Pediatric Device Consortia Grant Awarded September 2009
The Office of Orphan Products Development (OOPD) is pleased to announce the recipients of the Pediatric Device Consortia Grant Program Awards. The recipients are as follows:
· James Geiger, M.D. and the Michigan Pediatric Device Consortium, $1,000,000/ per year for two years
· Pedro DelNido, M.D. and The Pediatric Cardiovascular Device Consortium, $500,000/ per year for two years
· Michael Harrison, M.D. and the University of
· Pablo Garcia and Sanjeev Dutta and the MISTRAL Device Consortium, $500,000/ per year for two years
Applicants were judged on the organizational capacity of their proposed consortiums to exert a sustained, powerful influence on the field of pediatric device development, as well as an assessment of potential device projects.
Those who received funding scored best in their unique abilities to serve as a national platform to advance the development of pediatric medical devices while supporting device projects whose outcomes could have a significant impact on the practice of pediatric medicine.
Innovation Center (MIC), a multi-disciplinary collaborative effort launched by James Geiger, M.D., a pediatric surgeon, and Professor Albert Shih, Ph.D., a mechanical engineer. Pediatric device innovators will be supported through the MIC's Inventor Assistance Program. During their one-year, full-time fellowship program, the 2011 MIC Fellowship Class will develop solutions for unmet clinical pediatric device needs. Other important Consortium activities include a Pediatric Technical Advisory Group that will validate unmet clinical needs before investing time and resources into solutions; the collaboration of the members of the area's medical innovation ecosystem to overcome barriers unique to the commercialization of pediatric devices; and the development and distribution of standardized practices to facilitate pediatric device innovation more broadly. Initial projects supported by this consortium may include the development of a device for the treatment of short bowel syndrome; and the development of nonthrombogenic, antiseptic catheters for children.
The UCSF Pediatric Device Consortium will provide the infrastructure, expertise, and resources for device development to innovators seeking to solve urgent pediatric clinical problems by designing and developing novel devices. Led by Michael Harrison, M.D., a pediatric and fetal surgeon and veteran innovator of pediatric devices, the UCSF Pediatric Device Consortium will unite a diverse group of clinicians, scientists, engineers, and device industry representatives in facilitating the process of pediatric device development.
The UCSF Pediatric Device Consortium will build on the work of the UCSF Clinical Solutions Group, a weekly forum for collaboration between innovative clinicians and device experts from both within and outside the university. The consortium will provide expertise in patenting issues, the regulatory approval process, the conduct of clinical trials, and the marketing of devices. With prototyping equipment, testing facilities, and funds for consulting fees, fabrication costs, studies in animal models and other expenses, the UCSF Pediatric Device Consortium will be a comprehensive resource for clinical innovators seeking advice and assistance as they take their projects through the development process. By connecting these innovators to the relevant experts at each stage of device development and by providing them with educational resources, seed money, and administrative support for their projects, the UCSF Pediatric Device Consortium will become a “pipeline” for pediatric devices, accelerating the pace at which creative and potentially life-saving ideas move to the market. Initial device projects supported by this consortium include the treatment of pectus excavatum through use of an implantable magnet; and the development of a novel device to treat scoliosis.
The Pediatric Cardiovascular Device Consortium, headed by Pedro del Nido, M.D. of Boston Children’s Hospital, consists of an strong organizational administrative core which will coordinate the efforts of the three other core facilities and their interactions with individual device projects. The three core facilities include: 1) a clinical trials core which will coordinate with the Pediatric Heart Network 2) an engineering core which will mentor devices at the preclinical stage from initial concept to protyping to preclinical evaluation and 3) a regulatory and commercialization core facility to mentor projects through regulatory requirements and business development components. Initial projects undertaken by this consortium include projects involving pediatric valve replacement and repair; improved pediatric echocardiography imaging techniques; and pediatric vascular assist device development.
The MISTRAL Consortium is led by Pablo Garcia and Sanjeev Dutta, M.D.
MISTRAL PDC is a consortium of non-profit organizations founded jointly by SRI International and Stanford University with a mission to act as a catalyst for pediatric medical product development by speeding the time to market of ideas or devices applicable to children. The objectives of the consortium over the next two years are to: 1)Create an open, national infrastructure to foster the development of products by connecting key stakeholders in the development and commercialization of pediatric medical devices (inventors, companies, funders, clinicians, hospitals, regulators, etc.). 2)Develop product sustainability plans for at least four new critical pediatric medical devices and have them adopted by companies for introduction into the market. In order to accomplish these objectives, the MISTRAL PDC will be entering into a partnership with the Institute for Pediatric Innovation (IPI).