Anatomy of a Life Saver
Inventor Larry Miller overcame technical issues, patent problems and institutional resistance in the course of creating a successful medical product
By Charles J. Murray, Senior Technical Editor, Electronics -- Design News, December 14, 2009
No one knows how many lives Larry Miller's drill has saved. Tens of thousands for sure. Maybe hundreds of thousands.
But from the first day Miller conjured up the vision for his medical product while attending a standing-room-only funeral in Texas seven years ago, the path to success has never been easy.
By most accounts, it should have been a slam-dunk. Miller, an emergency room physician, had an eminently logical idea: To restore fluids in patients who have lost massive amounts of blood during life-threatening emergencies, he wanted to use the body's bones. Bones, it seems, transport blood to the heart quickly, just as our veins and arteries do. The difference is that bones don't collapse when blood pressure plummets.
"The vision was, 'There are thousands of people who are dying because we can't get into their veins,'" Miller recalls. "So I said, 'If we can develop a needle and a mechanism to get into their bones, it would save lives and be a big hit.'"
In retrospect, Miller's vision was dead-on. Since he launched Vidacare Corp. in 2001, the company has shipped more than a half-million needle sets and treated more than 350,000 patients with its hand-operated bone drill. Approximately half the ambulances in the U.S. now employ the technology. In a few years, the company's annual revenues have climbed to more than $20 million. Moreover, Vidacare is moving into a new medical arena this month by launching a drill that will take much of the pain out of bone biopsies for cancer patients.
For engineers, though, the real story of Miller's success is one of persistence. During the past seven years, Miller's product has become a monument to the kind of staying power that's needed by every would-be inventor. In the course of achieving success, Miller tried nail guns and drills, worked with thousands of cadaver bones, tested more than 100 needle tip designs, struggled with patent problems, hunted for funding and battled institutional indifference, before finally realizing some measure of success.
"It was astronomically difficult getting this accepted," says Scotty Bolleter, a flight paramedic for San Antonio AirLife and a nationally known educator familiar with the technology. "It's always very, very difficult gaining acceptance in the medical industry, and this technology was no exception."
Miller's journey began after a friend and paramedic, Nick Davila, died in an auto accident. At the scene of the crash, ground paramedics tried desperately to start intravenous (IV) fluids, sticking Davila unsuccessfully nearly 20 times before he fell into cardiac arrest. Although paramedics say Davila's death a few minutes later was not caused by the lack of an IV, the emotional trauma of the event planted the seeds of an idea in Miller's mind. He was determined to find a more reliable way of administering fluids.
"I went to the funeral and there were thousands of people, standing-room-only," Miller says. "Standing there, I said, 'This should never happen.' It was a moment of truth for me."
Indeed, it was a moment of truth for Miller, largely because he understood from previous experience the value of using bones as a conduit for fluids. A decade earlier, Miller tried to launch a product called Osteoport that administered cancer drugs through a connection to the hip bone or tibia. Although the company never took off, the experience served as a lesson for him.
"That's when I first learned about the capability of bone marrow to transfer drugs and fluids," Miller says now.
Indeed, his experience with Osteoport gave Miller a unique perspective, especially in light of his 30-plus years as an emergency room physician. After years at Chicago's Cook County Hospital (the hospital where the NBC drama "ER" was set), he had seen victims of virtually every imaginable illness, accident and violent crime, and had struggled countless times to stick IVs into patients whose traumas had caused their veins to collapse.
"It's a cruel law of nature that the worse a patient needs an IV, the harder it is to find the vein," he says.
That's where Miller's idea came into play. Although bones had rarely been used to transport fluids, emergency medical technicians and physicians knew that they could do the job.
"Coming out of the bone, you find veins, running into bigger and bigger veins," says flight paramedic Bolleter. "It's a dynamic flow. I can measure it with a pressure transducer. I can hook up a bone and show you the blood pressure inside it."
Getting "Knocked Down"
Within days of Davila's funeral, Miller hooked up with biomechanical engineers in the prototype lab at the University of Texas Health Science Center at San Antonio. There, he began work on the sticky problem of finding a mechanism to deliver fluids to the center of a bone.
"We got cadaver bones and started trying different things," Miller recalls. "We shot the bones with a nail gun. That seemed to be a good idea until one of the engineers shot himself through the finger."
Miller subsequently began working with drills, but learned that when he pulled the drills out of the bone, he couldn't locate the hole for the IV. He tried putting funnels into the bones, but that didn't work either.
After more than a year of research, a solution emerged. Growing up in Ypsilanti, MI, as the son of an automotive engineer, Miller had been exposed to manufacturing technology. Eventually, his memories from those days kicked in. "I woke up one night and had the answer," he says. "I remembered my dad had a tiny, hollow, oil-cooled drill. I figured we could use that kind of drill and hook an IV to it."
The hollow drill worked, largely because it provided an avenue for fluid travel. Miller could now keep the drill tip engaged in the hole, while connecting the IV to it.
As the design evolved, Miller applied for a patent. But here, obstacles appeared. Earlier searches for so-called "intraosseous" infusion products (products that inject fluids into bone marrow) had yielded nothing. But after countless hours of research, patent attorneys told Miller that there was another such product that hadn't been noticed previously because it spelled intraosseous with a dash ("intra-osseous") and had therefore evaded earlier computer searches.
"When you're inventing a new product, you have to be ready to get knocked down," Miller says now. "But when I saw that, I said, 'No one will ever invest in us now.'" Worse, the patent was about to expire for lack of payment because the owner had given up on the idea.
Still, Miller wasn't ready to quit. He tracked down the patent's owner, a retired pediatric emergency doctor in Detroit, and traveled to Michigan to visit him. "I said, 'We don't have money but I need your patent and I can give you some shares in our company.' So the patent became ours."
Refining the Design
With the patent reinstated in his name, Miller started looking for funding. But potential investors were dubious.
"I took it around to investors and told people I had this little device that looked like a Dremel drill," Miller says. "I showed them the hollow needle and demonstrated how you could hook an IV to it. But it was too crude. The investors looked at me and said, 'A Dremel drill won't work for this.'"
Miller still wasn't giving up, though. Deciding he needed a more refined prototype, Miller traveled to a medical design show in Anaheim, CA and searched for engineering contract firms that could build one for him. He found five companies, mailed out requests for bids, and waited.
"One company in Colorado wanted $80,000 and six months to complete it, another wanted $40,000 and three months, a third just wanted to do the CAD drawings," he recalls. "Finally, a fourth one — BC Tech in Santa Cruz, California — called and said they wanted $14,000 and told me they could do it in two weeks."
Miller chose BC Tech's bid and, sure enough, had a prototype in hand two weeks later. With the refined prototype, which was about the size of a glue gun and powered by a 9-V battery, he began to attract investors.
"It's amazing how close today's product is to that first prototype," Miller says.