Spending time in any emergency room can be an unsettling experience. Often in the ER, the trusted tool of ultrasound is used in a diagnostic capacity to identify or rule out a medical problem. When ultrasound technology is used to guide the insertion of a central venous catheter to the targeted area, it is a difficult and precise demand upon a physician. Today a patient requiring medical treatment that involves a CVC will have a safer, easier time, and so will the doctor. Like the needle he guides to the target vein, Columbia’s Dr. Stephen F. Ridley has persevered for nine years to guide an idea into a reality.
Steve, born in Norwood, Mass. and raised in rural Maine, has made his mark in many fields. He is a born inventor and spent his childhood days building and taking things apart. When asked about childhood inventions, Steve recalls something that would have even impressed Ferris Bueller. “Back when telephones hung on the wall, I spent a day home from school because I was sick. I developed a way to mechanically answer the phone while I was lying on the couch with a system of pulleys and strings all the way in the other room.” A railroad tie spike weighted the receiver, which the patient kept with him, and a tug of the line would allow him to rest comfortably and talk on the phone.
Training and Traveling with the U.S. Olympic Speed Skating Team
Steve also spent his early years running. “I was a runner and paid my way through college running,” he says. “I grew up in the North and also skated my whole life, ending up with an opportunity to train with the Olympic speed skating team.” Steve spent five years training and traveling to places like Calgary and Butte in Europe. He describes it as a wonderful time of travel, new experiences and lasting friendships. “I realized in this past Olympics, it was the last time I would watch anyone I knew. Everyone has grown up and moved on.” With a huge smile Steve adds, “I never made the team, but I got to travel and compete, and I had a great time. It was one of those things you put your heart and soul into. I gave it everything I could. How can I regret that?”
From Engineering to Medicine
Once that chapter in his life came to a close, Steve Ridley worked as an engineer in Boulder, Colo. There he developed specialized urethane foam and urethane foam processing technology for the U.S. Department of the Navy. He was responsible for the design and development of process control systems that remain in use in Navy shipyards today. Steve’s love for the outdoors and biking led to another idea. What about a device that easily reinflated a mountain bike tire without removing the tire or the need for tools? Steve got to work on this, and he also continued to follow his interest in a possible future medical career by taking the necessary prerequisites for medical school. It was at this point in his life that he met and married Greenville native Marcella Hagy.
The year before the couple took the plunge into medical school, Steve patented his mountain bike tire inflator. Even today he is enthusiastic about the invention. “It was excellent, a really excellent device, and it worked.” However, it was “now or never” for medical school, which prompted Marcella to put her husband on “invention detention.” Then came their first child, Stephen, Jr. “Now with one child and more to come, we wanted to be close to family. USC School of Medicine was the answer. I had spent a bunch of money — and we didn’t have any money — on paying for a patent for a really excellent mountain tire device but I never had the opportunity to take it to market because of medical school,” says Steve.
In due time he was thriving under the pace and challenge of emergency medicine at Palmetto Health Baptist, where he served as Chief of Emergency Medicine, and Palmetto Health Richland where he also teaches residents. In emergency medicine, ultrasound is widely used. “At Palmetto Health Richland there are a couple of faculty members who are cutting edge, ultrasound gurus. We have always had a very strong ultrasound program here as part of the emergency medical program. This was true even before ultrasound was mainstreamed. Now, ultrasound training is required for emergency medicine,” says Steve.
Ultrasound is designed to image tissue. “For example, if a patient comes in with abdominal pain, ultrasound can rule out or confirm gall bladder complications, aortic dissection, kidney stones and more,” he explains. “We use it for the heart, and every day we use it for more and more purposes.”
A Million Little Lights
Ultrasound is also used for guidance for vascular access, and this application is increasing due to regulatory pressure. “Ultrasound was never designed to image tiny, cylindrical, highly reflective objects like a needle. Although you can image the needle, you have to image it in a constrained way. The needle has to stay at a shallow angle, and you have to keep the needle precisely in the plane of the ultrasound, which is only a millimeter thick. It is difficult to do, and difficult for many physicians to learn,” says Steve. The doctor and teacher became ever more bothered by this problem, especially as it related to patient care. As always, Steve’s mind began to problem-solve.
“People think of inventions as a light bulb going on, and ‘boom’ you have this idea. It’s more like a million little Christmas lights going on, one at a time, that show you what you’re looking for,” he explains. Three of those lights were the difficulty of the training, possible complications and regulatory changes.
Steve experienced that it was arduous to teach the average physician how to use ultrasound guidance for vascular access. The training took a long time, and even with practice many doctors remained uncomfortable with it. Additionally, although the procedure is relatively safe, complications do occur. The longer the procedure takes and the number of passes and needle insertions required can influence some of these complications. Steve also understood that ultrasound is on the increase, along with regulatory pressure to safely use ultrasound guidance for vascular access. “So all these things made me realize what a problem this was going to cause. These series of experiences led me to decide there has got to be a better way, and I am going to find it.”
Invention Detention Over
Marcella Ridley could temporarily keep her husband, who many friends and family affectionately call “Doc,” in detention. But when Doc presented the basic design of his unfolding invention to her father, Dexter Hagy, she was outnumbered. Steve’s idea was to combine traditional ultrasound imaging with magnets to pick up the hard-to-detect needle. Along with traditional ultrasound imaging, magnetic technology could visualize and track the needle. Marcella’s almost-retired engineer father appreciated many aspects of his son-in-law’s business plan. Patient care would improve, prices would drop and training would be much easier. They were ready to step into the future as partners. Steve says, “Dexter Hagy funded this thing and came up with all of the intricacies of the design. We refined it together.”
The duo hired a team in Boston to create the algorithms and electronics, and they had some prototypes made. Steve and Dexter hired an ultrasound transducer company to create the transducer, which would allow compatibility between existing ultrasound machines and the new device. After a year-long wait, they still didn’t have what they needed and had to go elsewhere. “We had to purchase all of this, and lots of other pieces also had to come together,” says Steve.
Hurry Up and Wait
The main delay was getting through the Food and Drug Administration. “Neither of us had ever had any experience with the FDA. We had no idea how difficult it was going to be and how much time it was going to take. It is not anything a non-specialist could do. It required hiring an FDA specialist. It was overwhelming.” They secured the necessary 510(k) FDA approval once they proved their needle guidance in conjunction with ultrasound was as accurate as they claimed it would be. As they moved forward in the process, Steve Ridley and M. Dexter Hagy co-founded Soma Access Systems LLC in 2004 as a medical technology company that develops innovative devices to solve real-world medical problems while making healthcare safer, simpler and more cost effective.
Supply chain matters were also complicated. “For our two-person company, no one wanted to take the time to provide us with any product,” Steve says. “Just purchasing cables was really difficult if not impossible. Some of the stuff we had to have custom made because we just couldn’t purchase it.”
Despite these obstacles, Steve and Dexter knew this device would be greatly desired because of new mandates to use ultrasound for vascular access. “We knew we were on the right path, but a few times we were afraid we were going to miss the boat because it was taking us so long. Someone else could have beaten us to the punch. We knew from meetings with ultrasound companies that they had been working on this problem for years.”
The Medical Community Welcomes AxoTrack™
With FDA clearance and a tight patent in hand, SonoSite, Inc., a subsidiary of FUJIFILM Corporation and a world leader in bedside and point-of-care ultrasound, announced the launch of AxoTrack™ Needle Guidance Technology in March of 2013. Dr. Ridley began training physicians in the use of AxoTrack™. They are amazed that they can now enjoy real-time visual updates of needle location, and instead of around a 30 percent first pass, first stick success, with AxoTrack™ the initial effort is successful more than 90 percent of the time. The training, which used to be frustrating, complicated and time-consuming, is now accomplished in about 15 minutes. Steve has also trained Soma sales representatives who are now qualified to train others. The sales representatives report tremendous response around the country. In August, SonoSite introduced AxoTrack™ in Europe and has plans for introduction in Canada, South America, Australia and New Zealand in 2014. It is not a wonder that Popular Science Magazine, which Dr. Ridley has always read but not necessarily dreamed of being featured in, named AxoTrack™ one of 2013’s best new inventions.
“It was overwhelming for me the first time I used AxoTrack™. There was so much riding on its success — the health of the patient and nine years of work. To have it work beautifully was just overwhelming. Now I hear back from physicians all over the country who say, for example, ‘I used this device last night on a difficult patient, and it was so easy I can’t believe it.’ It is surreal to realize people out there are using this device that we developed.”
Does an Inventor’s Mind Rest?
Even when Marcella and Steve Ridley were just beginning their lives in Columbia and in medicine, “Doc” received the Sydney Burns Award for Compassion. More recently, in 2012 Steve was named the Jack H. Warren Emergency Physician of the Year by the South Carolina College of Emergency Physicians. The award notes Dr. Ridley’s “innovative efforts and fearless dedication to the pursuit of patient safety and quality of care.” Now that he has a company doing his marketing and selling, will he go back to the inflatable tire? “If I could I would, but the patent is aging.” With typical enthusiasm “Doc” insists, “It is a fantastic concept and it works, and there’s nothing like it on the market.”
As Dr. Stephen Ridley leaves the interview and heads to ICU to train more physicians how to use his invention, he is asked whether he is musing about another forthcoming invention. The irrepressible yet slightly exhausted inventor, doctor, teacher, husband, father and plain “Ole’ Doc” to many people near and far simply smiles.
