Being a hospital CEO sounds like a mind-numbing, innovation-crushing job to me. I imagine days filled with insurance hassles, egotistical docs, malpractice lawyers, and boring meetings about saving on rubber gloves. At night, I envision wining and dining donors to keep the place afloat.
But in between doing everything that a hospital CEO must do, Tom Hansen of Seattle Children’s discovered what could be a disruptive idea for saving lives of vulnerable newborn babies. Hansen has led a team at Children’s that has invented a prototype called the Hansen Ventilator. It uses technology that’s so simple that it could sell for a fraction of the cost of existing life-support machines, be far easier to use, and save thousands of newborns around the world from premature death.
If any of this materializes, it would be a big deal for global health. An estimated 1 million premature infants die every year worldwide because their lungs aren’t developed enough, and they suffocate. Most of those deaths are in poor countries, where medical staff can’t afford to buy ventilators that cost $30,000 to $40,000 apiece. Even if you donate old ventilators from the U.S. and Europe to people in poor countries, they aren’t likely to do much good, Hansen says, because they are too complicated to operate, are hard to maintain, and aren’t as effective as they could be.
The team at Children’s, with support from PATH, the Seattle-based global health nonprofit, has been working on a ventilator for a couple years. The Children’s scientists just published some intriguing scientific findings from a rabbit study, and are laying the foundation for real-world clinical trials in India that could prove whether they have created a better way to keep premature infants alive and breathing.
“If we can even make a 10 percent difference in that, it would mean 100,000 lives saved each year,” Hansen says. “I could live with that.”
Hansen is no amateur pulling some bigfoot act over the junior staff—he’s a neonatologist by training that has been treating premature infants for more than 30 years, long before he climbed the executive ranks. When he took the Seattle Children’s CEO job in 2005, one of his contract stipulations said he could still keep working in the lab. He talked so fast about this technology during my visit, that I could barely keep up with handwritten notes, and that rarely happens.
“This is the culmination of his life’s work,” says Children’s spokeswoman Teri Thomas.
Still, like almost everything in biomedical research today, this isn’t a one-man project. Hansen is part of a team of about 10 people at Children’s working on this idea, along with Charles V. “Skip” Smith and Rob DiBlasi.
Ventilators today use continuous positive airway pressure (CPAP) that is, like the name suggests, supposed to keep a continuous flow of oxygen through the lungs of infants, via tubes inserted into the nostrils. Pressure is maintained on the exhalation end of the tube by sticking it in water, so when the infant breathes out, he or she sends out a stream of bubbles that are a sign of small pressure vibrations transmitted back into the lungs.
The Hansen Ventilator is designed to transmit higher pressure and lower frequency vibrations than the conventional systems. It’s supposed to make sure there’s always enough pressure in the lungs to make sure the lungs don’t collapse, Hansen says. To keep the pressure from going to zero, the Children’s team tinkered with running the exhalation tube to different depths in the water, and a variety of different angles through which the bubbles are blown out. There’s still a lot left to be explained in terms of the math and physics of this approach, but essentially, the Children’s team thinks they may have hit upon the right formula by placing the tube at a deeper depth in the water and tilting the plastic tube upward in the water at a 135 degree angle, creating just the right balance of pressure to keep the lungs open, without pushing them too hard or flooding them with too much oxygen. The device has two simple dials, not a confusing bunch of bells and whistles like the standard machines, that allows a medical staffer to adjust breathing rate.
The Children’s machine can get its oxygen from a standard industrial tank, and can be made with commodity parts. Hansen estimates that it could be made for $500, making this far more affordable than anything sold to neonatal intensive care units in the U.S.
“I remember saying ‘guys, I think we can build this for a couple hundred bucks,'” Hansen recalls. “So they started building.”
Data to support the technique is still preliminary. The Children’s team ran an experiment with young, healthy rabbits that showed that its method could provide the same kind of lung support as a conventional ventilator. But researchers found that rabbits with severe lung impairment had 50 percent less stress on their lungs when they were on a Hansen Ventilator, compared with a conventional one. The findings were published in June in the journal Pediatric Research.
The next step, of course, is to show this can work in people. Children’s is mapping out its next steps in India, the world’s second most populous country, and which has one of the highest infant mortality rates in the world. Children’s wants to see if it can interest physicians there in a clinical trial, and designing the right kind of clinical trial that could demonstrate the tool is useful.
“All we have to do is prove that it’s just as good,” as existing ventilators, Hansen says, because then people would buy it because of the lower price.
Hansen didn’t offer a timeline for when such a trial might get underway. And since Seattle Children’s Hospital is a nonprofit, it will need a commercial partner at some point to manufacture, market, sell, and distribute this tool if it’s going to ever change the standard procedures for ventilating infants.
That least piece, the distribution/delivery piece of the puzzle, is often the hardest part of the problem to solve, as PATH CEO Chris Elias often likes to say in public talks. Hansen acknowledged it, saying it’s partly why Children’s has sought help from PATH, which specializes in making technological solutions practical in the developing world. Part of the challenge with infant mortality is even getting women to give birth in a hospital setting, which has a ventilator at the ready. And any safety concerns with the new approach could easily torpedo it.
Before I left, Hansen made it clear that he’s not content with just inventing something cool, getting his name on a few scientific papers, and polishing up the CV while he runs the day-to-day operations of a hospital. He wants this to get adopted in the developing world, and maybe even leading-edge hospitals in the U.S., although that will take more time to run trials that will pass scrutiny of the FDA.
“We’ve got a 100-fold advantage on value,” Hansen says. “The hard part will be diffusing it out. But this is so simple, you could have it in a village health clinic.”
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