Pediatric Medical Device Competition Helps Turn Ideas into a Clinical Reality

Posted November 24, 2015

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is accepting proposals for medical innovations that address a significant, yet unmet pediatric need as part of its device innovation competition. Five winners will be selected to receive $50,000 to help bring their device to market.

“Now in our consortium’s third year, we’ve seen some impactful innovations advance to the clinical stage as a result of this competition, and we’re hopeful that trend will continue,” said Kolaleh Eskandanian, PhD, executive director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center in Washington, DC, which helps lead the NCC-PDI.

One of these impactful innovations was a noninvasive intracranial pressure meter developed by Vittamed, a start-up company located just outside of Boston, MA. This device, which utilizes ultrasound technology, was originally developed for adults, but there was a clinical need for pediatric patients. Current methods for monitoring intracranial pressure in kids with traumatic brain injuries or hydrocephalus require drilling a hole in the skull to insert a catheter into the brain.

Remis Bistras, PhD, president and CEO of Vittamed, submitted a proposal to the 2014 competition to modify the device for children and was selected for funding. “Thanks to the grant we received, we were able to develop a head frame for the pediatric population,” Bistras said, as he was exhibiting the technology at the largest medical device trade show in the world.

But the benefits of participating in the competition went far beyond the money. “If you start small, the seed grant can go a long way toward developing a commercially viable device, but you get support other than money,” Bistras said. “By working with the NCC-PDI, which is funded by the FDA, you get advice about the regulatory pathway. They also can connect you to a network of physicians, which is extremely valuable for a start-up company.”

Vittamed recently secured $10 million in series A financing to support the launch of its intracranial pressure meter in European nations, Australia, and other countries; a 510k submission to the FDA; and commercialization in the United States. The company is also collaborating with clinicians from the Children’s National Health System on a clinical trial that is expected to begin early next year.

“A non-invasive means of measuring intracranial pressure will represent a quantum leap forward in the care of children. We look forward to validating this metric during our collaboration with Vittamed,” said Robert Keating, MD, chief of neurosurgery at Children’s National Health System.

Engineers, researchers, entrepreneurs, clinicians, and other innovators who have a pediatric device idea that lends itself to commercialization are invited to participate in the NCC-PDI’s third-annual competition. Written proposals must be submitted by Dec. 30. For more information about the competition and proposal requirements, visit the NCC-PDI’s website.