Medical devices for children tend to have small markets, so development can lag up to a decade behind similar devices for adults. The Boston Pediatric Device Consortium (BPDC), formed through an FDA initiative, aims to change that math.
This month, the BPDC and the Innovation and Digital Health Accelerator at Boston Children’s Hospital announced five winners of a national pediatric device challenge. Each winner will receive a combination of up to $50,000 in funding per grant award and/or in-kind support from leading medical device strategic partners, including Boston Scientific, CryoLife, Edwards Lifesciences, Health Advances, Johnson & Johnson Innovation, Medtronic, Smithwise, Ximedica and the Boston Children’s Simulator Program. These organizations will provide mentorship, product manufacturing and design services, simulation testing, business plan development, partnering opportunities and more.
“We have a major unmet need for pediatric medical devices that are specifically designed to address the demands of a growing, active child,” said BPDC leader Pedro del Nido, MD, chief of Cardiac Surgery at Boston Children’s, in a press release. “We are pleased to support these teams as they work toward accelerating their technologies from concept to market.”
The five Challenge winners are:
A smart urinary sphincter
Nivedita Dhar, MD, a urologist at Wayne State University (Detroit, MI), and Bert Müller PhD, Bekim Osmani PhD, Tino Töpper PhD, engineers at the University of Basel (Switzerland), received an award for a Smart Artificial Urinary Sphincter to treat stress urinary incontinence. Urinary continence is a rapid, dynamic response to sudden pressure changes caused by actions such as coughing. The device uses sensory feedback to mimic the natural response, minimizing urethral damage and associated complications. The only approved artificial urinary sphincter, not designed for children, requires eventual re-operations in up to 55 percent of children. The new device is designed to self-adjust as a child grows, but could also be used in adults.
Fast, intelligent needle delivery
Andrew Cothrel of Xact Medical (Springboro, OH), was awarded for the Fast Intelligent Needle Delivery (FIND) system, a robotic, hand-held tool to facilitate placement of central venous lines for long-term patient monitoring, medication delivery and other needs. Designed for clinicians of all levels of experience, it uses ultrasound and algorithms to plot a 3D needle path and integrated robotics to automatically and safely guide the access needle. At right, an early proof-of-concept prototype.
An expandable cardiovascular graft
Andrea Martin, PhD, Doug Bernstein and Arush Kalra, MBBS, MS of PECA Labs, a spinoff of Carnegie Mellon University and the University of Pittsburgh, were awarded for an expandable cardiovascular conduit — a graft that can grow to keep pace with a child’s growth, reducing the need for repeat open-heart operations. It can be expanded with a standard angioplasty balloon.
Nitric oxide at the bedside
David Zapol of Third Pole Therapeutics (San Francisco and Arlington, MA) was awarded for a nitric oxide generator and therapy delivery system to help treat severe persistent pulmonary hypertension in newborns. Nitric oxide dilates the arteries, allowing oxygen into the blood. The technology was featured in Science Translational Medicine in 2015.
Assessing heart-valve repairs
David Hoganson, MD, of Boston Children’s Hospital, received support for an array of sensors, placed through repaired heart valves, that would allow cardiac surgeons to gauge success of the repair. Currently, there is no quantitative way to evaluate heart valves. Valves function by coaptation — two valve leaflets pressing together. Hoganson’s mapping device measures the length over which the leaflets touch, or coaptation height, an essential predictor of how well the valve will work long-term and its likelihood of leaking.
The Challenge was funded in part by the FDA Office of Orphan Products Development.