Pediatric Device Task Force Update

Patrick J. Cahill, MD
Pediatric Device Task Force Chair

The joint SRS/POSNA Pediatric Device Task Force have several updates. Our main activity is to interface with regulatory bodies with the goal of improving access to new technology and innovations for our pediatric patients. Great progress has been made in this regard.

• First, we have lobbied the OrthoPAC, the lobbying entity of the AAOS, to adopt the cause of advocating for changes to FDA policies to lower the burden on innovators (industry and surgeons), to the adoption of new devices.
  • In order to get this support, we successfully received approval from the following AAOS bodies:
    • AAOS Office of Government Affairs
    • The AAOS Board of Subspecialties
    • The AAOS Advocacy Committee
  • We now have the resources of the AAOS’ lobbying machine behind our efforts. AAOS lobbyist Jordan Vivian is the point person in Washington leading these efforts. His counterpart with the AAOS staff is Brandy Keys
  • We are actively developing a time line for our legislative action efforts within the next 6 weeks.
  • We have initiated conversations with other entities with lobbying resources to partner in our efforts. These include: NeruoPAC (the PAC of the AANS), CureSMA, AAP, and ADVAMED. Leadership of the FDA are also aware of our efforts although not formally allowed to participate in them.
  • Participation of membership of both societies will be crucial to the efforts. Members can help by recruiting families of patients who have benefitted from recently approved devices who would be willing to share their stories publicly or even in person with congress members and their staff. Pediatric specific devices include: Magec Rods, vertebral tethers, Shilla rods, etc. Stories can be sent to Jordan Vivian at [email protected]. Please include a brief (~3 sentence summary of the patient story and the patient address {necessary for identifying appropriate elected representative}).
• The FDA continues to try to find new ways of improving access to device innovation. Their latest effort is entitled the System of Hospitals for Innovation in Pediatric Medical Devices (SHIP-MD) Program. This program will provide infrastructure for collaboration on FDA device trials across 5 or 6 pediatric hospitals. It has been in development for the past year and a half. It was publicly unveiled and discussed with a 3 day virtual public meeting on February 9-11. Recordings are available.
• Additionally, members of the group continue to build strong relationships with the FDA.
  • Several members of the SRS participated in the FDA’s annual symposium on clinical registries. Not only does this activity build relationships but positions pediatric spine well within AAOS to receive support for a subspecialty registry.
• The Task Force was approached by the AAOS and AAP to support increased funding for the Pediatric Device Consortia. Adopting this effort is under consideration by SRS leadership.
• The Task Force has developed a position statement in favor of payors supporting reimbursement for vertebral tether. This statement has been adopted by both POSNA and SRS. Special thanks to Dr. Noelle Larson and Michael Vitale in their efforts with this document.
• We have developed panels of experts in the various sub-sub-specialties of pediatric orthopedics to assist the FDA in evaluation of applications for new devices. These sub-subspecialties include: pediatric orthopedic oncology, pediatric hand surgery, pediatric orthopedic trauma, pediatric sports medicine, pediatric limb deformity, and pediatric spine. Thank you to all who have agreed to participate on these standing bodies.
• Planning is underway for the 8^th Annual Kids’ Forum in conjunction with the Annual meeting of the AAOS. This forum will occur September 3^rd, 2021 in San Diego, CA at 3 PM. This meeting is an opportunity to bring together leadership from industry, the FDA, and academia to discuss hurdles to and brainstorm solutions for access to pediatric devices. Mark your calendars.

 

Chair: Patrick J. Cahill Committee: Behrooz A. Akbarnia; Laurel C. Blakemore; Moyo Kruyt; Richard E. McCarthy; Colin Nnadi; Peter O. Newton; David W. Polly, Jr.; James O. Sanders; Brian D. Snyder; Paul D. Sponseller; Ronald Tangente; Michael G. Vitale