Doctors and medical staff at Children’s National Hospital in Washington D.C. were recently faced with a life-and-death dilemma. A tiny baby with an underdeveloped heart was in critical condition and would almost certainly die without a lifesaving procedure.
The six-pound girl needed a stent, a tube the width of a toothpick, to give her a shot at life. The plan called for a stent to be placed into an artery in her leg and gently positioned into a blood vessel near her heart, where it would (hopefully) keep blood flowing. When she was bigger, doctors surmised, she would need open heart surgery. The stent, doctors concluded, could buy her the time she needed to develop.
Besides the extremely complex and delicate procedure, the doctors had another problem. There are no stents designed for young children. The smallest stent available in the U.S. is made for an adult’s smallest vein; it isn’t flexible enough for a small baby. The surgeons at Children’s National Hospital had to obtain a smaller stent from Europe and seek a compassionate use exemption from the U.S. Food and Drug Administration (FDA). Precious time was lost.
It was far from a perfect solution. And this is far from an isolated incident, says Kurt Newman, pediatric surgeon and the president and chief executive officer of Children’s National Hospital.
“In the U.S., the development and commercialization of medical devices for children lags significantly behind that of adults,” Newman offers. “Over the past decade, only 24% of lifesaving medical devices approved by the FDA have an indication for pediatric use, and the majority of those are for children 12 years and older.”
A group of researchers, medical professionals and manufacturing experts from Indiana and Purdue universities and Bloomington-based Cook Medical are taking aim at this very serious problem with a groundbreaking partnership.
Purdue, the IU School of Medicine and medical device company Cook are forming a new alliance to focus on the clinical needs of pediatrics. It’s one of the first partnerships of its kind in the U.S. The initiative is led by a seemingly simple premise: Infants and children are not scaled-down versions of adults.
The Crossroads Pediatric Device Consortium will focus on meeting unmet needs for pediatric patients by accelerating the development, approval and availability of innovative medical devices for children.
Cook will provide the alliance with expertise in such areas as product design, regulatory approval and manufacturing.
“There is a huge need and opportunity to develop more options for pediatric care. We know that less than 12% of the National Institutes of Health budget funds pediatric research, and less than 10% of all health care spending is for pediatrics,” expounds Blayne Roeder, Cook’s senior director for corporate development. “Cook has experience creating devices with pediatric indications, and we know the prestige of Purdue’s and IU’s research, so this is a collaboration we’re excited to join. With expertise from all three organizations, we have more resources and more bright minds to innovate new technologies for this underserved patient population.”
Engineer George Wodicka, the Vincent P. Reilly Professor of Biomedical Engineering at Purdue, says there’s a tendency to think a technological solution for an adult medical problem can simply be scaled down to work for children.
“In reality that’s not the case,” he states. “Infants and children have different diseases and clinical problems. So, the research and development of pediatric devices is a distinct undertaking with a unique set of challenges.”
This issue has posed a challenge to the medical community – and young patients – for some time. Though we may not always think of medical care as a business, there is certainly a business component to this issue.
“In short, very few medical devices are FDA-approved or cleared for children. At the root of the problem is that the costs to develop a pediatric medical device are high while the commercial market is small,” explains Dr. Christopher Almond, professor of pediatrics at Stanford University and the director of cardiac anticoagulation services at Lucile Packard Children’s Hospital in Palo Alto, California. “Thus, clinicians are forced to improvise – by squeezing an adult-sized device into an infant or child or by using a device with outdated technology. In both instances, numerous studies show that children have inferior outcomes compared to adults because of the size mismatch or use of dated technology.”
Due to market and economic pressures, few technologies developed for infants and children leave the laboratory. Cook Medical will help bridge the gap between academia and industry, company officials said, by collaborating with Purdue and IU School of Medicine innovators throughout the entire product development life cycle to identify the most efficient path to market and accelerate the translation of their innovative ideas to the clinic.
The Crossroads Pediatric Device Consortium is expected to open doors to new creative biomedical engineering solutions that impact children’s lives. According to consortium officials, it has already attracted interest from additional clinical and corporate partners with complementary expertise that would increase even further the breadth of childhood diseases that could be impacted.
The overarching goal of the consortium is to leverage the strengths of IU, Purdue and Cook to bring life-changing technologies to address the toughest problems in pediatric medical care and help children in need.
“Our jobs as IU School of Medicine faculty and IU Health doctors are to come up with solutions to the problems that our patients face, so this initiative is a seamless integration,” explains Dr. Benjamin Gaston, the Billie Lou Wood Professor of Pediatrics at the IU School of Medicine and a pulmonologist at Riley Hospital for Children. “The opportunity to collaborate with other experts at the intersection between engineering and medicine enhances our creative problem solving. There’s so much we can learn from each other about our respective fields; when you get everyone at the table talking, you get to a solution faster.”
IU School of Medicine’s close alliance with Riley Children’s Health, which provides care to patients in 19 communities across Indiana, will connect consortium researchers with state-of-the-art inpatient and outpatient facilities that supply a pathway for sharing research-based solutions with Indiana children, Gaston adds.
There are few consortiums that have the kind of statewide reach and corporate partnership that the Crossroads Pediatric Device Consortium boasts. In 2018, Stanford University – which is renowned for its medical device making expertise – partnered with the University of California at San Francisco to form the trailblazing UCSF-Stanford Pediatric Device Consortium. But the California consortium is missing one key component the Indiana consortium has.
“We are the first such consortium to integrate major medical device companies as integral members, bringing substantial regulatory, product development, and manufacturing expertise to allow pediatric device translation into patient care at increased scale and scope,” Wodicka explains. “Cook Medical is our foundational partner in this regard. We are working with other Indiana medical devices companies now to add them as members in the near future.”
“There are challenges that have faced pediatricians for decades that, up until now, were almost overwhelming for us to consider,” Wodicka adds. “But now we’re positioned to tackle those through our collective strength.”
As a bonus, consortium members said these efforts will build momentum for the planned institute for engineering in medicine between Purdue and IU School of Medicine that will bolster Indiana’s position as a hub for innovations in health research and patient care.
