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VCU experts guide innovators’ path to commercialization with the Atlantic Pediatric Device Consortium

Photo: (From left) Barbara D. Boyan, Ph.D.; L. Franklin Bost, M.B.A., Bruce Rubin, M.D., Ph.D.

Richmond, Va (December 2, 2016) - Improving health care for children is one of medicine’s most compelling goals, but achieving it is often hampered by challenges associated with developing medical devices specifically for pediatric patients. The Atlantic Pediatric Device Consortium (APDC) brings together partners from Virginia Commonwealth University, the Children’s Hospital of Richmond (CHoR) at VCU, the Georgia Institute of Technology, Emory University and Children's Healthcare of Atlanta (CHoA) to stimulate innovation in the high-impact — but traditionally underserved — area of children’s health care devices. APDC is one of eight pediatric device consortia funded by the U.S. Food and Drug Administration to provide support services to inventors of technologies that aid in the diagnosis, treatment and care of pediatric patients.

“Due to the relatively small market size as compared with the large adult population, device development for pediatrics is more economically challenging. The consortiums assist inventors and small companies in early stage development and consulting services,” said Barbara D. Boyan, Ph.D., dean of the VCU School of Engineering. “Children are not small adults and require special focus to develop suitable products for their care.”

Boyan assembled a team of medical, academic and business colleagues to found the “Atlanta” Pediatric Device Consortium in Georgia in 2010. The opportunity to establish an FDA supported pediatric device consortium program meshed perfectly with Boyan’s background in medical device entrepreneurship, her role as director of the Georgia Tech/CHoA Laboratory for Craniofacial Plastic Surgery and Center for Pediatric Technology Innovation and her academic research in pediatric bone growth. “We were already invested,” she said. “We applied and we won the first five-year APDC program award.”

In 2013, the FDA awarded renewal funding to the renamed “Atlantic” Pediatric Device Consortium. The renewal application added VCU, where Boyan had become Dean of Engineering in 2013, as a consortium partner. Boyan is now director of the VCU site and co-director of APDC with David Ku, M.D., Ph.D., at Georgia Tech. She is currently mentoring a project that is developing a hydrogel to delay re-synostosis following treatment for craniosynostosis, a process that causes premature fusion of cranial sutures. APDC is also working with the developer of an infant cardiac monitor that is woven into a T-shirt.

Bruce Rubin, M.D., M.B.A., the Jessie Ball duPont Distinguished Professor and chair of the Department of Pediatrics at the VCU Medical Center and physician-in-chief of the Children’s Hospital of Richmond at VCU, serves as an APDC pediatric adviser at VCU. Rubin is also a medical device entrepreneur who holds a master’s degree in engineering. He has an appointment as professor of biomedical engineering at VCU and is a medical device entrepreneur. He is currently advising several groups with APDC funding.  

“I would like to see more entrepreneurship as part of our CHoR program. As an academic institution, we create new discoveries,” Rubin said. “In fact, VCU Health System’s slogan was ‘Every day, a new discovery.’ APDC provides a wonderful opportunity to apply those ideals to children’s health. We can be nimble, given our resources across the VCU medical and academic campuses. This is a scalable way of making a difference.”

APDC’s annual Innovation Competition is its centerpiece program for connecting inventors to financial and expert consulting resources. Applicants include physicians, surgeons, dentists, nurses, rehabilitation specialists and students, and even family members of pediatric patients. Applications for unique products are reviewed by a panel of experienced mentors. Finalists then participate in a “shark tank”-style competition judged by an interdisciplinary team of experts. The sixth annual funding competition concluded in October, 2016. Seed grants of $25,000 to $50,000 were awarded to inventors of six novel devices. APDC board members mentor each of the teams and provide connections with experts in FDA regulatory affairs, clinical studies and business processes.  The seventh APDC Innovation Competition is scheduled for fall of 2017, and VCU will again be involved in promoting the event and providing expert advising to winning teams.

“We seek projects that are clinically worthy and can fill a specific unmet need in children's healthcare. We also review the background and passion of the development team and look for a good execution plan,” said L. Franklin Bost, director of the VCU Institute for Engineering and Medicine and founding member of APDC’s board of Directors. “If the inventor has these fundamental elements  in place, we ask, ‘What is needed for the next step toward development and ultimately commercialization?’” This often includes creation of prototypes, assistance in software control coding, electrical design, product design, regulatory assistance with the FDA and business planning guidance.

Bost, who is an experienced developer of medical devices in industry, provides medical product development advice to entrepreneurs. He explained how innovations the Consortium funds are generally in one of two categories. “Quick wins” are relatively simple projects, often devised by nurses or parents. With help from APDC, these projects can get through the development and regulatory processes and into clinical use in a few years. Examples of quick wins include a novel device that physiologically overwhelms the body’s pain nerves; a point-of-care, self-contained, disposable, diagnostic test for anemia; and a mobile device-based digital stethoscope with a highly accurate computer algorithm to discriminate the benign Still’s heart murmur from pathological murmurs.

At the other end of the development continuum are what Bost terms “big, hairy problems.” These are inherently complex clinical innovations usually addressed by hospital physicians and may take five to 10 years to reach the market. Examples are a heart valve that grows as the patient grows, a hemodialysis machine for renal failure specifically designed for small and low-weight patients and a pediatric transcatheter pulmonary valve replacement that can help treat stenosis caused by valve dysplasia.

At every scale, the designs that APDC supports embody an ethic that Boyan champions in supporting current and future innovators.  

“You can’t just size down a product designed for adults,” Boyan said. “You have to rethink clinical goals and sizing to benefit pediatric patients effectively.”

Additional information on APDC can be found at http://atlanticpediatricdeviceconsortium.org