“All attention right now is on the impact to the supply chain from COVID-19,” said Scott Shankle, VP of operations at MicroPort Orthopedics, a Memphis, Tenn.-based multinational producer of orthopedic products. “Employee safety, local or state orders guiding operations facilities, disruptions at suppliers, bans on elective surgical procedures, and everyone in the supply chain being cash conservative while trying to manage inventory and readiness for the global recovery is the current environment. The most significant trend to watch is how and when global recovery advances. I expect the cash conservation to squeeze smaller organizations the hardest, and expect at least some consolidation in OEMs and contract manufacturers.”
Due to the shortage of general doctors and supporting staff, orthopedic clinicians are being redeployed to treat COVID-19 patients. They must also be trained to treat these patients because impact on joints and bones, chills, and muscle pain have been observed as symptoms of the virus. As a lack of operational facilities and hospital staff continues, orthopedic surgeries and the implant market are on hold.
But this too shall pass; the market will be set to gain traction from the ever-increasing geriatric population (the World Health Organization expects the world’s population over 60 to double over the next 30 years), a rise in osteoporotic bone fractures, growing obesity levels, and adoption of sedentary lifestyles. According to Fortune Business Insights, the orthopedic implants market was valued at $46.5 billion in 2018, and is expected to touch $64 billion by 2026, growing 4.1 percent each year.
The orthopedic industry is prone to personalization because successful joint replacement is more likely with an implant customized to individual anatomy. Global orthopedic manufacturer Zimmer Biomet took this to heart in naming its Persona knee replacement franchise. Its most recent addition, the Persona revision knee, features anatomic tibial and femoral cones, various stem choices, and multiple bearing constraint options. The Persona implants are manufactured from the company’s proprietary Trabecular Metal, a highly porous biomaterial made from elemental tantalum with structural, functional, and physiological attributes similar to bone.2 The material’s interconnected pore structure supports bony ingrowth and vascularization.2,3
In the first week of April, the company took knee replacement personalization one step further by achieving FDA clearance to use OrthoSensor’s Verasense single-use intelligent sensor to measure tibial coronal alignment and provide soft tissue balance. Verasense transmits real-time data to a display in the OR to facilitate for informed decisions about implant alignment and soft tissue balance.
Kirk Bailey, chief technology officer of Zimmer Biomet, commented, “Trends are moving away from traditional metal and plastic offerings toward integrated ecosystems of products and solutions that aim to improve patient outcomes through data captured during the episode of care.”
Bailey added that other technological advancements impacting the market are “leveraging 3D printing technology where appropriate for unique geometries and applications, coating technologies to address patient needs arising from emerging sensitivities, anti-infectives, and cobalt alternatives.”
In line with a number of other specialties, orthopedic surgeons continue to gravitate toward minimally invasive techniques. New research and technologies have led to improved methods of joint replacement, arthroscopic repairs of sports injuries, microscopic treatment of musculoskeletal conditions, and many others.
“As with most therapy areas, we see movement toward more minimally invasive techniques,” said Eoghan Groonell, a business development executive at Aran Biomedical, a Galway, Ireland-based developer of customized medical implant product solutions, with expertise in medical textiles, stent coating, and encapsulation, as well as resorbable implants. “Our expertise in the orthopedic market is custom textile solutions development—we see a trend of lower profile textiles that maintain the high-strength or other desired performance characteristics of bulkier solutions.”
Hip, knee, and shoulder replacements can now be performed through minimally invasive surgery. Traditional joint replacement surgery requires a large incision to expose the entire joint, and can also mean detaching and reattaching muscles and tendons to access the entire joint. Minimally invasive joint replacement uses small incisions and disturbs surrounding tissue as little as possible.
“The trend toward more minimally invasive techniques will continue, increasing use of low profile and in some cases resorbable biomaterials,” continued Groonell. “This will provoke new development of new products featuring high-strength and resorbable biomaterials—performance polymers will optimize these products.”
Spinal interbody cage design and materials have evolved significantly over the past few decades. Since the early 2000s, non-threaded, box-shaped titanium or polyetheretherketone (PEEK) cage designs have grown more common. The modern design helps to achieve larger cage stability in flexion, axial rotation, and bending. Advances in 3D printing technology have also been able to achieve architectures that promote fusion by facilitating bony cell ingrowth from the cage’s endplates. Some of these have a core that mimics the cancellous and cortical bone structures, while others feature textured surfaces.
“We have seen increased design complexity for implanted nails and spinal cages,” said Vicken Chitilian, PMP, program manager of NPI and automation at Orchid Orthopedic Solutions, a Holt, Mich.-based provider of complete implant procedure and product design services, as well as complete single source manufacturing. “With that comes the complexity of not only how to produce, but also to measure (metrology). We have begun investing in tomography metrology equipment, better explained as see-through X-Ray measurement systems. These allow us to measure complex features at great confidence and assurance, ensuring parts ship to our customers’ quality standards.”
The orthopedic market is generally populated by large device makers (Stryker, DePuy Synthes, Zimmer Biomet) that have commoditized certain sectors of the industry like hip and knee replacements. But they are far from the sole sources for interesting and innovative technologies—plenty of novel orthopedic solutions arise from smaller firms flying under the radar. An aging population and new technology allows for more customizable, niche products. Startups can base their business models on those needing specialized medical technology. Manufacturing partners have to adjust their own business models as a result to stay successful.
“We see an increase in implant startup companies with very niche designs that are enhancing both patient and surgeon experience, leading us to see high mix and low volumes,” said Chitilian. “Our business model is transforming to adapt technology platforms for quicker prototypes and cellular manufacturing integration (where applicable) to turn these requests into a reality.”
As orthopedic firms battle to claim share of growth markets like small bones and spinal surgery, “me-too” technologies just won’t do. Research and development teams must devise novel designs, materials, manufacturing strategies, and many other aspects with the goal of always improving patient outcomes. Manufacturing partners will have to become competent in working with new designs and materials, going so far as to make them a specialty as quickly as possible. Otherwise, OEMs will seek out a partner who has the necessary capabilities from a large pool of specialty manufacturers.
“As more and more companies produce similar orthopedic devices, there is a push to differentiate towards higher-level devices (osteoinductive and osteogenic vs. osteoconductive),” said Jevon Nyemscek, senior manager, process development at DSM Biomedical, an Exton, Pa.-based global solutions provider in biomedical science and regenerative medicine. “This will result in newer materials and products that we will need to strive to understand and process.”
Building a Better Implant
The majority of orthopedic implants are still made using conventional machining. Orthopedic device makers seek quicker speeds to market, reduced cost, and manufacturing partners to help shorten their supply chain. Small specialty companies also partner with device makers to focus on a specific product. As the implants become more complex and challenging to make, orthopedic companies can partner with firms specializing in traditional machining or whichever method is needed to produce implants.
Manufacturing orthopedic implants can involve several machines or computer numerical control (CNC) cutting processes, including grinding or potentially even metal additive manufacturing. Traditional methods like machining are leveraged for parts not requiring unique structures or part geometries made possibly only by additive manufacturing. Machining operations on a knee implant can include roughing, tray base roughing/finishing, chamfer milling, T-slot undercut machining, wall finishing/chamfering, and undercut deburring.
“Robotics, twin spindle, and high-speed milling machines are powerful tools to maximize production, said Stephen Keil, vice president of business development at ARCH Medical Solutions, a Seabrook, N.H.-based contract manufacturer of surgical instruments, implants, and medical devices for orthopedic and medical device companies. “On the Swiss side, we brought in machines with more axes to both increase our production capabilities to include more complex geometries, and eliminate multiple setups.”
“Multi-pallet high-speed machining and advanced inspection techniques and equipment such as vision systems and CMMs have had a significant impact,” added David Francis, general manager at Autocam Medical, a Kentwood, Mich.-based global contract manufacturer of orthopedic implants, spinal implants, precision instruments, and orthopedic cutting tools.
High-precision machining has evolved far beyond the lathes and mills of years past. Modern CNC Swiss machines can reach 13 axes to make parts with complex geometries and can be programmed for optimal speeds and feeds. Multiple spindle machining can complete parts in a single setup, and some machines have capabilities like turning with live tooling and wire electric discharge machining.
“In house and off-the-shelf quick-change creative fixturing and machine technology advancements essentially combine three machines into one. Eight or more jobs can be tooled up and ready on one machine—we make one of each job, then cycle through the next set of eight again,” said John MacDonald, president of AIP Precision Machining, a Daytona Beach, Fla.-based provider of precision machining services for the medical industry. “This way, we can feed the customer and produce in a more just-in-time fashion instead of making one size, then the next, and so on.”
Advances in additive manufacturing have drastically reduced lead times for prototyping and small-volume production of complex parts. AM provides design freedom and stability to make products that can’t be built using traditional subtractive manufacturing. Its flexibility also allows for production of multiple size variants of a design.
“When you look at AM processes, lattice generation software has made a large impact on what we can do to design and apply unique structures for orthopedic applications,” said Ryan Haynes, vice president of business development at Amplify Additive, a Scarborough, Maine-based additive manufacturing company specializing in design, engineering, and manufacturing of 3D metal-printed orthopedic implants. “We have used tools like Autodesk Within Medical, nTopology, Magics Structures, and Autodesk Netfabb. These make it much easier to apply structures, and through AM, reduce time to market.”
AM’s ability to create unique structures and surface textures offers a clear clinical benefit. Engineered porous lattice, tortuous internal channels, and internal support structures are not possible using traditional approaches. Complex lattice structures can help significantly accelerate healing by improving osseointegration, improving the implant’s effectiveness and boosting the patient’s long-term quality of life.
“Additive manufacturing is a clear winner as far as superior clinical outcomes for patients,” said Brian McLaughlin, president of Amplify Additive. “Hip cups are a great example where there is a significant improvement in initial fixation and bone in-growth, coupled with the reduction of supply chain, there are simply no questions about it.”
Manufacturing operations are headed toward a streamlined, intelligent, connected network of machines, devices, and systems—also known as “Industry 4.0.” In time, connected processes might replace conventional machines completely, or else be synchronized with legacy systems to make sure large streams of data are available.
“Artificial intelligence improves robustness of processes and development and 3D printing increases both agility for manufacturers and value to customers,” said Steve Breen, director, Materials, at DSM Biomedical. “Industry 4.0 technology is combing and connecting digital and physical technologies to drive more flexible, responsive, and interconnected systems capable of making data-based decisions. All of these coming together allows for higher throughput without the risk of reducing quality.”
Data collected from IoT sensors and platforms can help provoke more effective operations. For example, smart meters could be installed to efficiently manage energy flow, or equipment could be automated or powered appropriately to monitor environmental impact. Tracking performance and real-time data lets manufacturers better prepare for equipment malfunctions or errors. Predictive models and algorithms can also be used to identify potential failure points that go unnoticed by the naked eye.
“We expanded into autonomous machining technologies,” said Chitilian. “During metal-cutting processes, the machine is programmed to be self-aware and self-monitors for tool wear, measuring critical features while in the fabrication process and able to make corrections. All these features yield higher quality product with increased reliability and lessened lead times.”
“Automation and advanced software is expanding production capabilities. For example, Dynamic Tool Path creation in Mastercam has helped to improve CNC programs.” added Mat Hudon, engineering manager at Autocam Medical. "Dynamic Tool Path analyzes a variety of machining parameters to optimize tool paths within the CNC program. Some of the parameters analyzed include material, part geometry, chip load, step over percent, cutting speed, and feed rates combined with efficient tool path strategies. We have observed improvements in cycle time, quality, and tool life when this feature is optimized."
In the medical manufacturing industry, robotics is being utilized across the whole production line, from assembly to inspection to packaging. Industrial robots grant manufacturers the consistency to reproduce devices with relative ease. They can be programmed to make identical products to precise specifications without error.
“Robotics have been influential to help in throughput of device manufacturing, and smarter systems in vision and statistical feedback loops have helped maintain and even improve quality of devices while meeting increased volumes,” said Nyemscek.
All of these tools—enhanced machining capabilities, additive manufacturing, Industry 4.0 technologies, robotics, automation—will continue to improve medical device manufacturing. And in the future, manufacturing will get even smarter.
“In the next few years we’ll see the final transition to MES controlled paperless manufacturing, virtual/augmented reality in manufacturing training and technical tasks, and increased manufacturing and business process automation, including use of artificial intelligence,” said Shankle.
Strengthening Internal and External Partnerships
OEMs are clear about what they need from their manufacturing partners—design for manufacturability, quality and regulatory compliance, price and lead time. As competition ramps up, one of the most important services a manufacturing partner can provide is meeting customer lead times, which continue to shrink. Speed to market and meeting production schedules and deadlines are integral for specialty manufacturing firms to survive. OEMs are trending toward “just in time” delivery, and manufacturing partners must be quick, responsive, and have the necessary resources to meet challenging time constraints.
“We are being tasked to fulfill orders for multiple implant family sizes in very short order so the OEM can launch the full range of sizes, said MacDonald. “This means machine shops need to manufacture lower quantities of over 20 different sizes in the same implant family. Each product range’s launch phase results in extreme capacity constraints on both machine and programmer/machinist. We continue to develop tools, talent, and chose equipment based on quick change versatility to keep the OEM fed with product.”
Medical device manufacturers also want their manufacturing partners to design the most efficient manufacturing process for their product to boost efficiency, reduce chance of error, save time, and bring products to market faster. More complex orthopedic designs usually require custom manufacturing solutions as well.
“It’s important to quickly distill an idea into a meaningful product meeting all requirements (complex geometries, regulatory compliance, surgeon preferences, cost),” said Haynes. “Orthopedic manufacturers that can leverage and balance multiple technology disciplines should do well. Having implemented a lean manufacturing strategy with a disciplined ability to execute effectively while moving the client fluidly through the process is a valuable attribute for a manufacturing team.”
Success in medical manufacturing isn’t just about having the right technology and processes in place. A skilled manufacturing workforce is still needed to operate the equipment and employ the best design strategies for efficient production and ensure robust, quality parts suited for the orthopedic industry’s precise demands. Quality manufacturing can only occur with quality workers on the shop floor who are in constant communication so no aspects of the process are under-addressed.
“Rely on highly skilled programmers, machinists, and engineers to apply advanced manufacturing techniques and creativity to make complex orthopedic implants,” said Mark Travis, operations manager at Autocam Medical.
Manufacturing has always relied on talented craftsmen, even though their contributions are often understated. Creative thinking and technical know-how help solve manufacturing dilemmas the machines can’t fix. Manufacturing technology has advanced exponentially and has let specialty manufacturing companies deliver parts they may have been unable to with older technology, it’s true. But the machines and technologies are just a pile of metal, wires, and circuity without the expertise of a creative manufacturing workforce.
“Hire and retain talented craftsman who know their business,” said MacDonald. “Not people who pretend to know, but people who learned it at the school of hard knocks. Our average length of service is over 16 years—we find good people and keep good people. A talented manufacturing workforce is key to success in this business; anyone who says otherwise will not make it in complex product manufacturing.”
- Bobyn JD, Hacking SA, Chan SP, et al. Characterization of new porous tantalum biomaterial for reconstructive orthopaedics. Scientific Exhibition: 66th Annual Meeting of the American Academy of Orthopaedic Surgeons; 1999; Anaheim, Calif.
- Karageorgiou V, Kaplan D. Porosity of biomaterial scaffolds and osteogenesis. Biomaterials. 2005; 26:5474-5491.