Pediatric Medical Device Competition Winners Announced

Ten medtech innovators focused on pediatric cardiology will compete for $300,000 in grants in the “Make Your Medical Device Pitch for Kids!” competition later this month in Toronto.
 
The Oct. 14 competition is presented by the Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the U.S. Food and Drug Administration (FDA), and Additional Ventures, a nonprofit focused on accelerating research progress and improving clinical care for individuals born with single ventricle heart defects. Selected by an internal committee, 10 finalists will compete for up to $50,000 each in grant funding and opportunities to access support services and technical expertise provided by APDI and Additional Ventures, including engineering, regulatory, reimbursement, clinical trials study design, and data science services.
 
The U.S. Centers for Disease Control and Prevention estimates about 40,000 children are born annually with a congenital heart defect. Children with heart conditions need medical devices tailored to their specific physiological needs. There is a significant unmet need for pediatric devices designed to monitor and treat young patients effectively in cardiology, interventional cardiology, cardiac surgery and electrophysiology. This competitive grant program is designed to identify and support the development and commercialization of devices that can address these needs.
 
The finalists competing for grant money include: 

• Bloom Standard (Minneapolis): Autonomous, hands-free ultrasound
• Compremium AG (Bern, Switzerland): Noninvasive central venous pressure estimation for pediatric patients
• Kardio Diagnostix (Halifax, Nova Scotia): Artificial intelligence-driven heart auscultation platform
• Massachusetts Institute of Technology (Cambridge, Mass.): Polymeric auxetic stent to treat pediatric aortic coarctation
• OxiWear (Arlington, Va.): Home measurement of oxygen levels in pediatric congenital heart disease
• PyrAmes Inc. (Cupertino, Calif.): Improved, wearable noninvasive pediatric blood pressure monitor
• Rhaeos (Evanston, Ill.): Wireless noninvasive sensors to continuously monitor cardiac output
• SeeMedX (Las Vegas): Noninvasive, continuous hemodynamic monitoring
• Sibel Health (Chicago): Hospital-to-home monitoring for pediatric heart conditions
• University of California (Irvine, Calif.): Humanitarian device exemption for growth-accommodating IRIS TPVR system

“There’s a profound market failure in the development of medical devices for pediatric heart patients,” said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National Hospital, and program director and principal investigator of the APDI. “Not only are existing technologies often suboptimal adaptations of adult devices—lacking in accuracy, safety, and comfort for children—but in many cases, essential pediatric-specific technologies are entirely absent. This program empowers us to address this critical void by supporting the creation of innovative devices designed exclusively for children, providing the necessary funding and expertise to help innovators successfully navigate the complex journey of bringing new pediatric devices to market.”
 
The competition is a highlight of the 12th Annual Symposium on Pediatric Device Innovation, presented by Children’s National on Oct. 14. The symposium, co-locating with The MedTech Conference powered by AdvaMed, brings together medtech experts for multidisciplinary panel discussions focused on critical issues in pediatric device development, regulatory and reimbursement processes, device clinical trials, and pediatric healthcare innovation gaps.
 
“For too long, innovation in pediatric cardiovascular devices has been deprioritized, and with it, funding has stagnated,” Additional Ventures CEO Kirstie Keller, Ph.D., said. “We are proud to partner with APDI to support the critical need to develop and commercialize new technologies that are designed and built for children and are encouraged by the caliber of the 10 groups selected to compete. We look forward to seeing these and other breakthroughs reach patients and revolutionize how we treat and monitor children.”
 
APDI is one of five nonprofit consortia in the FDA’s Pediatric Device Consortia grant program that receives funding to provide a platform of services, expertise, and grants to support pediatric innovators in bringing medical devices to the market that specifically address the unmet needs of children. Led by Children’s National, APDI partners include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, MedStar Health Research Institute, MedTech Color, and OrthoPediatrics Corp.
 
Washington, D.C.-based Children’s National Hospital, established in 1870, currently is the nation’s No. 5 children’s hospital and ranked in all specialties evaluated by U.S. News & World Report. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated three consecutive times as a Magnet hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the Washington, D.C., metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. 
 
Additional Ventures is a purpose-driven organization leveraging evidence-based research and deep subject matter expertise to make an outsized impact. Its biomedical research work focuses on a rare form of congenital heart defect called single ventricle heart disease. While this field is in its infancy, with limited knowledge of cause, risk, outcomes or treatments, the organization is confident that through coordinated strategic and interdisciplinary work, dynamic teaming and flexible funding, it can illuminate a functional cure for patients and their families.