The Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center is facilitating an international consensus paper as an outcome of its first annual International Symposium on Pediatric Surgical Innovation, held in June to discuss the current status and challenges to pediatric surgical innovation and medical device development. The symposium included discussions such as strategies for seeking regulatory approval in the top three medical device markets – the United States, the European Union, and Japan.
Following the day-long symposium, the organizers held a closed session with key opinion leaders and speakers from the conference to begin the formation of the white paper, which will be published in the last quarter of 2013. This document will outline a consensus from world-renowned thought leaders on recommended priorities and changes to address current challenges and to speed advances in pediatric surgical innovation and device development. The white paper will address the unique nature of innovation in pediatric surgery and device development, current regulatory pathways, economic models, ethical concerns specific to medical product development for the pediatric population, the impact of regulatory standards worldwide, and best practices that might be shared across different regions of the globe.
“Calls are growing, from around the world, for change that will spur innovation in surgery and medical device development for pediatrics,” said Peter Kim, MD, CM, PhD, Vice President of the Sheikh Zayed Institute for Pediatric Surgical Innovation. “This white paper will provide a consensus, from leaders across the many disciplines involved, on priorities and steps to address the clinical, technical, economic and regulatory requirements that can hinder progress, if not addressed strategically.”
Topics the white paper will address include the FDA’s 510(k) clearance process, which applies to most pediatric medical devices, based largely on equivalence to existing devices created for adults. The white paper will also discuss factors related to the small size and vulnerable nature of the pediatric population, which presents distinct challenges for surgeons, researchers, manufacturers, and regulators in device development for this population.
“We know that infants and children are not simply small adults—their physiology is different, and they experience rapid anatomical and physiological change,” said Mark Batshaw, MD, Executive Vice President, Chief Academic Officer, and Physician-in-Chief at Children’s National. “An improved regulatory framework for pediatric devices and surgical tools will reflect these substantial differences, keeping safety paramount while encouraging future innovation and investment.”
The Sheikh Zayed Institute symposium drew nearly 250 high-level participants, including representatives from the U.S. Food and Drug Administration, European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, U.S. National Institutes of Health, American Academy of Pediatrics, American Pediatric Surgical Association, World Federation of Associations of Pediatric Surgeons, children’s hospitals, pediatric device consortia, device makers, and experts in intellectual property and regulatory science. Presentations from the Symposium can be viewed here.
Video Highlights from the symposium.