Marybeth Spanarkel, MD, FACG, on Developing a Medical Device

by Jill Gaidos, MD, FACG

Dr. Marybeth Spanarkel & Dr. Jill Gaidos

I met Dr. Marybeth Spanarkel at a GI conference several years ago, where she was demonstrating the use of the ColoWrap®. In researching for my upcoming talk on Other Career Options for the ACG Bridging the Leadership Gap in GI conference, I reached out to Dr. Spanarkel to find out more about the pathway to developing a medical device.

Jill Gaidos (JG): There is very little about you on the internet. All I could find was that you received your medical degree from Duke University and then worked as a private practice gastroenterologist in the Durham, North Carolina area for 20 years.

Marybeth Spanarkel (MS): I went to Marymount College in Carytown, NY. From there, I went to Duke Medical School and graduated in 1979. I went and did my internal medicine internship and residency at the University of Pennsylvania in Philly, and from there I went to the National Institutes of Health and Johns Hopkins and did a combined bench research and clinical fellowship, at those two institutions. I was being groomed for more of the bench research/academician. I was offered a job down at Duke. At the time, Dr. Ian Taylor was the Chief of the GI division. Serendipitously, was also offered, at the same time, a private practice position at the Duke private hospital. It was a very big decision at the time because I was groomed as a researching academician, and to make this leap into private practice…but I had some really good mentors at the time who told me to ‘follow your heart, follow your passion.’ I had come to realize at a very early stage in my career that what I really loved was clinical medicine. So, I cut that academic umbilical cord (with some folks telling me I was cutting my throat, at the time) taking the private practice position, and that is where I remained for 28, almost 30 years—at the Duke private hospital in Durham. What then happened was, sort of toward the end of my career—I didn’t realize it was going to be the end of my career—until I had a sudden injury. A minor, but sudden, injury which resulted in a slipped disk in my neck and paralysis of my right arm.

JG: Oh my gosh!

MS: Yeah! I actually had 12 colonoscopies scheduled for the following day and had to cancel everything and find out what the heck was wrong with my arm. I went through the MRI, subsequently had neck surgery, then had a frozen shoulder and had minor shoulder surgery, 6 months of physical therapy. And basically, had to end my career because of the persistent weakness and numbness in my right arm. Shortly before this happened, I was developing an idea about ColoWrap®. The idea sprung from recognizing over 28 to 30 years what was a ubiquitous problem in colonoscopy, which is sigmoid looping, that results in all the torquing and turning and all of the current interest in ergonomics for physicians. I and other physicians over the years would try an abdominal binder—there must be an easier way to do this. When you think about manual compression, which is what most people use, in conjunction with patient repositioning, it is a little barbaric. In the era of all these technically fine scopes and advanced AI, what we are doing to knead the patient’s abdominal and get the scopes around? What I saw was a problem, this sigmoid looping, and what I tried to do is develop an external compression device. There must be some way to do this. We investigated different textiles and I had the advantage of having some wonderful patients who let us try it. Really, what you need as a clinical are people who are skilled in the execution of ideas. As serendipity would have it, I have two sons who are MBAs and one has an MBA/JD degree; both are entrepreneurial spirits but they were the ones who took my idea, along with my clinical background and experience, and executed the idea of a medical device. And so, what we tried to do was to simulate manual compression. And manual compression is not 100% effective—nor is the ColoWrap®—but what we found, particularly with the newer model of the ColoWrap® and its variable compression limb, it indeed replaces manual compression and the need for patient repositioning. So, why was this good? Well, all these fancy scope companies were trying to do stiffer scopes and more flexible scopes and scope straighteners and variable tension. But nobody had come from the outside and said, “What works? Manual compression. So, let’s try and simulate manual compression.” So, what happened was, we found that the patients were more comfortable; that they needed, oftentimes, less sedation; the doctor needed less torquing, and the ancillary staff, the nurses and techs, were not having to apply all of this continuous manual compression, which we believe has resulted in one out of three or four of our endo nurses begin injured. Then we started to look at the economics of injuries, both in our ancillary staff and in our physicians, one-in-five or one-in-six physicians are being injured. Such a simple but elegant solution could offset this enormous cost for workman’s compensation and career-ending injuries. It’s how, over the last three to five years, we have developed into a small but relatively successful medical device company. Now, along the way, what I learned coming from an academic and research-oriented position to then 25 to 30 years of clinical practice, was I had to learn a new industry. It’s not just developing an idea or an entrepreneurial pursuit, but I have learned the ins-and-outs of business development, angel investment and series A and series B investment, medical device regulatory concerns, legal liability concerns, and how industries can manipulate data for the clinicians. We, clinicians, we were trained as smart people who were A+ students, who require good performance to get into medical school, and—with our heart and souls—approach basic science research and clinical research with not only passion but with an expectation that it is all honestly presented and credible.

“We, clinicians, we were trained as smart people who were A+ students, who require good performance to get into medical school, and—with our heart and souls—approach basic science research and clinical research with not only passion but with an expectation that it is all honestly presented and credible.”

JG: Absolutely.

MS: And what I have learned in this industry is that we sometimes naively accept things that require a little bit more cautious interpretation. I think what I now lend to the company, to ColoWrap®, is I’m very cautious about credibility and about presenting things that are accurately accepted. It has been an eye-opener to be in the medical device corporate world. It has been an incredibly rewarding position to be in to be able to consult and to be able to stay part of the community of gastroenterology but to see it from a completely different perspective at the end of my career. I feel very fortunate to have this perspective now and to be in this position. And, to be honest with you, Jill, I love being part-time. I love the lack of stress from a clinical perspective and from an expectation about your performance by your bosses and by the people who we think count, you know, interpreters of our performance.

JG: Can you tell me about the process to get ColoWrap® from a prototype to having it on the market?

MS: That is a very interesting pathway, to take a medical device or to take an idea to the medical device market. It is nowhere near as simple as one would think. First of all, what we did with ColoWrap® was to develop the idea. The problem is ubiquitous. There is not a colonoscopist that I have met over the past 30 years who doesn’t recognize that looping and insertion of the scope is a problem. Then, we developed several ways to simulate manual compression. We went to a variety of textile experts, we went to different biomedical engineers from Duke, we had the ability to test different prototypes because I had some wonderful patients who allowed us to test some of the early prototypes. We then made a prototype and had some early on testing with it. From there, we went on to further biomedical engineering to further develop the adjustable strap. That is not an easy process. You need legal counsel. You need regulatory counsel. You need experienced clinicians that can offer guidance in that process. You need someone who understands the importance of the problem that you are trying to correct. I certainly was in the position, by serendipity, to have those entrepreneurs with a business background available, but it was the combination of their interest and experience with 30 years of clinical experience that kind of made this flow a little bit more smoothly.

JG: About how many years to do you think this process took?

MS: From start to launch on the commercial market it probably took about two to three years. And, then, in the last two to three years that it’s been on the market what we then had to do was shift our attention to sales, marketing, and advertisement. Which, in and of itself, is a whole new learning experience in a whole new industry. As a small medical device company, it is very difficult to compete with large companies that have endless budgets, endless monies for lobbying, and huge budgets for clinical studies. But, if you still maintain your perseverance and your passion for your product and you believe in your product, then with word of mouth and good clinical advertising, it slowly but steadily catches on. We have a small sales force in marketing. Some of these big pharma companies, they have 150 to 250 salespeople alone. It’s very difficult to compete with their ability to get into a very difficult market. Medical device is not only under the auspices of incredible regulatory concerns, but it’s very difficult now to get into hospitals to show the physicians, to show the ergonomics and risk management people, to show nursing staff folks why it works, how it works. Then you have to go through value committees on hospitals, then get it in the place to be tried. Then you begin the coding nightmare, how to get it reimbursed by coding which, in and of itself, takes years. It is not an easy market to infiltrate, but it certainly has been an eye-opening and enlightening third or fourth career for me.

JG: You mentioned currently being part-time. Do you have any patient care responsibilities?

MS: No, I don’t. The reason being, I had explored—both at UNC and at Duke, teaching positions. What I recognized was that, with the disability in my right arm, I could not teach procedures. I could not be in a position where I had to take over the scope, for liability reasons. So, my launch into ColoWrap® coincided with my very difficult decision to retire from clinical medicine. I really loved being a practicing clinical gastroenterologist. So, I went into ColoWrap® as a clinical consultant—Senior Medical Advisor is the actual term. And, I really do that part-time. They have issues that come up—editorial issues, clinical accuracy issues on some of their writings; they do a blog, I review all of the blogs for accuracy and I go to some of the sites where there are clinical trials going on just to answer questions and be available. We have one site, the VA hospital in southern Arizona has been just a really stellar place where they initiated a protocol for everyone with a BMI over 30; they use a ColoWrap® for injury protection for their staff. So, we have been out there a few times. Their ergonomics and nursing manager staff have been excellent in putting this protocol into place.

JG: Can you give me an idea about what people could expect salary-wise from the development of a medical device? Would most people be able to do this as a side job or is it something they could transition to full-time?

MS: In a start-up experience, such as ColoWrap®, most of the time what you are trying to do is acquire angel investors to support the start-up of a project. Usually there is no salary, at that time, there are stock options. As the angel investors and then the series A and series B, those people start to invest. They can really invest with stock options as opposed to a salary. How I am reimbursed is basically with what’s called redirected stock options so that as I contribute time and medical expertise, my stock options increase in the company. There are a lot of people who have approached ColoWrap® to become medical consultants and they can really recognize that it is reimbursed as a stock option. As a company gets further on in its revenue stream, there are a variety of ways to get reimbursed. Lots of times they will take on somebody—not ColoWrap® because I do most of the senior medical advising; with 30-years of experience there’s not much to be gained other than with a big name in GI, but most of those big names in GI will take stock options as opposed to a salary. Now, in big pharma and big medical device companies there are reasonable expectations to provide a full-time position with a salary comparable to one in academics would. Those physicians take on CEO or major management positions where the compensation would be higher.

JG: Any advice for others who may be interested in creating a medical device? Any words of wisdom?

MS: Yes. First of all, my entering the medical device market with ColoWrap® coincided with my leaving the practice. So, as a practicing and licensed MD, one would need to get legal counsel so that their positioning in a medical device company would be regarded as savvy, would comply with all the rules and regulations, Stark rules, etc. I think that most academic positions, if you develop a medical idea while you are on staff as an employee at an academic position, the device is at least partially owned by the academic institution, your boss.

JG: That is what I was thinking too.

MS: You could certainly find out a little bit more about that. I think if you are an employee of Duke and you develop a medical device as an employee at Duke it becomes, part and parcel, their ownership. I would be careful with that. I would also say that if you strike out as a clinician, you have to have people who are understanding of how to develop a business model, how one goes about getting investors, how one goes about complying with regulatory concerns—Stark rules, and medical devices. You must have somebody who can protect and develop IP (intellectual property). My son, who is the CEO of ColoWrap®, has an MBA and a JD. He understands patent law and was able to get the device securely patented with multiple patents pending and with international patents. Because my idea was developing toward the end of my clinical practice and I serendipitously retired, I entered the medical device [field], and because also, serendipitously, I had two young, business entrepreneur-minded people, the execution of ColoWrap® was streamlined. But I highly recommend getting people who understand patent development, the medical device field, and regulatory concerns, as well as protecting an MDs position in the execution of a new idea because you can’t look like you are referring to your own company. I think, interestingly, what I have become aware of in corporate medicine is the ability to manipulate some of those studies to promote the revenue stream of the company. It was something I was not clearly aware of as a practitioner, the ability to manipulate that kind of data. That’s not everybody, but we as busy clinicians will just often just read the headlines of a study.

What I have become aware of in corporate medicine is the ability to manipulate some of those studies to promote the revenue stream of the company. It was something I was not clearly aware of as a practitioner, the ability to manipulate that kind of data. That’s not everybody, but we as busy clinicians will just often just read the headlines of a study.

JG: That’s true!

MS: You have to be careful and go down and read the study methodology and the conclusions because we can be influenced and it’s not necessarily as pure of science as I once thought. It has been an eye-opener for me.

JG: Absolutely. That is all of my questions. Thank you so much for your time!

MS: You’re so welcome. I can tell you what I have learned from my clinical medicine. I was at Johns Hopkins when Tom Hendrix was there. He taught me the importance of communication with patients. When I got to the NIH, I was with Jerry Gardner and Bob Jenson, they were big Polytech-type research people. They taught me curiosity and the importance of diligence. But when I got into private practice, I started to understand the importance of doing a good procedure and, as I used to tell all my residents and young academicians, the importance of funding your retirement and paying your disability premium.

JG: Exactly! Because you just never know.

MS: And always maintain the joie de vivre. I used to always tell my students, you are all A students. Always put the passion into what you do but not at the expense of relaxation, family, friends, and understanding the joie de vivre which will carry you a whole lot further in the success of whatever path you choose in medicine. Joie de vivre is my new motto.

“Always put the passion into what you do but not at the expense of relaxation, family, friends, and understanding the joie de vivre which will carry you a whole lot further in the success of whatever path you choose in medicine.”