- The FDA announced a $5 million award to a pediatric device consortium to stimulate projects that will improve innovation and availability of medical devices for children.
- The consortium, led by Children's National Health System in Washington and the University of Maryland, College Park, will connect individuals who have pediatric device ideas with potential manufacturers and with existing federal and other resources.
- Members of the effort, called the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), include BioHealth Innovation, a Maryland-based organization that helps move research projects to market, and MedTech Innovator, a California-based medtech startup accelerator.
Medical devices for children take longer to come to market than devices for adults, and their development is further complicated by the need to size the devices to accommodate growth from newborns and toddlers to adolescents and young adults. Of the 66 devices approved by the FDA through premarket approval and humanitarian device exemption pathways in 2017, just 18 were indicated for use in a pediatric population.
“Crucial pediatric innovations often languish in areas like asthma, heart disease, and neonatal health," Paul Grand, CEO of MedTech Innovator, said in a press release.
Medical device executives attending a recent FDA workshop on barriers to pediatric device development told MedTech Dive that funding is a major challenge because of the small market for products for some pediatric sub-populations.
Some FDA efforts to promote pediatric device development have included early feasibility and expedited access programs, leveraging of existing clinical data for approval of pediatric devices, and acceptance of data from studies conducted outside the United States.
The NNC-PDI, like other nonprofit consortia funded by the FDA in Houston, Los Angeles, Philadelphia and San Francisco, will provide business, regulatory, legal, scientific, engineering and clinical expertise to strengthen pediatric device applications, the agency said. The five-year grant from the FDA’s Office of Orphan Products Development will assist NCC-PDI in:
- Connecting qualified individuals with pediatric device ideas to potential manufacturers.
- Mentoring pediatric device projects though the development process.
- Connecting innovators and physicians to existing federal and non-federal resources.
- Assessing the scientific and medical merit of proposed pediatric device projects.
- Advising on business development, personnel training, prototype development, post market needs and related activities.
- Providing regulatory consultation to support submission of pediatric device applications.