Inventing is in the Eye of the Physician

By: Rod Raabe, MD, Michael Tal, MD, and an Introduction by Frank Veith, MD
 

In all aspects of medicine and vascular surgery - as in everything else – innovation is the engine that drives practice forward.  It keeps a field exciting, fresh and interesting.  This has certainly been true in venous disease in the last decade with all the new less invasive treatments for varicose vein disease and the introduction of stents for deep venous disease, both congenital and post-phlebitic.  Hopefully physician inventors with the collaboration of industry will continue to produce effective new treatments that will maintain the vigor, interest and excitement of those interested in the management of venous diseases.  The following article will summarize what has happened with innovations in venous disease over the last several years and outline the possibilities for inventive new venous treatments in the near future.

Frank Veith, MD

Describe how you got involved with your product? Did you have a “eureka!” moment? What influenced you to develop your product, and why?

Michael Tal, MD – Clarivein

The idea came out of necessity. A patient with a rare venous anatomic anomaly that could not be treated with the heat based technologies available at the time. The improvisation used to treat that patient worked well and then the idea of using this non thermal technique for all varicose vein patients came about.
 

Rod Raabe, MD – Venaseal

Our product is Venaseal, which is an adhesive placed into the Saphenous Vein with a catheter delivery system to close the abnormal vein. As an Interventional Radiologist we perform multiple different endovascular procedures. One day while in the Vein Clinic doing procedures I was still thinking back to an arterial embolization procedure I had previously performed. I then had that “eureka” moment. I thought to myself, “If we can glue shut a high flow, difficult to get to arterial malformation, why can’t we glue shut a low flow, easy to get to Great Saphenous Vein.” I talked to several friends about the idea, for long time, to see what they thought, before I moved forward with the opportunity to start development of the product Venaseal and starting the company Sapheon.

How did you balance working as a physician and creating your product?

Michael Tal, MD – Clarivein

The creation of the product was the easier part. Most challenging and time consuming but also fulfilling was raising money, building the venture, performing animal and clinical studies for several years and then creating a company to market the device.
 

Rod Raabe, MD – Venaseal

I knew that taking this idea and developing it into a product would take years and was very risky from a financial point of view. I was lucky enough to initially work with an incubator group to get started and then quickly became an independent entity, a company we named Sapheon. We contracted with very talented people to work on the product development. Bringing talented individuals to work on the project allowed me time to continue working in my practice as a physician while the product and company took shape over several years. There is a down side to hiring people to help you. You have to raise investment money. Raising money became a constant ongoing project.

Do you feel having a physician background positively or negatively affected the invention progress?

Michael Tal, MD – Clarivein

Being a physician is the essential component. This could not have happened without direct patient care.
 

Rod Raabe, MD – Venaseal

I believe being a physician helped significantly. I was able to keep the physician perspective on the product development and its intended use at all times. We had to make the product “physician friendly” or “physician proof” which chemical and structural engineers sometimes forget. I was smart enough to know that I knew a lot about medicine as a physician but when it came to business we needed expertise that I didn’t have. From the very beginning I worked with a talented CEO, Don Crawford, who co-founded our company, Sapheon, and ran all the operations.

What were some of the initial challenges that impacted you during the development process? How did you overcome those challenges?

Michael Tal, MD – Clarivein

There were always many challenges, starting from engineering, clinical, regulatory and reimbursement. That is the true beauty of a startup. With a good, dedicated and motivated team of professionals, given the time and money, all challenges are ultimately addressed and successfully resolved.
 

Rod Raabe, MD -- Venaseal

When developing an idea or invention there are multiple ways to proceed. You can work with an existing Medical Device Company and co-develop your product. You can apply for patents and develop prototypes of your product and see if there is interest in someone purchasing your product at this level. Usually in this situation you may have to your own do bench top in-vitro testing or animal work to demonstrate your “proof of concept”. We decided on a different course where we wanted to take our product from “idea to market” and develop a company structure to facilitate our goal. We wanted to create the product, apply for patents, do the testing, go through the regulatory process, manufacture the product, and then market and sell the product to physicians.
We had multiple challenges starting with the early adhesive creation. Existing glue products did not work in this application when tested on the bench top and in animals requiring us to develop new chemical formulations. We initial worked with a contract manufacturer and then brought the R&D in house and tested hundreds different formulations until we found one with the right properties and biocompatibility. We also had to design a unique delivery system that was efficient and simple to use. The delivery catheter had to be clearly visualized on ultrasound and the catheter could not stick to the glue so it would not be glued into the vein. We were able to design these features by extensive “trial and error” on the bench top as well as in animal lab. We were able to come up with innovative new ideas along the way. But R&D required money. We were constantly trying to reach product development milestones so we could reach out to investors with a reasonable risk when raising money. When raising money we found the V.C.s (Venture Capitalists) where not interested in early stage investment. We had to get our investment dollars from friends of family and especially physician friends and individuals who saw our vision and were willing to take a risk with us.

What were some of the initial successes that aided you during the development process? How did you grow from these successes?

Michael Tal, MD – Clarivein

There were many successes and exciting moments. I’ll never forget the first case performed in the US by Dr. Steve Elias. It went beautifully and painlessly and I remember giving Steve a huge hug after the case, almost crushing him.
 

Rod Raabe, MD – Venaseal

When we were developing our glue we knew we were on the right track when we were finally able to find a formulation that would tightly close a vein wall in-vitro. We next moved into the animal lab. After much trial and error we finally developed an adhesive as well as a delivery system that consistently worked, and had animal histology that proved we developed fibrosis in the vein through a benign “foreign body” reaction. These milestones moved us forward into “first in man” where we worked with Dr. Jose Almeida and his team in the Dominican Republic. Once we were successful with Greater Saphenous Vein closure in humans and had clinical follow-up that showed success we were ready to move forward with our regulatory process and obtain CE Mark approval and eventual European distribution.

Looking back on all the challenges and successes you had, would you have done anything differently?

Michael Tal, MD – Clarivein

Yes, absolutely, I’ve learned a lot since starting this venture. The answer to this question could easily fill the whole newsletter.
 

Rod Raabe, MD -- Venaseal

Overall we were lucky and we had a team and leadership that moved us forward to the eventual sale of the company after six years of hard but extremely fun and invigorating work. We had stumbling blocks, but our unshakable beliefs in eventual success, and the supportive friends and people we worked with along the way lead us to continue to find solutions to the obstacles we faced.  There were consulting companies and people we would have chosen not to work with if we could do it over, but at the time we didn’t know better and just pushed forward.  In short, we wouldn’t have done a lot differently. What I would have done the same was work with talented leadership and people to form a team what eventually became the company Sapheon. We had a saying in our company, “Nobody is as smart as all of us”.

From a physician and inventor point of view, how do you see the venous world progressing in the future?

Michael Tal, MD – Clarivein

The venous world is the biggest untapped peripheral vascular market. Venous disease is 6 time more common than peripheral arterial disease. Venous ulcers are the most common ulcers and affect almost 1% of the population, costing the US healthcare about 2 Billion dollars per year. However, only a minority of those patients get endovascular treatment even though the treatments are effective. As new technologies are being developed and adopted, the venous disease world will grow and thrive. The companies that won’t enter the venous disease world will stay behind.
 

Rod Raabe, MD – Venaseal

Of course I’m biased, but I believe the superficial Chronic Venous Insufficiency (CVI), treatment will continue to trend toward more noninvasive and patient friendly treatments. That means non-tumescent treatments that get the patient back to work sooner and with fewer side effects will prevail. Compression stockings will always be a part of CVI treatment, but if you can decrease the need for compression, the treatment will be more patient friendly. Perhaps Venaseal will be the answer for the future. Perhaps with this noninvasive treatment that does not require tumescent anesthesia, sedation, or compression stockings we will see decrease need for ambulatory phlebectomy or sclerotherapy. Only time and further study will answer these questions.

What advice would you give to a physician who is considering developing a product?

Michael Tal, MD – Clarivein

Just do it.
 

Rod Raabe, MD – Venaseal

Apply for patents for your idea before you go too far.  Have signed CDAs (confidentiality agreements) before talking to too many people.
Product development is more than an idea. It is about developing a solution that has potential for significant improvements in patient care. The simpler and broader range the idea or invention the more potential impact it will have. Finally, pursuing your project will take time, energy, and money, but the real joy of inventing and product development is the journey you take with colleagues and friends.

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