IEEE Pulse. 2024 Sep-Oct;15(3):20-24. doi: 10.1109/MPULS.2024.3443548.
This article is an in-depth examination of the role of pediatric device consortia (PDC) in the development of innovative devices. Looking at the funding model, and at how the challenges that arise in the development of medical devices differ from the development of drug therapies, the article looks at how PDCs can help OEMs with not only funding, but also expertise, regulatory guidance, and more. There is also an examination of some successful devices that have been backed by PDCs, and a comparison with how pediatric devices are funded in Europe to who how the true value of the FDA's PDC grant program.
这篇文章深入探讨了儿科设备联盟(PDC)在创新设备开发中的作用。本文从资金模式入手,探讨了医疗器械开发中面临的挑战与药物疗法开发的不同之处,研究了 PDC 如何在资金以外的方面,如专业知识、监管指导等方面为原始设备制造商(OEM)提供帮助。文章还考察了一些得到 PDC 支持的成功设备,并将其与欧洲儿科设备的资助方式进行了比较,以评估 FDA 的 PDC 资助计划的真正价值。