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Current & Critical

Navigation and Preoperative Planning Solutions Drive New Generation of Robotics

In writing this year’s installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®, we were drawn to the amount of strategic activity that surrounded computer assisted surgery systems, including robotics, planning and navigational systems, in joint replacement and spine during 2014. The large players—DePuy Synthes, Stryker, Zimmer, Biomet, Smith & Nephew, Medtronic—have all entered into agreements with producers of such technology or launched their own, and startups have entered the market, seeing opportunity in developing technology that provides accurate, consistent and improved patient outcomes.

ORTHOWORLD queried a number of market players for a better understanding of where robotics is in its lifecycle. Consensus is that the technology is no longer in its infancy, but still in early childhood.

Arguments against robotic systems center on increased costs in time and dollars resulting from equipment purchase, surgeon training and insufficient data to support improved outcomes. In response to those challenges, smaller portable planning and navigation systems that are not implant-specific or THAT allow for custom-designed implants have gained support.

For perspective on recent adoption, Blue Belt Technologies announced milestones of its 500th partial knee replacement performed worldwide using the Navio Surgical System in August 2014 and its 1,000 in February of this year. In January, OrthAlign reported completion of more than 25,000 KneeAlign Total Knee Arthroplasty cases worldwide, an increase from 13,500 in January 2014. OMNIlife science’s APEX Robotic Technology reached U.S. total knee replacement milestones of 3,000 and 4,000 in February and September 2014, respectively. Stryker MAKO sold 20 robots in 4Q14 compared to eight in 3Q14. More than 719,000 inpatient knee replacements were performed in the U.S. in 2010, according to recent Medicare statistics.

Further, the opportunities for robotics—both technological improvements and market penetration—are recognized in continual discussions about the future of the industry, including two ORTHOWORLD events.

At OMTEC® 2014, Dirk Kuyper, President and CEO of IlluminOss Medical, said robotics will be one of the significant technologies to shape orthopaedics in the coming years.

“I think it’s just starting to come into its own in orthopaedics,” he said. “There’s a little bit in spine, but not much at this point. I think the ability to take what a human being does and improve upon it is the future. Some of the customized implants coming out through the ability to 3D print is a good step in the right direction.”

At Symposium: The State and Future of the Orthopaedic Industry® in January 2015, B. Sonny Bal, M.D., J.D., Chairman, President and CEO of Amedica and a joint surgeon, was more candid when he said that robotics is a bit of a buzzword while noting the above-mentioned arguments against the bulkier systems.

“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,” he said. “At the end of the day, it’s just a computerized algorithm that will give you garbage if you put garbage in.”

Bal, who has used ConforMIS technology, said robotics remains in evolutionary stages and the wave of pre-navigated cutting instruments is the right track for better accuracy, though improvements still need to be made.

So, what will become of the next generation of robotics in orthopaedics? Our query of players in this segment asked them to provide a better understanding of the challenges they face with surgeon adoption and specific requests they’re fielding from surgeons. Here’s a portion of their answers that originally appeared in March 2015 issue of ORTHOPRENEUR®.

ORTHOKNOW: What are surgeons asking for when it comes to robotics?

James Kim, Vice President of Marketing and Business Development, OrthAlign: Real-time data, technology that doesn’t alter the surgeon’s workflow, that has proven clinical data, doesn’t cost an arm and a leg, has repeatability, isn’t implant-specific (limiting use to only a certain implant brand for the surgeon).

Christopher Prentice, CEO, MAZOR Robotics: They’re asking for more assistance, whether you call it robotic or not. They’re getting to, “What can a device do to eliminate repetition, an arduous task or the need for me to be highly exposed to radiation? Can it help me plan and execute better? Can it allow me to do the things that I am not able to do?” 

Richard Randall, CEO, OMNIlife science: Like anything else, after you are able to move a surgeon to your technology and you’ve replaced old habits with new ones, then guess what happens? They want more. We are approaching 5,000 total knees that have been operated on or robotically assisted on a global basis. We have a strong cadre of surgeons who have been using this technology for some time, and they are challenging us every day with new developments or new technologies that we can bring into the robotic format to fit even more of their patients.

Many of the surgeons who have started using our technology are migrating to the minimally invasive techniques that we’re seeing, particularly in knee surgery, so that they can send these patients home in a rapid recovery mode, sometimes the same day. As we develop customers based on our total knee offering, they’re anxious for us to move the robotic into total hip replacement, as well as the unicompartmental or partial knee replacement.

James Rottman, Marketing Communications Specialist, Blue Belt Technologies; Adam Simone, Director of Marketing & Clinical Services, Blue Belt Technologies: Improved outcomes and efficiency. Navio is in many cases time-neutral to conventional techniques, requires minimal OR space, is surgeon controlled and has been commercialized at a price point that is financially feasible for many different types of institutions.

ORTHOKNOW: What challenges does robotic technology face in its adoption?

Kim: Though the surgeon receives reimbursement for using technology, hospitals do not; this acts as an enormous barrier for surgeon use. Getting through Value Analysis Committees may be the biggest obstacle in driving adoption.

Many surgeons are stuck in their old way of doing things, so they prefer to not alter a method that’s worked for them over the years.

Prentice: Some of the challenges, of course, are regulatory. Getting a device out there is always a challenge, and it’s not becoming easier. There’s also past perception of robotic devices, which can be good or bad. There have been robotic devices that weren’t well-adopted, so you have to overcome that. You have to educate [surgeons], and they can make an informed decision about what they think is the applicability of this in their practice.

Randall: The main challenge is getting surgeons to make a transition to incorporating new technologies into their traditional techniques—or to replace their traditional techniques. Surgeons, rightfully so, are very reluctant to change. Old habits that work are very difficult habits to break. That’s really our largest challenge is how do we get a surgeon to depart – other than the early-adopter surgeon, which is a small percentage of the total market – how do we get the mainstream surgeons to move away from what they’re doing and adopt a new technology? The approach has to be practical, and be accompanied by a very strong reason to change.

Rottman and Simone: One of the biggest challenges faced by a company like ours when introducing leading-edge technology into the OR is to provide the right educational opportunities for users to understand the underpinnings of how the Navio system works, while allowing them to move it efficiently into their OR workflows. Blue Belt is committed to a training program that over-delivers on user and surgical team preparation.

Reimbursement, capital cost and the ability to meet vast surgeon requests will need to be addressed for robotic adoption to mature across all segments of the industry, in coming years. For now, the following pages summarize strategic activity that has taken place in the last two years for a better understanding of where the current promise of the technology lies.


M&A and Collaborations
As depicted below, OEMs have acquired technology and inked agreements for co-marketing and distribution around the world. The following exhibits better describe the types of technology that OEMs are implementing for operating room efficiency and better outcomes.
 

Acquiring Company Acquired Value
2013
EOS imaging OneFit Medical, publisher of knee and hip surgery planning software and manufacturer of patient-specific cutting guides €4MM (~US $5.4MM) in cash and shares.
MAKO Surgical Pipeline Biomedical’s orthopaedic devices and related instruments Not disclosed
  Stanmore Implants Not disclosed
Stryker MAKO Surgical, RIO® Robotic Arm Interactive Orthopedic System and RESTORIS® family of implants ~US $1.65BB in a cash for shares transaction
2014
Globus Medical Excelsius Surgical, developer of a surgical robotic positioning platform for spine and other applications Not disclosed
Materialise OrthoView, provider of 2D digital orthopaedic pre-op planning/templating software £8.47MM (~US $13.7MM) plus potential milestone payments
Medtronic Visualase, developer of an MRI-guided laser and image guided system for MIS neurosurgery US $105MM
2015
Exactech BlueOrtho computer-assisted surgical technology development and manufacturing firm €10MM (~US $11.6MM

 

Parties Description of Collaboration
2013
OrthoSensor + Biomet Partnered to employ VERASENSE™ trial bearings in the Vanguard® Complete Knee
Blue Belt Technologies + DJO Agreement to co-market DJO Surgical’s EPIK® Unicompartmental Knee System with the NavioPFS™
DePuy Synthes Spine + Brainlab Expanded collaboration through worldwide launch of VIPER® 2 and EXPEDIUM® Spine systems, and an exclusive global agreement to co-market Airo® Mobile Intraoperative CT.
Global Orthopaedic Technology + Optimized Ortho Agreement for exclusive use of knee simulation technology for Australian market
Medstrat + Zimmer Agreement to provide “Joints” pre-operative templating and planning system and services to all of Zimmer's U.S. distributors
Optimized Ortho + Corin Co-developed and launched a delivery platform for use with Corin’s total hip replacement devices.
OrthoSensor + Zimmer Entered into a co-marketing partnership to offer Zimmer knee systems with OrthoSensor’s VERASENSE™ Sensor-Assisted Technology, to be used initially with the NexGen system.
OrthoSensor + Stryker Orthopaedics Extended a co-marketing agreement for use of VERASENSE™ intelligent instruments with the Triathlon® Knee.
2014
Blue Belt Technologies + DePuy Synthes Entered into worldwide commercial agreement to support use of the SIGMA® HP Partial Knee with Navio™.
EOS Imaging + DK Medical Solutions Established distribution partnership in South Korea.
Mazor Robotics + GPO Signed an agreement with one of the largest U.S. group purchasing organizations for hospitals and freestanding surgical centers for supply of the Renaissance™ robotic guidance system for spine surgery.
OrthAlign + Lima Agreement to distribute KneeAlign® Total Knee Arthroplasty system in France
OrthAlign + Biomet Entered into an exclusive distribution agreement with Biomet Japan for its KneeAlign® Total Knee Arthroplasty (TKA) technology
OrthoSensor + Smith & Nephew Agreed to co-market VERASENSE™ sensor-assisted surgical technology for soft tissue balancing with JOURNEY™ II and LEGION™ total knees.
Blue Belt Technologies + Smith & Nephew Global agreement for use of the Navio® orthopaedic robotic surgical navigation system with the JOURNEY™ UNI partial knee.
2015
LDR + Sentio Entered distribution agreement to distribute SentioMMG nerve mapping system.


 

Regulatory Activity
Reported regulatory activity doubled from 2013 to 2014, with Blue Belt Technologies and EOS Imaging among two of the more active companies seeking clearances globally. Here is a summary of just some clearances for this period. A full list can be found at ORTHOWORLD.com.

Blue Belt Technologies
  • FDA 510(k) clearance to market the NavioPFS orthopaedic surgical system for Uni Knee Replacement; STRIDE™ Uni Knee for
    treatment of medial and lateral compartment OA; Navio Surgical System for patellofemoral joint replacement
  • CE Mark for STRIDE Uni Knee for use with Navio Surgical System

Intellijoint Surgical
  • FDA 510(k) clearance to market Intellijoint HIP™ surgical guidance tool

MedTech
  • CE Mark for ROSA Spine minimally invasive robotic surgery assistant

OrthAlign
  • FDA 510(k) clearance to market ORTHALIGN PLUS single-use navigation device for Total Hip and Total Knee Arthroplasty 
  • CE Mark approval to market OrthAlign Plus

OrthoSensor
  • CE Mark approval of the VERASENSE Knee

THINK Surgical
  • FDA 510(k) clearance to market TSolution One Surgical System for total hip arthroplasty

Zimmer
  • FDA 510(k) clearance to market iASSIST Knee Personalized Guidance System

Sources: Company websites, press releases


Carolyn LaWell is ORTHOWORLD’s Content Manager. Reach her by email.