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U.S. Department of Health and Human Services

For Industry

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Pediatric Device Consortia Grants Awarded September 2009

 

In September 2009, the Office of Orphan Products Development announced the recipients of the Pediatric Device Consortia Grant Program Awards.  The recipients were:

  • James Geiger, M.D. and the Michigan Pediatric Device Consortium, $1,000,000 per year for two years

  •  Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 per year for two years

  •  Pedro Del Nido, M.D. and The Pediatric Cardiovascular Device Consortium, $500,000 per year for two years 

  • 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 impact the field of pediatric device development and also 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 pediatric medicine.

 

The University of Michigan Pediatric Device Consortium (M-PED) brought 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 was managed by the MedicaI 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 were supported through the MIC's Inventor Assistance Program.  During a one-year, full-time fellowship program, the 2011 MIC Fellowship Class worked on developing solutions for unmet clinical pediatric device needs.

 

Other important Consortium activities included formation of a Pediatric Technical Advisory Group that validated unmet clinical needs before investing time and resources into solutions; the collaboration between 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 included the development of a device for the treatment of short bowel syndrome; and the development of non-thrombogenic, antiseptic catheters for children.

 

The UCSF Pediatric Device Consortium provided infrastructure, expertise, and resources to innovators seeking to solve pediatric clinical problems by designing and developing novel devices.  Led by Michael Harrison, M.D., a pediatric, fetal surgeon and veteran innovator of pediatric devices, the UCSF Pediatric Device Consortium united a diverse group of clinicians, scientists, engineers, and device industry representatives in facilitating the process of pediatric device development.

 

Twice a week, the UCSF Pediatric Device Consortium held a forum for collaboration between innovative clinicians, engineers, and device experts both from within and outside the university.

 

The consortium provided 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 provided 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 aimed to 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 included the treatment of pacts excavate 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, consisted of an organizational administrative core which coordinated the efforts of the three other core facilities and their interactions with individual device projects.  The three core facilities included:  1) a Clinical Trials Core which coordinated with the Pediatric Heart Network; 2) an Engineering Core which mentored preclinical stage devices from initial concept to retyping to preclinical evaluation; and 3) a Regulatory and Commercialization Core facility which mentored projects through regulatory requirements and business development components.

Initial projects undertaken by this consortium included projects involving pediatric valve replacement and repair; improved pediatric echocardiography imaging techniques; and pediatric vascular assist device development.

 

The MISTRAL Consortium led by Pablo Garcia and Sanjeev Dutta, M.D.
MISTRAL PDC was 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 initial objectives of the consortium over the next two years were 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 entered into a partnership with the Institute for Pediatric Innovation (IPI).