Kenny Pinot and Marilys Blanchy
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.
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