Winners of Pediatric Device Competition Show Progress

The National Capital Consortium for Pediatric Device Innovation is now accepting proposals for medical innovations that address a significant, yet unmet pediatric need. Five prizes of $50,000 each will be awarded to the winning presentations at the consortium’s third annual competition in February 2016.

IDDM asked Kolaleh Eskandanian, executive director for the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and the NCC-PDI, about the competition.

IDDM: What company has made the most progress since the inception of the NCC-PDI competition?

Eskandanian: We have conducted two pediatric device innovation competitions and already seen some impactful innovations advance to the clinical stage.

I can confidently say that all companies we have selected have demonstrated significant progress to date. One of the companies is Vittamed, who came to us in 2014 with an idea to modify the company’s noninvasive intracranial pressure meter for pediatric use. The device, which had received the CE mark in the EU, was developed for patients 18 years and older. There was an unmet clinical need for younger pediatric patients, because current methods for monitoring intracranial pressure in children with traumatic brain injuries, such as hydrocephalus, require drilling a hole in the skull to insert a catheter into the brain. Vittamed received $50,000 from NCC-PDI in 2014, allowing the company to develop a head frame for the pediatric population. NCC-PDI also opened up its network of clinicians, engineers, business and regulatory experts to the company. Neurosurgeons at Children’s National Health System showed a high level of enthusiasm for the device, and now Vittamed is collaborating with the hospital on a clinical trial that is expected to begin early next year.

Recently, the company also secured $10 million in Series A financing to support the launch of its product in Europe, Australia and other countries, a 510k submission and commercialization in the U.S.

IDDM: Is there an area that has a big unmet need that hasn’t been addressed by participants in the competition?

Eskandanian: Unmet pediatric device needs exist across all disease areas and specialties. To understand where the “big” unmet needs are, the FDA and NIH are leading a project on needs assessment for medical devices for rare diseases. In 2010 the Institute of Medicine Rare Diseases and Orphan Products Report recommended that FDA and NIH assess unmet device needs and priorities relevant to rare diseases. The pediatric population is a very important focus of the FDA’s needs assessment project.

IDDM: Over the last year, has there been progress within the FDA to get pediatric devices to market?

Eskandanian: The FDA-funded Pediatric Device Consortia are the conduit for pediatric device developers to work with the agency. Through the PDCs, we have seen great progress in getting pediatric devices closer to market. Specifically, in 2015 through the help of the PDCs a good number of supported companies were able to receive 510(k) clearance.

In 2015 the FDA released draft guidance on “leveraging existing clinical data for extrapolation to pediatric uses of medical devices,” which could be good news for device developers and regulators. This document outlines a framework for device developers to demonstrate that their devices are safe for use in pediatric populations. In many cases, if a device is safe and effective in adults, it may be safe and effective in children. Leveraging relevant available clinical data may lead to more devices being approved for pediatric use and address the challenge associated with extensive off-label use of adult devices in children.