Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery
The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.
Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and Zimmer Biomet as well as smaller challengers in the growing market for robot-assisted joint replacement. CEO Benjamin Sexson, an engineer by training, sees a pressing need for personalized implants made to fit each patient’s specific anatomy.
This interview has been edited for length and clarity.
MEDTECH DIVE: What are some of the challenges in knee replacement that you are trying to solve with your surgical robot?
BENJAMIN SEXSON: The idea is to move away from what’s called mechanical alignment, which is how we’ve always done it with manual instruments. A lot of the robots on the market today are just basically helping surgeons put the knee into mechanical alignment – everybody gets the same knee, the joint line is basically restored to be parallel to the floor.
With functional, or more personalized, alignment approaches, surgeons are tweaking the plan based on, I have my patient’s specific data, I have the CT scan, and I can assess intraoperatively what do I think looks best? And they can make very, very precise and accurate tweaks to the surgical plan that, over time, we’re seeing are enhancing patient satisfaction.
Stryker and Zimmer both have the ability to use a CT scan or advanced imaging to preoperatively plan. Stryker has been driving this trend. Stryker is showing that patients are happier when you can do some degree of personalization of the surgery.
Other players in the space have been struggling [because] they are imageless. They made the bet that insurance companies would not be as accommodative in the future to reimbursing the cost of the CT scan, and so their surgeries correlate to generalized models. We think that over time, this is going to be increasingly problematic for those other players.
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What gives you confidence that there is room for another robot in the orthopedic marketplace?
Investors generally [say], “Well, everybody already has an orthopedic robot.” OK, but really only two companies are CT-based, and only one of those companies is actually [using surgeon-initiated] cutting. So there’s really only one navigated, efficient, cutting, CT-based robot, and that’s Stryker, and they have 90% of the market. And only 10% of knees today are robotic. So there’s a huge opportunity.
It’s inefficient for a small-footprint private clinic to be forced to buy five-plus different robots, one that’s good for the spine, one for the hips, one for the knees, one for the shoulders, one for the ankles, etc. The fundamental difference between our philosophy and our competitors is that Monogram seeks to develop one robot optimized for many applications.
Why did you decide to focus first on the knee market?
I’ll start by saying that our robot is not a knee robot. It’s an orthopedic robot. It just so happens that knees are our first application for a number of reasons. One is that we didn’t want to go on a missionary effort trying to convince people in, say, the shoulder space, to use an orthopedic robot and develop a whole new surgery. We wanted to come into a market that already had billing codes and an established market presence and some level of acceptance.
There are about a million knee replacements a year in the United States, and about 10% of those fail every year. And a lot of people are not satisfied with their knee replacement. We think we can make it a lot less scary and a lot less risky.
Where are you in the process toward gaining FDA approval?
We’ve had what’s called a pre-submission meeting with the FDA. This is a 510(k) submission, so we’re going to be claiming substantial equivalence to a system that’s already on the market. Where we are is, the FDA is accepting of our clinical pathway. They’re accepting of our predicate [Stryker’s robot] and intended use. The question that’s still outstanding is whether or not the technical differences with our predicate need to be tested with clinical data. Our plan is to take a defensive approach and submit to the FDA with clinical data. Our plan is to lean heavily on capturing that data outside the U.S.
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