Research Project
8673708
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.
