One tool doesn’t fit all when it comes to surgery.
Pediatric surgeons know this all too well when it’s time to operate on a baby. Some infants are born prematurely. Others have congenital defects — some part of their internal anatomy that just didn’t develop the way it was supposed to.
In other words, plumbing problems. That’s what Dr. Sanjeev Dutta, a pediatric surgeon at Lucile Packard Children’s Hospital in Palo Alto, Calif., calls it. His job is to fix exactly these kinds of problems.
Often times, the instruments he uses when he does these surgeries weren’t built for tiny babies. They were made for adults. “So we sort of struggle with instruments that were never designed for the type of patient that we’re operating on, and we adapt,” he says.
The issue here isn’t really safety, he says. Most of these surgeries are, by now, pretty routine. But pediatric surgeons have to improvise in ways other surgeons don’t. Physically, sometimes it’s pretty awkward.
“Really, I have to stand a foot-and-a-half away from the patient in order to just do the operation, because the instrument is so big,” he says.
Partly because of problems like these, pediatric surgeons have a reputation as mavericks particularly good at improvising. Take Dr. Mike Harrison, at the University of California at San Francisco. He’s known as the father of fetal surgery, working on the smallest patients of all — those still in the womb. Twenty years ago, when the field was just getting started, he says his team had to make almost everything from scratch.
“We had to make all the tools and devices that allowed the fetal surgery — that is the stuff on the mom and the uterus,” he says. “All that stuff we had to make up, because the tools were ten times too big.”
Harrison describes this era — the 1970s and early ’80s — as a sort of golden age of pediatric surgery. A time when you could rig up a new tool, run your own tests on animal models, if necessary, and then bring it into the operating room.
That’s not possible today, though. In the late 1970s, the U.S. Food and Drug Administration began regulating surgical devices, much the same way it regulates drugs. It now can take a decade or longer to get a device through the regulatory process — longer for pediatrics.
Along with the fact that these procedures are rare, it’s had a chilling effect on manufacturers, according to Harrison. “The market is too small to justify the research and development for new devices,” he says. “That’s the fundamental problem.”
So in 2007, in an effort to help spur innovation in pediatrics, Congress set aside a small pot of money — about $3 million for each two-year cycle, split among several different teams. The idea is to bring together doctors and engineers to work on problems in pediatric surgery. Harrison said that traditionally, these can seem like two very different worlds.
Dutta has paired up with an engineer named Pablo Garcia. Garcia works at a non-profit research institute called SRI International, in Menlo Park, Calif. In 2009, he and Dutta received $500,000 from the FDA to fund their collaboration.
Right now, they are standing around a table in Garcia’s engineering lab, rifling through a pile of metal gadgets, or prototypes. Dutta pulls out a tool from one of their very early projects. It’s a favorite of his. It has a plastic grip, like what you’d hold on a paint roller, attached to a thin metal tube with a tiny clamp at the end. The tool designed to treat a condition called esophageal atresia.
“The esophagus, which is the swallowing tube which goes down to the stomach, has a gap in it,” he says. “The child is born with a gap in that tube and so therefore can’t eat.” So Dutta and Garcia’s tool is designed to make surgery on this problem a lot easier, and much less invasive.
But it could be years before this device ever makes it into the operating room. Dutta and Garcia’s grant from the FDA has run out. They hope private philanthropy will sponsor their device to the point where a manufacturer might see the profit in making it.