Pediatric medical devices are critical for proper medical care of children.
The connection between innovation and realization of pediatric medical devices is a challenging one as there are market size and budgetary constraints. Information, collaboration, and realizing one’s resources are key in successful development of pediatric medical devices.
Development and approval of pediatric medical devices poses hurdles not seen with devices meant for adult patients. The fundamental hurdle to getting these products to market is the cost to develop devices for children is high while the market is relatively small. Less than 12% of the NIH’s budget funds pediatric research and less than 10% of healthcare spending is for pediatrics.
Over the past dozen or so years, the FDA Center for Devices and Radiological Health (CDRH) has developed programs to accelerate innovations in pediatric medical devices, but the development has not taken off as hoped. Premarket approvals labeled for adults has increased approximately twice the rate of devices labeled for adult & pediatric use and more than 20% more than the rate of devices labeled only for pediatric use.
Often doctors, nurses and other medical professionals must resort to retrofitting medical devices designed for adults to use in their pediatric patients. In other cases, outdated devices are used; in both retrofitted and outdated devices, less than optimal outcomes have occurred for the pediatric patient. Off-label use of FDA-approved devices for adults on pediatric patients is a practice which exposes risks since clinical safety and efficacy data is largely absent. An approach which could help gain FDA-approval for pediatric medical device use is the use of adaptive platform clinical trials. Adaptive platform clinical trials allow the flexibility to adapt key study design features during the study. These trials may require fewer participants and make better use of time and funds.
In an attempt to address the difficulties facing development of pediatric medical devices, partnerships have developed between device manufacturers, pediatric healthcare providers and research institutions. For example, Purdue, the Indiana University School of Medicine and Cook, Inc. have partnered (the Crossroads Pediatric Consortium). The Consortium’s aim is to focus on finding ways to accelerate the “development, approval and availability of medical devices for children”. Their mantra is: “Infants and children are not scaled-down versions of adults”.
Another partnership, the Pediatric Device Innovation Consortium (PDIC), consists of the University of Minnesota’s Clinical and Translational Science Institute, University of Minnesota, Bakken Medical Devices Center and DesignWise Medical. This consortium has been involved in twenty-two (22) pediatric medical device projects and licensed and advanced technologies for patient use. Their model for a collaborative approach in developing pediatric medical devices is comprised of academic innovation centers with commercial engineering and product development teams and funding partners.