{"title":"PDCs:儿科设备资金汪洋中的重要一滴。","authors":"Jim Banks","doi":"10.1109/MPULS.2024.3443548","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":49065,"journal":{"name":"IEEE Pulse","volume":"15 3","pages":"20-24"},"PeriodicalIF":0.3000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"PDCs: A Vital Drop in the Ocean of Funding for Pediatric Devices.\",\"authors\":\"Jim Banks\",\"doi\":\"10.1109/MPULS.2024.3443548\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":49065,\"journal\":{\"name\":\"IEEE Pulse\",\"volume\":\"15 3\",\"pages\":\"20-24\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"IEEE Pulse\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1109/MPULS.2024.3443548\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"IEEE Pulse","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1109/MPULS.2024.3443548","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
引用次数: 0
摘要
本文深入探讨了儿科器械联盟(PDC)在创新器械开发中的作用。文章探讨了资助模式以及医疗器械开发过程中出现的挑战与药物疗法开发过程中出现的挑战有何不同,并探讨了儿科器械联盟如何不仅在资金方面,而且在专业知识、监管指导等方面帮助原始设备制造商。文章还研究了一些获得 PDC 支持的成功器械,并与欧洲儿科器械的资助方式进行了比较,以说明 FDA PDC 资助计划的真正价值。
PDCs: A Vital Drop in the Ocean of Funding for Pediatric Devices.
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.
期刊介绍:
IEEE Pulse covers both general and technical articles on current technologies and methods used in biomedical and clinical engineering; societal implications of medical technologies; current news items; book reviews; patent descriptions; and correspondence. Special interest departments, students, law, clinical engineering, ethics, new products, society news, historical features and government.