Strong Team in Development of Tendon Product

In 2011, Erik Kubiak, M.D., an orthopaedic trauma and adult reconstruction surgeon and Associate Professor of Orthopaedic Surgery at the University of Utah, co-founded CoNextions Medical to treat tendon repairs differently than traditional, suture-based methods.

Earlier this year, the company received the Utah Innovation Award in the Life Sciences – Medical Device category for its sutureless tendon repair technology, a non-triggering, biocompatible device that removes knot variability. The device is intended to shorten procedure times and produce more durable tendon repairs than those achieved using traditional epitendinous sutures.

CoNextions is working toward FDA clearance and CE Mark approval, expected in the next year.

ORTHOPRENEUR spoke with Kubiak to discuss the product development process and the importance of a strong team to help execute your ideas.

ORTHOPRENEUR: Your company was awarded the Utah Innovation Award for its technology. Can you explain its inception?

Kubiak: Product development typically takes about seven years from the time you finally put the people together to make it happen – which is a pretty quick timeline. This started when I was a resident, the idea of trying to get away from tying a knot to fix soft tissue and patch sutures. Part of it is my background as a commercial fisherman. That’s all we ever did, was tie knots. We had this idea of a sutureless form of fixation or soft tissue fixation.

We worked with bioengineering students here [at the University of Utah] for a couple of years. This university is aggressive about getting ideas out in the local community. We have a unique entrepreneurial community in Utah, particularly in the medical device industry.

My collaborator and a partner, Rich Linder [CEO and President of CoNextions] had success in the endocardial world, which brought interesting talents to the table because in orthopaedics, we don’t do a lot with the materials used in that world and we haven’t traditionally done a lot with little things, like suture anchors and knots.

We got to a point of laying out the basic design concepts. Then, it became a tooling issue. Once it’s a tooling issue, you have to raise capital to make parts. Then, we had the usual fits of a young start-up, such as a monetary/enthusiasm gap that you have to get across. We got to a point recently with consistent devices that, when in the hands of the surgeons who use them, lead to a lot of enthusiasm. We’re at a good point where all of those things have come together.

ORTHOPRENEUR: Do you plan to roll out more products?

Kubiak: One risk of a young company is, when you put a lot of smart people in a room – surgeons and engineers alike – they get bored with finishing things. They really enjoy the start. It’s like you’re building a car and you’ve got the frame and the body panels on and you’re engineering the wheels on, but no one wants to get to the nitty gritty to make sure it lines up just perfectly and it goes and doesn’t pull one direction or the other. A lot of the hard work goes in after the thing looks like it’s done. To become a really viable commercial product, a lot of tinkering still takes place. I think that’s why we often see iterations after the initial product launch.

We’ve maintained a specific, diligent focus on tendon fixation in Zone 2 of the hand, which is the part of the hand that has the worst outcomes and is the most demanding to design around.

The philosophy of that is, if you do the hardest thing first, then all the other stuff will come less painfully.

ORTHOPRENEUR: How do you balance practicing orthopaedic surgery with your involvement in the company?

Kubiak: The “me” piece is not that important. If you focus on yourself, the whole thing will flounder. There’s a whole network of people working to make this happen. You have to figure out all those moving pieces and empower all the moving pieces to make the whole enterprise move forward. At times you’re going to have trouble, because some of those pieces aren’t going to be the right ones, though you thought they were in the beginning. One of the most painful things is leaving personnel pieces behind.

ORTHOPRENEUR: What were some challenges you faced with development of your technology?

Kubiak: We had technological challenges. When you start each project, you have to ask yourself, is there a material that exists to make this from?

Then came the material challenges of what we were trying to hold onto – tendons are actually pretty hard to grab.

In a way, that ties to the personnel challenges. We’ve had brilliant, wonderful people who helped bring things along, but then we got to a point where we stopped moving forward. Then we had to bring on other people. That was the hardest piece of this, moving on from people who had really brought the project to a point and then it kind of stalled. We had to change coaches a couple of times.

ORTHOPRENEUR: What advice do you have for orthopaedic surgeons seeking to embark on entrepreneurial endeavors?

Kubiak: Traditionally, pre-2006, I would draw something on a napkin. If a company wants to talk to me and they take this thing on a napkin, I get a royalty stream off the thing on a napkin and everything happens.

Post-2006, that’s not happening anymore. Now you have to start a company with the idea. You have to figure out how much you’re going to spend on patents. You have to find a CEO, because you can’t be the CEO. I think that’s a huge mistake for physicians, trying to be the CEO and a surgeon doing something else. Finding that CEO, finding the engineering team and finding your finance team puts a lot of burden on the surgeon that he didn’t have before. You need a few other advisors who are willing to say yay or nay, and be really honest about whether it can move forward or not.

Then, the big challenge is how much of your own money are you going to put on the line to get it started. It’s not that easy to write checks for $25,000 a month for a year or two, trying to move something forward. At the same time, if you don’t do that, you won’t own much of the company at the end.

Alternately, a surgeon may say, “Well it’s my idea, I shouldn’t have to put any money in and I should still own most of the company because it’s my idea.” Then business people, the guys who had to put in their money and work it to make it happen, get grumpy about the fact that the surgeon didn’t put in money. In our situation, everybody has put about an equal amount of skin in the game and in doing so, there’s not a lot of resentment. Nobody’s there just because they showed up. Everybody there has some degree of risk in the situation.

Every surgeon should try it, particularly if you have a really good idea. I think it’s more painful, but more rewarding, to have done it organically than the way that we used to do it, which was you sort of sell out to a big company and they maybe push your idea through.