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One of the most important questions concerns reimbursement.
September 23, 2024
By: Sean Fenske
Editor-in-Chief
In 2016 while in my first year as part of the ODT team, I attended the North American Spine Society annual meeting for the first time. During that event, I observed the state of the spinal industry, which I summed up as the spinal fusion show. However, tucked away between spinal implant companies and fusion technology providers were a variety of vendors showcasing their more natural solutions—biologics. These innovations captivated me and I boldly proclaimed in an Editor’s Letter soon after that the industry would be transformed, possibly in 10 years. Fast-forward to almost eight years later and the orthopedics industry (not just spinal fusion) is very much in a rapid transformation. Biologics, however, are not driving that change. Rather, digital-based technologies are spearheading a new wave of orthopedic products and procedures. These devices have eliminated any trace of “art” within orthopedic surgeries and replaced it with science based on data. They are providing surgeons with more exact measurements to help ensure accurate surgeries to ultimately lead to more successful procedures. At least, that’s the idea. Unfortunately, we’re not quite there, according to research on robotic procedures versus more traditional techniques. A study presented at the 2024 annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) revealed evidence of robotic-assisted procedures not significantly impacting surgical outcomes. Researchers looked at 9,220 cementless total knee arthroplasty procedures, 45% of which were performed with robotic assistance. They found reasons for revisions at two years were similar between both techniques. They also found the rates of revision due to infection were similar. Finally, they found the instance of mechanical loosening is not significantly different between robotic-assisted and conventional surgeries. This is only one study, but it does resemble anecdotal information I’ve heard in my discussions with industry representatives on both sides of the conversation. Unfortunately, however, it’s not the only challenge faced by the digital revolution in orthopedics. A September 2023 article published by Cureos features an overview of “The Role of Robotics” in orthopedics. It cites both advantages and disadvantages associated with the use of robotics in orthopedics. Among the benefits mentioned were: enhanced precision, personalized treatment, minimized tissue trauma, improved implant placement, real-time feedback, ability to execute complex maneuvers, and reduced radiation exposure. Curiously, some of those advantages are called into question by studies such as the one presented at the AAOS event. Unfortunately, the list of disadvantages could be considered more significant than the benefits realized. They included: high initial costs, learning curve, limited flexibility, dependency on technology, time-consuming setup, complexity of integration, and ongoing maintenance and costs. A fair number of these can be resolved with future innovations and ongoing development of future generations. We’re just at the infancy of the robotics’ debut and the systems will undoubtedly improve in multiple ways. There is, however, one concern brought up that extends well beyond robotics; rather, it’s prevalent for the digital technologies being embraced in the orthopedic space (and the medtech sector at large). Who’s paying for these if they offer no or minimal significant improvements on the current standard of care? I recently spoke with one of the panelists for the upcoming MPO Summit about this very topic. While he’s worked with several companies on enabling technologies, he maintains one of the most important questions concerns reimbursement. If the product is not being covered by payers, it’s not going to succeed. Before the digital transformation of orthopedics or medtech can take place, the financials need to make sense.
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