Justyn Ross wasn’t getting up.

Clemson’s star receiver had been running a routine slant and was knocked to the ground by a linebacker he didn’t see approach.

Neither the slant nor the hit was unusual. Failing to notice an impending tackle was a bit odd for Ross, but not totally out of the ordinary, either.

Not immediately bouncing back from the hit, however, was unusual.

Also somewhat peculiar was the arm numbness and tingling Ross felt as he lay on the turf. Probably just a stinger, he reckoned. Nothing unusual about that.

Nothing at all: An estimated 65% of college football players experience stingers—common neck and shoulder nerve injuries caused by trauma (i.e., a forceful impact). These afflictions are rarely serious and usually resolve themselves within two days.

True to form, Ross’s stinger subsided in a few days. Business as usual, he thought.

More like business unusual—tests revealed that Ross’s “stinger” was not a simple nerve compression injury but rather a congenital spine condition called Klippel-Feil syndrome, the fusion of two or more cervical vertebrae. Though he likely was born with the rare disorder, the lack of any post-injury scans or testing prevented the condition from ever being discovered.

With a formal Klippel-Feil diagnosis, Ross faced the devastating possibility he might never again play football (those afflicted with the condition are advised to avoid neck-injuring activities). And the timing couldn’t have been worse: Ross completed 112 receptions for 1,865 yards and 17 touchdowns in his first two seasons at Clemson. He was a top NFL prospect.

“It was heartbreaking,” Ross told ESPN. “I’m not going to lie.”

Surgery was Ross’s only chance of averting heartbreak and keeping his professional football dreams alive. Relieving the pressure on his cervical spine could potentially rescue Ross’s future, but doctors were doubtful —no high-level American football player with Klippel-Feil syndrome had ever participated in the sport. Moreover, a successful surgical procedure wouldn’t necessarily guarantee a return to the game.

But Ross was willing to take that chance. He just couldn’t imagine a life without football. Through Clemson’s medical staff, Ross connected with David O. Okonkwo, M.D., Ph.D., neurosurgeon for the Pittsburgh Steelers and director of the Neurotrauma Clinical Trials Center at the University of Pittsburgh. Okonkwo and Joseph Maroon, M.D., surgically repaired Steelers linebacker Ryan Shazier’s spine after a brutal tackle in December 2017. Though the injury ended Shazier’s professional football career, the surgery preserved his ability to walk.

After ensuring Ross was a good candidate for surgery, Okonkwo performed the potentially career-saving procedure, removing a cervical disc that was pushing backward to clear space for the spinal cord. He stabilized the area with a graft and plate.

“The procedure itself is a very common procedure, but this procedure for this specific reason is very rare,” Okonkwo explained to ESPN. “It is virtually unique to have done this surgery in someone with Klippel-Feil syndrome, who happens to be one of the most talented football players in the United States of America. There are other options, but those other options are surgeries where no one goes back to play football. This was the best combination of the exact right treatment for Justyn Ross as a person, while simultaneously preserving the possibility of playing football again.”

Okonkwo preserved that possibility quite well—about 14 months after his June 2020 surgery, Ross was cleared by doctors to practice with Clemson. He was back on the gridiron for the Tigers’ 2021 Opening Day game against the Charlotte 49ers, popping back up after tackles, but was sidelined that November by a stress fracture in his left foot that eventually required surgery. Still, in the 10 games he played that fall, Ross achieved team highs in catches (46) and receiving yards (514) and added three touchdown catches on 471 snaps. He’s now a wide receiver with the reigning Super Bowl champion Kansas City Chiefs and scored the first touchdown of his NFL career in a pre-season game against the New Orleans Saints.

In stepping onto the field during the Chiefs’ home opener against the Detroit Lions, Ross became the first player with Klippel-Feil syndrome to ever play in an NFL game.

Ross’s comeback from a career-threatening injury is a testament not only to his resolve and perseverance but also to the technological advancements that enabled the surgical repair. The advent of 3D printing, robotics, augmented reality, machine learning, artificial intelligence, biomaterials, digital navigation, and molecular biology have considerably widened the scope of spinal treatment options in the last decade.

The integration of these innovations and biological breakthroughs are spawning solutions that result in smaller incisions, less trauma to normal tissues, speedier recoveries, improved surgical accuracy, and better patient outcomes.

“Injection molding of polymers, 3D printing, MIMS, and automated manufacturing operations in general are helping create instrument and implant solutions that reduce cost, improve efficiencies in the OR, and generate better patient outcomes,” noted James B. Schultz, vice president of Customer Solutions at ECA Medical Instruments, a Thousand Oaks, Calif.-based developer of single-use instrumentation for torque limiting and surgery-ready procedural kits. “The focus is always on achieving the best patient outcomes and helping the surgeon and OR team become more efficient.”

ECA Medical augmented that focus last spring with the launch of its TruTORQ and TruPWR precision torque limiting instruments. TruPWR speed-controlled torque limiting adaptors mate with Stryker Corp. and Conmed power tools; torque limiting set points ranging from 0.8Nm to 14Nm make them ideal for trauma, sports medicine, craniomaxillofacial, and extremities plate and screw ex fix systems and demanding spine and large joint implants. Securing plates, screws, and constructs safely and accurately under power, TruPWR tools can be used for lengthy and complex scoliosis procedures. 

The TruTORQ hand-operated torque limiters have similar set points (0.5Nm to 14Nm) and the same use range as the TruPWR portfolio. TruTORQ’s ergonomic limiters are manufactured in popular hand styles and connectors, including a one-quarter square industry standard. The tools also feature AO for a quick connection with customer drivers and shafts.

Both instrument/implant lines have audible feedback and tactile feel features to indicate torque achievement—properties that can help reduce surgeon fatigue and improve operating room turnover. The single-procedure products also are designed to enhance overall procedural efficiency and reduce costs: They are available sterile pack and surgery ready with all validations or non-sterile to fit into legacy sterile pack sets, thereby enabling OEM implant companies to privately label and distribute the products across their sales channels, hospitals, and ambulatory surgery center (ASC) customers. 

Besides facilitating more proficient distribution, the surgery-ready nature of TruTORQ and TruPWR devices also permit sales reps to engage more effectively with surgeons, expand and scale their business, and support more difficult cases. ECA Medical claims the products are cost efficient and more environmentally friendly as well because they eliminate reprocessing expenses. Studies have shown that single-procedure instruments like TruTORQ and TruPWR yield a 30% to 40% carbon footprint reduction compared to traditional reusable devices.

“TruPWR has become the instrument of choice for surgeons to secure implants used in scoliosis and other complex spine procedures. OEM implant firms tell us the biggest benefit is reduced surgeon fatigue and quicker surgeries, as TruPWR allows them to rapidly secure implants following a several-hours-long procedure,” Schultz said. “Developing clinically robust and cost-effective single-use instruments requires the application of state-of-the-art technology and equipment, and decades of ‘know-how’ to meet customers’ needs.”

Meeting customers’ needs is, of course, a basic tenet of any successful business strategy. But medtech firms that can predict and address changing customer demands within the evolving healthcare ecosystem will be in the best position to seize their expected share of traditional revenue growth and leverage the new opportunities arising in the $12.8 billion spinal implant/devices market.

Helping customers meet their current needs and future goals requires “decades of know-how” as Schultz said, but also solid market knowledge, new value propositions, market trends awareness and navigability, early collaboration, and creativity.

Tegra Medical uses the latter two elements to bring their customers’ ideas to fruition. The Franklin, Mass.-headquartered medical device contract manufacturer offers clients a full range of product development services—including Design for Manufacturing, prototyping, pilot production, and more—through its GENESIS Tech Center. The Center’s engineers work in tandem with their customer’s engineers to explore alternatives in processes and materials and determine costs.

“Getting involved with our customers early in the Design for Manufacturing, or DFM state, allows us to identify potential problems and fix them early in the product development lifecycle, the least expensive stage,” said Mike Treleavan and Michael Horton, Tegra’s senior vice president of engineering and sales director, respectively. “We create an innovative manufacturing process for our customers, help them navigate the many hurdles, decrease their time to market, and control costs.”

Located in Hernando, Miss., Tegra’s GENESIS Tech Center encompasses a 3,200-square-foot facility that houses 4- and 5-axis CNC milling, CNC Swiss machining, electrical discharge machining, and gun drilling. The Center’s engineers and production personnel work with clients to create implants and instruments used in complex spinal and trauma procedures, and instruments for large joint and extremities reconstruction. Three years ago, the company added 4,000 square feet to its Hernando operations to house a new manufacturing cell with highly advanced, automated machinery.

Tegra uses that machinery to create various medical products, including cervical spine interbody fusion cages (for scoliosis and spondylosis), retractors and spreaders (for surgical access), and finished, sharp-tipped meniscus suturing devices. The machines also have fostered Tegra’s intramedullary nail prowess.

The company has created a proprietary method for creating an impeccable anatomical bend—the point at which the nail diameter changes, and the screw holes and slots are placed. Creating the bend can be challenging but Tegra has developed a way of bending the intramedullary nail that does not damage its special features.

“Tegra Medical has expertise with metals and plastics, including keeping the device’s ‘business end’ sharp, even during insert molding,” Treleavan and Horton boasted. “Manufacturing parts with complex geometries requires operational excellence.”

Speed, flexibility, and diversified expertise are important, too. ARCH Medical Solutions Corp. has been steadily broadening both its capabilities and product offerings through strategic acquisitions. In the past 14 months, the company has completed a half-dozen deals that have bolstered its precision manufacturing, precision grinding, and surgical robotics capabilities, and expanded its product lineup of orthopedic and spinal surgical instruments.

Last summer’s bid for MedTorque, for example, added custom-engineered silicone surgical instrument handles, ratchet drivers, torque -limiting drivers, and single-procedure devices to ARCH Medical’s portfolio.

“Scale, capability expansion, and rounding out product offerings has generated the most impact for abilities to support customers,” stated John Ruggieri, senior vice president of Business Development for the multi-site contract manufacturer, with headquarters in Bloomfield Hills, Mich. “Most spine projects need the flexibility and adaptability to meet customer demands. These characteristics are required due to unforeseen volume fluctuations, redundancy for mitigation of risk, and abilities to expand or pivot manufacturing resources on short notice.”

ARCH Medical Solutions augmented its already robust, multifarious manufacturing base with last December’s purchase of the specialist in precision grinding of surgical cutting tools, Nicholas Precision Works (North Manchester, Ind.), and enhanced its instrument expertise with the July 2023 deal for gSource LLC.

“We find a large need for producing patient-specific devices for both implants and instruments. The speed with which they need to be produced do not fit within the conventional production lead times,” Ruggieri explained. “This requires a dedicated staff with access and control of the required resources to deliver at the necessary speed. A wide variety of manufacturing capabilities is mandatory and a technical staff tied into the collaborative network of customers’ engineering teams is the only way to make it all come together. We have made the necessary investments in technology and human capital to help customers push the limits of manufacturability, all while increasing efficiency and repeatability.”

Intech Medical accomplishes the same goal by acting as a “one-stop shop” for orthopedic surgical device manufacturing/development and distribution. The company’s intechLabs division offers custom proprietary design assistance and in-house testing services, while the Prototype Garage accelerates new product launches through regulatory and verification/validation process support. Depending upon project complexity, The Prototype Garage can deliver production-equivalent prototypes in four to six weeks.

“Over the past several years, [customer] relationships have evolved from purely transactional to a true partnership,” said Romain Ibled, global sales director for the 24-year-old French contract manufacturer. “Spinal instrument/implant manufacturing requires very broad capabilities: 5 axis milling, EDM sinker, chrome coating, laser welding, 3D printing…and experts in each of those departments. As a contract-designer with proprietary products, OEMs are seeking our assistance to design and support the regulatory aspects as they launch new products on the market.”

Intech’s own product launches are more sporadic, though the firm did debut a Modular Retractor System this past spring. Developed by intechLabs in cooperation with medical device companies and surgeons, the system is designed to provide operating room flexibility. Its kit enables various configurations, including pedicle-, midline-, or four-blade frame-based, to facilitate safe and efficient spinal access for implant placement.

Last fall, Intech announced a collaboration with SMADE, a smart tracking solution that helps customers track assets in the field, solving one of the industry’s deep-rooted pain points. SMADE combines hardware (smart trackers) and software (advanced data analytics platform) to deliver precise data from the field by turning surgical instruments and trays into smart assets that actively gather and transmit critical data. This empowers medical device companies to determine in real time the precise location and usage patterns of their devices to make informed decisions.

In line with its mission to deliver cutting-edge innovations and prioritize customer satisfaction, Intech is dedicated to becoming the industry’s partner of choice by helping clients with customized yet proven portfolio-enhancing offerings that range from design and manufacturing to distribution, through informed asset management solutions.

“Thanks to SMADE smart tracking solutions embedded in Intech trays or instruments, we collect, analyze and deliver the most accurate field data to customers, helping them transcend their performance,” InTech President/CEO Laurent Pruvost said when the partnership was announced. “Agile and collaborative, SMADE inside process will give our customers the knowledge and technology they need to leverage the potential of their devices.”

The OEM Perspective

As contract manufacturers evolve to become full-service providers to their customers, orthopedic OEMs are striving to gain market share through a mix of core competencies (i.e., joint replacements), supporting technologies, and specialized solutions.

San Diego-based NuVasive Inc., for instance, hatched the eXtreme Lateral Interbody Fusion (XLIF) technique 20 years ago as a minimally invasive alternative to conventional spine surgeries. Performed through the side of the body (lateral) instead of the front (anterior) or back (posterior), the XLIF approach avoids major nerves between the incision site and spinal column.

Since its inception, roughly 300,000 XLIF procedures have been performed, and more than 60 related products released. Clinical data has proven the approach produces better and more predictable outcomes than traditional spinal fusion procedures. Specifically designed to treat pathologies at levels L4-L5 and above, XLIF also reduces operative time, incision size, blood loss during surgery, hospitalization, postoperative pain, and postoperative recovery time, clinical studies have shown.

Similarly, ZimVie Inc. beat its rivals to market a decade ago with the first U.S. Food and Drug Administration (FDA)-approved cervical disc to treat up to two cervical spine levels. Its three-component Mobi-C Cervical Disc—approved for use in France since 2004—is comprised of two cobalt-chromium-molybdenum endplates and a flat-bottomed polyethylene insert with a rounded top that slides and rotates inside the disc for automatic self-adjustment to the cervical spine’s movements. The hydroxyapatite-coated plates are lined with teeth on the top and bottom that press into the vertebrae without chisel cuts, thus sparing bone.

Ten years of Mobi-C clinical data show positive long-term outcomes for one- and two-level replacements. Patient-reported outcomes either were unchanged or better between seven and 10 years, and both arm and neck pain improved. Moreover, study documents indicate that no subsequent adjacent-level surgeries occurred between the seven- and 10-year follow-ups.

In August, the FDA approved a smaller Mobi-C height (4.5 mm) in seven footprints to better address American patients’ anatomical needs. 

“For ZimVie, the Mobi-C and Tether products have had the most impact, but that is only part of the equation,” Rebecca Whitney, president of Global Spine, and Michael Minette, senior vice president of Strategy and Corporate Development at ZimVie, told ODT. “These solutions are differentiated and proven but we still have a lot more work to do to get them to become standards of care. We have just scratched the surface—only one out of three indicated patients currently receive a cervical disc replacement, and only one out of 10 indicated patients receive vertebral body tethering (VBT).”

The Tether – Vertebral Body Tethering System is ZimVie’s humanitarian device exemption-approved treatment for idiopathic scoliosis. In addition to intraoperative initial correction of the curve, The Tether uses a patient’s natural growth to continue to straighten the spine over time. This may allow patients to receive treatment sooner and without the limits to mobility and growth associated with a traditional spinal fusion procedure. As a top 10 finalist and winner of the People’s Choice award in last year’s Coolest Thing Made in Colorado competition, the Tether’s SULENE polyethylene terephthalate (PET) tensioning cord allows the spine to continue bending and flexing, even after treatment. The device is like an “internal brace” for the spine, with anchors and vertebral body screws placed laterally from a thoracoscopic or thoracotomy approach to keep pressure on the convex side of the vertebral curve and allows the concave side to continue growing to further straighten the spine.

“We have a long history of working closely with innovative surgeons…our renewed focus will deliver newer innovations to the market,” Whitney and Minette said. “We are constantly bringing new solutions to market, especially those that change the standard of care.”

So are ZimVie’s competitors.

DePuy Synthes’ alternative to ZimVie’s Tether is the ALTALYNE Ultra Alignment System, an adolescent spinal deformity solution that aims to address the challenges of intraoperative rod flattening. Cleared last fall by the FDA, the ALTALYNE system offers a 5.5 mm profile with 36% greater resistance to rod flattening than a standard 6 mm cobalt chromium rod. 

Intraoperative rod flattening in adolescent idiopathic scoliosis treatment can hinder the device’s ability to achieve and maintain the corrected spinal contour and restored balance necessary for free movement. Rods with a higher bending yield strength are more resistant to intraoperative flattening; and while cobalt chrome has been a popular choice for replacement joints and spinal wires, the metal has never-before been used in spinal rods.

“Making healthcare decisions comes with a lot of variables. First and foremost, patients want the best care possible to achieve good outcomes and the ability to return to life as usual as quickly as possible,” declared Eric Buehlmann, R&D director at DePuy Synthes Spine. “Surgeons are looking for high-quality implants and instruments with a seamless workflow enabling them to better meet patients’ expectations. At DePuy Synthes, we try to deliver products that offer improved functionality and ease of use, along with complementary enabling tools that help surgeons meet these expectations. There is a general expectation that digital and enabling technologies can improve outcomes, and even predict outcomes prior to surgical intervention, and direct effective non-surgical intervention. The digital and enabling technologies are being developed with these goals in mind.”

DePuy Synthes is helping precipitate that reality with its TELIGEN System, a technology platform for spinal procedures cleared by the FDA last fall (within a week of the ALTALYNE Ultra Alignment System). TELIGEN is an integrated technology platform that enables minimally invasive surgical transforaminal lumber interbody fusion (MIS-TLIF) procedures using digital tools for visualization and access. The system encompasses a tower with a camera control system, a VueLIF-T procedure kit with a disposable HD camera, a TELIGEN clear discectomy device, and patient-based single-use ports.

The TELIGEN System delivers an advanced visualization experience and user-centric procedural control, according to DePuy. The digitally enabled TELIGEN VUE Camera, located at the patient-specific port’s distal end, eliminates the need for a microscope and can provide an unobstructed view of the surgical site. It offers hands-free visualization during the procedure, along with a multidirectional and expanded field of view.

Additionally, the self-cleaning camera includes LED lighting and gives surgeons the ability to manipulate image clarity based on their preference. Moreover, the TELIGEN System heads-up display allows for surgeons to maintain ergonomic posture during procedures. 

DePuy Synthes’ new system integrates the company’s Unleash bundle of implant solutions that streamline the main stages in MIS-TLIF.  Based on a small cadaveric study (n=6), the TELIGEN System reduces fluoroscopy time by 47% (p=0.003) compared to MIS-TLIF procedures performed using a surgical microscope. In addition, the TELIGEN System provides a reduction in instrument trays and processing costs per surgery for the 10 additional trays not required with the TELIGEN System.

“Digital solutions are early in their implementation across the industry. Digital enablement is one of the trends driving the spinal implant market,” Buehlmann said. “The rapid adoption of digital technology is driving the integration of enabling technology and increased procedural integration, and, in turn, increasing market share for suppliers of implants who are incorporating digital enablement. As an integrated technology platform, TELIGEN delivers an advanced visualization experience, user-centric procedural control, and economic value, and is a great example of how digital solutions can help patients, surgeons, and hospitals.”

Another example of a beneficial digital solution is Stryker’s Q Guidance System.

Stryker’s Q Guidance System with Spine Guidance Software combines a redesigned, fourth-generation FP8000 camera with an intuitive user interface and sophisticated algorithms to improve surgical spine planning and navigation. When used with the Q Guidance System, the Spine Guidance Software is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery and is the first spine navigation software to receive FDA clearance for use with pediatric patients aged 13 and older.

“Tools like pre-operative planning and artificial intelligence to help surgeons understand how they are using this new technology are quickly becoming the next phase of innovation,” Stryker Vice President and General Manager Keith Evans asserted. “In spine, there are many ways to solve the same problem and we will see these technologies increasingly being used to solve them in the coming years. Imaging, navigation, and in the future, robotics, will be very important [market] drivers. We are trying to make sure we think about the implants and enable them with the corresponding technology to create a seamless experience for the surgeon and their patient. That sits at the core of our [business] strategy.”

Released last September, the Q Guidance offers surgeons numerous benefits, including:

• A proprietary camera that offers unmatched speeds and the flexibility of multiple optical tracking methods, including full-spectrum active/passive hybrid optical tracking. It is the only guidance system with proprietary active technology and a non-invasive patient tracker, SpineMask.
• Image processing: Spine Guidance Software features completely redesigned applications, semi-automatic and automatic processing features, gesture recognition, and broad compatibility with various types of image sets.
• Spine Guidance Software: Spine Guidance Software is designed to help surgeons optimize their workflow and address complex clinical decisions and techniques intraoperatively. Its computational power is designed to support the company’s spine product and software roadmap.

“With the Q Guidance System, we spent a lot of time and energy developing a proprietary camera that is faster and more responsive than most off-the-shelf products. We believe accuracy and the ability to respond quickly to what the surgeon is doing are critical,” Evans said. “We believe there’s tremendous opportunity in spine. Stryker is very committed to advancing spine care, and one of the ways we can do that is by leveraging technologies like navigation, imaging, and robotics, and ensure the incorporation of those technologies is helping create economies of scale. If we can align our supporting technologies and business processes that way, we will be uniquely positioned to be a partner of choice.”

And the choices are many.