Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study

Catherine Roussel, Alexandrine Salis, Sylvia Pelayo

2020

Abstract

Medical Devices are health products that combine complex technologies and new organizations. They are under high constraints, both economic and regulatory, but also in terms of quality and safety requirements. The new European regulation comes in addition and questions all of the actors of the maturation process from the idea-to-market for medical devices (MDs). The objective of this qualitative study was to collect and analyze feedback from various European stakeholders involved in the clinical evaluation of medical devices, with a special focus on innovative high-risk medical devices. This paper presents the results of the first phase which scope was limited to France with sixteen interviews. Results show the complexity of the clinical evaluation of MD, particularly when dealing with an innovative, high-risk medical device. The need for training and support of actors through specialized platforms was highlighted, as well as the need for coordination between public and private actors, from the upstream phases of R&D. The collection of clinical data must be part of an overall strategy considering the maturation cycle of the product and its different dimensions. The collection of real-life data must be amplified and structured, with the contribution of new digital technologies opening up new fields of research. This approach must be strengthened by (i) the development of methods based on choices justification, and (ii) making it possible to capitalize on and cross-reference data on the Medical Device throughout its life span. The brief overview provides convergent conclusions, but the understanding of the required level for the evaluation of medical devices and of the way to reach it was not uniform. This reflects a heterogeneous sector and it introduces the need of compromises regarding development strategies and methodological approaches.

Paper Citation

in Harvard Style

Roussel C., Salis A. and Pelayo S. (2020). Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study. In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed, ISBN 978-989-758-398-8, pages 329-336. DOI: 10.5220/0009372903290336

in Bibtex Style

@conference{clinmed20,
author={Catherine Roussel and Alexandrine Salis and Sylvia Pelayo},
title={Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study},
booktitle={Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,},
year={2020},
pages={329-336},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0009372903290336},
isbn={978-989-758-398-8},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies - Volume 1: ClinMed,
TI - Practices and Requirements of Stakeholders Involved in the Clinical Evaluation of Innovative High-risk Medical Devices: A Qualitative Study
SN - 978-989-758-398-8
AU - Roussel C.
AU - Salis A.
AU - Pelayo S.
PY - 2020
SP - 329
EP - 336
DO - 10.5220/0009372903290336