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）： 小儿装置的开发和评估被认为是改善先天和熟食儿童的生活和福利的迫切需要。设备开发人员和制造商面临的众多挑战导致对儿科设备，尤其是心血管设备的未满足需求。波士顿儿科设备联盟（BPDC）的总体目的是为设备开发人员和制造商提供专业知识和资源，以加快创新速度，以加快新型儿科心脏设备开发所需的每个步骤。 BPDC是工程专家，心脏临床科学，临床试验设计和绩效，设备开发专家以及行业合作伙伴的合作，其主要目标是为患有心血管缺陷的儿童开发和评估新型疗法。该财团是波士顿之间的合作伙伴关系 儿童医院，WYSS研究所（哈佛医学院内的工程组织和工程和应用科学学院）以及医学与创新技术一体化中心（CIMIT），以及与新英格兰研究所（NERI）进行监管批准专业临床试验咨询。财团结构由一个行政和执行团队组成，该团队将是创新者与财团资源之间的主要接口。行政团队将获得必要的信息，以全面评估设备，首先要了解临床需求，然后围绕需求的业务，要应用的最佳技术以及评估安全性和有效性的潜在方法。该财团将促进并加速儿科医疗设备开发的速度。 BPDC旨在利用其在儿科临床和多中心试验中的专业知识，小儿设备中的工程知识，监管和商业化专业知识，以及协助各种各样的发明家，设备制造商和开发人员在搬家设备上为儿童提供市场的记录。