Anatomy of a Life Saver

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Read this in the latest copy of Design News that was sent to me and I thought it was pretty interesting stuff:

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."

Tragic Inspiration

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.

Continued....

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Dealing with Resistance

At that point, though, the real engineering was just beginning. Miller, now teaming with a design engineer and a quality engineer, soon realized his product needed more power to go though bone more efficiently. Over the course of the next year, Miller and the engineering team tried more than 100 different types of needle tips. They learned that minor changes in pitch — as little as 3 degrees — could dramatically affect the torque, as well as the time it took to reach the center of a bone. They tried various hollow tips, including twist drill tips and paddle tips, along with different shapes, angles and materials, including 316 and 304 stainless steels. Ultimately, they settled on a uniquely shaped, hollow 304 stainless-steel tip manufactured by K-Tube Corp., machined in the U.S. then sent outside the country for injection molding of two pieces of the attached hub.

In concert with the needle design, Vidacare engineers also developed the drill's electromechanical driver. The company won't provide names of vendors or the details of the design, but Miller does say that engineers selected a 30,000-rpm off-the-shelf electric motor and linked it to a planetary gearbox to reduce the speed to about 1,200 rpm. The speed reduction prevents it from getting bogged down and stalling as it bores through a patient's bone.

"We had to have a certain amount of torque and a certain amount of speed to make this drill work," says Bob Titkemeyer, senior director of quality assurance and regulator affairs for Vidacare. "To find a motor-gearbox that was reliable and that we could afford in high volume — that was a chore in itself."

The U.S. Food and Drug Administration, however, was not impressed by any kind of motor-gearbox. "They told us it was dangerous to put a needle into bone using a powered device," Miller says. "We had to do studies showing it was actually safer using power."

After FDA approval in 2004, there was still skepticism. Many in the medical community insisted that drilling would cause infection. "Immediately after FDA approval, we conducted a study on our first 250 patients, and it worked like a charm," Miller says. "It had a 97 percent success rate, saved lives, and had no infections and no complications."

But even after studies had proven the value of the drill, uptake of the technology was still slow, say experts. "We in medicine change very slowly," Bolleter says. "We don't adopt new ideas easily. Most people didn't realize the importance of this technology at first."

Growth Potential

In 2005, however, the medical world began to see the wisdom in Miller's device, which by that time had been dubbed EZ-IO Intraosseous Infusion System.

"There were some early adopters — people who 'got it' immediately," Bolleter says. "Since that time, some of the most prominent physicians and nurses in the country have rallied behind it and written articles about it. But it went slow at first."

Indeed, EZ-IO appears to be taking off now. In 2008, it won The Wall Street Journal's Gold Technology Innovation Award and during the first half of 2009, revenues jumped 30 percent over the previous year. Sales of the device also recently topped the 500,000 mark.

Still, the little company's engineering staff continues to improve the device. To eliminate the possibility of batteries degrading over time, engineers recently switched from eight AA-sized alkaline batteries to AA-sized lithium units, which provide about 20 times as much life.

Vidacare engineers say they got the idea for the battery pack and other improvements from users in the field. "You've got to be willing to do continuous improvement," Titkemeyer says. "We've done an extraordinary job of putting the product out there and then saying, 'That's not good enough.'"

Recently, the engineering staff has begun taking the technology to new medical fronts. This month, Vidacare rolled out a drill-based product known as the OnControl Biopsy System, which enables doctors to shorten painful bone marrow biopsy procedures from seven minutes to about five seconds.

"Patients who have leukemia have to get biopsies four or five times a year, and they hate it," Miller says. "With this, we cut the length of the procedure down to 15 seconds at worst. The patients like it better and so do the oncologists."

The company says it will continue to innovate. Miller is considering branching into areas involving orthopedic surgery, dental care and even veterinary medicine.

"We're still very early in the game," says Philip Faris, the firm's CEO. "We have a high amount of growth potential left."

Vidacare's staff members say if the business grows fast, they're ready. In his office, Titkemeyer keeps a photo of a paramedic, a smiling mother and her child, who was saved by EZ-IO after nearly drowning in a pool. "When I'm working, I look at that picture," Titkemeyer says. "Then I know why I'm putting in all the long hours."



EZ-IO works because veins and arteries pass blood in and out of bones.

Link

Watch an animated video of EZ-IO at work.

Watch a video of an IV being fused into a tibia.

Watch Miller perform a knee aspiration with EZ-IO.

Watch a demonstration of the power and ease with which the EZ-IO can penetrate bones as fragile as an egg.

This fluoroscopy video demonstrates in real time fluids reaching the heart using the EZ-IO inserted into the humerus bone.

Watch an actual demonstration of the EZ-IO being inserted into the humerus.