The use of computer-assisted surgery systems that incorporate robotics, surgical planning and navigation have the potential to bring reproducible results to orthopaedics through imaging, alignment and guidance tools that control surgical variables.
But, will hospitals pay for these technologies? Detractors say that these systems are too costly for hospitals to adopt, require too much time for surgeons and OR teams to master and lack long-term clinical data. Yet, activity in the space suggests that these technologies are gaining support. Certain large and mid-tier players see these systems, whether developed internally or procured through agreements, as integral products in their portfolio.
Exhibit 1 highlights 2016 announcements that demonstrate this activity.
Reiterated its goal to launch a robotics platform during 2016, hired a Vice President of Sales to direct the segment.
Approaching 17,000 procedures performed with the Renaissance surgical robotic assistance system. Ended 1Q16 with 113 systems installed globally, 68 in the U.S., up from 86 and 47, respectively, in 1Q15.
100 spinal surgeries successfully performed with the ROSA™ Spine robotic-assistive device for minimally invasive surgery. The system received CE Mark approval in 2014 and FDA 510(k) clearance in 1Q16.
Entered into strategic agreement with Mazor for equity investments and co-
development/potential global distribution of certain Mazor products.
Entered into a strategic partnership granting Corin distribution rights in Australia for the intellijoint HIP™, to complement Corin’s Optimized Positioning System™ technology.
2015 revenue grew greater than +50% vs. 2014, and 40,000th KneeAlign® Total Knee Arthroplasty case was completed.
|Smith & Nephew||
Completed acquisition of Blue Belt Technologies, developer of the Navio surgical robotics assistance system for unicondylar or partial knee replacement.
Acquired Stanmore Implants Worldwide, with a portfolio comprising patient-specific and off-the-shelf implant systems for limb salvage. (Stanmore received FDA 510(k) clearance to market its Sculptor Robotic Guidance Arm™ for precision implant placement in unicompartmental knee surgery in 1Q13.)
Sold 31 Mako robots worldwide in 4Q15 (24 in the U.S.); sold 72 units in 2015.
Next-generation iterations and line extensions of computer-assisted technologies appeared among joint reconstruction segment product launches for 2015, such as updates to ExactechGPS for total knee and a next-gen version of the intellijoint HIP™. NuVasive launched its Integrated Global Alignment platform for spine in 2015, while Stryker Navigation presented SpineMask, a non-invasive navigation tracking that doesn’t require an additional incision.
Smaller, portable planning and navigation systems that are not implant-specific may gain support faster in the industry, as they typically have a smaller price tag and can be implemented into the surgeon’s workflow with less of a challenge.
Andrew Pearle, M.D., an orthopaedic sports medicine surgeon at Hospital for Special Surgery and Clinical Director of the Computer Assisted Surgery Center, began using robotics for partial knee replacement about eight years ago. Due to expense to the hospital, Pearle emphasizes examining whether computer-assisted systems are making the surgeon better, to justify the cost of the system and the time it may take to master the new process.
“In terms of adapting it to the OR, it does slow you down initially, but now it’s pretty much time-neutral for me; my cases are faster with the robotics than manually,” Pearle says. “We’re beginning to see a clinical impact in partial knee replacement. Once you have a clinical impact, you have to do a cost-effectiveness analysis.
For partial knee replacement, we found that the revision rate at two-and-a-half years was about 30% to 70% less compared to previous studies.”
Ultimately, Pearle thinks that adoption of smart technology will continue, but iterates the importance of choosing the tools that will produce the greatest clinical impact for each procedure.
“Advanced technology will be more common, whether it’s robotics, custom jigs, navigation or some other tool. I always talk about what the tools can do and what they can’t do,” Pearle says. “What does the robot do in partial knee replacement? It controls certain surgical variables (like alignment of the limb, positioning of the implant and soft tissue balance), but it doesn’t control all of the variables. It doesn’t control fixation, which is probably the most important one. Moving forward, I hope to see us get smart enough to use the tools in a refined way, so that we use mechanical instrumentation when that is most efficient, and use robotics, navigation or custom jigs when those are most efficient, and we really master when we’re using tools effectively—and when we can just use traditional, less expensive systems.”
ORTHOKNOW spoke to seven companies that offer computer-assisted surgery devices, from mobile planning apps to navigation tools to imaging to guidance platforms and robotic systems, to gauge the varying opinions on these technologies in orthopaedics. These companies appear in alphabetical order.
Products: TraumaCad® Mobile, a mobile solution for pre-operative orthopaedic surgical planning and digital templating for total hip and knee arthroplasty. TraumaCad also has applications for deformity, pediatrics, trauma, spine, upper limb, foot and ankle.
Marc Mackey, General Manager of Orthopedics
ORTHOKNOW: What has feedback been on TraumaCad Mobile?
Mackey: It reduces the amount of time surgeons spend planning. It can actually save costs; printing out x-ray films is expensive. The hospital will stop printing x-rays entirely and then this becomes the only option to plan.
From a surgical navigation and robotics perspective, what we’ve seen is an increase in price pressures on disposables. That gives us a particular advantage because our disposables are inexpensive. The system itself can be purchased in a lease or capital, so depending on whether the hospital wants to put everything in their operating budgets it certainly has some tax advantages, or if they put it on their capital budget, then maybe it doesn’t hit their P&L.
With CJR, surgeons have to make sure that they can accurately reproduce every procedure. One outlier is catastrophic to the P&L of the hospital. With a digital measurement system, they can be sure that they’re not going to have these strange outliers.
We have a close partnership with DePuy Synthes; we’re working on the next generation of navigation with them, which consider cost pressures in the market and the increased need for measuring and collecting data.
Many digital measurement technologies are available; there are companies that use gyro sensors or robots. Robotics may have a place, but we’re not sure that the expense can be justified. We’re keeping our eye on different robotic technologies out there, but right now we don’t see the value.
Product: The intellijoint HIP™, a miniature 3D surgical measurement tool intended to address instability, hip dislocation and leg length discrepancy; compatible with the majority of implant vendors.
Armen Bakirtzian, CEO
ORTHOKNOW: What value does your product seek to provide?
Bakirtzian: You can reduce revisions, readmissions and legal disputes on leg length discrepancy, which is the number one reason for litigation against orthopaedic surgeons in the U.S. All of that plays in our favor and supports the value proposition.
Surgeons have sought a technology that helps to enhance their skills, but doesn’t get in the way. Traditional navigation and robotic solutions provide valuable information to the surgeon in the OR, but I don’t think they solve some of the more critical issues, like is it cost effective? Is it effective in terms of time of surgery, and is it complex? Though traditional navigation and robotics add value to the hospital, patient and surgeon, that value is never really commensurate with the cost of the system, time and actual dollar value. We don’t charge the hospital any capital fee, which is a completely different model from surgical navigation or robotics. If you go to a hospital administrator and you’re trying to sell a robot that’s over $1 million, it’s not an easy thing to do. We charge by procedure, which includes the fee for the technology and all of the disposables; it includes everything.
We’re focused on simplicity and integration of workflow, because surgeons aren’t going to change what they do significantly, and we’re focused on bringing the right surgeons into our design team to help ensure that we’re creating intelligent products that enhance surgeon workflow.
Product: Renaissance® Guidance System, used for biopsies, adult reconstructive spine surgery, minimally-invasive spine surgery, scoliosis, fusion and vertebroplasty
Chris Prentice, CEO
ORTHOKNOW: What feedback have you received from surgeons?
Prentice: It depends on what type of surgeon you’re speaking to. Some deformity surgeons have been surprised during the planning on some of the anatomy; they wouldn’t have assumed that’s what it looked like. They thought the pedicle would be a certain size and it wasn’t. Now they’re able to identify the pedicle beforehand. They’re surprised at the efficiency; most people think that you add equipment and you’re adding time and steps. For larger deformity surgeons, they’re cutting time down, not adding it.
ORTHOKNOW: Have you received any pushback from hospitals?
Prentice: You can’t just add technology for the sake of technology. There’s definitely prudence, and there should be. They want to make sure that whatever they’re adding from an equipment standpoint adds value. That’s what we have to display to them. We’ve shown that not only can we improve operational efficiencies in the room, not only can we reduce the hazard to their teams with lower fluoroscopy, but it’s also translating to patients through fewer complications, fewer revisions, less opioid use, faster return to activity, shorter length of stay – and we have actual data to show that. The immediate knee-jerk reaction is, ‘Is this needed?’ which is fine, and we can speak to that.
When you’re talking about skeletal structures, robotics can easily be integrated. In 20 years, you will not have an orthopaedic procedure without some kind of robotic element. Consider how you approach the situation. If you look at just what’s currently there and fixate on the constraints, you might say no, that will never happen. You could argue about who is going to do it, which modality or which brand, but it’s going to happen. We’re starting to see more openness to it, especially in spine, and more of the opinion that it will happen.
Product: ROSA™, spine robot for minimally-invasive spine surgery
Teresa Prego, Senior Director of Marketing
ORTHOKNOW: What’s your approach for hospital adoption?
Prego: When we look at a hospital, we look at the economics as well. If there’s a revision or a readmission, [hospitals] pay. In around 40 percent of spinal fusion cases, the patient still has issues and some of that may be related to screw placement or infection. A larger incision has a higher potential for infection. There are some positive features with a minimally invasive approach. It’s not just looking at a cool technology and saying you’ve got to have this technology just for technology’s sake. You have to bring value.
Robotics has seen tremendous growth. The understanding of robotic-assisted surgery has grown enormously. Now we’re trying to expand beyond the surgeon community to referring physicians, like primary care physicians or neurologists, and even patients.
As a piece of capital equipment, we will probably receive more scrutiny from the hospital because you have to have a great story in addition to a compelling technology. With some of these products, as part of a purchasing organization, you know that you’re going to buy them over and over—perhaps there is less scrutiny in that situation. But there’s always some skepticism about robotics. Solid clinical value will be needed for robotics to really have use long-term.
Products: OrthAlign Plus®, a total hip and total knee navigation system in a palm-sized, single-use device, compatible with all implant systems; KneeAlign®, the same platform for tibial and femoral navigation; UniAlign for unicompartmental knee arthroplasty.
James Kim, Global Vice President of Sales and Marketing
ORTHOKNOW: How are hospitals receiving your technologies?
Kim: Hospitals themselves are still trying to understand where they’re going. The future of orthopaedics is not in the implant; it’s in the tools and technologies you’re going to provide to a surgeon so that he or she can be more precise and accurate, and get better outcomes. There’s only so much you can give in an implant. More and more of these big companies are trying to get away from that service; instead of asking how can I give you more resources in terms of human personnel, it’s now, how can I get that rep out of the room? Large console navigation systems are so complex and the surgeon’s going to have to alter the way he or she does surgery; there’s a huge learning curve.
If you’re comparing [OrthAlign’s products] to big box computer-assisted surgery systems, patient specific cutting blocks and conventional guides, we’re saying that you can get the best of everything by taking out all that clutter you don’t need. You can have everything in the palm of your hand, with all the data you need, and not pay a fortune.
Product: VERASENSE™ sensor-assisted total knee arthroplasty disposable instrument
Ivan Delevic, CEO
ORTHOKNOW: What clinical value does your product seek to provide?
Delevic: If you look at the studies on patient satisfaction over the last 15 years, about 20% of patients end up unhappy with their knee surgery. That number is much lower in hip. Revision rates have been coming down, but new implant designs have not made a dent in patient satisfaction.
We supply sensors for five knee systems: Stryker Triathlon®, Zimmer Biomet Vanguard®, Zimmer Biomet NexGen®, Smith & Nephew Journey® II and Legion®. They are specific to each knee system in size, shape, curvature and they are 100% equivalent to the non-sensor trials. The sensor technology that we apply has potential application in other joints and in time, we will try to apply this technology more broadly.
Our concept and the vision of our company was that balancing the soft tissue, in addition to placing the implant properly, is the ultimate solution that is going to bring the number of satisfied patients in knee closer to or better than the number of satisfied patients in hip. Our vision is to bring intelligence and quantification to orthopaedics. The movement from pay-for-service to pay-for-quality requires measurement. By the nature of our device, which provides digital signature, we believe that this can contribute to that measurement.
Products: Primary and total knee and total hip applications for robotic-arm assisted surgery
Stuart Simpson, Vice President and General Manager, Commercial Business Unit
ORTHOKNOW: What has initial feedback been like?
Simpson: We’ve had positive feedback, from a business perspective and the clinical perspective on quality and accuracy of the surgery. It’s almost like surgeons become hooked on the technology once they start using it.
With the changing healthcare reimbursement environment we’re in right now, hospitals and physicians are challenged to be able to provide high quality and low cost care. We believe we can be a contributor to both that higher quality and lower cost of care.
Hospitals and physicians starting this program are perceived as technology leaders, and typically you see their business and practice start to grow. We think that it will become a standard of care.
Hannah Corcoran is Associate Editor at ORTHOWORLD. She can be reached by email.