In an exciting year for healthcare, orthopedic device companies underwent mergers and acquisitions, strove to find the most innovative solutions and made calculated decisions in the hopes of achieving long-term success as the market becomes increasingly competitive. So who had the best 2016?
The new Trump administration and Republican Congress – and all the accompanying change and uncertainty – is the major story for the medical device industry.
But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, a slew of cardiology research breakthroughs including a customizable robotic heart out of Harvard, and much more.
Here are the top medical device stories of early 2017.
Dr. Matthew T. Hummel of Commonwealth Orthopaedic Centers performed the first total knee replacement surgery using new robotic-arm assisted technology at St. Elizabeth Healthcare — technology available at only a handful of medical centers in the nation.
Today’s successful surgery was performed using a device called the Mako Robotic-Arm Assisted Surgery System. The surgeon’s use of the robotic-arm system brings exceptional accuracy to the surgery — which can mean the patient has a much better result, with more natural movement and less pain after the surgery.
Together with highly detailed computerized scans of the knee before surgery, the robotic arm-assisted device ensures incredibly accurate cuts for the surgery, along with precise alignment and placement of the knee implant. The device allows for accuracy within a single millimeter, or the thickness of a thread.
“I think our ability to use this advanced technology can really change the world for our patients who need this type of surgery,” Hummel said. “With our surgical expertise and with this equipment, this surgery can now be performed with exceptional accuracy, providing better results for patients.”
Surgical robots dominated the annual meeting of the American Academy of Orthopaedic Surgeons as Stryker launched its highly anticipated Mako total knee application, Smith & Nephew showed off a prototype of its Navio total knee application (with a projected launch of mid-2017), and Zimmer Biomet announced an aggressive timetable for launching its Rosa total knee application within the next 18 months.
All the hype surrounding robotics begs the question, do these robots represent the future standard of care in orthopedics, or are they just a fad?
“We think robotics are real and here to stay,” said Mike Matson, an analyst with Needham & Co. “But the tougher question is, just how big will it get?”
Matson said he does not expect robotics to break out of its niche and become the standard of care. He also predicted that adoption of surgical robots could be slower than some investors are anticipating.
“Has robotics addressed the difficulties of navigation (ease of use, learning curve, added time, etc)? We’re not convinced that it has, at least in its current form,” Matson said.
On the other hand, Matson said patients seem to have an easier time grasping the concept of robotics than navigation, which should make consumer marketing more effective. Still, he added, “we’re not sure that this is enough to make robotics the standard of care.”
Arthur Renowitzky can’t help but command attention as he walks down the street on a sunny autumn morning.
A driver lowers her window to flash a smile and a thumbs-up. “You got this,” she says. A neighbor waves from his front yard. “Go get ’em A.R.”
Renowitzky has been paralyzed since 2007 after being shot in the chest for $20 and a fake gold chain. But he can stand and walk, using crutches for balance, when wearing an exoskeleton suit with motorized hips and knees powering his movements.
Wearable robots aren’t new. DARPA has been funding their development since the early 2000s with the aim of building motorized armor to enhance soldiers’ strength and endurance. Panasonic, Ekso Bionics and others offer upper-body suits that help construction and factory workers lift heavy loads. But their most powerful promise may be in helping people regain control of their bodies.
For roughly three decades, medical robots have assisted surgeons in the operating theater. They provide a steady hand and can make tiny incisions with pinpoint accuracy. But as robotics improve, a new question has emerged: How should autonomous robots be treated? The US Food and Drug Administration (FDA) approves medical devices, while medical societies monitor doctors. A robot that can operate on its own falls somewhere in between. To help, Science Robotics has produced a scale for grading autonomy in robot-assisted surgery. If adopted, it could help regulators decide when and how machines should be treated like humans.
Zimmer Biomet (NYSE:ZBH) expects to launch a robot-assisted surgery platform for total knee procedures during the 2nd half of 2018, the company said this week at the annual conference of the American Academy of Orthopedic Surgeons in San Diego.
A prototype of the device, on display at the AOSS conference, is based on the Rosa technology Zimmer Biomet acquired when it put up $132 million for Medtech in July 2016. Montpellier, France-based Medtech developed the Rosa Brain and Rosa Spine robot-assisted surgery platforms; the Rosa Spine device won 510(k) clearance from the FDA early last year. Both Rosa systems have CE Mark approval in the European Union.
Zimmer Biomet is hoping to land 510(k) approval from the FDA for a Rosa device for total knee procedures by the 2nd half of 2018, according to Leerink Partners analyst Richard Newitter. The company will also pursue 510(k) clearance for partial knee and hip indications, Newitter wrote today in a note to investors.