Washington, DC – One of the greatest challenges in children’s healthcare is that the market for pediatric medical products “insufficiently supports investment” needed for their development, according to Peter Kim MD, CM, PhD, Vice President, and Kolaleh Eskandanian, PhD, MBA, PMP, Executive Director, Sheikh Zayed Institute for Pediatric Surgical Innovation.
To overcome barriers in pediatric device development, strong collaboration in industry, nonprofit, academic, advocacy, and medical societies, is critical, they wrote in an editorial for the American Academy of Pediatrics newsletter.
“Only in that way can pediatric medical devices be more readily brought to market,” Drs. Kim and Eskandanian wrote.
Pediatric legislative initiatives, especially through Section 505 of the Pediatric Medical Device Safety and Improvement Act of 2007, have prompted “much progress” in boosting the development of pediatric medical devices. However, “barriers to pediatric device development persist, particularly in the lack of investors’ support to bring pediatric devices to market,” they added.
To continue the dialogue, the Sheikh Zayed Institute for Pediatric Surgical Innovation plans to host the 2nd Annual Symposium on Pediatric Surgical Innovation, on the theme of “Lessons from Drugs to Devices: A Pediatric Perspective.”
The forum will bring together key leaders from the National Institutes of Health, the Food and Drug Administration, industry, law firms, pediatric societies, advocacy groups, together with scientists, engineers, clinicians, and policy makers. The keynote speaker at this year’s event is FDA Commissioner Margaret Hamburg, MD. Since 2009, the FDA has awarded grants to consortia to advance the development of pediatric medical devices, and has spearheaded a number of public workshops that touch on the issue of pediatric device development, according to Drs. Kim and Eskandanian.
Last year’s Symposium participants offered recommendations to improve the current state of pediatric surgical and device innovation and the regulatory clearance and approval process. In their editorial, Drs. Kim and Eskandanian focused on key recommendations on the development path, the 510(k) process, and the International considerations.
- Development Path. Although medical devices have to be continuously refined to improve their performance, special efforts should be made to promote the design of devices for use in a pediatric population. Special effort should be made to promote the design of devices dedicated for use in the pediatric population.
- The 510 (k) Process. While industry representatives say the FDA’s 510 (k) approval process clears most medical devices for the pediatric population as safe, they note costly data requirements. “There needs to be an important balance between safety and timely innovation and regulation,” Drs. Kim and Eskandanian wrote.
- International Perspective. The uncertainties in the FDA regulatory approval process prompt innovators and investors to shift investment overseas, Drs. Kim and Eskandanian wrote. It generally takes about one to three years longer to launch new medical devices into market in the U.S., compared to the European Union. The Children’s National officials note that the International Medical Device Regulators Forum (IMDRF) is working toward a harmonized regulatory strategy that would be most attractive to investors, particularly related to funding strategies.
Contact: Joe Cantlupe or Leah Parker at 202-476-4500.
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