After seeing hundreds of infants undergo open-chest surgery, Dr. Charles Berul knew there had to be a better way to put in pacemakers and defibrillators in babies.
Berul and his team have spent the past three years developing a solution: a surgical tool that can help doctors access the heart with a hole slightly larger than a needle. The entire procedure can be completed in minutes and requires little recovery time.
Finding funding, however, has been a challenge for Berul, co-director of the heart institute at Children’s National Health System.
The market for child-specific devices tends to be small — and therefore not very profitable — meaning manufacturers tend to focus on innovations with more profitable potential.
To help fill that gap, District-based Children’s National has begun hosting annual pitch competitions to find and fund promising pediatric devices. The program is one of eight around the country that receives funding from the Food and Drug Administration.
This week, four teams, including Berul’s, received a $50,000 grant from the National Capital Consortium for Pediatric Device Innovation. The consortium, which also awarded two $25,000 grants, is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National and the A. James Clark School of Engineering at the University of Maryland.
The program, in its third year, is one of the few sources of funding for pediatric projects, according to hospital executives.
“The fact is that there are simply not enough incentives to make devices for children, neither in terms of carrots or sticks,” said Kolaleh Eskandanian, executive director of the Sheikh Zayed Institute. “Because of the lack of options, clinicians are often forced to use an adult device improvised on the fly for children. That’s not ideal.”
On Monday afternoon, a dozen teams from around the world gathered in a conference room at Children’s National to compete for one of six grants. The finalists presented five-minute pitches, then took questions from a panel of judges that included a biomedical engineer, pediatric urologist and early-stage venture capitalist.
The winning devices included a socket-liner to make prosthetics more comfortable for growing children (created by Benevolent Technologies for Health in Woburn, Mass.) and a battery-operated device that uses vibrations to stimulate breathing for babies with breathing issues (by Sensory Innovations Solutions in Riverside, Calif.).
In addition to providing much-needed funding, the grants also have another benefit, Eskandanian says: They serve as endorsement to help the projects raise additional money from other sources.
“Funders, whether they are venture capitalists or government-sponsored, look very carefully at who else has validated the idea,” said Eskandanian, who heads the consortium.
Since 2013, the consortium’s 51 grant-winners have raised an additional $19 million in capital. Previous years’ winners include Velano Vascular, which earlier this year received regulatory clearance for its needle-free blood-draw device, and Vittamed, which recently snagged $10 million in venture capital for a device that uses ultrasound technology to monitor children with traumatic brain injuries. (The current procedure requires drilling a hole in the skull and inserting a catheter into the brain.)
For Berul’s team, the $50,000 will help cover patent fees and fund longer-term animal studies in piglets, which tend to be the size of newborn humans and have similar-size hearts.
Berul said he hopes to begin clinical trials in children next year. From there, it will take another few years — and more funding — to get the product to market.
“Companies realize their adult-sized products are suboptimal for kids,” Berul said. “But because of the financials, you have to make a more convincing market case.”