Cautious Stryker pushes launch of total knee replacement on its Mako robot to 2017

Mako Rio robot-assisted surgery system

Stryker ($SYK) purchased Mako Surgical for $1.65 billion in 2013, with an eye on performing total knee replacement with the company's Mako Rio robot-assisted surgery system. Three years later, that has yet to occur despite approval to do so in August 2015.

The company previously said it would roll out the new application slowly and reach full speed toward the end of 2016. Now the company is targeting a 2017 launch.

Stryker is conducting two clinical trials of the Mako knee this year as it prepares for commercialization. Although laypeople are often unintentionally misled into believing that robotic surgery devices replace surgeons all together, that is not the case. The quality of the operator is as important as ever.

"So we're trying to figure what's the training protocol for somebody who has never used a robot and what's the training protocol for someone who already has some robotic experience," Stryker CEO Kevin Lobo told MD+DI. "[We want to know enough to say things like], 'You've never used a robot before, so for you it's going to take 6 cases to be proficient.' We want to set the right expectation."

A complicating factor is the April 1 commencement of CMS' mandatory Comprehensive Care for Joint Replacement Model in 67 metro areas. The program is designed to encourage cost-effective hip and knee replacement via penalties on hospitals that don't meet cost-of-care targets.

The Mako robot is believed to cost $1 million or more. But most of the cost-cutting at hospitals is supposed to occur on the post-procedural care side of the equation, for the program takes into account costs incurred for 90 days after the procedure, as well as 72 hours prior to it.

"I absolutely think Mako can win in a bundled payment environment," Lobo told MD+DI. "We are going to show much less soft tissue disruption. Every surgeon is going to be able to do it the same way. We're going to have much more consistent, predictable outcomes and that's going to be enabled by a robot."

International growth should also help offset uncertainty in the U.S.

"We have sold over 300 such robots across [the] globe. In India, we aim to sell about 40 robots in next 5 to 6 years," Lobo told the Hindustan Times. "Mako will be a game changer for us. It is a disruptive technology as the precision produced with Mako is beyond human capacity as it enables [the] moving of [the] implant (knee or hip) within millimeters." Stryker plans to launch about 20 new products in Lobo's home country this year, which he called the most exciting market in the world due to slowing growth in Russia, China and Brazil.

The Mako is already being used as a platform for total hip replacement and partial knee replacement, but total knee replacement, when it begins, will be the main attraction and driver of Mako sales.

The company casts the robot as a market share and quality improvement play, both crucial factors given the slow growth of the hip and knee replacement market, and dearth of significant technological innovations (especially in the hip arena).

"We know that up to 30% of patients who receive a total knee, regardless of whose it is, are dissatisfied. That doesn't mean they're getting a revision. So, revision means your implant failed. The 30%, they have a functioning implant. They're just dissatisfied with the way it feels and maybe it was done with how it's positioned, was it optimally aligned, do they have a lot of collateral ligament damage done due to the knee manipulation post-surgery," Stryker vice president Katherine Owen said during a healthcare conference earlier this month. "So, those physicians standing up and talking about the impact they're having on those, we know what the data is with Triathlon. We know it has the lowest revision rate, but the fact that this patient dissatisfaction reflected there, these doctors talking about that, we think it's going to be a big driver of the adoption."

Stryker sold 31 Mako robots in Q4 and 72 over the entire year.

Lobo told MD+DI that the slow rollout of the Mako total knee is an effort to ensure the critical Mako application is adopted. He hopes to avoid a repeat of the experience with its Nav3 Surgical Navigation System, which hasn't gained much use outside of Australia.

"Stryker has never done this before by the way," the CEO said. "We've never had a product approved and then told the sales force you have to wait a year. We've never told our customers you have to wait a year."

- here's MD+DI's take
- here's more in the Hindustan Times 

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