Devices & Diagnostics, Hospitals, Startups

One year later, Philly pediatric medical device consortium shows progress of FDA program

This is the first of a two part series on the Pediatric Medical Device Consortia […]

This is the first of a two part series on the Pediatric Medical Device Consortia

It’s been about a little more than one year since the Philadelphia Pediatric Medical Device Consortium got started. In a recent interview with Matthew Maltese, the executive director and principal investigator of the group and Director of Biomechanics Research for Anesthesiology and Critical Care Medicine at the Children’s Hospital of Philadelphia, he talked about its members’ ambition to make Philadelphia the center of pediatric medical device development in the U.S similar to the medical device corridors in the Midwest.

“There really isn’t a home for pediatric medical device development in the U.S.,” Maltese said. “In Philadelphia there is citywide innovation.” He notes that the consortium is more than CHOP, University of Pennsylvania and Drexel University. It also involves professionals from Temple University and Jefferson and spans disciplines across engineering, medicine, business and investors.

As an example of the group’s growth, its goal to review 15 project proposals has surged to more than 30. The vast majority of the Philadelphia chapter’s collaborators are individuals or small businesses with under 50 people. A clinical and scientific advisory committee evaluates whether a device fills an unmet need. An oversight committee with experience bringing pediatric devices to market offers clinical and funding insights and guidance. It includes representatives from BioAdvance, Ben Franklin Technology Partners, Rosewood Capital, the University City Science Center, and Jefferson Health System.

Maltese talked about a couple of the projects that it greenlighted. The furthest along is the development of a device to clear clogged feeding tubes with Actuated Medical. The Central Pennsylvania business developed a faster way to clear feeding and decompression tubes without disconnecting patients fro them. Its Tube Clear system for adults initially received FDA clearance  in 2012 and got the green light for additional indications last year. Now its adapting the device for children and it’s poised to begin clinical trials.

The geography-agnostic program has led to a collaboration with the University of Galway on a solution to mitigate urinary tract reflux. It’s a common condition for hospitalized children and the current standard of care involves radiation intervention. An alternative treatment that could increase patient safety and lower costs and mean less time in the hospital would be a welcome development.

CHOP is also working with some companies to develop pediatric versions of FDA-approved CPR quality feedback tools developed for adults. The smartphone-sized devices are designed to measure motion and force on a patient’s chest during CPR to rapidly produce sound and visual prompts that improve the quality of CPR.

Next year there are plans to host a pediatric hackathon at CHOP and will get help from Boston Children’s Hospital, which has hosted hacking pediatric events.

The Philadelphia group got its $1.5 million, five-year grant from the FDA grant program that was signed into law seven years ago. The consortium evolved from an initiative to improve pediatric medication labeling. There are a lot of unmet needs when it comes to devices that are used to treat sick children. It’s a group that tends to be overlooked by medical device manufacturers because it simply isn’t commercially viable enough compared with the adult market. The complexities of testing devices on children is another factor.  Nine groups participate in the consortium and the FDA provided funding to seven of them in the most recent round last year.

One aspect of the PMDC that is particularly striking for a government program is the amount of flexibility built into it to allow each group to take its own approach to use their resources and advertise RFPs to help advance ideas from the napkin to the proof of concept stage. Each consortium takes a different approach, according to Linda Ulrich who manages the FDA program, which sits in the Office of Orphan Products Development.

One group has a monthly forum similar to what you might expect from a typical grand rounds seminar. Another uses an open competition to get RFP applications and has a panel of people who decide how to move forward. Another meets twice each week to discuss projects. National Capital Consortium for Pediatric Device Innovation in Washington, D.C. focuses on surgical devices. Richard Greenwald, the co-director of the New England chapter, is unique among the other consortia groups in that he is the president and founder of medical device company, Simbex. Ann-Christine Duhaime, the director of pediatric neurosurgery at Massachusetts General, is also a co-director.

Issues like intellectual property and duplication can get pretty sticky so members of the consortia have had to work hard to ensure they don’t step on each others’ toes. If the IP  isn’t clear, it can turn off investors. Duplication or overlap is also a particular concern because resources are limited and the intent is to target unmet needs. That makes communication and transparency between the consortia members paramount.

The consortium groups meet quarterly but have a lot of contact with each other outside of those meetings. “Sometimes we find a device that is geographically much closer to [another consortium] and ask them if they would prefer to take the lead,” Maltese said.

Although the grant money isn’t huge, it is meant to provide a launchpad for pediatric device ideas and the consortia members have to be shrewd about how they spend it. “Looking for handouts won’t make a real impact,” a member of one consortium said. “But having sustainable business models will.”

With so many consortia groups with a shared mission, members are excited by the possibilities of using their network for multisite clinical trials, although that’s still a ways off.

These groups are positioned to spur new developments among medical entrepreneurs in their respective communities. In phone conversations with representatives from a few of the groups around the U.S., it’s fascinating to hear how their ingenuity and collaborative spirit is spilling into the wider healthcare communities. In the second part of this feature, I’ll highlight some of the projects other consortia members are developing, along with the perspective of some of the consortia’s older groups.

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