National Capital Consortium for Pediatric Device Innovation 2.0

摘要 NCC-PDI的使命是促进指定使用的设备的开发和商业化 儿科的，用于治疗、诊断或治愈儿科患者 受苦受难。该联盟一直是医疗器械创新者的加速器，这些创新者打算将他们的 在美国，用于普通儿科人群或亚人群的装置。食品与药品 政府向国会提交的关于2016财年儿科设备使用的上市前批准的报告表明 在9年的时间里(2008-2016)，平均每年批准近9个设备，这些设备符合 适用于儿科患者；这相当于平均20.5%的上市前批准(PMAS)和 人道主义设备豁免(HDE)在这段时间。这代表着一个令人敬畏的进步 这在很大程度上要归功于2007年的《儿科医疗器械安全和改进法案》(PMDSIA)。一个 然而，仔细查看数据会发现，这些获得批准的设备中的大多数都被标记为 除老年人外，青少年亚群体(12岁至21岁)。仍然有一个 对标记为新生儿亚群(出生至1个月大)的设备的重大未满足需求， 婴儿(1个月至2岁)和儿童(2岁至12岁)。NCC-PDI的长期 该RFA的目标是为解决这一差距的国家努力做出贡献，并帮助将更多设备带到 市场。我们的短期和运营目标是不断增强我们为客户提供专家服务的能力 为儿科医疗器械的创新者提供咨询和支持服务，专注于产品的整个生命周期 医疗器械从概念，到上市前的开发，再到商业化。我们将到达我们的 通过实现以下具体目标来实现长期和短期目标。具体目标1.加强管道 高增长的儿科设备创业者，并特别考虑那些专注于 未满足的新生儿、婴儿和儿童亚群的需求。具体目标2.推动 通过访问经验丰富的业务、监管、报销 医学与科学、工程与原型、试验设计。具体目标3.通过实施 示范项目，制定、核实和实施证据生成和数据使用的方法， 并展示了跨不同设备和疾病的可扩展性。我们的联盟由主要成员组成 (儿童国家健康系统和马里兰大学)，成员(生物健康创新，MedTech 创新者、HealthCore/Neri和Resnick，Chodorow&Associates)，以及扩展成员(Smithwise， Cadence，i-ACT，PEDSnet，Bear Institute/Cerner，Digital Infuzion，Epidarex，Medical Murray，SFA Regulatory， CTSI-CN、CALCE、M-CERSI)。

ABSTRACT NCC-PDI’s mission is to facilitate the development and commercialization of devices that are indicated for use in pediatric patients or that are intended to treat, diagnose, or cure diseases from which pediatric patients suffer. The Consortium has served as an accelerator to medical device innovators that intend to label their device for use, in the United States, in the general pediatric population or a subpopulation. The Food and Drug Administration’s report to Congress on “FY 2016 Premarket Approval of Pediatric Uses of Devices” indicates that over a 9-year period (2008-2016), an average of almost nine devices were approved per year that were indicated for pediatric patients; this equated to an average of 20.5 percent Pre-market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) over this time. This represents a formidable progress that was achieved thanks in large to the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. A closer look at the data, however, suggests that the majority of these approved devices are labeled for the adolescent subpopulation (12 years through 21 years of age) in addition to older adults. There still remains a significant unmet need for devices labeled for subpopulations of neonates (birth until 1 month of age), infants (1 month until 2 years of age), and children (2 years until 12 years of age). NCC-PDI’s long-term goal under this RFA is to contribute to the national effort to address this gap and help bring more devices to market. Our short-term and operational goals are to continuously enhance our capabilities in providing expert advising and support services to innovators of pediatric medical devices, focusing on the total product life cycle for medical devices from concept, through pre-market development, to commercialization. We will reach our long-term and short-term goals by achieving the following specific aims. Specific Aim 1. Enhance the pipeline of high-growth pediatric device entrepreneurs with special considerations given to those who focus on the unmet needs of subpopulations of neonates, infants, and children. Specific Aim 2. Foster the advance of pediatric medical devices through access to a platform of experienced business, regulatory, reimbursement, medicine & science, engineering & prototyping, and trials design. Specific Aim 3. Through implementation of demonstration projects, develop, verify and operationalize methods of evidence generation and data usage, and demonstrate scalability across diverse devices and diseases. Our Consortium consists of lead members (Children’s National Health System and University of Maryland), members (BioHealth Innovation, MedTech Innovator, HealthCore/NERI, and Resnick, Chodorow, & Associates), and extended members (Smithwise, Cadence, I-ACT, PEDSnet, Bear Institute/Cerner, Digital Infuzion, Epidarex, Medical Murray, SFA Regulatory, CTSI-CN, CALCE, M-CERSI).