WASHINGTON – (March 23, 2021) – Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated by arrhythmias, a condition where the heart beats too rapidly, too slowly or irregularly due to a misfiring of the body’s electrical impulses. While the last decade brought great advances in technologies that improve the care of adult arrhythmias, pediatric patients have been left behind, with only five devices approved for use in children in the same period. As a result, pediatric specialists are often using off-label or improvised devices to treat pediatric arrhythmias, including the smallest newborns.
Recognizing this unmet need, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is accepting applications through April 12, 2021, for its annual “Make Your Medical Device Pitch for Kids!” competition. This year’s competition focuses on innovations in pediatric devices that treat CHD, with an emphasis on electrophysiology devices such as pacemaker systems, ablation catheters, wearable monitoring devices and related technologies that address arrhythmias in children.
“NCC-PDI was created, with the support of the Food and Drug Administration (FDA), to seek out and address significant unmet needs in pediatric medical devices,” says Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “We have learned from the experts that pediatric-specific technologies for treating arrhythmias would be a game changer in the care of their patients, so we are focusing our competition and grant awards on this opportunity.”
Using a virtual format, semi-finalists chosen from all submissions will make their first pitch on May 12, 2021. Up to 10 finalists selected from this event earn participation in a special pediatric-focused track of the MedTech Innovator accelerator program, the largest medtech accelerator in the world, beginning in June 2021. These innovators then participate in the pediatric competition finals in September 2021 where judges will award up to $150,000 in FDA-sponsored grants to the devices selected as most impactful and commercially viable.
“Because pediatric medical devices face unique challenges in achieving commercialization, MedTech Innovator’s accelerator program provides specialized mentoring and guidance from experienced industry leaders,” says Paul Grand, CEO of MedTech Innovator. “Our program is designed to provide immediate and long-term benefits to help innovators more rapidly achieve success on their journey to improving health care for children.”
How significant is the need for pediatric devices to address arrhythmias? In a recent survey of members conducted by the Pediatric and Congenital Electrophysiology Society (PACES), the vast majority (96%) said they believe there is a deficiency in devices available to serve the needs of pediatric patients. Conducted with the U.S.FDA, the survey also asked respondents to identify the biggest unmet need, which physicians identified as cardiovascular implantable electronic devices that are smaller, have better battery life and have pediatric-specific algorithms. Specifically, a leadless pacemaker designed for pediatric care was consistently on the most-wanted list.
“It’s evident that technologies for pediatric patients with CHD are not adequate and the experts are telling us what they need,” says William E. Bentley, Ph.D., Robert E. Fischell distinguished professor and director of the Robert E. Fischell Institute for Biomedical Devices at the University of Maryland. “I look forward to seeing the critical innovations that NCC-PDI will help to advance through this competition.”
NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the advancement of adult medical devices. NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland with support from partners MedTech Innovator, BioHealth Innovation and design firm Archimedic.
Eskandanian says that enhancing access to resources for pediatric innovators is also one of the aims of the Children’s National Research and Innovation Campus, a first-of-its-kind focused on pediatric health care innovation, with the first phase currently open on the former Walter Reed Army Medical Center campus in Washington, D.C. With its proximity to federal research institutions and agencies, universities, academic research centers, as well as on-site incubator Johnson and Johnson Innovation – JLABS, the campus provides a rich ecosystem of public and private partners which, like the NCC-PDI network, will help bolster pediatric innovation and commercialization.
Children’s National Hospital, based in Washington, D.C., celebrates 150 years of pediatric care, research and commitment to community. Volunteers opened the hospital in 1870 with 12 beds for children displaced after the Civil War. Today, 150 years stronger, it is among the nation’s top 10 children’s hospitals. It is ranked No. 1 for newborn care for the fourth straight year and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. In 2021, the Children’s National Research & Innovation Campus opened, the first in the nation dedicated to pediatric research. Children’s National has been designated three times in a row 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 D.C. metropolitan area, including the Maryland and Northern Virginia suburbs. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation and is the nation’s seventh-highest NIH-funded children’s hospital. 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.
The University of Maryland, College Park is the state’s flagship university and one of the nation’s preeminent public research universities. A global leader in research, entrepreneurship and innovation, the university is home to more than 40,000 students,10,000 faculty and staff, and 280 academic programs. Its faculty includes two Nobel laureates, three Pulitzer Prize winners and 58 members of the national academies. The institution secures $514 million annually in external research funding. The university’s Robert E. Fischell Institute for Biomedical Devices seeks to catalyze the transformation of basic research into clinical practice and commercial success. The Institute aims to drive innovation by immersing creative and energetic scientists and engineers in a nurturing and rewarding research environment where engineered health systems are conceived of and investigated. The Institute is comprised of staff, resources, facilities, and a network of experts who not only facilitate prototyping and manufacturing expertise, but who also facilitate venture creation, intellectual property creation, and product passage through various clinical, regulatory and reimbursement hurdles. For more information about the University of Maryland, College Park, visit www.umd.edu
Based in Los Angeles, Calif., MedTech Innovator is a nonprofit and the largest accelerator of medical technology in the world. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. MedTech Innovator matches healthcare industry leaders with innovative early-stage and emerging growth medtech companies for mentorship and support. Founding sponsors include Johnson & Johnson and RCT Ventures, and annual program sponsors include Baxter, Dexcom, Edwards Lifesciences, NIPRO Medical, Olympus Medical Systems, W. L. Gore, Asahi Intecc, Fujikura, Jabil, Maxim Integrated Ventures, Silicon Valley Bank, Medmarc, MTEC, Experien Group, Greenlight Guru, Proxima Clinical Research, Integrated Computer Solutions, Westwood & Wilshire, and Ximedica. The organization’s industry partners include AdvaMed, Health+Commerce, MedTech Strategist, and Wilson Sonsini Goodrich & Rosati.
For more information about MedTech Innovator, visit https://medtechinnovator.org/ and follow @MedTechAwards on Twitter.
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