Six of the finalists competing in the “Make Your Medical Device Pitch for Kids!” program by Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) were selected as winners during the 7th Annual Pediatric Device Innovation Symposium. Each company earned a $25,000 award and the opportunity to participate in NCC-PDI’s recently launched “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.
In addition to celebrating pediatric device innovation, the symposium also encouraged a better understanding of clinical trials for pediatric devices as well as awareness of the regulatory challenges.
The award-winning pediatric devices and companies are:
- AlgometRx Inc.'s AlgometRx Rapid Drug Test, used to detect and monitor neonatal abstinence syndrome. It aims to enable earlier assessment and intervention of opioid withdrawal to reduce physiological stress.
- Epitel's Epilog, an inexpensive, discrete, and disposable EEG machine offering real-time monitoring to help manage care for neonates suspected of hypoxic-ischemic encephalopathy.
- Novonate's LifeBubble, designed to secure and protect the umbilical catheter insertion site for neonates in intensive care with the goal of preventing infection from caregivers and parents.
- PyrAmes Inc.'s noninvasive and wireless Boppli Band, which is designed for risk- and pain-free continuous blood pressure monitoring for neonates.
- Raydiant Oximetry Sensing System, a non-invasive technology for detecting fetal distress during labor and delivery. It aims to reduce medically unnecessary cesarean deliveries and the occurrence of newborns suffering the consequences of metabolic acidosis.
- Rhaeos Inc.'s FlowSense, a wearable device that enables noninvasive monitoring of ventricular shunt function in patients who have hydrocephalus. It aims to obviate the need for imaging and unnecessary hospital visits and admissions.
Kolaleh Eskandanian, PhD, vice president and chief innovation officer at Children’s National and principal investigator of NCC-PDI, told MD+DI that these winners are the second “cohort” in the Pediatric Device Innovator Accelerator Program. The 12-month program provides a large network of development and marketing support, depending upon company needs, Eskandanian said. This second group of innovators focuses on tackling the health issues of NICU patients, whereas the first cohort of five companies are developing orthopedic and spine solutions for pediatric patients.
“We’ve been talking about unmet needs for some time, and we really work to make a real difference,” she said.
The symposium focused on educating stakeholders on pediatric clinical trials under the theme, “Pediatric Device Clinical Trials: Forging a Better Path.”
“Often devices don’t need to go through human trials,” Eskandanian said. “This is not well understood. Safety and efficacy are measured in pilot and pivotal trials, and postmarket surveillance is very important.”
Eskandanian reports that Children’s National is working with the members of the AdvaMed Pediatric Working Group to write and suggest a discussion paper for FDA on pediatric device trial conduct and best practices for IRBs, clinical sites, device sponsors, and investors. The targeted submission date is Jan/Feb 2021. “Innovation plays an integral role when it comes to conduct in pediatric device trials. There are alternative methods to trials, such as data extrapolation from adult studies. If we can be well informed when mining that data, we shouldn’t put kids at risk and delay time to market.” A randomized clinical trial would be unethical if it involved using a medical device that a patient doesn’t need, she added. “It is a very different paradigm than that used for drugs.” She said that companies can also take advantage of solutions in FDA’s toolbox.
Children’s National is leading preparations of the discussion paper, with input from FDA. (Funding for the “Make Your Medical Device Pitch for Kids!” competition is made available through NCC-PDI, a grant program available through the FDA Office of Orphan Development.)
Pediatric device development “needs a dedicated regulatory pathway,” Eskandanian told MD+DI. “The goal should be to bring certain pediatric devices that have established safety endpoints into trusted children’s hospitals, where the highest standards of safety and monitoring are in place, and there is a proven competency in the total lifecycle development of devices. To grant expedited access to these devices, there could be a predefined period in the controlled, monitored environments of these hospitals,” she said. “If we don’t establish efficacy endpoints, the use should be abandoned.” She added that Children’s National is the only children’s hospital that has received a CTSA grant from NIH, as the primary recipient. "This prestigious award is given to medical centers recognized for excellence in clinical research," she said.
"Children’s National also plays a strong advocacy role at the Congressional level in pushing the agenda for more incentives, both carrots and sticks, for pediatric device development,” she said.
The National Capital Consortium for Pediatric Device Innovation 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. NCC-PDI recently added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner Archimedic.