(Sack B, . . ., and Koh CJ. Pediatric medical device development by surgeons via capstone engineering design programs. J Ped Surgery, 2017)
The FDA has determined that a great need currently exists for novel medical devices that are designed specifically for children, as well as for the adaptation and validation of existing adult devices for children. This gap is most likely a result of economic, clinical, and regulatory challenges, as well as a lack of established mechanisms for joining pediatric device ideas with qualified individuals / programs and industry partners.
The Texas Pediatric Device Consortium (Texas PDC) began as an affiliated program of the Southern California Center for Technology and Innovation in Pediatrics (CTIP), which was formed in Los Angeles, CA in 2011 and which expanded to Houston, Texas in 2013. The Texas PDC now serves as a pediatric medical device consortium that includes Texas Children’s Hospital, Baylor College of Medicine, Rice University, Texas A&M University, Fannin Innovation Studios, Texas Medical Center, and local partners in the greater Houston area. The Texas PDC is dedicated to improving children’s health by supporting the development of innovative pediatric medical devices through all of the necessary stages - concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization.
CTIP is currently supported by a P50 Pediatric Medical Device Consortia grant (P50 FD004896)
from the FDA Office of Orphan Product Development.
Information on the FDA funded pediatric device consortia can be found at the AAP SOATT newsletter home page:
VaxImmune - www.vaximmune.com
Noninvasix - www.noninvasix.com
Polyvascular - www.tmc.edu/innovation/companies/polyvascular/
Current device projects:
Magnetic Stent Removal Apparatus and Methods (SBIR Phase I funding - NIDDK - R43DK115336)
Medical Device for Anchoring a Placental Membrane to a Uterine Wall (SBIR Phase I funding - NICHD - R43HD094456)