Fetal heart surgeries are one of the most delicate operations in medicine. Surgeons operate on a heart the size of a large grape, through an incision less than 3mm wide, guided only by grainy sonogram visuals. Because specialized tools don’t yet exist, they use repurposed medical devices designed for adults. Researchers in Texas A&M University’s Department of Biomedical Engineering want to change that by developing innovative solutions in biomedical engineering and business design.
The problem
Because the pediatric medical device market is so small, few specialized tools are manufactured, leaving surgeons with little choice but to adapt adult devices for fetal procedures.
“We did a very exhaustive analysis of the entire clinical literature on which devices are being used today across the world to do the various fetal cardiac procedures, and we were shocked at the amount of adult device off-label use,” said Dr. Balakrishna Haridas, a professor of practice in the biomedical engineering department.
“Off-label” refers to the use of devices for purposes other than those intended by the manufacturer.
“Physicians will customize something that's larger or customize something that's not intended for that particular use and modify it to make it work,” Haridas explained. “For some of these operations, if it's not done properly, 75% to 80% of those babies die at birth.”
Haridas presented his findings in the Pediatric Devices Sessions at the Design of Medical Devices Conference this April in Minneapolis, Minn. He was joined by fellow Texas A&M researchers Dr. John Criscione, Elizabeth Tenorio and Achu Byju, who presented technological breakthroughs in various areas of pediatric device development. The University of Minnesota hosted the pediatric sessions of the conference in partnership with the Southwest-Midwest Pediatric Device Consortium, an organization funded by the Food and Drug Administration (FDA) for the purpose of developing pediatric medical devices. It is led by Texas Children’s Hospital (clinical lead) and Texas A&M (academic engineering lead). As a co-founder of the initiative (along with founder and director, Dr. Chester Koh of Texas Children’s Hospital), Haridas serves as the consortium’s deputy executive director.
Criscione, a professor of biomedical engineering, presented a new pediatric heart compression device design that could avoid the high mortality rates associated with current technologies used during complicated recoveries after pediatric heart surgery. Tenorio, a biomedical engineering doctoral student, presented research on the design of materials for temporary medical devices that could safely break down after use. Byju, a biomedical engineering senior research engineer and Ph.D. candidate, revealed his preclinical work on a new medical device for a high-risk fetal heart surgery, one of the procedures that currently relies entirely on adult tools that are manufactured for other purposes.
If we don't do work in pediatrics, I don't think anybody will. It's something that the academic arena can do because our time scales are long and our monetary needs are relatively small. We can just percolate along and make progress, much more so than a company could.
Despite their potential to save lives, these engineering breakthroughs face significant challenges in being manufactured.
“It's an incredibly tiny patient population,” Byju explained. “There is no market for it.”
“Companies just don't stand to gain profits at the scale that they want from making devices for treating pediatric patients and as a result, they do not pursue the development of solutions for this vulnerable population,” Haridas added.
The solution
The key to solving the shortage of pediatric medical devices may lie in university-led innovation — with institutions like Texas A&M and Texas Children’s Hospital playing a leading role.
“If we don't do work in pediatrics, I don't think anybody will,” Criscione said. “It's something that the academic arena can do because our time scales are long and our monetary needs are relatively small. We can just percolate along and make progress, much more so than a company could.”
With funding from federal agencies like the FDA and private foundations focused on impact over profit, university departments like Texas A&M's biomedical engineering are uniquely positioned to engage in the labor-intensive research and development process required to invent new medical devices. Once a device is proven effective and receives FDA approval, researchers can then turn to investors.
“You can say, ‘I'm not using your money to do expensive research and development, I'm using your money to build a sales force and grow a business. You put in a few million today, and in five years, I'm going to build a $20 or $30 million business, which will return this investment back to you with the return on interest you are looking for,’” Haridas explained.
The payoff
The university-first approach may already be yielding unexpected rewards. In the Haridas lab at Texas A&M, Byju’s work on the fetal heart device — developed for a market considered too small to be profitable — may have created a much more lucrative opportunity. The same technology can work for adult heart failure patients, with a much larger market size and far larger profit margins. Without Texas A&M researchers pursuing the more challenging and low-profit-margin pediatric problem, this larger breakthrough would have never been discovered.