National Capital Consortium for Pediatric Device Innovation 2.0

国家儿科器械创新2.0资本联盟

• 批准号: 10247485
• 负责人: WILLIAM E. BENTLEY
• 金额: $ 100万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247485
• 关键词: National; Capital; Consortium; Pediatric; Device

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).

抽象的 NCC-PDI的使命是促进用于使用的设备的开发和商业化 在儿科患者或旨在治疗，诊断或治愈儿科患者的疾病中 遭受。该财团一直是医疗设备创新者的加速器，打算给他们标记 在美国，在美国的一般小儿人群或亚群中使用的设备。食物和药物 政府向国会关于“ 2016财年前市场批准儿科用途的报告”的报告表示 在9年的时间内（2008-2016），平均每年批准了近9个设备 为儿科患者指示；这相当于平均20.5％的前市场批准（PMA）和 人道主义设备豁免（HDE）这段时间。这代表了一个巨大的进步 在2007年的《小儿医疗设备安全与改进法案》（PMDSIA）中，非常感谢。 然而，仔细观察数据表明，这些批准的设备中的大多数被标记为 除了老年人外，青少年亚群（12岁至21岁）。仍然有一个 对标有新生儿亚群（出生直到1个月大）的设备的重要需求， 婴儿（截至2岁的1个月）和儿童（截至12岁的2岁）。 NCC-PDI的长期 此RFA下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入 市场。我们的短期和运营目标是不断增强我们为专家提供的能力 为小儿医疗设备的创新者提供咨询和支持服务，重点关注总产品生命周期 从概念到市场前开发到商业化的医疗设备。我们将达到我们的 长期和短期目标通过实现以下特定目标。特定目标1。增强管道 高增长的儿科装置企业家，并特别考虑那些专注于 未满足新生儿，婴儿和儿童亚群的需求。具体目标2。促进 通过访问经验业务，监管，报销的经验平台，儿科医疗设备， 医学与科学，工程与原型以及试验设计。特定目标3。通过实施 演示项目，开发，验证和运营证据生成和数据使用方法， 并展示潜水设备和疾病的可伸缩性。我们的财团由主要成员组成 （儿童国家卫生系统和马里兰大学），成员（MedTech BioHealth Innovation，Medtech Innovator，Healthcore/Neri和Resnick，Chodorow和Associates）和扩展成员（Smithwise， Cadence，I-ACT，PEDSNET，BEAR Institute/Cerner，Digital Infuzion，Epidarex，Medical Murray，SFA监管， CTSI-CN，CALCE，M-CERSI）。