Department of Cardiac Thoracic Vascular Sciences and Public Health, Unit of Biostatistics, Epidemiology and Public Health, University of Padua, Padua, Italy.
Healthcare, ASL VCO, Verbania, Italy.
Expert Rev Med Devices. 2022 Aug;19(8):613-621. doi: 10.1080/17434440.2022.2118046. Epub 2022 Sep 4.
Favoring innovation by making timely medical technology available to people and by securing patients' safety is a challenge.
The new European Medical Device Regulation (MDR) will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe.
Start-ups and small companies might not be able to cope with the increasing complexity and the required changes of perspective. Health-care institutions are facing an increasing availability of complex technologies, while data on their clinical efficacy and cost-effectiveness are rarely provided. A partnership/collaboration between health-care institutions, academia, and private industries will enhance their own specific interests with the common goal of improving overall health and quality of life. The complexity of the subject combined with the variety of specialists and stakeholders involved requires the implementation, in hospital centers of clinical excellence, of units dedicated to the whole path of the medical device innovation. Stakeholders should quickly provide adequate measures to facilitate the complex medical device innovation path under the more stringent MDR aimed to increase safety and quality of care.
通过及时将医疗技术提供给人们并确保患者安全来推动创新是一项挑战。
新的《欧洲医疗器械法规》（MDR）将对新设备的开发产生核心影响，可能会影响它们的创新和可用性，并阻碍欧洲的研究投资。
初创企业和小公司可能无法应对日益增加的复杂性和所需的观念转变。医疗机构面临着越来越多的复杂技术，而很少提供关于其临床疗效和成本效益的数据。医疗机构、学术界和私营企业之间的伙伴关系/合作将以改善整体健康和生活质量为共同目标，增强各自的特定利益。该主题的复杂性以及涉及的各种专家和利益相关者，要求在临床卓越中心实施专门的单位，以涵盖医疗器械创新的整个过程。利益相关者应迅速采取适当措施，以简化更严格的 MDR 下复杂的医疗器械创新路径，旨在提高安全性和护理质量。
