In a recent discussion, Steve Miller, President of EPreward and Medical Materials, shared his story about inventing and patenting an esophageal migration assist device. In 2015, NE Scientific became an Original Equipment Manufacturer (OEM) with the release of the EsoSure Esophageal Retractor (www.esosure.com), a gastric tube stylet designed to move the esophagus laterally with the goal of preventing esophageal damage during left atrial catheter ablations in the EP lab. Steve has been a registered nurse for 37 years, with 15 in the cardiac cath and electrophysiology departments; in this article, he shares his experience transitioning from the lab to the industry side of EP.
Tell us more about your medical background. What interested you about EP?
During college I was unsure of a major, so I took an interest inventory test at the counseling center and it pointed towards nursing. The classes were very challenging for me as I did not have a good memory for details, so I spent a lot of time studying. In 1979, I graduated Sigma Theta Tau - Nursing Honor Society from the University of Northern Colorado — a big accomplishment, considering that I had failed out of my previous college.
I then worked at hospitals in Oregon, Maine, Colorado, and Florida. During the 1990s, I lived on a 40’ sailboat and taught sailing and navigation while taking people to the Bahamas. I worked per diem in ERs in the Ft. Lauderdale area when I wasn’t on a charter. Living on a boat, you constantly have to fix things, which fit me well. Although it was a wonderful time in my life, there were many months where I had less than $100 in the bank, so I began working full time around 1997 to save for an eventual retirement.
I worked in my first cath and EP labs at Northridge Medical Center in Ft. Lauderdale, and loved it. At the time, it was the premiere cardiac hospital in the county. However, there were occasions when some of the nurses would berate me because I was not good at remembering all of the steps in a procedure or the different pieces of equipment needed. To help compensate, I made 3x5 cards for these things and carried them in my scrubs. However, I loved solving problems. If something didn’t work or there were difficulties with a patient or family, I would often be called to find a solution. A few years later, I moved 20 miles north to the busy cath and EP labs at JFK Medical Center, where I worked for about 9 years.
Tell us about your time with EPReward. How did you make the transition from the lab to industry?
During my time at JFK Medical Center, the staff had been cutting the EP catheter tips and sending them out, and that responsibility was eventually passed down to me. Our lab worked with several EP catheter companies, but in my experience, they all paid poorly and had lousy customer service. I knew that I could do a better job, especially since these proceeds were used to assist EP departments with continuing education and departmental needs. So in 2003, I started EPreward (www.epreward.com) to provide platinum recovery services for EP catheter tips, and organized online EP education programs on our website for free. We have since expanded to buying whole used EP catheters, ultrasound catheters, and Agilis sheaths from EP labs as an alternative to reprocessing.
As EPreward grew, I gradually reduced my hours in the EP lab over the next 6 years. My first employees were next door neighbors. Two of them have been with me for about 10 years now and are wonderful people. We now have 10 great employees who are independent, collaborate well, and do an excellent job.
In 2010, I started Medical Materials, Inc. (MMI) (www.medicalmaterials.com) as an offshoot of EPreward. When I worked in the cath and EP labs, it would drive me crazy to do 6-month inventories and throw out dozens of catheters, stents, balloons, etc. worth tens of thousands of dollars because they had expired before they could be used. MMI’s goal is to redistribute “idle inventory” from a hospital that is not using devices on their shelves to another hospital that can use them. We also purchase expired products from EP and cath labs that can be used by research, education, and R&D departments. We are helping grow medical technology, saving hospitals money, and aiding the environment in our own little way.
Tell us about how the EsoSure came about.
In 2005, I worked with a patient who developed an atrial-esophageal fistula and nearly died. He was fortunate to have it diagnosed the day after the procedure, because patients usually do not get symptomatic until 2-4 weeks later when it manifests as sepsis, a stroke, or an embolic event. About 90% of these people die. In his case he was treated successfully, but when I found out what had happened and how close he had been to dying, I felt terrible and wondered how we could prevent this complication from happening again.
I was fortunate to have access to a fluoro unit at a business my wife (a health physicist) worked with, and there I put a gastric tube down my mouth, hopped up on the table, and took a baseline image. Then I took an .035 guidewire, bent a curve in the end, and slid it down the lumen of the tube. We took another image and saw that the esophagus was moved off to the side 1 cm or so. At this point I knew my idea could work, I just needed a little stronger wire and a different curve, and I continued tweaking the different aspects. The esophagus moves side to side all by itself and I felt that mimicking its natural migration would be the safest way to move it. The county morgue was a great resource during this time, as they obtained permission to let me work with a cadaver, although it’s much more difficult to move the esophagus in a cadaver.
Other steps taken to design the EsoSure included hiring a radiologist to take linear measurements of the GI tract from 53 CT scans, conducting two different animal studies at one of the premier medical facilities in the world, having NE Scientific work with different manufacturers and hiring Ximedica to review their results, and having initial users trial the EsoSure in their procedures. On five different occasions, I have also had over 17 different shaped stylets inserted into me. All of this was to help create a safe and effective device. I wouldn’t want to move forward and have this device used on the general public if I hadn’t done everything possible to avoid potential patient complications. As of February 22, the shape of the next generation EsoSure Plus has been determined and it will feature a temperature programmed Nitinol stylet, which will be soft at room temperature for easy insertion into the OG tube, then assume its curved shape at body temperature.
Approximately how long did the patent process take? Tell us about the link between this product and that initial patient in your lab.
It took about 4 years to get through the patent process. However, before the patent process even started, I had asked for feedback from Dr. Robert Fishel at JFK Medical Center where I worked. I showed him my idea for this product and asked if he thought this technology was feasible. He said yes, and recommended I explore a patent for it. Then at my first appointment in the patent office, I met with two patent attorneys, one of which was our patient who had the atrial-esophageal fistula in our lab! He had seen my invention and was beside himself, because he nearly died from this complication. He is a great guy and has been wonderful to work with, and as you can imagine he takes a personal interest in this product. It is really neat story — one that would be hard to write.
What are the next steps with FDA approval and commercialization?
After being unable to navigate the FDA regulatory process on my own, I signed an agreement with NE Scientific (www.smarthealth-care.com) to finish getting the product to market. Ten years since it was first envisioned, it is just about ready to be used on a large-scale basis.
All the regulatory and manufacturing aspects are now taken care of by NE Scientific. The device is currently registered with the FDA as a Class I device and they are working on a Class 2 status. They also have longer term studies set up with Yale University Medical Center and the University of Michigan. In addition, we have initial users, such as Dr. Vijay Swarup at the Abrazo Arizona Heart Hospital, gathering early data on the device to show how it performs in real life.
I believe the EsoSure has the potential to facilitate atrial fibrillation ablations in a couple of additional ways. If clinicians are able to move the device 2 to 3 centimeters to one side, it may have an impact decreasing procedure time, as an increase in distance from the ablation catheter to the esophagus may possibly reduce or even avoid the frequency and duration that ablation energy needs to be stopped to allow for cooling based on temperature probe measurements. Another benefit may be where the displacement of the esophagus will allow physicians to create ablation lesions in target areas which they may otherwise avoid or feel compelled to reduce ablation energy due to the underlying esophagus. However, the results of studies done by independent investigators will be necessary before we know to what extent these goals can be reached. We are very excited about the possibilities of the EsoSure, and to top it off, EPreward will be the distributor for the device.
What advice do you have for those working in a lab and have an idea for a product?
EP nurses and technicians are very smart people who recognize all sorts of issues currently happening in the lab, including things that don’t work as well as they should. I encourage these folks to evaluate the problems, try solutions, and if they work, go forward and see if it is something that can be developed into a successful service or product. I think people shy away from these steps simply because they do not know whether or not they can do it. My recommendation is to go ahead and find out. The staff I’ve worked with in the past have all been very intelligent and skillful, and probably could have solved this problem long before I did. I’m sure there are people who will read this and say, I thought of that idea a long time ago! But I was the lucky one to take those first steps. I found my strength in problem solving and am not afraid to work hard, so I encourage others to take those steps, because if I can do these things, they can as well.