Pediatric Medical Device Consortia: A Novel Pathway for Pediatric Device Development for Pediatric Urologists and Other Pediatric Specialists

Introduction: A great need currently exists for medical devices designed specifically 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. We describe our experience with forming a pediatric medical device consortium that originated from the pediatric urology division and the technology transfer office of a university affiliated children's hospital.

Methods: We reviewed the developmental history of a pediatric medical device consortium at a university affiliated children's hospital from March 2011 to June 2013 with emphasis on the organizational aspects of the consortium.

Results: A pediatric medical device consortium was formed with the assistance of university seed funding to encourage faculty collaboration across multiple campuses. The consortium continued its progress as a resource for pediatric device projects to become a Food and Drug Administration supported pediatric device consortium in 2013. This allows the consortium to expand its activities through the P50 PDC Grant Program.

Conclusions: Pediatric urologists can have a major role in organizing pediatric device consortia. Consortia can combine academic centers with the local business, investment, higher education and philanthropic communities to rapidly advance pediatric medical device projects. Novel approaches are necessary for pediatric device projects to overcome current barriers to commercialization, including an extended stay in the academic setting.