FDA Grants $1.5M to Pediatric Medical Device Consortium at California Children’s Hospital

The U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development has awarded a grant of up to $1.5 million over five years to the Southern California Center of Technology and Innovation in Pediatrics (CTIP), a consortium established by Children’s Hospital Los Angeles and the University of Southern California (USC) for the development of pediatric medical devices. The grant recognizes CTIP as a center of excellence for the development and commercialization of pediatric medical devices within the Southern California community.

According to CTIP Co-Director Dr. Yaniv Bar-Cohen, the program provides comprehensive guidance and resources to accelerate the commercialization of pediatric innovations by facilitating product development that may not otherwise be readily available.

“Being recognized as the focal point for pediatric innovation in Southern California allows us to provide a home for those in pediatric healthcare who need a place to move their ideas forward,” said Bar-Cohen, who also is the director of Cardiac Rhythm Devices at Children’s Hospital Los Angeles and associate professor of Pediatrics at the Keck School of Medicine of USC.

CTIP currently oversees dozens of projects, including a fetal pacemaker, ultrasound-activated nanoparticles for non-invasive imaging, and a redesign of ill-fitting adult ventilation masks for use by children. From concept to commercialization, CTIP provides guidance on issues related to intellectual property, prototyping, engineering, testing, grant writing and clinical trial design to aspiring device developers throughout Southern California.

The CTIP consortium also addresses an important component missing from pediatric device commercialization: the simultaneous engagement of clinicians, engineers, hospital administrators, patients, regulators and manufacturers to assess and develop new technologies tailored to the needs of children.

According to CTIP Co-Director Jessica Rousset, innovation in pediatrics — specifically as it relates to device and technology development — has long been recognized as an area with significant obstacles. This is due to the sometimes small patient populations that can benefit from individual innovations as well as a general focus on adult healthcare in commercialization efforts.

“Despite barriers to commercialization, pediatric medical device development is also an area of immense opportunity, both in the potential to help a large number of children with common and rare diseases, and in the ability to broaden the applications of pediatric products to the adult healthcare world,” added Rousset, who also is director of the Office of Technology Transfer at Children’s Hospital Los Angeles. “We are eager to support clinicians and device developers throughout Southern California who seek to commercialize novel pediatric medical devices.”

CTIP will work closely with other medical centers and leading academic institutions in Southern California to encourage pediatric device development throughout the region. Each year CTIP issues a “call for unmet needs” to clinicians in order to enrich and sustain this needs-driven pipeline of novel pediatric medical devices which it will extend to other medical centers in the region.

As the only pediatric medical device consortium in the western United States that was chosen for FDA funding, CTIP has an opportunity for outreach over a large geographic region. Additionally, CTIP will collaborate with the six other FDA-funded pediatric medical device consortia across the nation to develop strategies for improving pediatric innovation and overcoming obstacles to successful implementation. These consortia will work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations and agency guidelines to protect the health and safety of children.

“We are pleased by the FDA’s support of this critical area of innovation for unmet medical needs in pediatrics,” said Brent Polk, M.D., chief of Pediatrics at USC and director of The Saban Research Institute of Children’s Hospital Los Angeles. “As we work to reshape the future of child health, the ability to deliver cutting edge technology to the treatment of the most vulnerable in our society will be an important deliverable from this program.”