If you’ve ever spent time in Silicon Valley or among hi-tech entrepreneurs, you may have heard the term “Valley of Death.” It’s used to describe the huge gulf that can exist between coming up with a new idea, and getting a product to market.
It's a problem in hospitals, too. Just take the neonatal intensive care unit at the University of California San Francisco.
On a recent morning, Mardi Thompson was swaddling a baby the size of a burrito with firm assurance. She's been a nurse here for 13 years.
Some of the babies who come through here were born prematurely. Others were born with congenital defects; some part of their internal anatomy didn’t develop the way it’s supposed to.
"Maybe their diaphragm is missing, or part of their intestine is outside of their chest," says Thompson. Some suffer from a condition called esophageal atresia, in which the child's feeding tube isn't properly connected to her stomach. That condition affects roughly one in every 4,000 children.
Working with Tools Too Big for the Job
They are what Sanjeev Dutta refers to as "plumbing problems."
Dutta is a pediatric surgeon at Lucile Packard Children’s Hospital, in Palo Alto, where he operates on children with these and other problems. He says often, the instruments he uses when he does these surgeries weren’t built for tiny babies. They were made for adults.
"We struggle with instruments that were never designed for the type of patient we are working on, and we adapt."
Dutta says the issue here isn’t safety. Most of these surgeries are, by now, pretty routine. But pediatric surgeons have to improvise in ways other surgeons don’t.
Working with tools that are several times too large for his tiny patients, Dutta is sometimes forced to stand a foot and a half away from his patient.
Size isn't the only problem pediatric surgeons face. Many pediatric procedures are specific to infants and children, fixes to problems that, unaddressed, would be fatal. In such cases, often the right tools simply don't exist.
Partly because of problems like these, pediatric surgeons have a reputation as being mavericks, people who are particularly good at improvising the tools they might need to operate successfully. No one fits that mold as well as Michael Harrison, at UCSF.
A History of Improvisation and Innovation
Harrison is known as the father of fetal surgery. He says twenty years ago, when the field was just getting started, his team had to make almost everything from scratch.
"We had to make all the tools and devices that allowed the fetal surgery, [the tools for] the the mom, and opening and closing the uterus. 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 golden age of pediatric surgery, a time when you could rig up a new tool or procedure, run tests on animals, if necessary, and then bring it into the operating room. He says he never felt like they had a choice.
"It’s almost a moral imperative. It’s usually in a circumstance where this kid is going to die. The only way we think we might be able to save him is this new way. We’d have to have this thing. Let’s do it. And that’s what we can’t do now."
In the mid 1970s, the FDA began regulating surgical devices, much the same way it regulates drugs. It can take a decade to get a device through the regulatory process, sometimes longer for pediatrics.
Harrison says this -- along with the fact that many pediatric surgical procedures are rare -- has had a chilling effect on medical device manufacturers.
"The market is too small to justify the research and development for new devices," he says. "That’s the fundamental problem."
In 2007, Congress passed the Pediatric Medical Device Act, which set aside a small pot of money, administered through the FDA’s Office of Orphan Products, to spur innovation in the field of pediatric surgery.
The program was initially intended to receive $6 million for each two-year cycle, but appropriations have come out much lower: $2 million dollars for 2009-2010 and $3 million for 2011-2012.
The idea is to bring together doctors and engineers to solve problems in pediatric surgery. These are the kinds of partnerships that Mike Harrison has been trying to forge for a decade. He says it can be a culture clash.
"We’re, you know, sort of blood and guts. We're saying, 'hey we've got to have this device, we’re going into the operating room tomorrow.' And they were thinking nanotechnology and PhDs."
Developing Tomorrow's Kid-Sized Tools
But the FDA money is making these partnerships routine at a handful of institutions across the country, including Georgia, Michigan, and here in the Bay Area.
UCSF has received about a million dollars since 2009. That money has supported the development of tools to treat scoliosis, kidney failure and sunken chest, among other conditions. The pectus, or sunken chest device, is in clinical trials.
In Palo Alto, Sanjeev Dutta has paired up with an engineer named Pablo Garcia, from SRI International, in Menlo Park. In 2009, he and Sanjeev Dutta received 500 thousand dollars to fund their collaboration.
Garcia says there was an adjustment period on both sides, as he and Dutta learned how to collaborate. "When you actually put yourself in shoes of surgeon, things you thought were important actually are not. And things that you overlooked turn out to be the driving factors."
At one of their first meetings, says Garcia, Dutta asked whether a certain robotic instrument could be made smaller. "Sure," said Garcia. "But it'll take five to ten years."
One of the projects Garcia has developed in collaboration with Dutta is a catheter used to deliver nerve blocks to kids who have broken, for example, an arm or a leg.
Current catheters, says Garcia, "are placed blindly, based on anatomical landmarks, and they often get dislodged. So the catheter we designed has some features in the tip that allow it to grab onto the tissue, lock onto it, and navigate it in a more effective way than the current catheters."
One of Dutta's favorite tools is a device used to treat esophageal atresia. The surgery is complex and often invasive. Dutta says many surgeons rely on the same techniques they've been using for decades. A newer, less invasive method is becoming more common, but it's technically very difficult. Dutta and Garcia have developed a tool designed to make the less invasive procedure much easier, so that more kids can recover faster, and with less scarring.
The tool is just a prototype now, with many stages of trials standing between it and the operating room. With Dutta and Garcia's FDA funding running out, they'll need to find other ways to fund their work on this and other devices. Dutta hopes that private philanthropy can bridge the gap between R&D and commercialization.
Dutta says he knows, from the perspective of a commercial manufacturer, that the market for a tool like this is just too small to be profitable. "Eyes glaze over," he says, "if they hear ten thousand cases a year."
But what people need to realize, he says, is that the market could be a lot bigger. What’s helpful to kids could be useful in adult surgeries, too.
"What we need to do is figure out how we can connect the two markets," he says, "and make them sort of symbiotic."
In other words, Dutta and others are learning how to be not just surgeons, but entrepreneurs. Their business will be nurturing these products to the point where someone else will see the profit in making them.