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U.S. Department of Health and Human Services

For Industry

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Pediatric Device Consortia Grant Awarded September 2011


In September 2011, the Office of Orphan Products Development (OOPD) announced the recipients of the Pediatric Device Consortia Grant Program Awards for 2011/2012. The recipients were:

  • James Geiger, MD and Andre Muelenaer, MD of the University of Michigan  MPED & 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.

 

Applicants were judged on the organizational capacity of their proposed consortiums to impact the field of pediatric device development, as well as an assessment of their proposed potential device projects.

Those who received funding scored best in their unique abilities to serve as national resources to advance the development of pediatric medical devices while supporting device projects whose outcomes could have a significant impact on the practice of medicine.

The University of Michigan Pediatric Device Consortium (M-PED) and the Pediatric Medical Device Institute (PMDI) Device Consortium brought together a unique set of resources under the direction of James Geiger, MD and Andre Muelenaer, MD, to increase and accelerate the process of pediatric device innovation specifically targeting the needs of children. 

This consortium leveraged the biomedical discovery capability of the University of Michigan, as well as the established infrastructure, relationships, expertise in commercialization and product development of the Michigan Medical Innovation Center (MIC), and the Pediatric Medical Device Institute, which is based in Roanoke, Virginia. The combined resources of the MPED-PMDI consortium were fully engaged to accelerate the consortium-affiliated portfolio of pediatric devices to the next phases of product development. 

Specific aims of this consortium included: 1) growing and advancing the existing pediatric medical device portfolio along the total product life-cycle, 2) identifying funding support for high potential pediatric devices, 3) continuing to identify and prioritize unmet pediatric needs, and 4) providing assistance and education to innovation-minded faculty, clinicians, industry, students, and staff, while producing information assets on pediatric device commercialization.

The UCSF Pediatric Device Consortium provided infrastructure, expertise, and resources for device development to innovators seeking to solve pediatric clinical problems by designing and developing novel medical devices. Under the leadership of Michael Harrison, MD, a pediatric and fetal surgeon and veteran innovator of pediatric devices, and Shuvo Roy, PhD, a bioengineer, the UCSF PDC united a diverse group of clinicians, scientists, engineers, and device industry representatives in facilitating the process of pediatric device development. 

The UCSF PDC afforded expertise in device design and development, patenting issues, the regulatory approval process, the conduct of clinical trials, and the marketing of devices. The consortium conducted biweekly forums for collaboration between innovative clinicians, engineers, and device experts both from within and outside of the university. This consortium made available to all individual projects a core personnel and resource infrastructure (including prototyping capabilities, testing facilities, and consulting network).  The backing of PDC expertise and resources provided individual projects a strong foundation from which to attract their own funding for more expensive development costs.

The Atlanta Pediatric Device Consortium, led by Barbara Boyan, PhD, brought together the resources of Children’s Healthcare of Atlanta Pediatric Hospital, Emory University, and Georgia Institute of Technology’s College of Engineering.    The Consortium formalized existing relationships between the Georgia Tech Translational Research Institute for Biomedical Engineering and Science, which focuses on the need for 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. Consortium institutions had the opportunity to partner with the NIH-sponsored Atlanta Clinical Translational Science Institute, providing a venue for first-in-child testing and clinical assessments.  

This consortium provided innovators 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. A Clinical Advisory Board assessed scientific and medical merit of proposed devices. The consortium also provided a mechanism for generating external funding; and developed a cadre of clinicians, scientists, and engineers with an understanding of the requirements for design and implementation of devices for children.