“Innovation plays an integral role when it comes to conduct in pediatric device trials. There are alternative methods to trials, such as data extrapolation from adult studies. If we can be well informed when mining that data, we shouldn’t put kids at risk and delay time to market.” A randomized clinical trial would be unethical if it involved using a medical device that a patient doesn’t need, she added. “It is a very different paradigm than that used for drugs.” She said that companies can also take advantage of solutions in FDA’s toolbox.

“Congratulations to these outstanding innovators and startup companies for developing pioneering medical devices that can advance NICU care,” says Kurt Newman, M.D., president and CEO of Children’s National Hospital.

Kolaleh Eskandanian, PhD, is the vice president and chief innovation officer of Children's National Health System in Washington, D.C.

Here, Dr. Eskandanian outlines the big cybersecurity challenges and how she expects her role as the chief innovation officer at Children's National to evolve over the next few years.

While medical device innovation is quite active—at the university level, within incubators, and even in the R&D labs of established firms—there is a substantial lack of products being developed for younger patients. Since pediatric devices have a limited patient base due to most children being relatively healthy (of course, a positive factor), it’s not a focus for a great number of companies as it does not offer the promise of a substantial financial return.