Over the last decade, pediatric medical devices have made up only about 25% of all healthcare devices approved by the FDA. The medical community is eager for change.
In November 1989, expectant mother Sandra Muncy was sitting at home when her water broke. Although she might have been filled with excitement, Muncy only felt fear. Her baby was nine weeks early and complications were inevitable.
At the hospital, physicians rushed Muncy into an emergency C-section. Her baby was breech with a nuchal cord, and his heart rate was dropping. With no time to administer pain medication, Muncy was placed under general anesthesia and Andrew, a 3.9-pound premature baby, was born.
The first time Muncy saw her baby, it was inside an incubator through an obstruction of wires in the NICU, where he was connected to an IV, oxygen, NG tubes and a cardiopulmonary monitor. Fortunately, his providers had easy access to the pediatric medical devices he needed to survive, and today, Andrew is a healthy, 6’9” adult. Some children, however, don’t have such a happy ending because the devices they need to thrive don’t exist.
Shoring Up the Device Shortage
In the United States, just under 25% of FDA-approved medical devices are designed and marketed for children, and less than 4% of those are for patients ages 2 and younger. As a result, pediatricians are often forced to use a device off-label. For example, surgeons sometimes use adult biliary tract stents in place of pediatric heart stents.
“Sometimes there isn’t a suitable device solution for kids, which means we can’t treat our pediatric patients the way they deserve,” says Gwenyth Fischer, MD, Director of The Pediatric Device Innovation Consortium and Pediatric Critical Care Physician at the University of Minnesota Masonic Children’s Hospital Pediatric Intensive Care Unit and Cardiovascular Intensive Care Unit. “The problem with this is that those devices weren’t tested in kids and aren’t meant for the purpose we are using them for.”
In other words, pediatricians often don’t have the data needed to know if the devices they’re using off-label are safe and effective for children. Although the practice is legal and common, off-label use is not ideal and places the responsibility on physicians and parents to decide if an adaptable device is the best choice for their patient/child.
When there are no adaptable devices at the physician’s disposal, children may be left with potentially inferior options such as medication, invasive surgery or watchful waiting.
The Setback in the Process
Pediatric medical devices must undergo the same FDA approval process as adult devices, which involves:
1—Creating a prototype
2—Testing the prototype first in benchwork, then in human trials after FDA consultation
3—Product approval and going to market
But unlike adult devices, pediatric technology lags significantly behind.
According to Juan Espinoza, MD, FAAP, Principal Investigator at The Saban Research Institute and Director of The West Coast Consortium for Technology & Innovation in Pediatrics at Children’s Hospital Los Angeles, the reason for this lag can be split into four distinguishable categories: clinical, technical, regulatory and financial.
Clinical and Technical Considerations for Pediatric Device Approval
Pediatric patients are physiologically and neurodevelopmentally different from adults. When developing devices for children, researchers must be cognizant of the long-term growth of the child, and therefore, the long-term growth of the device.
“Medical device developers must consider the progressive growth of pediatric patients, which may impact the size, function and design of a device,” writes Dr. Espinoza in “Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities” published in Pediatrics. “Physiologically, multiple organ systems, such as the cardiovascular, respiratory, and renal systems, change from childhood to adulthood, with significant implications for medical devices.”
This means researchers aren’t developing one device for approval; they’re developing at least six — one each for neonates, infants, toddlers, school-aged children, teenagers and young adults. However, some materials or designs won’t work for miniature-sized models, making device engineering difficult and requiring developers to find other technology or draft new designs that work on a smaller scale. Even then, regulatory issues can present additional challenges.
Human trials require researchers to test on children. Because children are a protected class, this presents a unique set of challenges and delays, particularly in regard to institutional review board (IRB) approval. Even when researchers receive IRB approval, they must find children whose parents will agree to testing, making recruitment difficult.
Financial consideration is the biggest barrier to pediatric medical device development and approval because pediatrics occupies a fraction of the healthcare market.
“Most pediatric medical devices are for a much smaller market than adult devices,” Dr. Fischer says. “This makes it difficult to find funding to get through the various development phases of a medical device.”
Dr. Espinoza agrees that financial incentives are low for companies investing in pediatric medical devices.
“If a company makes a vascular graft, for example, they have two choices: they can either make an adult graft and have 3 million customers a year, or they can make a pediatric graft and have 600 customers,” Dr. Espinoza says. “There’s no magical price they can put on a per unit cost to recoup that difference. Finance is the single largest gap we need to close.”
Hope Is Not Lost
Pediatric medical device development may lag significantly behind that of adult devices, but improvements are underway. The FDA established the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD). SHIP-MD’s framework is to connect qualified children’s hospitals that are evaluating the safety of pediatric medical devices with the intent to accelerate development, reduce risk and stimulate investment.
With SHIP-MD, researchers hope to close developmental and approval gaps in pediatric medical devices. When this happens, providers will be able to give more children — like Andrew — a chance to grow up healthy.