Stryker’s success with its Mako robot-assisted surgery platform has other orthopedic device companies hastening to enter the space. The big question is whether long-term outcomes will justify the expensive technology.More than five years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way bringing robot-assisted surgery to the orthopedic space. The Kalamazoo, Mich.–based orthopedic device giant has already placed more than 650 Mako robots around the world, with more than 76,900 knee and hip replacement procedures performed in 2018 and double-digit growth in installations expected in 2019.
In the process, Stryker has also grabbed share in a knee surgery devices and implants market that was previously static, according to SVB Leerink analyst Richard Newitter.
“We’ve never seen any one company engender market share swings in the order of magnitude Stryker has in the last three years, and a good chunk of it is about robotics,” Newitter told Medical Design & Outsourcing recently. “If you use a Stryker robot, you have to use the Stryker knee. … It’s a Trojan horse.”
Stryker’s big competitors — Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew — are taking notice: They’ve either launched or are preparing to launch their own robots.
There’s little long-term data, though, on whether a $1 million robot such as Stryker’s Mako improves outcomes and reduces overall healthcare costs.
Stryker officials suspect the short-term benefits they’re seeing, such as improved readmission and reoperation rates, are a good sign. “If you see patient satisfaction and less pain, that’s a good indicator. So all the right indicators that we look for as an industry are in our camp,” Robert Cohen, VP of global R&D and CTO at Stryker Joint Replacement, told MDO.
Newitter, for one, is optimistic, and he thinks Stryker’s Mako so far is farthest along with best-in-class technology.
“My sense is we’re on to something here as an industry,” Newitter said.
The Mako difference
There are levels when it comes to computer-assisted surgery. There’s the preoperative data modeling and planning. Software and displays can assist the surgeon with navigation during the surgery.
“Looking at information preoperatively and intraoperatively would rely on a lot of different inputs. This is where robotics comes into play,” Cohen said.
After acquiring Mako in 2013, Stryker launched a total hip replacement tool in 2015 and a total knee arthroplasty application in 2017.
Cohen went through the steps of how the Mako system improves total knee replacement for someone with arthritis pain:
- The system takes a CT scan of the patient’s knee and converts it into a three-dimensional model of the knee joint, the femur, the tibia, and even the surfaces that the arthritis has damaged.
- The surgeon with his or her own preferences can then preoperatively plan the best location of a femoral component and tibial component over the model bone, based on factors including patient size, angle of legs, location of articulating services, and how the femur moves on top of the tibia.
- The health provider team then loads the plan onto the robot. The surgeon in the operating room compares the plan to the individual patient’s motion — bending the knee, flexing, straightening it out, all while looking at how the motion is replicated on the robot’s screen. Based on whether ligaments are lax or tense, the surgeon might tweak component positioning by fractions of millimeters before locking in the final plan.
- The Mako robot arm will lock the plane of its saw blade into a place relative to the position of the final three-dimensional plan — and assists the surgeon with performing the cuts. The surgeon actually pushes the saw, but the robot limits where the saw can go in space.
“The surgeon still performs surgery, but now with an accuracy and precision specific to a plan, specific to a patient that we could not do before with conventional, manual instruments,” Cohen said.
The robot’s haptic boundary prevents soft-tissue trauma, according to Cohen. He said Stryker has about 100 peer-reviewed publications on the Mako’s short-term benefits, including reduction in post-operative pain, increased patient satisfaction, increased flexion, less opioid drug use, reduction in length of stay, and fewer readmissions due to complications from the procedure.
Even as more knee replacement surgeries move from hospitals to outpatient surgery centers, Cohen thinks the Mako robot’s benefits will justify its price tag — which company officials in the past have said was about $1 million. The majority of Mako robots are in hospitals, but they are going into outpatient centers, too, he said.
“Because the outcomes are going to get measured on Medicare databases, on joint registries, outpatient surgery centers have to perform equal or better than the hospital environment. They can’t take a step back,” Cohen said.
Competition heats up
Stryker’s competitors, however, appear to see an opening with the shift toward outpatient. Perhaps there will be demand for more affordable robots.
Last year, for example, J&J’s DePuy Synthes bought Paris-based Orthotaxy, which is expected to launch an ortho-surgery robot in 2020. A prototype displayed at the American Academy of Orthopedic Surgeons conference in March was the size of a shoebox, attaching to an operating table.
“There are no blocks required. There’s no pinning required. We saw this as what the world actually needs. This is bed-mounted. It’s not a huge device that sits on the floor,” Liam Rowley, VP of R&D for knees at DePuy, told MDO.
The Orthotaxy robot will be much smaller and less expensive than surgical robots currently on the market. Because the Orthotaxy robot will not require surgeons to use disposable instruments, it can save from $1,500 to $2,500 per procedure, according to Rowley.
“It’s smaller. It’s actually quicker,” Rowley said. “There’s no CT required. In terms of world healthcare costs, this is not upping the cost that somebody has to bear to get standard of care. There’s a per-procedure reduction in costs.”
Other major orthopedic device companies are also making moves into the space:
- Zimmer Biomet’s Rosa robot-assisted total knee surgery platform won 510(k) clearance for knees in January and for spine in March. It includes 2D X-ray and 3D pre-operative planning tools, allowing surgeons to conduct virtual procedures ahead of the actual surgeries. The Rosa system also provides real-time intraoperative data on soft tissue and bone anatomy, the company says. Zimmer Biomet acquired the initial Rosa technology through its roughly $132 million purchase of French robot-assisted surgery firm Medtech in 2016.
- Smith & Nephew spent $275 million in 2016 to acquire Minnesota-based Blue Belt Technologies and its handheld Navio system, adding a total knee arthroplasty application to Navio in 2017. In March, it announced the purchase of Brainlab‘s orthopedic joint reconstruction business, with plans to install Brainlab’s hip software onto its currently-in-development Navio 7.0 software.
- Globus Medical announced in December 2018 that it had installed its ExcelsiusGPS robotic guidance and navigation system in several European countries. The company said health providers had performed numerous open and minimally invasive spine procedures with the system.
- Medtronic in December 2018 closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine, launching its Mazor X Stealth platform in the U.S. a month later. (Read more about Medtronic and the Mazor X Stealth here.)
- NuVasive put its Pulse integrated navigation platform on display at the North American Spine Society’s annual meeting last year. SVB Leerink’s Newitter said at the time that Pulse was a “step in the right direction,” but added that “it still feels like the company is behind on the robotics front.” FDA cleared Pulse as a spinal surgical automation platform in 2018.
Orthopedic surgeons are paying attention to robotics, and all the companies are starting to realize that, Newitter told us.
“Even if not necessarily proven to be better medicine, you can’t afford not to have an answer to robotics,” he said. “There’s a strategy now where having a robot is better than not having a robot.”
Helping hospitals introduce robotics for the first time is about more than just selling a robot, according to Stryker’s Cohen. It’s about setting up a training program, medical education, increasing satisfaction rates and more. “If you accept what I say on soft tissue protection and the saw blade not going into tendons and ligaments, there’s no other robot coming on the market that has that capability,” he said of Mako.
An expensive fad?
Still, there’s skepticism in the orthopedic device industry about robot-assisted surgery.
Stryker and other big ortho players turned to robotics because it gave them a competitive edge based on their size, since the systems are expensive to develop, explained Doug Kohrs, the former Tornier and American Medical Systems CEO and a serial entrepreneur in the ortho space.
Kohrs suspects that the enthusiasm for robotics in ortho surgery could be short-lived, due to be supplanted by an emerging technology. In two to three years, he said, patient-specific implants produced from surgical planning data – combined with computer-assisted navigation – could provide a more economical alternative.
“When you start putting that implant down the femur [if it’s a hip] or the humerus if it’s a shoulder, once you start it, since it matches the patient, you’re not going to get it out of alignment,” Kohrs said. “You do not need a robot to control the alignment of the implant because it can’t go anyplace other than the right place.”
And even at the relatively low price of $500,000, robots are still big-ticket items for increasingly cost-conscious healthcare providers.
“It’s not a criticism of robotics. It’s just acknowledging that there’s a better way to do it than robotics that’s more cost-effective,” Kohrs said.
Cohen counters that Stryker’s Mako allows for new ways of positioning implants that older manual instruments can’t achieve. Perhaps more important, he said, are the digital capabilities Stryker can layer on top of the technology.
“It’s all about writing new software. It’s all about different user information. It’s about new applications,” he said. “We will get into the world of predictive analytics and the things that we never could’ve conceived of before without a robot.”
Senior editor Nancy Crotti contributed to this report.