BOSTON PEDIATRIC DEVICE CONSORTIUM

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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.