There’s no turning back.

The digital genie is out of the proverbial bottle: Advancements like artificial intelligence (AI), machine learning, data analytics, and robotics are reshaping the way orthopedic care is delivered, from diagnosis and treatment to surgical outcomes and rehabilitation.

Traditional film-based radiography is quickly losing favor to digital imaging techniques that provide quicker photo acquisition, reduced radiation exposure, and enhanced storage and sharing capabilities. Computer-aided tools can now help diagnose these images more quickly and accurately than their human counterparts.

AI is lending a helping hand to physicians as well. Sophisticated algorithms can promptly analyze large sets of patient data to identify trends and predict outcomes, and AI-enabled software is turning robotic-assisted surgery into a cornerstone of personalized treatment for the worn-out joints and torn tendons of an aging world population.

Earlier this year, Johnson & Johnson MedTech began working with global software/fabless behemoth NVIDIA to test new AI capabilities for the company’s connected digital ecosystem for surgery. The partnership aims to enable open innovation and accelerate the delivery of real-time insights at scale to support clinicians before, during, and after procedures.

The collaboration is a testament to the orthopedic sector’s endorsement (and acceptance) of digital healthcare. Innovations incorporating AI, surgical software, and smart technology were prevalent this year as the industry further embraced its digital future.

“Surgical technologies will get more intelligent over time, bringing the power of advanced analytics to surgeons and hospitals,” said Shan Jegatheeswaran, vice president and global head of digital at J&J MedTech. “A collection of AI models could act like driver-assistance technology for surgeons, amplifying their ability to deliver care while reducing cognitive load.”

Take note of that “driver-assistance technology.” It is likely to lead orthopedics down some extraordinary roads in the near future. 

Generative AI’s Generous Future

They called it the Woodstock of AI. And in some respects it was, despite the lack of hippie fashion, live music, open drug use, mud, and carnivalesque atmosphere. Yet the comradery and cultural community bonding that helped define the iconic three-day festival in Bethel, N.Y., more than a half-century ago resurfaced this past March on the opposite side of the continent.

While nowhere near as large as Woodstock, the GTC 2024 crowd in San Jose, Calif., nevertheless shared the same sense of purpose and robust sense of belonging as the free-love counter- culture movement two generations ago. Rather than forming bonds of solidarity against war and the political establishment, GTC attendees bonded over technological advancements and hope for a brighter future through artificial intelligence (AI).

“In 2017, the transformer arrived. 2022—ChatGPT captured the world’s imagination. People realized the importance and capabilities of artificial intelligence,” NVIDIA CEO Jensen Huang remarked in a conference keynote address. “And 2023, generative AI emerged and a new industry begins. So how can we prepare today for what’s to come next?”

Huang answered his own question by unveiling Blackwell, a new AI processor the software and fabless multinational firm bills as the world’s most powerful computer chip. Packed with 208 billion transistors, Blackwell architecture GPUs enable organizations to build and run real-time generative AI on trillion-parameter large language models at up to 25x less cost and energy consumption than its predecessor.

“We need another way of doing computing,” Huang noted upon unveiling the Blackwell platform. “We need even larger models. The future is generative…we created a processor for the generative AI era. A new industry has emerged.”

And that new industry—powered by the Blackwell platform—is liable to foster boundless AI-driven possibilities for humankind. The prospects are particularly promising for healthcare, a sector that is just beginning to realize the full benefits of artificial intelligence technology.

While computer-simulated intelligence has been augmenting human medical acumen for at least half a century, AI’s presence (and acceptance) in the healthcare field only surged in the early part of the 21st century with the advent of sophisticated deep learning models. Over the last decade, AI-powered medical applications have skyrocketed as software advancements and sophisticated algorithms have improved the technology’s ability to emulate human cognition and analyze, interpret, and understand complex healthcare data.

Still, the medical profession has barely scratched the surface of AI’s virtually limitless capabilities.

“Every day, we learn more about the potential of AI to improve healthcare. One recent study by the U.K.’s Royal Marsden NHS Foundation Trust and the Institute of Cancer Research showed that AI was ‘almost twice as accurate as a biopsy at judging the aggressiveness of some cancers,’” a Jan. 17 article by the World Economic Forum stated. “These developments are incredibly promising. The excitement and uncertainty about what AI could ultimately mean for healthcare and people everywhere…has only grown in the last 12 months as AI developments have seemingly accelerated from week to week.”

More like day to day: Through the first half of 2024 (182.5 days), the U.S. Food and Drug Administration (FDA) approved 107 AI/ML (machine learning)-enabled medical devices. The annual total has grown steadily in the last decade (only six AI-enhanced devices were sanctioned in 2015) and the cumulative total (since 1995) is approaching 1,000, according to FDA data.

GE Healthcare has been the most prolific contributor to that running total, winning 72 510(k) clearances/authorizations to date in the United States. Siemens Healthineers ranks second with 64 AI-based approvals, followed by Canon with 28 and Royal Philips with 27.

A smattering of orthopedic firms anchor the opposite end of the FDA’s register, starting with Stryker Corp., which earned a golden ticket through its AI-enabled HipCheck—an intra-operative resection planning/execution tool—and the SurgiCount+ System, a software application for estimating blood loss and managing surgical sponges. 

Other last-place listers include Brainlab, Enhatch Inc., NuVasive Inc., Orthofix Inc., and Ortoma AB—all with only one AI-enabled innovation to their credit.

Brainlab secured its listing with its stereotaxic guidance technology for joint, spine, cranial, and craniofacial procedures while Switzerland-based Ortoma followed suit with its digital, server-based integrated AI platform for surgical planning, navigation, post-operative verification, and follow-up (the Ortoma Treatment Solution). 

NuVasive (now part of Globus Medical Inc.) earned its placeholder via the Pulse system, a spinal surgical automation platform that integrates multiple technologies into a single solution, and Orthofix reserved a roster spot with its medical image management/processing system (MIS app). Enhatch, meanwhile, gained entry upon the FDA’s 510(k) clearance of its patient-specific instrumentation system for total knee arthroplasty. The system features AI algorithms that convert patient X-rays or computed tomography images into detailed, 3D anatomic models for use in treatment plans.

“Our Intelligent Surgery Knee software plays a pivotal role in streamlining preoperative planning and crafting patient-specific guides with enhanced efficiency,” Enhatch President/Chief Technology Officer Michael Phipps said upon receiving the FDA’s authorization in January. “Leveraging cutting-edge AI technology for accurate modeling of individual anatomies and planning treatments, we are setting new benchmarks within the industry.” 

Enhatch is not alone in this task: Orthopedic firms are setting new benchmarks in all facets of AI-assisted musculoskeletal treatment/repair, from pre-operative planning, imaging, and surgical navigation to fracture detection, knee balancing, arthroplasty, and robotics. 

AI-powered implant templating and identification has become commonplace in orthopedics as surgeons seek to improve procedural accuracy and reduce OR time. AI-powered implant identification solutions have demonstrated up to 99% sensitivity and specificity in clinical studies, validating the superiority of machine over man in implant determination alacrity.

A similar supremacy exists in the pre-operative planning and navigation realms. AI and machine learning (ML) have repeatedly proven their dominance over humans in quickly and accurately analyzing patient data from X-rays, computed tomography scans, and MRIs. 

PeekMed’s AI-powered web-based automated planning solution, for example, generates an accurate surgical plan in under 30 seconds—a far cry from the hours or (sometimes) days it often took humans to complete the task. “We understood the pains of our surgeons…” PeekMed Chairman/CEO João Pedro Ribeiro said last winter after the company received FDA 510(k) clearance last winter for its automated planning solution. “Having the ability to get a plan in less than 30 seconds is just incredible…”

Incredible, indeed: PeekMed’s solution outpaces other planning software systems by minutes. Chicago-based ImmersiveTouch Inc.’s virtual surgical planning portfolio whittles the traditional pre-operative plotting workflow for craniomaxillofacial procedures from seven days to “just minutes.” The company augmented that platform this past summer with the FDA 510(k) clearance of ImmersiveAR, an augmented reality (AR) technology platform designed to help surgeons visualize and interact with 3D surgical plans, overlaid in an operating room environment. ImmersiveAR allows physicians to customize procedures by simulating surgical changes to bones and planning the final aesthetic result.

Medtronic offers custom surgical planning as well through its AiBLE smart ecosystem, which integrates advanced navigation, robotics, data, AI, imaging, software, and implants to enable more predictable outcomes in spine and cranial procedures. The company released several AiBLE improvements in September, including software for advanced navigation volumes, dose reduction, and better image confirmation/quality; computer vision technology for automatically analyzing lumbar MRIs to segment, label, and measure key aspects related to common pathologies; and a fully enabled procedural solution for improved surgical area visualization as well as workflows for fluoro, navigation, and robotic procedures in both cortical bone screw and pedicle screw trajectories.

Coinciding with Medtronic’s AiBLE enhancements was the FDA 510(k) clearance of Avicenna.AI’s CINA-CSpine, an AI tool designed to detect and triage cervical spine fractures from CT images. Validated on more than 300 non-contrast CT scans, CINA-CSpine achieved an overall sensitivity and specificity of 90.3% and 91.9%, respectively, when compared to the ground truth established by the consensus of three U.S.-board certified senior radiologists.

“Cervical spine fractures are serious injuries that require prompt and appropriate medical attention…” Avicenna.AI Co-Founder/CEO Cyril Di Grandi said upon the FDA’s authorization. “These results demonstrate that our CINA-CSpine algorithm is capable of providing prompt and accurate findings that could positively guide physicians towards better assessments and improved patient outcomes.”

Alphatec and Proprio are guiding physicians along that same path, courtesy of their respective AI solutions. Alphatec’s EOS Insight integrates standardized EOSedge scans and AI to improve surgical precision and outcomes. Launched in July, the platform leverages cloud-based software to generate critical information throughout the various stages of spine care, including AI-driven alignment calculation, 3D surgical planning simulations, patient-specific rods, intra-operative reconciliation, and post-operative analytics. Data generated through the applications will be used to continue the march toward more predictable spine care.

Joining Alphatec on that march is Proprio, whose Paradigm surgical guidance platform uses light field technology to provide real-time 3D anatomical mapping (think Google Maps for spine surgery). Leveraging advanced computer vision sensors, Paradigm captures high-definition multimodal intraoperative images and fuses that data with pre-operative scans to model the potential results of key decisions. 

Surgeons have used Paradigm in its first 50 cases to successfully place hundreds of implants in various challenging procedures, from scoliosis to collapsed discs.

“Our goal,” Proprio Co-Founder/CEO Gabriel Jones declared, “is to extend the boundaries of what humans and computers can do together and to continue to shape the AI-driven future of surgery.” 

Proprio is not the only organization on a boundary-breaking mission, though. Smith+Nephew, Exactech, and Johnson & Johnson MedTech all are testing the limits of human-computer integration in order to bolster clinical outcomes and improve patient care.

Smith+Nephew and Exactech, specifically, have incorporated AI into their knee replacement surgical software. Smith+Nephew’s RI.KNEE robotics version 2.0 with Personalized Planning provides artificial intelligence-powered reference values for guidance, enabling surgeons to set preferences for initial implant starting points that are customized to patient deformity.

Likewise, new ExactechGPS software released in August upgrades the company’s Newton Knee balancing technique to enable simultaneous femur and tibia resection planning. 

Johnson & Johnson MedTech, on the other hand, is using AI to boost its OR capabilities. The company announced a partnership in March with NVIDIA that will link the latter’s IGX edge and Holoscan edge AI platforms with the medtech giant’s surgery suites to deploy AI-powered software applications in the operating room.

“AI models are currently being created by experts in surgery in various parts of the world,” Shan Jegatheeswaran, vice president and global head of digital at J&J MedTech, remarked upon disclosing the NVIDIA partnership. “If we can create a trusted, open ecosystem that enables and accelerates coordination, it would create a flywheel of innovation where different groups can collaborate and connect at scale, improving access to advanced analytics across the surgical experience.”

The possibilities could be endless.

Read more: bit.ly/3AGYYEp

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EtO TKO

Sharon Lavigne longs to breathe clean air.

It’s a simple wish, but a critical one to Lavigne at this point in her life. Lavigne’s wish is shared by countless others in her hometown, yet it is likely to go unrealized, as the air quality there is ranked among the worst in the United States.

The air (and water) is so foul, in fact, that Lavigne and many of her neighbors have placed signs in their front yards that read, “We live on death row.” The slogan is pure hyperbole, of course, meant to accentuate their perceived punishment from Corporate America, but it’s based partially in truth—Lavigne and her fellow death row inmates live in one of the most polluted places on Earth.

That locale—tiny Welcome, La., (pop. 672)—sits in the bullseye of “Cancer Alley,” an 85-mile strip of gritty terrain crammed with fossil fuel and petrochemical plants. Roughly 200 of these steel beasts line the Mississippi River corridor between Baton Rouge and New Orleans, their cylindrical tubes bleeding blue fluid into deteriorating wetlands and towering smokestacks belching acrid vapor into the grimy air. 

“We’re dying from inhaling the industries’ pollution,” Lavigne, 74, president/founder of the grassroots environmental group Rise St. James, told Human Rights Watch in March 2023. “I feel like it’s a death sentence. Like we are getting cremated but not getting burnt.” 

Cremated slowly, at that. The figurative funeral pyre for Lavigne and her Cancer Alley cohorts has been burning for nearly half a century, gradually poisoning them from the inside out. Statistics show the neighborhoods surrounding these massive petrochemical plants—comprised mostly of Black and/or impoverished residents—have some of the highest cancer rates in America (Lavigne, for one, knows of at least 30 people who succumbed to the disease). 

Corroborating evidence can be found within a 2021 Tulane Environmental Law Clinic study that ranked nearly every census tract between Baton Rouge and New Orleans in the top 5% nationally for air pollution cancer risk and the top 10% for respiratory hazards.

But new research indicates the cancer risk among Cancer Alley residents is significantly higher than previously estimated. Johns Hopkins University data published this past June suggest the U.S. Environmental Protection Agency (EPA) has dramatically underestimated ethylene oxide (EtO) levels in southeastern Louisiana. Study investigators found EtO levels in Cancer Alley’s core were more than 1,000 times higher than the agency’s acceptable (safe) limit. Levels near industrial facilities reached 40 parts per trillion and overall average levels were more than double the acceptable threshold of 11 parts per trillion. 

“I don’t think there’s any census track in the area that wasn’t at higher risk for cancer than we would deem acceptable,” senior study author Peter DeCarlo, associate professor in John Hopkins’ Department of Environmental Health and Engineering who studies air quality, said in a news release announcing the results. “We expected to see ethylene oxide in this area. But we didn’t expect the levels that we saw, and they certainly were much, much higher than EPA’s estimated levels.”

Those levels, however, may soon fall back to Earth. This past spring, the EPA set new EtO and chloroprene emissions standards designed to improve air quality around sterilization and chemical plants. Through two separate final rules, the agency is requiring commercial sterilizers to reduce EtO emissions by 21 tons annually (90%) and synthetic organic chemical manufacturers to cut their annual EtO and chloroprene discharge by 54 tons and 14 tons, respectively.

“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution,” EPA Administrator Michael Regan said in a March 14 statement, “including the health of children, who are particularly vulnerable to carcinogens early in life.”

The EPA, truthfully, had no choice but to listen to communities in recent years as the outcry over EtO’s potential health hazards grew increasingly louder. Besides the clamor from Cancer Alley activists like Lavigne, there has been a growing backlash against EtO exposure from grassroots groups in Illinois, Georgia, California, New Mexico, and Michigan whose members live alongside medical device sterilization plants.

That backlash and the underlying debate over ethylene oxide’s biological harms has led to several sterilization plant closings and nearly 1,000 legal claims that eventually were settled for hundreds of millions of dollars. 

Those consequences, as well as the long-simmering controversy itself, have prompted a vociferous pushback from the medtech industry, which relies on ethylene oxide to sterilize half of all medical devices manufactured in the United States annually (20 billion products). The industry’s two trade groups—the Medical Device Manufacturers Association and Advanced Medical Technology Association (AdvaMed)—have repeatedly warned of supply chain disruptions and product shortages that are likely to accompany the new EtO regulations. The two organizations have dialed back their public dialogue since the rules’ mid-March finalization, with both CEOs releasing similar statements about reviewing the regulations and working to safeguard the medical device supply chain from any adverse impacts. 

“We have made clear that we value much-needed updates to the rule,” AdvaMed President/CEO Scott Whitaker said upon the new regulations’ announcement. “We have always approached government agencies with relevant oversight as partners and not as adversaries because this rule has a far-reaching impact on patients and public health. We will be reviewing the rule through that lens and remain hopeful that these changes will not have a negative impact on the healthcare system or the patients we serve.”

The Ethylene Oxide Sterilization Association (EOSA), however, isn’t leaving anything to chance (or hope). The sterilizer/device manufacturer trade group sued the EPA in June, claiming the new regulations are based on inappropriate EtO cancer risk estimates, disregard emission-capturing equipment installation costs, and set unrealistic compliance deadlines.

The latter accusation is debatable (and arbitrary), as the EPA actually extended the compliance deadlines in its final rule. Commercial sterilizers have two to three years to meet the new emissions limits, with exact timelines dependent upon annual EtO use. Facilities using more than 60 tons must comply with the rules in two years, while those using less than one ton have a three-year window (double the original 18-month deadline in EPA’s initial proposal). Facilities using between one and 60 tons of EtO per year have two to three years to comply with the rules. 

Despite EOSA’s compliance deadline protestations, the extension gives medical device manufacturers additional time to find suitable EtO sterilization alternatives. The U.S. FDA has held public meetings to discuss substitute methods, launched a program to better facilitate sterilization process changes, and initiated innovation challenges to foster the development of EtO cleaning alternatives. 

One such substitute is vaporized hydrogen peroxide (VHP), a process commonly used in hospitals to clean reusable devices. VHP sterilization uses H2O2 vapor to fill the sterilizer chamber and clean exposed product surfaces. After the sterilization cycle is completed, the vapor is vacuumed from the chamber and converted to water and oxygen. 

VHP works well for temperature-sensitive devices, pre-filled syringes, implants, and products with electronics, but is incompatible with cellulose-based and highly absorbent materials. The FDA in early January officially recognized VHP as a Category A sterilization method in an effort to facilitate its broader adoption.

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized device that can help prevent medical device shortages,” Suzanne Schwartz, M.D., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in a statement. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”

For Cancer Alley residents like Lavigne, that protection is a small but important victory in their multi-faceted battle for clean air. Although they commended the EPA for establishing new EtO emission limits, the area’s activists are acutely aware their battle is far from over.

“While there is a lot to cheer about,” environmental scientist Wilma Subra, who was part of an environmental justice team that advised the EPA on the finalized rule for chemical plants, told digital news site DeSmog. “…only time will tell if they will ever be enacted.”

Unfortunately, Cancer Alley lifers don’t have that kind of time to spare.

Read more: bit.ly/3TYP8UN

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Robotics Reign

Lukas Schubert couldn’t live with the pain anymore.

For years, the Austrian footballer endured the near-constant misery imparted by his faulty left wrist—the unwanted remnant of a routine training session mishap.

“A cross was coming in from right the side, it hit my wrist and broke it,” Schubert recalled in an online video. “I had pain moving it, and any kind of pressure would be very painful. It handicapped me in my daily life.”

Nevertheless, Schubert tolerated the pain throughout his football (soccer) career. Upon his retirement, however, he decided to undergo surgery to relieve his suffering. 

In a supermicrosurgical procedure performed in Austria, physicians replaced Schubert’s damaged wrist bone with a small piece of knee bone and connected the vessels in the grafted part to those in the wrist. The surgery successfully relieved Schubert’s pain and left him with a smaller than normal scar. 

“I’m very happy with my small scar. All the doctors were happy with the healing process,” he said. “…I’ll have hopefully a pain-free life in front of me.”

That pain-free life will come courtesy of the Symani Surgical System from Jacksonville, Fla.-based Medical Microinstruments Inc. (MMI), which was used to connect Schubert’s knee bone vessels to those in his wrist. The first-of-its-kind robotic platform aims to provide enhanced surgical precision and control—even in the smallest vessels—using sutures between 8-0 to 12-0.

Combining the world’s smallest wristed instruments with tremor-reducing and motion-scaling technologies, the Symani System—which garnered U.S. FDA De Novo Classification in April—addresses the scale and complexity of microsurgery and supermicrosurgery. It also represents a crowning achievement in the evolution of orthopedic surgical robotics. 

While the technology has existed for decades, robotic-assisted solutions have only recently become a centerpiece of surgical innovation. The industry’s embrace of digitally enabled healthcare is spawning the creation of sophisticated robotic systems that advance current platforms past their current capabilities. 

Case in point: Zimmer Biomet Holdings Inc. expanded its robotics surgical platform beyond total hip and knee arthroplasty in February with the FDA’s 510(k) clearance of the ROSA Shoulder System. Touted as a world-first for shoulder replacement, ROSA Shoulder helps enable precise implant placement and allows for flexibility in technique (anatomic or reverse). It also is reportedly one of the only systems that can reproduce humeral head resectioning. Moreover, instruments are more easily inserted into incisions because ROSA does not require a pin in the glenoid center during procedures.

As with other ROSA applications, Zimmer Biomet’s shoulder solution supports data for physician decision-making based on patients’ unique anatomies. Pre-operatively, ROSA Shoulder integrates with the company’s Signature ONE Surgical Planning System 2.0, which uses a 3D image-based approach to visualization, surgical planning, and patient-specific guide creation. The platform provides surgeons with real-time, intra-operative data during procedures to help them control, execute, and validate personalized plans for glenoid and humeral placement, as well as reduce patient complications.    

“One of the challenging aspects of performing a shoulder replacement is accurate glenoid and humeral placement, which is a critical factor for post-operative function and long-term implant survival,” John W. Sperling, M.D., professor of Orthopedic Surgery at the Mayo Clinic, said upon ROSA Shoulder’s clearance. “This approach is designed to allow surgeons to virtually walk through a procedure before making any resections, and then receive live feedback and the ability to control glenoid ream depth and intra-operatively validate cut resections during the procedure.”

ROSA Shoulder’s market debut prompted Zimmer Biomet rivals Smith+Nephew, Medtronic, Stryker, and Johnson & Johnson MedTech to step up their (robotics) games as well this year. 

Smith+Nephew incorporated new software (R.I.KNEE ROBOTICS v2.0) into its CORI Surgical System over the winter to enable joint line restoration and improve knee arthroplasty outcomes, while Medtronic introduced a new Live Stream function for its Touch Surgery Performance Insights platform over the summer, adding 14 new AI algorithms across procedural workflow, instruments, and anatomy detection. The algorithms are designed to enhance the Touch Surgery ecosystem’s digital capabilities within post-operative analysis. 

Stryker, meanwhile, spent the better part of 2024 promising (and hyping) spine and shoulder applications for its industry-leading Mako robotic system before the end of year, only to be upstaged by J&J MedTech’s spinal robot launch in August.

Developed in collaboration with eCential Robotics, the dual-use VELYS SPINE system features both a standalone navigation and active robotics platform that offer surgeons flexibility in their approach and plans.

The VELYS SPINE system offers a customizable experience with pathology-specific workflows, aided by capabilities such as VELYS Adaptive Tracking Technology and VELYS Trajectory Assistance. It can be used with J&J MedTech’s core spine product portfolio, including the TriALTIS Spine System and Navigation Enabled Instruments, the SYMPHONY Occipito-Cervico-Thoracic System, VIPER PRIME System, and EXPEDIUM VERSE Systems.

“This is a major step in our commitment to supporting spine surgeons and their patients with advanced tools,” Aldo Denti, company Group Chair, DePuy Synthes, said in the VELYS SPINE’s release formal announcement. “We are shaping the next frontier of orthopedic innovation with a relentless focus on digital advancements and excellence in surgical robotics and navigation.” 

THINK Surgical Inc. is helping shape that frontier as well, but in an unconventional way: by providing open-platform robotic-assisted solutions that support implants from various manufacturers. This year, the company added implants from b-ONE Ortho Corporation, Waldemar Link GmbH & Co. KG, Maxx Orthopedics, and Signature Orthopaedics to the THINK Surgical ID-HUB, a proprietary data bank of implant modules for use with its FDA-cleared TMINI Miniature Robotic System.

Besides bulking up its implant data bank, THINK Surgical gained FDA authorization over the summer and early fall to use Medacta International’s GMK Sphere and SpheriKA Knee Systems and Zimmer Biomet’s Persona Knee on the TMINI Miniature Robotic System. 

“We believe there are two distinct customer segments, one which prefers an open platform where the customer can choose from a range of implants on the robot and another which prefers an exclusive platform where the customer gains access to the robot in return for loyalty to a single implant brand,” THINK Surgical President/CEO declared after inking a limited distribution deal with Zimmer Biomet in June. “We believe these two customer segments are approximately equal.”

Equal catalysts, that is, for future robotics advancements. 

Read more: bit.ly/4hIF6RW

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Muted M&A 

The art of prognostication is not an exact science.

The reason? Forecasting is neither completely an art nor a science but rather a combination of both, mixing intuition and creative interpretation with metrics, predictive modeling, and data analysis to draw conclusions about the future. 

At best, this harmonious brew of mortal insight and analytical rigor produces remarkably accurate forecasts. Often, however, forecasting is purely a guessing game. Wharton School professor Philip E. Tetlock proved as much in a 2005 study that showed expert predictions are only slightly better than chance yet still worse than “dart-throwing chimps.”

Further evidence in support of the chimps arrived with the COVID-19 pandemic. As the world shifted into lockdown mode four springs ago, a plethora of soothsayers began issuing doom-and-gloom predictions about SARS-CoV-2’s impact on national economies. Financial experts, scholars, and civic leaders alike prevised a grim future defined by secular stagnation, economic nationalism, globalization reassessments, political power shifts, and most chillingly, “decades of economic fallout.”

“As the lockdowns began, the first impulse was to search for historical analogies…Since then, what has come ever more to the fore is the historical novelty of the shock we are living through. There is something new under the sun. And it is horrifying,” Columbia University history professor Adam Tooze, director of the school’s European Institute, said in an April 2020 foreignpolicy.com roundup of the pandemic’s future economic impacts.

“The longer we sustain the lockdown,” he predicted, “the deeper the economic scars, and the slower the recovery. The economic fallout defies calculation.”

Three months after Tooze sounded the economic decimation alarm, the Congressional Budget Office predicted a 10-year recovery (at minimum) for the post-pandemic labor market.

Score one for those dart-throwing chimps: U.S. employment levels were higher last year than in 2019.  And by the end of 2023, the pandemic’s effect on real U.S. GDP per person had completely disappeared, according to Scott Fulford, Ph.D., a senior economist at the Consumer Financial Protection Bureau.

“By the end of 2023, real U.S. GDP per person was back to where it would have been if the pandemic had never happened and the economy had just kept growing the way it had in the previous 10 years,” Fulford wrote in a May 2024 Princeton University Press essay. “By 2023, it was as if the pandemic hadn’t happened, macro-economically speaking.”

The U.S. economy may have shaken off all traces of the COVID-19 pandemic, but the orthopedic industry is still nursing a hangover. Financing is down this year and companies are struggling to maintain top-line growth amid reimbursement challenges, slowing procedure volumes, and tighter hospital budgets.

The IPO (initial public offering) market remains closed, and cash reserves among the major OEMs are shrinking, concludes EY’s Pulse of the Medtech Industry Report 2024. Dealmaking remains tepid, too: the 99 medtech M&A transactions completed between July 2023 and June 2024 comprise the lowest annual total in 15 years, the analysis states.

“From a venture standpoint, value ticked up a little bit but the overall pace of those [investments] has slowed a little bit,” EY Global MedTech Leader Jim Welch noted. “Deal-making continues to be a little bit slow. The deals are not as big, but the dollar value is up.”

Indeed, the dollar value rose for overall medtech acquisitions, but not for orthopedic deals. Almost all of the sector’s most active buyers kept their deals’ financial terms under wraps, with only OrthoPediatrics Corp. and Smith+Nephew revealing purchase prices.

OrthoPediatrics shelled out $22 million for Boston Orthotics & Prosthetics to expand its existing specialty bracing division. The company closed $80 million in debt financing to support the early January transaction.  

Within days of OrthoPediatric’s purchase, Smith+Nephew closed its $180 million deal for Bioventus discard CartiHeal, developer of a knee cartilage regeneration treatment for osteochondral lesions. The purchase not only expands Smith+Nephew’s growing sports medicine portfolio, but also grants the company access to a previously unserved patient population.

“With its proven superiority to current standard of care, Agili-C has the potential to transform cartilage repair outcomes,” Scott Schaffner, Sports Medicine president at Smith+Nephew, said when the deal closed. “Our expertise in regenerative therapy and leadership in knee repair gives me great confidence that this will be a significant value creator for Smith+Nephew.”

Value creation seemed to be the main M&A driver this year in the orthopedic sector, as companies increasingly turned to tuck-in deals to secure long-term growth.

Zeda Inc., for instance, boosted its additive manufacturing capabilities by acquiring the Orthopedic Implant Company, and Bone Health Technologies (BHT) augmented its solutions platform with the purchase of Wellen, a Brooklyn-based health tech firm reinventing exercise-based osteoporosis care. 

Zimmer Biomet Holdings Inc. took part in the industry’s tuck-in trend too, buying OrthoGrid Systems Inc. to expand its hip replacement market footprint. Included with the early August purchase was OrthoGrid’s intelligence-enabled fluoroscopy-based surgical assistance platform Hip AI, two additional artificial U.S. FDA-cleared orthopedic applications, and more than 40 patents.

Stryker Corp., however, trumped Zimmer Biomet and other shoppers this year by scoring a half-dozen deals that expanded and/or strengthened its offerings in virtual care, pain management, neurology, breast cancer surgery, and foot/ankle remedies.

The company added soft tissue repair technology to its portfolio through its June bid for Artelon, whose differentiated synthetic technology enhances biological and mechanical ligament and tendon reconstruction. 

“On the surface, this would appear to be just another Stryker tuck-in acquisition from a well-worn playbook which has allowed Stryker to maintain its robust growth profile,” BTIG analysts noted at the time, “but the [Artelon] acquisition is worth noting because competitors have also targeted other soft tissue repair companies…”

Other deals of note emanating from Stryker’s “well-worn playbook” include its takeover of NICO Corporation and pickup of two foot/ankle repair products from 4WEB Medical. 

The NICO deal expands Stryker’s portfolio of solutions for tumor resection and intracerebral hemorrhage (ICH) treatment. NICO’s BrainPath and Myriad products provide an ICH treatment option with improved functional outcomes compared to guideline-based medical management alone.  

Likewise, 4WEB’s Osteotomy Truss System and Ankle Truss System broadens Stryker’s foot/ankle lineup through new limb length restoration and osteotomy solutions. 

Stryker kicked its tuck-in binge up a notch over the summer, snapping up three companies within a month’s span: care.ai, Vertos Medical Inc., and MOLLI Surgical Inc. The triple-crown achievement augments Stryker’s capabilities in healthcare IT and wireless connectivity; digital minimally invasive pain management; and breast cancer care, respectively.  

Read more: bit.ly/4ftGFS2