Recipients of the FY 09 Pediatric Device Consortia Grant Program Awards

The Office of Orphan Products Development is pleased to announce the recipients of the Fiscal Year 2009 Pediatric Device Consortia Grant Program Awards.  The recipients are as follows:

• James Geiger, M.D. and the Michigan Pediatric Device Consortium, $1,000,000
• Pedro DelNido, M.D. and the Pediatric Cardiovascular Device Consortium, $500,000
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000

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.  

The University of Michigan Pediatric Device Consortium (M-PED) will bring together schools of business, engineering, nursing, dentistry and medicine, along with its children's hospitals and other major health system facilities, to advance the development of pediatric medical devices.  The Consortium will be managed by the Medical 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.