Therapie. 2025 Dec 14:S0040-5957(25)00154-4. doi: 10.1016/j.therap.2025.10.006. Online ahead of print.
ABSTRACT
Medical devices for professional use professional use medical device (DMUPs) are playing an increasingly important role in healthcare systems, driven by the rise of digital technologies. They encompass a wide range of equipment, from robotic surgery to diagnostic software solutions. There is no specific definition for DMUP, which complicates their integration into financing channels. Since years 2010s, two main dynamics have accelerated their spread: on the one hand, technological innovation (robotics, artificial intelligence, remote monitoring, connected objects) improving precision, efficiency, and quality of care; on the other hand, growing pressure on healthcare systems linked to an aging population and medical demographics. In France and Europe, regulatory authorities recognize their potential, while highlighting the difficulties of integrating them into traditional reimbursement frameworks. The French model, centered on the list of reimbursable products and services (LPPR), is ill-suited to DMUPs, particularly heavy equipment and digital medical devices. These are financed through grants or integrated into hospital rates, without any real systematic evaluation. European Regulation (EU) 2017/745 has strengthened clinical requirements, while experiments such as ETAPES have paved the way for innovative financing. Nevertheless, the evaluation of DMUPs remains hampered by the difficulty of demonstrating their clinical value and the insufficient consideration of their organizational impact. In response to these challenges, new approaches are emerging value-based models, broadening evaluation criteria to include organizational gains, and increased use of real-world data. In this context, the Giens 2025 Workshops devoted a round table to the evaluation and financing of DMUPs, in order to propose recommendations tailored to the needs of healthcare, the health system, and manufacturers.
PMID:41513582 | DOI:10.1016/j.therap.2025.10.006