NEW ENGLAND PEDIATRIC DEVICE CONSORTIUM

新英格兰儿科设备联盟

• 批准号: 9143569
• 负责人: RICHARD M GREENWALD
• 金额: $ 70万
• 依托单位: NEW ENGLAND PEDIATRIC DEVICE CONSORTIUM
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-16 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9143569
• 关键词: NEW; ENGLAND; PEDIATRIC; DEVICE; CONSORTIUM

DESCRIPTION (provided by applicant): Although children represent 25% of the American population, pediatric product development lags far behind development of medical devices and drug products targeted for the treatment of adults. The applicant specifies that the main reason for this disparity is that the pediatric marke represents a small fraction of the whole medical market resulting, potentially, in a low return on investment for these companies and less incentive to invest in new pediatric product development. The applicants state that the New England Pediatric Device Consortium (NEPDC), an infrastructure resource center, will provide a national resource for pediatric and orphan technology researchers, clinicians, bioengineers, and technology inventors for translation and commercialization of pediatric and orphan technologies. The expertise and core partner organizations will provide analysis of clinical needs, early stage product and market evaluation, technology assessment, regulatory pathway planning and execution, prototype development, laboratory and animal testing, pre-clinical and clinical evaluation, comparative effectiveness clinical trial design, commercialization planning and execution, and outcomes assessment. The applicants indicate that the NEPDC will link the pediatric research, clinical care and innovation community to industry, and will address the unique challenges surrounding the development and translation of pediatric products for clinical and consumer use.

描述（由申请人提供）： 虽然儿童占美国人口的25%，但儿科产品的开发远远落后于针对成人治疗的医疗器械和药品的开发。申请人指出，造成这种差异的主要原因是儿科马克市场仅占整个医疗市场的一小部分，这可能导致这些公司的投资回报率较低，并且投资于新儿科产品开发的动机较低。申请人声明，新英格兰儿科器械联盟（NEPDC）是一个基础设施资源中心，将为儿科和孤儿技术研究人员、临床医生、生物工程师和技术发明者提供国家资源，用于儿科和孤儿技术的翻译和商业化。专业知识和核心合作伙伴组织将提供临床需求分析、早期产品和市场评估、技术评估、监管途径规划和执行、原型开发、实验室和动物试验、临床前和临床评估、比较有效性临床试验设计、商业化规划和执行以及结果评估。申请人表示，NEPDC将儿科研究，临床护理和创新社区与行业联系起来，并将解决围绕临床和消费者使用的儿科产品开发和翻译的独特挑战。