Interested in obtaining pediatric labeling for medical devices?

Children’s National Hospital and CobiCure launch program to help FDA-cleared medical devices achieve pediatric labeling.

Interested in obtaining pediatric labeling for medical devices?
Children’s National Hospital and CobiCure

Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announce the opening of a request for proposal to solicit companies interested in obtaining pediatric labeling for medical devices that may address an unmet need in the pediatric population and that already have clearance or approval for adult use by the U.S. Food & Drug Administration (FDA). The objective of this program is to generate the real-world evidence (RWE) needed to facilitate the pediatric regulatory pathway for U.S. market clearance. The deadline to apply is 5 p.m. EST on Feb. 9. To learn more and apply, visit http://www.innovate4kids.org.

Instead of assessing medical devices based on data derived from clinical trials, this pioneering initiative, which brings together a coalition of leading healthcare and academic organizations, is focused on leveraging real-world data (RWD) that can be translated into RWE to gain FDA clearance or approval for use with children.

The new partnership with CobiCure aims at addressing the significant gap that exists between devices labeled for adults and children. Additional coalition partners are MedStar Health Research Institute and all other Pediatric Device Consortia members, which include Center for Technology Innovation in Pediatrics (CTIP), the UCSF-Stanford Pediatric Device Consortium, the Pennsylvania Pediatric Device Consortium and the Southwest National Pediatric Device Consortium. Funded by the FDA and facilitated through NCC-PDI and the Office of Innovation Ventures at Children’s National, this program will provide winning companies with technical expertise, including but not limited to regulatory, study design, and data science services.

"We are delighted to partner with this coalition of trusted healthcare leaders that share our vision for advancing pediatric health. We know all too well that pediatric device development presents several unique challenges and that children have medical device needs that are considerably different from adults,” says Kolaleh Eskandanian, Ph.D., M.B.A, P.M.P, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI. "There are already a number of medical devices on the market that have been FDA cleared or approved and proven viable, and this partnership will help provide important evidence generation and other wraparound services to guide device creators through the regulatory path for pediatric labeling.”

As part of the collaboration, CobiCure is seeking to support pediatric device labeling opportunities in the fields of interventional cardiology, cardiac surgery and associated critical care needs. Such support may include funding, regulatory and project management support for specific projects that fit with CobiCure’s mission. CobiCure is a not-for-profit focused on curing rare, life-threatening diseases in children that is part of Advancium Health Network, which was founded by Deerfield Management and the Deerfield Foundation and is dedicated to advancing healthcare services and health equity.

“We are thrilled to work with Kolaleh and the NCC-PDI on this important initiative. Using real-world data to support pediatric labeling fits with our mission to support the availability of medical technologies that are critical to the care of pediatric patient populations,” says Mark Veich, president of Advancium Health Network and executive director of the Deerfield Foundation.

Eskandanian adds that while Randomized Clinical Trials (RCT) have traditionally been the gold standard when investigating a medical product’s efficacy and safety, many important populations, including children, are excluded from RCTs for ethical reasons. This means that pediatric researchers must make safety and efficacy decisions in the absence of data from such trials. RWE, including data from electronic health records (EHRs), healthcare claims data, disease registries and data gathered through other health applications, can close this gap in pediatric studies. She said that MedStar Health’s capabilities in applying RWE will be a formidable asset to the chosen applicants.

“We are living in an exciting time with the emergence of new technologies, real-world data and computational power that gives us the ability to accelerate science and medicine. By fast-tracking the process for device approval in pediatric patients, children‘s health will be positively impacted,” said Nawar Shara, Ph.D., director for MedStar Health’s Center for Biostatistics, Informatics and Data Science. “I am honored to partner with Children’s National and CobiCure on this important project that will help us advance the care we can provide to our littlest patients.”

Proposals for companies seeking pediatric labeling for their medical device will be reviewed by an esteemed panel of judges specializing in data science, medical device development, evidence generation, post-market surveillance and the FDA’s regulatory pathway. Children’s National, in partnership with the coalition formed under this effort, will provide companies selected through the RFP process with technical expertise in support of their effort to achieve pediatric labeling. This will include access to mentors, a design study protocol implementing RWE generation best practices, the facilitation of IRB submission and study implementation, data science support, and regulatory, reimbursement and supply chain consultation.

NCC-PDI is one of five consortia in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the A. James Clark School of Engineering at the University of Maryland, with support from partners MedTech Innovator and design firm Archimedic.

To date, NCC-PDI has mentored 250 medical device projects to help advance their pediatric innovations throughout all stages of the total product life cycle.

To learn more about NCC-PDI and to review the RFP guidelines, visit http://www.innovate4kids.org.

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