Starring Role for Atlantic Pediatric Device Consortium (APDC)
Atlanta-based consortium on leading edge of pediatric device development.
Most children are healthy, so they comprise a small percent of the healthcare industry’s profit base, which makes the development of purpose-driven pediatric devices very challenging.
“There are many challenges, but two major ones, probably,” says David Ku, the Lawrence P. Huang Chair Professor of Engineering Entrepreneurship, who leads the Atlantic Pediatric Device Consortium (APDC), which is based at the Georgia Institute of Technology. “One is that the market size for all pediatric devices is small compared to adults. There is a lower return on investment, too low to garner much attention, so medical device companies or investors typically have less interest in pediatrics.”
Way less, in fact. According to the nonprofit Institute for Pediatric Innovation, about 6% of healthcare dollars are spent on children, who are overwhelmingly outnumbered by adults (by a 4-to-1 ratio), who tend to have a lot more health problems, making grown-up medicine a much safer and therefore more prevalent investment. Consequently, there aren’t many options designed explicitly for children, which gets to the second problem on Ku’s list.
“The second thing is, designing medical devices just for children isn’t easy,” he says. “Most devices are built with adults in mind, and we try to scale them down, but you almost have to create a different device, because it’s not just a matter of size and proportional scaling. Children’s bodies are growing, and they may have long-term needs that change over time.”
So, to address those specific pediatric needs, the U.S. Food and Drug Administration (FDA) created the Pediatric Device Consortia Grant Program in 2009. The effort has been inspiring medical device projects across the country, and the APDC (one of seven FDA consortia in the country) has taken a starring role, making the Georgia Institute of Technology a leader in the development of pediatric technologies.
APDC, founded in 2011, is a partnership between Georgia Tech, Emory University, Children’s Healthcare of Atlanta and the Virginia Commonwealth University (APDC’s founding leader, Barbara Boyan, former dean for research in Tech’s College of Engineering, is now dean of VCU’s School of Engineering).
The consortium exists to increase accessibility of pediatric medical devices by helping researchers and entrepreneurs develop and commercialize them more efficiently. Interest in the effort has manifested in the form of large investments, such as the $20 million joint venture by Tech and Children’s (announced in June 2012) for developing solutions to improve kids’ health, and more recently, a $3.5 million award from the FDA to the APDC announced early this year. In addition to that, APDC administers seed grants each year in its annual Pediatric Device Innovation Competition.
In April, APDC awarded seed grants (in the $30,000 to $50,000 range, according to Martha Willis, APDC program manager) to eight projects selected by a panel of physicians, scientists and business leaders. One of the most promising is an adaptable implant to treat cleft palate, developed by Ku at Georgia Tech.
Cleft palate is a congenital defect that causes major speech and swallowing problems for young children, with potential social implications, because it is unsightly. The usual best strategy is to repair the defect during infancy, before swallowing and speech problems develop. But surgical correction is a challenge because of growth issues.
“Early closure leads to growth restrictions, and late closure leads to defects in speech. So the question is, how do you get something that fits in there and grows with the child,” says Ku, who answered the question by using material developed at Georgia Tech about 15 years ago.
Polyvinyl alcohol cryogel (PVA-C) is a biocompatible material that is easily molded into a design that can resist pressure while allowing for growth of a child’s mouth. “This is a soft and compliant hydrogel, easy to clean and it can be molded in the physician’s office,” says Ku.
It’s a new, long-term version of the palatal obturator, which is typically a short-term prosthetic. And because Ku’s device is a more advanced and adaptable version of a device that already exists, the regulatory pathway to commercialization (and a child’s mouth) is less burdensome, thanks to a law passed almost 40 years ago.
In May 1976, the Federal Food, Drug and Cosmetic Act (FD&C) was amended to include medical devices. Specifically, section 510(k) of the FD&C allows the FDA to determine whether a new device is somehow equivalent to commercial devices that existed before May 1976. If deemed “substantially equivalent,” a new device doesn’t have to go through premarket approval.
“It’s possible to get this cleared and to the marketplace in two years, instead of the 10-year timeframe that is typical for some new devices. By appropriate design, the cost to bring this to market is on the order of $2 million to $5 million, versus $50 million to $75 million,” says Ku, who began his career as a surgeon before moving fulltime into research at the Parker H. Petit Institute of Bioengineering and Bioscience.
Ku’s device provides a physiological correction for cleft palate. Full correction through surgery comes around the age of 5, but by then, ideally, the child patient has learned to speak, and to create the hard, pressure consonant sounds (that a cleft palate hinders), thanks to an effective, efficient device. Ku, who is Regents' Professor in the George W. Woodruff School of Mechanical Engineering, will use the seed grant to provide design control documentation and prepare for FDA 510(k) application.
The idea behind the seed grant program is to kick start promising projects that have a good chance of securing larger sums of venture capital later on. It’s a strategy that has worked very well for one of APDC’s early seed grant recipients. When APDC was started in 2011, says Wilbur Lam, “we had to pitch a handful of ideas to the FDA to show that we here in Atlanta had the technologies and infrastructure, as well as the commercialization know how, to take a handful projects to the next round of development.”
So, he pitched CellScope, Inc., and its mobile microscope product, the Remotoscope, a clip-on attachment and app combination that turns your iPhone into an otoscope. Lam, an assistant professor in the Wallace H. Coulter Dept. of Biomedical Engineering, started the project with his colleagues at the University of California, Berkeley, and brought it with him when he joined the faculty at Georgia Tech in 2011, when CellScope secured $50,000 in seed money from FDA through APDC.
“The bottom line is, APDC allowed CellScope to receive initial funding to develop the technology further, enabled us to work on the hardware and perhaps most importantly, gave us street cred, which enabled us to find venture capital funding and take our company to the next level,” says Lam, a pediatrician and researcher whose company is now supported by funding from Khosla Ventures, a Silicon Valley firm. “In terms of commercialization, we’re very close.”
The idea behind the Remotoscope is, basically, to allow parents at home to use their cell phone’s camera and flash to provide light for otoscopic images. Mom can take a snapshot of her child’s inner ear, then send it electronically to the pediatrician for a remote diagnosis. The devices have been distributed to physicians across the country for their initial testing.
“We’re about to do a study with our partners at Children’s Healthcare of Atlanta, in terms of getting these devices to families of children with chronic ear infections, to see if we can use the device to save healthcare expenditures by preventing emergency room visits,” says Lam, a Petit Institute researcher based at Emory, who treats patients at Children’s. “Over time, we hope it’ll also help reduce unnecessary antibiotic use.”
His thought is, because physicians will be able to check for infections more frequently now, they can cut back on prescribing drugs for infections that can improve on their own. Because time is usually pretty short during an office visit, pediatricians often prescribe an antibiotic whether the infection is caused by bacteria, or a virus (which antibiotics can’t fix), and this can eventually result in antibiotic resistance, therefore limiting the drug’s ability to fight bacterial infections (which antibiotics are designed to cure). “This is a big public health issue, the issue of antibiotic resistance,” says Lam, a co-director of APDC and one of the consortium’s principal investigators.
The seed grant program doesn’t guarantee a device’s commercialization and success, but it does provide an important boost for the researcher who is putting purpose ahead of profit on the development path.
“You know, $50,000 isn’t much in the scheme of things,” Lam says, “but sometimes that can be just enough to enable an inventor to take the next step. It allows creative people to move forward with great ideas that can have a big impact down the road.”
- Workflow Status: Published
- Created By: Colly Mitchell
- Created: 06/04/2014
- Modified By: Fletcher Moore
- Modified: 10/07/2016