SRI International (SRI) and the Stanford University School of Medicine present this proposal for the MISTRAL (Multidisciplinary Initiative for Surgical Technology Research - Advanced Laboratory) Pediatric Device Consortium (PDC). The purpose of the MISTRAL PDC is to institutionalize the entire process of bringing medical devices appropriate for children into the market. The applicant is proposing a set of collaborators and complimentary projects that address pediatric device development at every stage, from product conceptualization to full entry into the market. Pediatric-specific processes will be developed for device design, intellectual property (IP) disposition, FDA approval, reimbursement and funding mechanisms. The MISTRAL PDC includes the following key features to improve the opportunity for successful development of pediatric devices: (1) Early and ongoing involvement of pediatric clinicians working together with engineers and scientists in the device development, with a strong emphasis on addressing clinically validated needs through the design and technology development process;(2) an independent venture-philanthropic funding source for products that lack market pull, but are assessed to be worthy of development;(3) a device register, including a Pediatric Medical Device Registry and a standardized human subjects clinical, and regulatory process to facilitate compliance with FDA requirements for limited use devices;and (4) a networked community dedicated to the successful transition of pediatric medical devices into the market with regular communication to the industry on pediatric device use and development of best practices - seeding a network of hospitals, companies and venture capitalists dedicated to the creation off new medical devices. The need for the proposed consortium is based on the lack of availability of appropriately developed medical devices for children. The objective of the consortium is to act as a catalyst for pediatric medical product development by speeding the time to market of ideas or devices applicable to children. The consortium can provide services ranging from engineering and regulatory services to marketing and fundraising initiatives.
