NATIONAL CAPITAL CONSORTIUM FOR PEDIATRIC DEVICE INNOVATION

全国儿科器械创新财团

• 批准号: 9331336
• 负责人: Kolaleh Eskandanian
• 金额: $ 91.05万
• 依托单位: CHILDREN'S NATIONAL MEDICAL CENTER
• 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 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9331336
• 关键词: NATIONAL; CAPITAL; CONSORTIUM; PEDIATRIC; DEVICE

DESCRIPTION (provided by applicant): One of pediatrics' greatest challenges is that marketing of pediatric medical devices would not generate sufficient returns to justify the investment needed for their development. The applicant notes that the Request For Applications states that, "the development of pediatric medical devices lags behind the development of devices for adults..." and "there currently exists a great need for pediatric medical devices, including devices developed originally for pediatric patients as well as existing adult devices adapted for pediatric use." The applicants state that at the highest level the barriers to pediatric device development are characterized by the technical, business, testing, and regulatory complexities of research and development (R&D) in general, and the deficiency of business community support for bringing pediatric devices to market. The complexity of forces required for success includes multi-disciplinary skills, competencies, and experiences in which the whole is greater than the sum of the parts. The applicants indicate that it takes a strong collaboration of many entities in industr, non-profit, academia, advocacy groups, and medical societies to make pediatric device development a success. Children's National Medical Center, its flagship Sheikh Zayed Institute for Pediatric Surgical Innovation, and the University of Maryland's A. James Clark School of Engineering, as well as their affiliate institutions, and collaborators, state they will meet these challenges by creating he National Capital Consortium for Pediatric Device Innovation (NCC-PDI) in response to the FDA RFA-FD-13-010. To achieve these goals, the NCC-PDI will be built around five integrated pillars, each of which will include institutional coaches, internal and external advisors, and shared resources. These components are: (1) Business Planning/Finance, (2) Regulatory, (3) Scientific/Engineering, (4) Clinical, and (5) Intellectual Property.

描述（由申请人提供）： 儿科最大的挑战之一是儿科医疗器械的营销不会产生足够的回报来证明其开发所需的投资是合理的。申请人指出，申请请求指出，“儿科医疗器械的开发落后于成人器械的开发......并且目前存在对儿科医疗装置的巨大需求，包括最初为儿科患者开发的装置以及现有的适于儿科使用的成人装置。" 申请人指出，在最高层面上，儿科器械开发的障碍主要表现为研发（R&D）的技术、商业、测试和监管复杂性，以及商业界对儿科器械上市的支持不足。成功所需力量的复杂性包括多学科技能、能力和经验，其中整体大于部分之和。申请人指出，需要行业、非营利组织、学术界、倡导团体和医学会中许多实体的大力合作，才能使儿科器械开发取得成功。 儿童国家医疗中心，其旗舰谢赫扎耶德研究所儿科外科创新，和马里兰州大学的A。James Clark工程学院及其附属机构和合作者表示，他们将通过创建国家儿科器械创新资本联盟（NCC-PDI）来应对这些挑战，以响应FDA RFA-FD-13-010。 为了实现这些目标，NCC-PDI将围绕五个综合支柱建立，每个支柱将包括机构教练，内部和外部顾问以及共享资源。这些组件包括：（1）业务规划/财务，（2）法规，（3）科学/工程，（4）临床和（5）知识产权。