Another non-profit looks to develop pediatric medical devices

By Mary Vanac

CLEVELAND, Ohio — Tim Moran remembers hearing his prematurely born daughter scream in pain when the only available, excessively large airway mask was strapped to her head.

Years later, Moran, a medical device inventor who has helped commercialize and raise money for others’ devices, started PediaWorks, a not-for-profit organization that will work with medical professionals to develop pediatric medical devices, spinning off for-profit companies to commercialize those devices.

“This is something that’s geared to the common good of pediatrics,” Moran said. “It’s a great mission that I’d like to see everybody in the medical device community get involved in.”

In this age of technological plenty, health care still needs pediatric medical devices in multiple specialties. Lacking devices made just for children, doctors modify adult devices, sometimes causing their tiny patients discomfort, pain or injury. Other times, the modified devices — most often used “off label” or for uses unapproved by regulators — fail to work properly. Some patients must wait for procedures or treatments until they have grown big enough to accept them.

Most for-profit corporations are unwilling to invest in developing pediatric devices because they see small market potential, insufficient insurance reimbursement, difficulties in getting clinical data for Food & Drug Administration approval and looming legal liabilities, said Steve Girouard, senior director of emerging technologies for Johnson & Johnson (NYSE:JNJ), who has also worked for Guidant Corp. and the Cleveland Clinic.

“It’s do-able,” Girouard said of PediaWorks. “The hardest part is getting the capitalistic forces, and the philanthropic and altruistic forces behind it. But I think there’s a path here.”

Moran formed PediaWorks late last year as a nonprofit organization so it could accept philanthropic money from big medical device makers and foundations. He plans to use the organization to gather ideas and develop devices, then create small, for-profit businesses to commercialize the products. The small businesses would have access to federal Small Business Innovation Research grants.

So far, though, the organization is short on cash — it’s raised just $30,000 through a grant from Cleveland’s Civic Innovation Lab, as well as support through the local trade group BioEnterprise. It’s relying on an extensive network of pediatric surgeons and specialists to supply the ideas, professionals at large device manufacturers who might allow their adult-sized products to be re-engineered for kids and engineering professionals to redesign the products or come up with new ones.

Moran is the only employee of PediaWorks, but Bob Johnson, leader of the medical devices team at BioEnterprise, and Dr. Fahd Khan, a senior neurosurgery resident at Case Western Reserve University and University Hospitals Case Medical Center, as well as a biomedical innovation fellow at the Case Department of Biomedical Engineering, also lend a hand.

Moran has tapped into the Congenital Cardiovascular Interventional Study Consortium, a group of international cardiologists who share information about pediatric products, procedures and outcomes. He’s also working with UH Rainbow Babies & Children’s Hospital in Cleveland, Cleveland Clinic Children’s Hospital and Lucile Packard Children’s Hospital at Stanford to identify unmet device needs. He works with the University of California, San Francisco and Stanford Research Institute to design, engineer and prototype the devices.

PediaWorks and its collaborators are working on four products:

1. A series of cardiac catheters designed for the size and anatomy of the pediatric heart (CCISC and the Clinic Children’s Hospital);
   
2. A simple device that would reduce the time it takes to remove a pediatric brain tumor to less than five minutes from 30 minutes, while also dramatically reducing brain trauma (UH Rainbow);
   
3. A portable, low-cost way to ensure clinicians can place endotracheal tubes as quickly and safely as possible (Case biomedical engineering students);
   
4. A method and device to verify central vein catheter placement without the need for X-rays (UH Rainbow).

The Center for Clinical Research and Technology at University Hospitals Case Medical Center is “very much behind the effort,” said Stephen Behm, the research center’s director of technology management. The center is providing access to UH clinicians and is working with PediaWorks to identify marketplace needs, Behm said.

In the future, the center expects to help PediaWorks design and conduct clinical trials and help commercialize its products, he said.

Moran is already talking with contract manufacturers who could make the devices.

“My goal for the organization is not to do any direct manufacturing,” he said, but to build a large enough product design portfolio and sales and marketing operation to make the organization and its spin-off companies sustainable.

Moran picked up the pediatric medical device thread more than a year ago. Previously, he founded, managed and raised a round of venture financing for CSF Therapeutics, a developer of devices to treat neurodegenerative diseases and a spin-off company from the Cleveland Clinic.

He also managed a financing round for Intelect Medical, another Clinic spin-off, and guided the market launch of Minimally Invasive Devices in Columbus. He’s also a co-inventor of PCT/US2008/012355 — a device for increasing blood flow to the brain.

PediaWorks is one of a few recent efforts to fill the need for children’s medical devices. Acknowledging the problem, the FDA in 2007 announced a $2 million annual grant program to stimulate the development and marketing of medical devices for children. Late last year, the regulator made its first grants to pediatric medical device consortia in Ann Arbor, Mich., Boston and San Francisco.

Mechanical engineer Brad Slaker started DesignWise Medical in Minneapolis around the same time to do similar things, using mostly volunteer medical and industrial professionals and college students.

In 2007, the Institute for Pediatric Innovation in Cambridge, Mass., formed as a nonprofit to focus on improving health care for children. The institute soon put together a consortium of pediatric hospitals, including UH Rainbow, to help with its mission.

Girouard said the nonprofit aspect of PediaWorks invites product collaboration by big device makers. “I think there is potentially a willingness among the big medical device companies to provide access to technology and freedom to operate if there’s not a competitive threat.”

Products designed for pediatric markets eventually could cross over to minimally invasive surgery markets for adults. “If you design for pediatrics, you are inherently making smaller devices,” which could be used in adult microsurgery, Moran said. There’s a “sizable market share there.”

Ohio already has some natural synergies to help grow a pediatrics medical device practice. Well-regarded hospitals including Akron Children’s Hospital Medical Center, Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital in Columbus, as well as Rainbow and Cleveland Clinic, all could contribute to such an effort. Plus, Cleveland has increasingly strong ties to OrthoPediatrics, an Indiana company that develops implants and therapies for children.

Girouard also said Cleveland is as likely a place as Minneapolis, a medical device powerhouse, to make devices for children or adults. “I think it may be a way that we can distinguish [Cleveland], grow a budding little device manufacturing core,” he said.

Chris Seper contributed to this report.