To view this article on the Orthopedic Design & Technology Magazine website, click here.

Over the past half-century or so, the American Academy of Orthopaedic Surgeons (AAOS) annual meeting has grown to become one of the industry’s most important events. The 39,000-plus member organization bills the show as a “powerful week of education, innovation, and collaboration” but the meeting is more than a networking, social, and learning affair for orthopedic surgeons—it’s an essential part of the business strategy for any company that wants to gain market share for their products.

This year’s meeting in San Francisco was no different. The ever-constant fight for both market share and notoriety involved companies that launched new innovations and others that pumped out solution-driven propaganda.

A closer examination of some key industry battlegrounds follows.

The Robotics Revolution

In an ironic twist for this year’s meeting, a Johns Hopkins Medicine study found similar revision rates in conventional and robotic-assisted cementless total knee arthroplasty (TKA) two years after surgery.

Using information gleaned from the American Joint Replacement Registry (AJRR), researchers compared the results of patients who underwent robotic-assisted cementless TKA procedures with those who endured traditional non-robotic surgeries between January 2017 and March 2020 (with a minimum two-year follow up). Statistics from patients aged 65 years and older was used due to the data linkage between AJRR and inpatient/outpatient Medicare claims information, which allowed researchers to track patients if they switched hospitals.

Of the 9,220 total cementless TKAs identified, 4,120 (45%) were performed using robotic assistance. Results showed:

• The odds of all-cause revision two years after surgery were similar between the conventional and robotic-assisted cohorts (odds ratio 0.8, 95% CI .05 to 1.3; p=0.4).

• The odds of revision from infection were similar between the two groups (OR 1.47 95% CI 0.8 to 2.6; p=0.19).

• Mechanical loosing was not significantly different between the cohorts (OR 3.2, 95% CI 0.8-12; p=0.09

Given the intense battle for robotic technology market share, this study obviously sparked significant debate during the AAOS meeting. Robotics proponents quickly pointed out the study authors’ acknowledgement of their research’s limitations: first, the AJRR—like most national registries—was reliant on the accuracy of submitted data; second, nearly two-thirds (60%) of AJRR TKAs did not indicate whether robotic assistance was used; and third, younger patients were excluded from the investigation.

Although this study could potentially hamper robotics’ future momentum in the orthopedic industry, there clearly is no immediate impact because nearly every large implant manufacturer has developed (or acquired) their own robotic-assisted solutions or other enabling technologies to help surgeons pre-plan or navigate (or both) knee surgeries. The industry has invested too much into this evolving technology to slow down now. And while we agree with this concept, we strongly urge industry influencers to use this initial data to continuously improve their current and future robotic solutions.

New Players Creating an Impact

While still relatively small in market share, Think Surgical Inc. is creating quite a stir and bit of concern among their larger competitors. And for good reason: The Fremont, Calif.-based company’s TMINI Miniature Robotic System is a small, handheld wireless solution that can support different implants from various manufacturers, thereby expanding its appeal to a broader market. Think Surgical continuously updates its implant library to provide its technology to more customers; during the academy meeting, the company identified three future inductees into its library, announcing collaborations with Waldemar Link GmbH & Co. KG, Maxx Orthopedics Inc., and b-ONE Ortho Company to eventually add those firms’ knee solutions to the TMINI lineup.

Besides its open implant system, Think Surgical has secured major financial backing from KDB (Korea Development Bank) Investment, a subsidiary of KDB Bank. Moreover, Think Surgical’s commercial execution and strategy are led by two successful industry veterans—Executive Board Chairman and investor David Dvorak, former president and CEO of Zimmer Biomet, and CEO Stuart Simpson, a former Stryker executive who helped Chairman/CEO Kevin Lobo develop the company’s highly successful MAKO robotics market penetration strategy. It’s no wonder Think may be creating some sleepless nights for the orthopedic industry C-suite.

Another source of anxiety for the big players (or potential acquisition opportunity for one of them) came from an inaugural competition for novel orthopedic products. Presented by MCRA LLC and AAOS, OrthoPitch featured four finalists competing for various industry-specific rewards; the victor, CytexOrtho, won over the judges with its implants that integrate into cartilage defects of injured joints. Made of polycaprolactone, the implants restore anatomic structure and function while preserving natural bone. The preclinical stage company will now be rewarded with exposure to investors and an MCRA-conducted regulatory or reimbursement assessment, among other spoils.

Canary Medical Inc. did not make any formal announcements at AAOS but nevertheless captured attention with updates on the promising performance of its “canturio te” sensor solution. Paired with Zimmer Biomet’s Persona Personalized Knee implant, Canary’s product is designed to remotely monitor and record range of motion and patient activity after surgery, giving clinicians a new tool to help manage prosthetic knee post-op recovery.

Shoulder Surgery Enabling Technology—An Emerging Battlefield

While it’s not the largest market segment, shoulder replacements seem to be the next combat zone in the ongoing war for enabling technologies dominance. Both Zimmer Biomet and Smith+Nephew made major announcements during the show about their respective shoulder repair solutions. Smith+Nephew disclosed the U.S. commercial availability of its AETOS Shoulder System, along with U.S. Food and Drug Administration (FDA) 510(k) clearance for its use with ATLASPLAN 3D Planning Software and Patient Specific Instrumentation for total shoulder arthroplasty. Zimmer Biomet, meanwhile, hinted at pending FDA clearance for its ROSA Shoulder System (and has since won that authorization). ROSA Shoulder is now the world’s first robotic surgical system for shoulder replacement and the fourth application for the ROSA portfolio.

Not to be eclipsed by its rivals, Stryker announced that its Mako system will offer a shoulder solution by the end of the year. Both Enovis and DePuy Synthes have skin in the shoulder game as well, and are likely working on their own versions of robotic-assisted shoulder replacement technology. Don’t be surprised if either (or both) unveil their solutions in the near future.

CT Imaging for Knee Surgery

Due to reduced costs and lower radiation doses, X-ray imaging historically has been the standard of care in the U.S. for pre-operatively assessing the knee for replacement surgery. But the success of Stryker’s Mako knee system, which requires CT Imaging, has triggered an interesting debate. Not surprisingly, the companies that have developed CT imaging-based solutions are biased toward computed tomography, while those partial to X-ray imaging tech contend their innovations are superior for the patient.

The dominant imaging modality, of course, is yet to be decided. There also is no clear-cut answer about the better solution for patient outcomes. With technology constantly evolving, the favored solution may entail combining the best of both worlds—i.e., using artificial intelligence to convert 2D images to 3D images. One company, Ortoma AB in Sweden, is close to achieving such a compromise. This seems like the future solution for knee surgery imaging modalities.

Whether X-ray or CT imaging, an open or closed implant system, or robotic-assisted or conventional joint replacement, it is critically important that all of these technologies and industry battles are performed with the patient’s best interests in mind. Most companies subscribe to this philosophy, ensuring the future remains very bright for anyone seeking orthopedic care. Here’s to tomorrow! 

Florence Joffroy-Black, CM&AA, is a marketing and M&A expert with significant medtech industry experience, including working for multinational corporations based in the United States, Germany, and Israel. She currently is CEO at MedWorld Advisors and can be reached at florencejblack@medworldadvisors.com.

Dave Sheppard, CM&AA, is a former medtech Fortune 500 executive and is now focused on M&A as a managing director at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com.

To view this article on the Orthopedic Design & Technology Magazine website, click here.