FDA awards 2011 pediatric device grants

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The FDA's Office of Orphan Products Development (OOPD) announced the 2011/2012 recipients of the Pediatric Device Consortia Grant Programs.

The recipients are as follows:

  • James Geiger, MD, and Andre Muelenaer, MD, at the University of Michigan Pediatric Device Consortium (M-PED) & Pediatric Medical Device Institute (PMDI) Pediatric Medical Device Consortium, $1,100,000/per year for two years.
  • Michael Harrison, MD, and the University of California, San Francisco Pediatric Device Consortium, $500,000/per year for two years.
  • Barbara Boyan, PhD, and the Atlanta Pediatric Device Consortium, $900,000/ per year for two years.

Those who received funding scored best in their abilities to serve as a national platform to advance the development of pediatric medical devices while supporting device projects whose outcomes could have an impact on the practice of medicine. The M-PED and the PMDI Device Consortium developed a set of resources under the direction of James Geiger, MD, and Andre Muelenaer, MD, to increase and accelerate the process of pediatric device innovation targeting the needs of children.

The consortium leverages the biomedical discovery capability of the University of Michigan, as well as the established infrastructure, relationships and expertise in commercialization and product development of the Michigan Medical Innovation Center and the Pediatric Medical Device Institute, based in Roanoke, Va.

The UCSF Pediatric Device Consortium (PDC) will provide the infrastructure, expertise and resources for device development to innovators seeking to solve pediatric clinical problems by designing and developing new medical devices. Under the leadership of Michael Harrison, MD, a pediatric and fetal surgeon and a veteran innovator of pediatric devices, and Shuvo Roy, PhD, a bioengineer, the UCSF PDC unites clinicians, scientists, engineers and device industry representatives in facilitating the process of pediatric device development. The UCSF PDC provides expertise in device design and development, patenting issues, the regulatory approval process, the conduct of clinical trials and marketing the devices.

The Atlanta Pediatric Device Consortium, led by Barbara Boyan, PhD, brings together the resources of Children’s Healthcare of Atlanta Pediatric Hospital, Emory University and Georgia Institute of Technology’s College of Engineering. The Consortium will formalize relationships between the Georgia Technology Translational Research Institute for Biomedical Engineering and Science, which focuses on engineering systems that result in commercial products; the Global Center for Medical Innovation, which designs and produces GMP-manufactured prototypes; and the GLP-certified large animal facility at St. Joseph’s Translational Research Institute.

The Consortium will partner with the National Institutes of Health-sponsored Atlanta Clinical Translational Science Institute, providing a venue for testing and clinical assessments. The consortium will provide access to a continuum of services for identifying novel technologies, determining a development plan for commercialization, and partnering with Consortium Centers to assist with execution.