Orthopedic manufacturing is a complex process and requires a variety of tools and technologies to meet the industry’s ever-growing machining needs. Orthopedic companies continue to recover from the COVID-19 pandemic, especially by reworking their supply chains. In the wake of the pandemic, many medical device manufacturers (MDMs) took the proactive step of stockpiling inventories, resulting in a temporary decline in sales over the past two years.

However, as the market stabilizes, “we are witnessing a resurgence in medical contract manufacturing, indicating a shift towards increased production activity,” said Barbara Van Essen, business development executive for Unity Precision Manufacturing, a Dayton, Minn.-based contract manufacturer of medical devices, including spine implants and surgical instruments. “This change suggests a recovery phase, with a renewed focus on meeting the demand for orthopedic devices through advanced machining capabilities. Overall, the industry is gradually rebounding, adapting to new challenges, and preparing for future growth.”

Technology and innovation are leading the industry out of the pandemic. Modern computer numerical control (CNC) manufacturing machines are abundant in production facilities, which typically feature automatic handling systems for loading and unloading workpieces. Machining processes continue to see advances in cutting tools. New sintered materials or extremely hard coatings enable optimization of production times. Many improvements are also being delivered through modular enhancements such as add-on laser modules, in-machine inspection probes, and software upgrades, which can be far less expensive than investing in all-new machine classes.

Although automation for lasers is not yet on the same level as in machining processes, there is a clear trend toward full automation of laser processing, especially for miniaturized components and devices. “Ultra short-pulsed laser sources in the picosecond or femtosecond range are becoming more affordable and do not introduce thermal stress deep into the material during laser processes,” said Guido Pankoke, head of production engineering for Komet Medical, a contract development and manufacturing organization (CDMO) based in Germany that specializes in developing and manufacturing cutting, fixation, insertion instruments, and other orthopedic tools and devices.

With advancements in automation, software, and smart digital tools, today’s manufacturers can consistently achieve extremely tight tolerances—less than 10 microns—”which is critical for making high-quality implants and surgical tools,” said Raghu Vadlamudi, chief research and technology director for Donatelle Plastics LLC, A DuPont Business that provides medical component and device contract manufacturing services. “By combining traditional machining with 3D printing, built-in measurement systems, and data-driven controls, companies can now produce more complex parts faster and more reliably than ever before, while also meeting strict quality and regulatory standards.”

As a result of these advances, a large number of players have entered the contract manufacturing market for orthopedic devices, which had an estimated global value of $51 billion in 2024 and is projected to have a 4.8% compound annual growth rate (CAGR) through 2030.¹

“Most of these companies are thriving and continue to develop more efficient and technically advanced manufacturing methods,” said Tom Graham, chief operations officer for Elevaris Medical Devices, a CDMO for MDMs that specializes in precision micro-components, complex tubular components, and sub-assemblies. “Some contract manufacturers cover the whole range of orthopedic surgery components, while others specialize in particular market segments. CNC machining and laser processing are key technologies that drive this growth.”

Ken Altman, vice president of TriTex Medical Manufacturing, a Mt. Morris, Mich.-based contract manufacturer of high-precision surgical cutting instruments for orthopedic, spine, trauma, and dental OEMs, agreed.

“The orthopedic machining space is seeing steady evolution,” he said, noting that single-use instrumentation and minimally invasive surgery (MIS) systems are hot markets that demand compact, precise, and often disposable cutting tools.

“Precision keeps improving as CNC platforms integrate better controls and adaptive feedback,” Altman added. “Meanwhile, inspection systems have become smarter, often enabling in-process verification. Operator training is also progressing, thanks to online platforms and simulator-based instruction. While not revolutionary, these incremental gains improve consistency and throughput, making manufacturing more efficient and cost-effective.”

Current Trends

One of the biggest trends in machining orthopedic devices is the size reduction in parts and tighter tolerances. “This miniaturization is driven by the growing demand for minimally invasive devices, which offer numerous benefits, such as reduced postoperative pain, faster recovery times, and fewer complications,” said Steve Breen, director of engineering for Roechling Medical, a Denver, Pa.-based contract manufacturer (CM) of complex medical components and devices leveraging a wide range of technologies including metal machining. 

The trend toward miniaturization is reshaping the manufacturing and measurement processes required to make these devices, which sometimes pushes the limits of current machining technologies.

“For example,” said John Turner, senior project engineer for new product introduction for Roechling Medical, “as miniaturization progresses, so does the need for laser processes that do not create heat-affected zones, or at least reduces their impacts. Methods are also needed to control laser-generated particulate waste. The cleaner and less heat-affected the laser process, the less post-processing is required.”

The integration of artificial intelligence (AI) and Internet of Things (IoT) results in more capable automated machining systems that can perform multiple tasks at the same time. A goal for many MDMs is to have a smart factory, where production processes run as autonomously as possible, without manual intervention. Also known as “lights out” manufacturing, this process often requires AI and advanced IoT-based monitoring platforms. To achieve this goal, “machines and systems must be capable of monitoring themselves and the process outcomes, and—if necessary—initiating corrective actions, including shutdowns,” said Pankoke. “Of particular importance in this context are the growing capabilities of digital image processing technologies, which can be used for dimensional measurement and optical surface inspection.”

For several years, the development of additive manufacturing (AM) capabilities has been a significant factor in the manufacture of orthopedic device components. In many areas, AM has replaced traditional machining for implant and instrument components. This is especially true for patient-specific device design, where the individual requirements are translated into a 3D model, from which a printed component is created.

Now, however, CNC machining and laser technology are catching up to AM’s ability to make patient-specific devices. “Some CDMOs offer quick-turn machined components to device manufacturers providing customized patient solutions,” said Graham. “The power of computer modeling and machine post-processing continues to develop, resulting in faster responses and more accurate translations.”

Orthopedic companies are sharply focused on increasing efficiency, reducing costs, and speeding up time to market. There is also a growing emphasis on innovation in machining programs and capabilities, as MDMs explore creative (and faster) solutions to optimize their operations. With this in mind, many of the latest trends in machining are centered around automation and the integration of robotic systems to enhance efficiency and precision. 

“For example, we are focused on cost-reduction strategies to remain competitive, which include providing design for manufacturability assessments early in the project lifecycle,” said Van Essen. “Collaborating from the outset significantly reduces design changes and expedites the product launch process. Additionally, the use of blanket orders enables companies to manage inventory effectively while decreasing lead times.”

What MDMs Want

Surgeons are pushing MDMs to provide devices that perform new procedures or provide better solutions to an existing procedure. This often results in more complex characteristics in the device, such as articulation, multiple tool functions, or adaptable features. The challenge is then passed on to the CDMO to find manufacturing processes that will create the design and hit the key price points. “Laser machining, laser welding, 3D printing, and CNC machining all play a part in these solutions—often in combination, which is where we see lots of innovation happen,” said Graham.

MDMs require very specific tolerances, some of which are as tight as one hundredth of a millimeter. In addition, a high surface quality is expected—the surfaces should be as smooth as possible but not show mirror-like reflection. Laser marking, too, is subject to stringent requirements. “Markings must remain highly legible and corrosion-resistant, even after multiple uses and reprocessing cycles,” said Pankoke.

Orthopedic manufacturers are also looking for precise and reliable lead times to better manage their production schedules. They also seek stable and clear timelines to help them plan more effectively and minimize production delays. Another request is designing products as a family of components. “This approach not only simplifies manufacturing but also optimizes supply chain efficiencies by reducing variation and enabling economies of scale,” said Van Essen.

More complex prototype parts and intricate assemblies are also high on the MDM wish list. They are pushing their machining partners for advanced or difficult-to-machine materials, tighter tolerances (sub-micron tolerances for cannulas and intricate surgical tools), and more sophisticated implant and instrument designs—”often still with the expectation of lower costs and faster lead times,” said Michael Mannion, director of Swiss machining for SpiTrex Orthopedics, a Lancaster, Pa.-based vertically integrated contract manufacturer that specializes in spine, trauma, and extremity implants.” 

In response, SpiTrex Orthopedics provides in-depth design for manufacturability (DFM) feedback to help reduce costs and improve overall machinability early in the process. To stay ahead, the company also makes full use of its equipment and is not afraid to think outside the box. “We regularly ask ourselves, ‘How can we reduce this from two operations to one?’ or ‘This may not look like a Swiss part—but can continuous, lights-out production make it cost-effective?’” said Mannion. “This mindset allows us to meet demanding expectations while maintaining quality and efficiency.”

Ultimately, MDMs want more than just accurate and consistent machining. They expect their suppliers to provide digital traceability, manufacturing efficiency, and additional value-adding services, such as surface finishing, laser marking, inspection, and packaging—all in one place. “There is also a stronger focus on regulatory compliance and the ability to provide a range of products, from early prototypes to full-scale production, using the same high-quality standards,” said Vadlamudi. “In addition, companies are looking for smart automation and advanced quality systems that make it easier to manage documentation and demonstrate regulatory compliance.”

Tools, Tolerances, and Tech

Digitalization continues to play a key role in the advancement of machine technologies, especially the ability to collect and analyze machine data. For example, digital twins can communicate key production parameters—or even detailed reports on machine conditions—to operating personnel. “Based on this data, early signs of process instability, wear, or other potential failures can be detected in advance,” said Pankoke. “As a result, corrective actions can be taken, or the process can be automatically stopped before any non-conforming product is manufactured.”

Tolerances continue to get tighter—for example, centerless grinding and Swiss turning are in the range of ±0.0002 to ±0.0005 inches. Ultra short-pulse lasers such as femtosecond can offer micro machining (±5.0 µm) with little to no heat-affected zones. Hybrid machines are gaining in popularity due to the increased efficiency and time savings they provide. For example, CNC turning/milling systems can be integrated with laser cutting tools at the same workstation. Laser cutting, laser welding, and laser ablation can all be combined into a single manufacturing system that provides significant benefits in cycle times, holding/fixturing accuracy, and quality control. Laser-assisted machining is now being used to machine hard-to-cut materials such as cobalt-chrome and polyether ether ketone (PEEK) more efficiently. Hybrid machines that combine 3D printing, CNC milling, and lasers in a single system are also becoming available. “Inspection systems can also be mounted directly on turning centers,” said Altman. “These hybrids reduce part handling and cycle times, improving both cost and quality.”

Machining Versus AM

Machining and AM are now being used together instead of being viewed as competitors. AM is excellent for creating complex shapes and lattice structures, while machining is still needed to provide smooth surfaces, threads, and the tight tolerances required for medical devices. 

The best manufacturing processes often rely on both methods—”AM is used to build parts close to their final shape, followed by machining to meet strict product specifications and quality standards,” said Vadlamudi. “CNC machining is still the go-to method for parts that need very precise dimensions and surface finishes, although AM is making fast progress, especially with materials such as titanium, PEEK, and bioabsorbables.”

AM processes offer clear advantages for the prototyping of visual samples. However, when products require very tight tolerances in the hundredths of a millimeter range—or even smaller—AM becomes complex and, in most cases, post-processing using conventional machining is necessary.

“3D printing is preferred for some components, such as producing porous surfaces or complex implant geometries, such as acetabular cups or tibial trays,” added Altman. “But for cutting instruments, subtractive machining remains dominant. Features like cutting edges, flute angles, and concentricity are still best achieved through grinding and turning.”

Ongoing advancements in equipment, tooling, and automation are significantly reducing lead times and increasing throughput, allowing CNC machining to remain highly competitive with AM.

Machining and AM each have their unique strengths. CNC machining offers superior precision, surface finish, and material versatility, making it ideal for high-volume production. In contrast, 3D printing provides design flexibility and rapid prototyping for complex geometries.

“Rather than competing, these technologies can coexist, with each having its niche,” said Van Essen. “As AM advances, it will complement CNC machining, allowing both to enhance manufacturing capabilities for various applications.”

Moving Forward

Future advancements in the orthopedic space will involve data—how to collect it and analyze it to optimize manufacturing systems, quality, and speed. 

IoT is changing how machining is accomplished by making it smarter and more connected. Machines equipped with sensors that track parameters such as tool wear, vibration, and temperature in real time help to prevent breakdowns and improve performance. IoT and automation can also forecast equipment failures, reducing downtime and improving reliability—driving utilization and key performance efficiencies upward. “These smart machines can also connect with manufacturing and quality systems to automatically track parts and store digital records,” said Vadlamudi. “New tools such as augmented and virtual reality are being used for training, machine setup, and troubleshooting. Cloud-based software lets teams update machining programs from any location. Together, IoT and automation are moving the industry closer to fully automated, around-the-clock production with minimal human involvement.”

Unity Precision Manufacturing has incorporated automation and robotics into many of its processes, including CNC machining, turning, electrical discharge machining (EDM), and quality inspection. “This level of automation not only streamlines operations, but also enhances precision and consistency across processes,” said Van Essen. “Furthermore, we are exploring how AI can be leveraged to increase production capacity and optimize machining analysis. By analyzing data collected from IoT devices, AI algorithms can identify trends, detect anomalies, and suggest improvements, ultimately leading to more efficient production workflows and better-quality products.”

A key advantage of digital technology is the inspection processes that can be fully integrated into manufacturing processes. For example, on-machine inspection equipment enables 100% in-process inspection with automatic rejection of non-conforming parts. “Digital vision measurement provides instantaneous data analysis and decision making,” said Graham. “There is no interruption to the manufacturing flow. This capability is also more reliable because it is not necessary to pick up a finished component as a separate item and then find a suitable measurement technique.” The next step—how to integrate this capability into closed-loop adjustments of the machining system for tool wear, material property variances, and real-time statistical process control (SPC) data utilization—is currently being developed.

Despite these advanced capabilities, several challenges continue to limit innovation. High capital investment in hybrid and automated platforms is a barrier, especially for small- to mid-sized manufacturers. A growing skills gap is a major issue, as machining now requires knowledge in mechatronics, software, and regulatory compliance. Integrating the machining process with digital inspection and quality systems remains complex, and short product lifecycles demand faster retooling and validation. “To stay competitive, manufacturers must invest in automation, AI, and process digitization while building a workforce with multi-disciplinary expertise,” said Vadlamudi.

On the Horizon

Emerging technologies—especially AI-enabled—are poised to significantly advance machining. The use of AI will open up entirely new opportunities for process improvement. “This applies to equipment productivity, especially in production planning and control, product engineering, reduction of order lead times, and increased efficiency in machine development and technical documentation,” said Pankoke.

AI-driven computer-aided manufacturing (CAM) platforms are already optimizing tool paths in real time based on material feedback and part geometry. Autonomous machining systems with integrated metrology and tool management are also entering production environments. The use of AI to automatically adjust feed rates, spindle speeds, and cutting paths mid-cycle is improving both accuracy and tool life.

Hybrid platforms that combine additive, subtractive, laser, and polishing functions in a single setup are redefining the manufacturing workflow. “Some fully integrated hybrid machines can 3D print a near-net part, precision-machine the critical features, and perform laser processing and final polishing—all on one platform,” said Vadlamudi.

Mannion is excited about where the continued convergence of additive and subtractive technologies will lead. Beyond hybrid machines lies the promise of the hybrid cell. “Imagine a tightly integrated production cell that includes additive manufacturing, palletized part handling, multi-axis machining, and automated inspection—all working together in a seamless workflow,” said Mannion. “This is where things will start to get really interesting.”

The industry is not far off from this reality, Mannion maintains, and when it happens, it will “fundamentally change how we think about manufacturing complex implants and assemblies. It is less about one machine doing it all and more about intelligently linking specialized equipment to create a flexible, fully automated production line.”

Reference

¹ tinyurl.com/odt250921

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.