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The dozens of industry experts and thought leaders gathering at OMTEC 2015 will include the Keynote Panel, offering perspectives from Doug Kohrs, Past President and CEO of Tornier, B. Sonny Bal, M.D., J.D., Chairman, President and CEO of Amedica, and Rod Mayer, President of Nextremity Solutions. The three convened for a nearly three-hour conversation to discuss orthopaedic technology evolution at the ORTHOWORLD Symposium in January. In anticipation of OMTEC, we highlight some of their previous discussion on the latest technologies and players to enter the market.
Robotics
Doug Kohrs: I want to touch on robotics, having studied it a lot over the years. Let’s divide it into the subsegments as I see them: knee and hip, we’ll keep those together; then spine, shoulder, foot and ankle. As you look at your extremities businesses, do you see a place for robotics in some of the more complex surgeries?
Rod Mayer: It’s amazing to me to see robotics and the part they play. I can remember a very gifted total joint surgeon who, using traditional instrumentation, skin to skin, did 30 minutes for a total knee replacement with excellent results…published results, in fact, showing 15-20 years of excellent results. That surgeon decided to embrace this concept of robotics, and his procedures turned lengthy with not necessarily the same outcomes.
As I think about our product portfolio and what we see as our pathway over the next three to five years, robotics doesn’t play a part in the foot and ankle space. Could it in upper extremity, shoulder? Perhaps, but a lot of foot and ankle surgeons prefer to use their hands.
Dr. B. Sonny Bal: There are a lot of dimensions to this question. In robotics, presumably more inputs would lead to more accuracy if the surgeon or the team performing the surgery knows how to use the robot correctly. At the end of the day, it’s just a computerized algorithm that will give you garbage if you put garbage in. The published data is not showing consistent improvement; it does increase operative time. The promise of robotic technology was to make certain outputs consistent so that a surgeon who doesn’t do many primary knees and is doing his first one in two months can make cuts correctly. In hips, the idea was to avoid the common complications, leg length discrepancy being one of them.
I think robotics were a nice buzzword, like “Wi-Fi enabled” and “3D printing” that to some extent have been adopted by surgeons to market themselves and differentiate themselves. Patients love high tech; they hear buzzwords and they think they all sound good. I think robotics is an evolutionary technology. In the next wave, we’re already seeing many companies develop prenavigated cutting instruments. Let’s say you expose a tibia; this guide is already configured to fit like an erector set and is based on a computer algorithm that doesn’t use one or two points, but multiple points. There the accuracy is better. Not completely there, but better.
I know for a fact that many companies are working on hip systems now in which, during surgery, the equipment you use —the cutting guides or blocks—is predesigned to reference existing anatomic patient landmarks that we routinely expose. Why not use them to make the cuts more accurate? I think the result would be more consistent, the outcomes would be safer and patients would be happier. That’s the advantage of this technology.
Orthobiologics
Kohrs: I was reading an analyst’s report recently about Wright Medical. I think everybody knows that Wright is back on a pathway to get their new orthobiologic product approved through the PMA process. The article said that this will be the first orthobiologic approved through the PMA process in more than ten years. It’s an interesting thing to think about. If you go back 20 years, the buzzword was orthobiologics. They were going to change the world! A lot of products have come and gone, and people have gotten in trouble with orthobiologics—ones with products and ones without. I’ve worked on orthobiologics over the years, so many I can’t even remember. What do you see for the future?
Dr. Bal: I think application in cartilage is still in its infancy. Any field in which you don’t have all of the answers, there’s a lot of room for innovation.
Let’s get back to bone, which is basically the reconstruction of missing bone. You may have a structural loss, meaning something a patient puts weight on that you have to replace. The standard now is bone allograft, or some sort of porous metal. There is nothing on the horizon that I’ve seen that can provide structural replacement. Certainly a lot of research being done, though.
The second use of biologics is during revision surgery, bone cyst removal, reconstruction or bone fusion; the surgeon adds something from a syringe or tube or jar, whether it’s a putty or liquid or something that solidifies, and the idea is that over time this thing will become bone. A claim I think yet to be made by any of the orthobiologics. Most surgeons who go back years will tell you, you’re still digging this stuff out with a spoon, so it hasn’t quite become bone. It is transforming to some extent to bone.
I don’t think we have all of the answers. There is certainly room for growth in the area of orthobiologics enhanced to release bone growth factors—most importantly, antibiotics. We’re still giving people systemic antibiotics. Imagine in the future if we had an orthobiologic coating on the implant that released its own reservoir of antibiotics. Those are practical applications of orthobiologics, growth factors, BMP, fusion proteins. The future is there, the promise of growing bone or becoming a structural replacement for bone.
New Players
Audience Question: Do you see insurance companies and hospitals starting to participate in product development or product ownership?
Kohrs: Yes. I do. Hospitals are doing that because they want to wrestle control away from the patient and the insurance companies.
What’s happening now is, when you put out a request for proposal—say you’re trying to get into a hospital on the West Coast; hospitals are asking manufacturers for a proposal with and without a sales rep. They know there’s a lot of cost tied up in that sales rep. (Product commercialization by hospitals) is just the next step. They find out what that price is, and will say, ‘Well, if we’re going to manage it internally, if we’re going to manage the inventory and go down that route, we might as well own the implant also.’
Mayer: At Del Palma Orthopedics, we tested this. I believe that this is another opportunity for the future if you can figure out a way to align the patient, provider and payor. Del Palma has a technology for which we identified a simple procedure that we call a trigger finger release. It’s often done in an outpatient setting or surgery center, or shifting to the ASC. When you look at the average reimbursement and the cost associated with that procedure, it was absurd. We had executives at the highest level of Blue Cross and Blue Shield of North Carolina tell us that once that technology was available on the market, they would mandate that their insurees who needed that procedure had to find a surgeon in their market to do that procedure with that device.
Yes, there are tremendous challenges, but in all of those challenges there lie opportunities. If you can find a way to get that patient, payor and provider together, there’s tremendous upside.
New Technologies
Kohrs: Let’s say that you are going to start a new knee and hip company. It’s all your money; you don’t have any investors. You could focus on the new wear-resistant coatings, you could focus on preoperative planning and patient matched implants, or you could look at what’s happening in healthcare and say maybe we could make a high-quality, low-cost system for the 65 percent that was mentioned earlier. You have to pick one model. What do you choose?
Mayer: I would focus on the highest quality at the most economically priced level. High quality that can be well positioned in the marketplace, given the dynamics that exist.
Dr. Bal: I would say something that I borrowed from Jonathan Black, one of the premier biomaterial scientists. I asked him that question, and you would think he would answer with biomaterials. He said something that I’ve never forgotten. He said, ‘The challenge of the future will be to de-skill the procedure. Some surgeon in a small hospital in China should be able to do this on an outpatient basis with the exact correct acetabular position and femoral position.’
We have enormous technology in navigation, in iPads and iPhones, and it’s being applied more and more in how to place implants. When you combine it with skill, you should be able to do this easily and consistently. Once you have market share and you have growth behind this company that has a highly de-skilled procedure with consistent outcomes, then I would take my earnings and invest that into biomaterials.
The OMTEC Keynote—The State and Future of the Orthopaedic Industry – Executive Interview—will also include perspective from MedShape Co-Founder and CTO Ken Gall, Ph.D.
