Winning Innovators in Pediatric Medical Device Competition Announced

Two pediatric medical device innovators, AventaMed of Cork, Ireland and Prospiria, Inc. of Galveston, Texas, were selected from eight finalists to each receive a $50,000 award in the annual competition held by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System. The competition was part of the institute’s third annual symposium focused on fostering innovation that will advance pediatric healthcare and address unmet surgical and medical device needs for children.

“Our heartfelt congratulations to this year’s winners, who were selected from a highly competitive field of worthy devices,” said Kolaleh Eskandanian, PhD, MBA, PMP, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation. “In the institute’s role as a catalyst for pediatric innovation, we see this as the beginning of our relationship with AventaMed and Prospiria. Along with the monetary prize, we will make available our institute’s expertise in pediatric product development, including a network of engineering, regulatory, and business advisors to help them get their devices to market faster.”

Recognizing that pediatric ear tube surgery is the number one reason children undergo surgery that requires general anesthesia, Ireland-based AventaMed has developed a hand-held pediatric ear tube device that does not require full general anesthesia. “We are elated about this prize because it will allow us to expand our clinical trial to the US more quickly and increase the number of patients, enabling us to submit for FDA approval sooner,” said John Vaughan, Co-founder and Chief Technical Officer of AventaMed.

Prospiria, Inc. presented a noninvasive device using optoacoustic imaging to monitor endotracheal tube (ET) positioning for pediatric life support patients. Donald S. Prough, MD, Interim CEO of Prospiria, and Rebecca Terry White Distinguished Chair of Anesthesiology at UTMB, explained that there is currently not an expedient solution to identify the 20 to 50 percent of ETs that are initially malpositioned, or that move during intubation. Incorrectly positioned ETs pose serious risk to patients, especially infants. “The prize money has an enormous impact because it enables us to complete clinical studies, conduct a thorough marketing analysis and obtain outside expertise to create a more user-friendly display,” Dr. Prough said. “Winning a competition of this caliber, as judged by a highly skilled multi-disciplinary panel, also gives us the validation needed to pursue additional funding.”

A total of 53 submissions from five countries were received for the competition. The finalists each made five-minute presentations to the symposium audience and then responded to judges’ questions. The highly competitive line-up included:

• Healthcare Unbound, San Francisco, Calif. – noninvasive therapy for chest deformities in children
• Massachusetts Institute of Technology and Media Lab, Cambridge, Mass. – device offering improved sensitivity and accuracy of ear infection diagnostics
• Texas Tech University Health Science Center, El Paso, Texas – internal, motorized bone lengthener device for children
• Stanford University, Stanford, Calif. – neonatal umbilical catheter stabilization and infection protection device
• Children’s National Health System, Washington, DC – real-time, non-invasive fetal electrocardiogram to diagnose fetal arrhythmias
• Actuated Medical, Bellefonte, Pa. – controlled, micron-scale needle oscillation system to enable oblique access as well as reduce insertion force, anesthesia exposure, and reoperation rates for pediatric bone biopsies and bone marrow aspirations.

The judging panel included moderator Bryan Vartabedian, MD, of Texas Children’s Hospital; Charles Berul, MD, of  Children’s National; Martha Connolly, PhD, of Mtech Baltimore; James Clessuras of Wilson Sonsini Goodrich & Rosati; Tiffany Wilson of Global Center for Medical Innovation; Peyvand Khaleghian, MD, PhD, of Avicenna Partners Investment Company; and one of the 2014 competition winners, Justin G. Shaka, MBA, of REBIScan.  Emily Blum, MD, the Joseph E. Robert, Jr. Fellow in Pediatric Surgical Innovation of Children’s National, served as medical consultant to the judges.

For the third annual symposium, the Sheikh Zayed Institute for Pediatric Surgical Innovation brought together key leaders from the National Institutes of Health, the Food and Drug Administration (FDA), researchers, innovators, venture capitalists, regulators, policy makers, and patients and their families to examine and discuss the challenges surrounding the pediatric market and the need for incentives and legislation to stimulate pediatric surgical and device innovation. The event drew more than 250 attendees.

Recognizing the importance of the patient families – both parents and children – who actively participated in the symposium panel discussions, Kurt Newman, MD, President and CEO of Children’s National said, “The voice of the patient is essential in creating innovations that will improve pediatric healthcare because their wants, needs, and experiences provide invaluable insights that shape better solutions.”

Keynote speakers included Geoffrey Ling, MD, PhD, leading innovator and Director of DARPA Biological Technologies, and Vasum Peiris, MD, Chief Medical Officer of Pediatrics and Special Populations, Center for Devices and Radiological Health at the FDA. Anthony Chang, MD, Chief Intelligence and Innovation Officer of Children’s Hospital of Orange County, was the luncheon keynote speaker.

The program included panel discussions on insights learned from the Berlin Heart trials and approval process; gap funding in pediatric surgical and medical devices; off-label and investigational use of marketed medical devices in pediatric populations; and pediatric device benefit-risk assessment.

With the goal of making pediatric surgery more precise, less invasive and pain-free, the Sheikh Zayed Institute for Pediatric Surgical Innovation serves as an incubator, accelerator, and advocate for advancements in pediatric healthcare. The institute combines research and clinical work in the areas of imaging, bioengineering, pain medicine, immunology, and personalized medicine to develop knowledge, tools, and procedures that will benefit children globally.