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专业使用的医疗器械:如何评估,如何资助?

Valéry-Pierre Riche¹, Laure de Place², Xavier Armoiry³

¹Direction de la recherche et de l'innovation, Nantes université, CHU de Nantes, 44000 Nantes, France.

Therapie

|January 9, 2026

概括

专业使用医疗器械 (DMUP) 是至关重要的,但由于定义不清楚和评估困难,医疗器械面临融资挑战. 新的基于价值的模型和真实世界的数据正在出现,以解决医疗保健系统和制造商的这些问题.

科学领域:

医疗保健创新医疗保健创新
医疗技术评估医疗技术评估
卫生经济学卫生经济学

背景情况:

专业医疗器械 (DMUP) 在医疗保健中变得越来越重要,这得益于人工智能和机器人等数字技术的进步.
它们的广泛采用是由技术创新和人口老龄化和医疗人口统计学带来的压力加剧所加速的.
现有的融资和退款框架,特别是在法国 (LPPR),不适合DMUP,特别是复杂的设备和数字解决方案.

研究的目的:

解决评估和资助专业医疗器械 (DMUP) 的挑战.
探索创新方法,并提出将DMUP纳入医疗保健系统的建议.
调整医疗保健提供者,卫生系统和医疗器械制造商的需求.

主要方法:

审查法国和欧洲当前的监管格局 (欧盟2017/745).
分析现有的融资机制,包括赠款和医院费率.
探索新兴的评估策略,如基于价值的模型和现实世界的数据利用.
来自吉恩斯2025研讨会的讨论和建议.

主要成果:

缺乏明确的DMUP定义使其融入融资道变得复杂.
目前的退款模式难以适应DMUP的独特性质,导致临时融资.
证明临床价值和考虑组织影响仍然是DMUP评估中的重大障碍.
创新的融资和评估方法,包括基于价值的模型和真实世界的数据,正在获得引力.

结论:

对于专业医疗器械 (DMUP) 进行适应的评估和融资框架至关重要.
基于价值的医疗保健模型和现实世界的数据为更好地整合DMUP提供了有希望的途径.
需要提出建议,以确保DMUP有效地满足医疗保健系统和制造商不断变化的需求.

关键词:

评估评估的方法进入市场的市场准入权.专业使用的医疗器械退款方式退款方式退款方式

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