Atlantic Pediatric Device Consortium planting seeds of support
The Atlantic Pediatric Device Consortium (APDC), headquartered at the Georgia Institute of Technology, was started five years ago to pursue a specific if ambitious mission that came with a built-in set of significant challenges.
APDC was founded, “to address the issues related to designing and commercializing devices to improve children's health,” says Barbara Boyan, dean of the School of Engineering at Virginia Commonwealth University (VCU), who was a professor at Georgia Tech in the Wallace H. Coulter Department of Biomedical Engineering when she co-founded the APDC in 2011.
And unlike much of the population these technologies are designed to serve, the related issues are definitely not small.
“There are a number of problems involved in successfully taking a product to market that is specifically for children,” explains Boyan, who remains an APDC director. “Often market size is limited, so the clinical studies needed to prove safety and effectiveness cannot be adequately powered and for the eventual market size are simply too expensive.”
Also, unlike adults, who comprise the vast majority of the medical device market, children are still growing.
“And as they grow their physiology is changing,” Boyan says. “Thus, manufacturers may need to make multiple sizes and may even need to modify the kinds of materials that they are using. It is important to remember that children are not just little adults. It isn't enough to simply scale down a device. I think you can see why it is a challenge for small companies and indeed large companies to tackle these challenges.”
Those challenges are why the U.S. Food and Drug Administration (FDA) funds a network of centers like the APDC. A major goal of the FDA-sponsored Pediatric Device Consortia (APDC was one of the earliest funded, and there are currently seven nationwide) is to provide expertise and services to inventors, entrepreneurs and companies that are developing pediatric healthcare technologies – companies like Safe Heart USA, based in Atlanta and helmed by Georgia Tech graduate Yale Zhang.
“APDC has really helped put our company on the map and build a buzz,” says Zhang, CEO of Atlanta-based Safe Heart USA, an award-winner in the most recent APDC Pediatric Device Innovation Competition. “The best thing about this program is, it really is focused on commercialization. It’s about having a social impact and simultaneously being able to take something to market. So, it’s not just about cool ideas.”
Even so, it’s nice to have a cool idea, and Zhang’s company has one. APDC’s review committee (an experienced panel of pediatricians, engineers, business professionals and venture capitalists) selected Zhang and his company for seed grant funding for a new smart-phone based oximeter to help monitor the early stages childhood pneumonia.
It’s the logical next step for a device Safe Heart USA already has produced, the iOximeter (and the iOX mobile phone app), which is geared for adults. The company is shifting gears slightly with development of this new, pediatric-focused product, inspired by a global health challenge from the Bill and Melinda Gates Foundation, to improve the diagnosis of childhood pneumonia in developing countries (pneumonia remains the leading cause of death in children under five, worldwide, but particularly in Sub-Saharan Africa and South Asia).
“We want to provide an affordable mobile device that is easy to use,” says Zhang, a 2006 graduate of the Stewart School of Industrial and Systems Engineering at Georgia Tech, whose challenge is to make one that fits a child’s needs. “So our goal is really to make a non-disposable, durable, washable, sterilize-able oximeter probe that can be used on kids.”
Zhang says the probe will be inexpensive to produce and the iOximeter also saves money in how little energy it uses. No batteries or expensive, power-hungry hardware required. The device uses the cell phone processor for its juice. “That’s the most innovative part about this product,” he adds.
Innovation (as well as commercialization potential) is at the heart of what APDC is looking for. It’s right there in the name of the annual Pediatric Device Innovation Competition. APDC hosted the fourth such round of competition in February. This seed grant competition is a chance for academic researchers, students, businesses, clinicians and entrepreneurs to develop and commercialize a pediatric medical device.
“These early stage development grants can often launch an idea from a university laboratory to the next level,” says APDC Executive Director David Ku, Petit Institute faculty member and professor of engineering entrepreneurship in the Scheller College of Business. “APDC advisors monitor progress and are available to assist innovators through whatever stage of development they are currently in.”
Ku has been involved in bringing a number of medical devices to the market. He and the other APDC principal investigators at Emory, Children’s Healthcare of Atlanta, and the Virginia Commonwealth University have been the recipients of seed grant funds like this in the past.
More than 25 proposals were initially submitted for this year’s competition, according to Martha Willis, APDC’s program manager. Of those, 15 were invited to Atlanta to make oral presentations of their projects, competing for seed grant awards in the $5,000 to $50,000 range. The APDC Review Committee based its assessment on a number of factors: clinical significance; approach to product development; likelihood of marketing success; project team, environment and resources; and potential for additional funding. “The point of the APDC seed grant is to move a pediatric medical device project along the development pathway on its way towards commercialization,” says Willis.
In addition to Zhang and Safe Heart USA (which was the only Atlanta-based awardee), the winning projects/products included:
• Nephrostomy Catheter: This device is designed to significantly reduce a young patient’s exposure to imaging radiation potentially reduce bleeding during a percutaneous nephrolithotomy (removal of kidney stones). It will also enable a pediatric urologist to conduct the procedure, rather than sending the pediatric patient to an interventional radiologist. Principal investigator is Jason Wynberg, attending urologist at Detroit Medical Center.
• Transcatheter valve for treatment of pediatric pulmonary valve stenosis: This project will address one of the most prevalent congenital heart defects, pulmonary valve stenosis due to valve dysplasia. The goal of principal investigator Eric Sirois (whose company, Dura Biotech, is based in Storrs, CT) is to develop a replacement valve suitable for treating pulmonary valve dysplasia in children and adolescents.
• Automated Point-of-Care Recognition of Innocent Still’s Murmur in Children: This mobile device-based digital stethoscope, accompanied with a highly accurate computer algorithm, would distinguish Still’s murmur (benign and prevalent) from the more serious pathological heart murmurs. The device could significantly reduce the current rates of unnecessary (and costly) referrals to cardiologists, while reducing the financial and emotional costs of unnecessary testing. Principle investigators are Raj Shekhar and Robin W. Doroshow, based at the Sheikh Zayed Institute for Pediatric Surgical Innovation in Washington, D.C.
• Drug Error Prevention and Advisory System for Pediatric Anesthesia: This system is designed to utilize QR (Quick Response) code technology for syringe labeling, to identify medication before administering and advise the recommended dose. It is also intended to make compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO) regulations efficient and easy. Principle investigator is Nadia Koltchine, the youngest awardee – she is a member of the science team at Joel Barlow High School in Redding, CT.
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