BOSTON PEDIATRIC DEVICE CONSORTIUM

描述(由申请人提供)： 儿科设备的开发和评估已被认为是改善患有先天性和后天性疾病的儿童的生活和福利的迫切需要。设备开发商和制造商面临的众多挑战导致了对儿科设备，特别是心血管设备的大量未得到满足的需求。波士顿儿科设备协会(BPDC)的总体目标是在新型儿科心脏设备开发所需的每一步为设备开发商和制造商提供专业知识和资源，以加快创新步伐。BPDC是一个由工程学、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协作体，其主要目标是为患有心血管缺陷的儿童开发和评估新疗法。该财团是波士顿和波士顿之间的合作伙伴 他还与儿童医院、Wyss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)和医学与创新技术集成中心(CIMIT)合作，并就监管批准专业知识的临床试验与新英格兰研究所(NERI)提供咨询。联合体结构由一个行政和执行团队组成，该团队将成为创新者和联合体资源之间的主要接口。管理团队将获得对该设备进行全面评估所需的信息，首先了解临床需求，然后了解围绕该需求的业务、要应用的最佳技术以及评估安全性和有效性的潜在方法。该联合体将推动儿科医疗器械创新，加快儿科医疗器械研发步伐。BPDC的目标是利用其在儿科临床和多中心试验方面的专业知识、儿科设备方面的工程知识、监管和商业化专业知识，以及帮助不同的发明家、设备制造商和开发商将儿童设备推向市场的记录。

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.