BOSTON PEDIATRIC DEVICE CONSORTIUM

波士顿儿科设备联盟

• 批准号: 8675646
• 负责人: Pedro J. del Nido
• 金额: $ 20万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8675646
• 关键词: BOSTON; PEDIATRIC; DEVICE; CONSORTIUM

DESCRIPTION (provided by applicant): Pediatric device development and evaluation has been recognized as a critical need to improve the lives and welfare of children with congenital and acquired illnesses. The numerous challenges faced by device developers and manufacturers have resulted in a large unmet need for pediatric devices and in particular, cardiovascular devices. The overall aim of the Boston Pediatric Device Consortium (BPDC) is to provide expertise and resources to device developers and manufacturers at each of the steps necessary for novel pediatric cardiac device development, in order to accelerate the pace of innovation. The BPDC is a collaborative of experts in engineering, cardiac clinical sciences, clinical trials design and performance, device development specialists, and industry partners whose primary goal is to develop and evaluate novel therapies for children with cardiovascular defects. The consortium is a partnership between Boston Children's Hospital, the Wyss Institute (an engineering organization within Harvard Medical School and the School for Engineering and Applied Sciences), and the Center for Integration of Medicine and Innovative Technology (CIMIT), as well as consulting with New England Research Institute (NERI) for clinical trial for regulatory approval expertise. The consortium structure consists of an administrative and executive team which will be the main interface between the innovators and the resources of the consortium. The administrative team will obtain the necessary information for a full assessment of the device, starting with understanding the clinical need, then the business around the need, the optimal technology to be applied, and potential method for evaluation of safety and effectiveness. This consortium will promote innovation in and accelerate the pace of pediatric medical device development. The BPDC aims to use its strengths of expertise in pediatric clinical and multi-center trials, engineering knowledge in pediatric devices, regulatory and commercialization expertise, and track record of assisting a diverse group of inventors, device manufacturers, and developers in moving devices for children to the market.

描述（由申请人提供）： 儿科器械的开发和评估已被公认为是改善先天性和后天性疾病儿童生活和福利的关键需求。器械开发商和制造商面临的众多挑战导致对儿科器械（特别是心血管器械）的大量需求未得到满足。Boston Pediatric Device Consortium（BPDC）的总体目标是在新型儿科心脏器械开发所需的每个步骤中为器械开发商和制造商提供专业知识和资源，以加快创新步伐。BPDC是一个由工程、心脏临床科学、临床试验设计和性能、设备开发专家和行业合作伙伴组成的合作组织，其主要目标是开发和评估针对心血管缺陷儿童的新疗法。该财团是波士顿和 儿童医院、Wessels研究所（哈佛医学院和工程与应用科学学院内的一个工程组织）和医学与创新技术整合中心（CIMIT），以及新英格兰研究所（NERI）的临床试验咨询，以获得监管批准专业知识。联合体的结构包括一个行政和执行团队，这将是创新者和联合体资源之间的主要接口。管理团队将获得对器械进行全面评估所需的必要信息，首先了解临床需求，然后了解围绕需求的业务、待应用的最佳技术以及评价安全性和有效性的潜在方法。该联盟将促进创新，加快儿科医疗器械开发的步伐。BPDC旨在利用其在儿科临床和多中心试验方面的专业知识，儿科设备的工程知识，监管和商业化专业知识以及协助不同的发明者，设备制造商和开发人员将儿童设备推向市场的记录。