Devices & Diagnostics

Pediatric device consortia wants to close the supply-demand gap

The Pediatric Device Consortia Grant Program encourages inventors to think small, developing much-needed pediatric devices that may not make a lot of money.

Bridging the Gap Medigap bridge money

Pediatric care has a fundamental problem: adult devices don’t always work in children and pediatric devices don’t always exist. In some cases, providers must rig solutions on the fly to make adult equipment work in smaller bodies. That’s the issue the Food and Drug Administration’s Pediatric Device Consortia Grant Program is trying to address.

“Most of the time children receive dumbed-down versions of adult medical devices,” said Wilbur Lam, bioengineer, pediatric oncologist and director at the Atlantic Pediatric Device Consortium (PDC), in a phone interview. “The surgeon will cut off a piece so it fits kids. We know that’s not ideal, but the medical device community is not incentivized to develop products for children because the population is so small.”

Initiated by the Pediatric Medical Device Safety and Improvement Act of 2007, the program encourages inventors to think small, developing much-needed pediatric devices that may not make a lot of money. To some degree, PDCs are trying to reverse market forces.

“The PDC program has shined a bright light on a big disconnect in our society,” said Matthew Maltese, executive director and principal investigator at the Philadelphia Pediatric Medical Device Consortium in a phone interview. “If you asked a parent: ‘Would you develop a device that saved your child or saved your parent?’ I defy you to find anyone who would choose the parent. The economic incentives get in the way.”

While the dollar amounts are small – the program awarded $3 million through eight consortia in fiscal 2016 – PDCs contribute many layers of support to help inventors succeed. They recognize that engineers, physicians and other innovators may be strong on science but weak on business.

“We serve as guides,” Lam said. “We help them at every step: from the idea to prototype development to initial testing; doing full-on clinical studies, and then helping them through the regulatory pathway and hooking them up with investors and larger companies that we hope will license their technology.”

The devices meet a variety of needs, such as mitigating the pain and fear that makes children dread the doctor’s office. Buzzy is a bumble bee-shaped cold pack and vibrator that came out of the Atlantic PDC and decreases pain from needle sticks.

Some devices are more high-tech. A tiny heart valve is being developed by St. Jude Medical with support from the Boston consortium. Others simplify care and reduce costs, such as an incubator supported by the National Capital Consortium that can be used virtually anywhere.

“The cardboard incubator is one example of bringing state-of-the-art care to low-resource settings,” said Govind Rao professor of chemical and biochemical engineering and director of the Center for Advanced Sensor Technology at the University of Maryland Baltimore County via email. “The device will potentially lead to millions of lives being saved.”

The consortia have also helped create R&D networks, collaborating with multiple organizations to pool resources and expertise. The Philadelphia consortium teamed up with the Childress Institute for Pediatric Trauma. They recently awarded a $50,000 grant to 410 Medical, which is developing a rapid blood delivery system for children experiencing sepsis or trauma.

“We both had an interested in helping kids,” Maltese said. “They were interested in research on trauma. We were interested in devices for kids. So we joined forces to do something for devices for kids for trauma.”

According to a 2016 FDA review, the consortia have actively supported 148 projects since 2013, and five products have been approved. Many of these projects might never have gotten out of the lab, given their low potential ROI. In some cases, PDC endorsement has led to increased interest from private investors.

“What’s unusual here is that a regulatory body has recognized a problem and figured out a way to address that problem,” said Pedro del Nido, principal investigator at the Boston PDC and chief of cardiac surgery at Boston Children’s Hospital in a phone interview. “We jump on the FDA for a lot of things, but this is something we should be touting.”

Photo: BigStock

 

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