The end of a year marks a time to take a moment to reflect on what’s happened and what’s potentially coming. It’s a reminder to celebrate the successes, learn from the failures, and plan for tomorrow. That, after all, is the purpose of the Year in Review feature that appears in every November/December issue of ODT. Be sure to see what was identified as the biggest topics within orthopedics in this year’s edition.

Rather than pontificate exclusively in this Editor’s Letter on my thoughts (after all, I have five other issues to do that throughout the rest of the year), I invited members from the ODT editorial advisory board to respond to two questions. First, I asked them what they thought was the most significant headline, event, or technology in 2021. Then I asked what they would be keeping an eye on in 2022 (i.e., what will have an impact, positive or negative, on the orthopedic device industry).

William Pratt, vice president of operations and director of creative design at Kinamed Inc., offered his thoughts. Regarding the first question, Bill said, “The assertion that performing joint replacement surgery in the ASC setting is building irreversible momentum, and along with it, the requirement for single-use instrumentation and navigation to accommodate the limited logistical support typically found at ASCs.”

Growth in the types and volume of procedures taking place at ASCs is certainly growing rapidly, but may see a significant stumbling block with ongoing instability in reimbursement decisions (again, see the Year in Review feature on page 30). In my view, this will be a temporary challenge (although “temporary” could still mean years), and this trend will eventually continue. As such, device makers may want to consider the ASC environment for their technologies.

For the second question, Bill wished, “That joint replacement volumes will trend up toward 2019 levels as the impact of COVID on hospital capacities declines (hopefully).”

I think many of us are thinking along the exact same lines as Bill in this instance. The backlog for procedures is still substantial and demand for devices will likely continue to rise well into 2022 (if not beyond).

James B. Schultz, executive vice president at ECA Medical Instruments, offered the following response to that question: “The advent of precision single-use and sterile pack torque-limiting instruments on power tools is a game changer in the spine implant market. The ability to final tighten pedicle screws and constructs up to 13 Nm set point using power for a full scoliosis case, for example, greatly reduces surgeon fatigue and shortens OR time (hence less blood loss and anesthesia), and results in precise implant fixation, reducing risk of revision or complications. The technology is on the market today and being broadly adopted by spine implant companies and surgeons.”

Two advisory board members each included a comment on single-use instruments. Does anyone else detect a trend, or is it just me? Is your company in a position to be involved in their development?

Similarly, both board members mention ASCs in their responses. For the second question, Jim said, “The growth in the numbers and size of ASCs will see nearly 70 percent of all surgeries taking place in the outpatient setting by 2022. Orthopedic cases are among the most profitable. To help ASCs service this customer (patient) demand, implant OEMs are turning to single-use and sterile pack, surgery-ready instrument kits and sterile implants to provide ASCs with cost savings and efficiency gains. A wave of new sterile pack solutions for trauma, upper and lower extremities, and spine are rolling out to the market throughout 2022 and onward to increase OR turnover rates, eliminate reprocessing costs, and improve margins. Implant OEMs with on-the-shelf single-use, sterile pack instrument and implant solutions enjoyed the benefit of sales during the COVID-19 surge when their reps could not be present on site.”

David Kelman, chief development and compliance officer for Sterile Edge Inc., saw the pandemic as still prominent in 2021. “Obviously, COVID-19 still dominates and impacts the medical device market. The downstream impacts of the pandemic and the potential impact to healthcare—from telehealth, remote monitoring, and where care will be performed.”

His response to the second question, however, had a familiar ring to it. “The change in reimbursement by CMS allowing more complex procedures to occur in ASC settings, and a greater desire of patients to have their care performed there. The result is more sites of care that will stress medical device companies’ supply chains.”

What did you consider most significant in 2021 and what will you keep an eye on in 2022? Share your thoughts with me anytime, but until then, have a fantastic holiday season and new year. 

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com