Orthopedic Implant Manufacturing Is in a State of Flux

Orthopedic implant manufacturers continue to focus on patient-specific, digital, and engineered material solutions for their new products, especially for robot-assisted procedures. Other key trends include the growth of porous titanium implants for improved osseointegration, more opportunities for bioabsorbable materials, and antimicrobial coatings to reduce infection risks. Additive manufacturing (AM) continues to be a disruptive and dominant technology with processes such as powder bed fusion, selective laser melting, and electron beam melting, which create complex devices that standard machining processes cannot.

“Implant manufacturing is in a hybrid phase,” stated Sebastian De Boodt, business line director for Materialise, a multinational company based in Leuven, Belgium, that develops software and AM manufacturing solutions for the medical device industry. “Conventional manufacturing still dominates for standard implants, but additive manufacturing has matured into a production-ready approach for both patient-specific devices and, increasingly, repeatable implant platforms that benefit from complex geometries, especially porous structures, and integrated features.” 

One of the most significant shifts in the industry is that manufacturing is becoming more digital end-to-end, not just at the printing step. AM and personalization are no longer doubted; the main concern has become scalability. “The limiting factors are workflow fragmentation, collaboration friction, and business models that do not scale cleanly with patient volume,” he added.

“Implant manufacturing is at a point where innovation and expectation are both accelerating, but the bar for demonstrating control has never been higher,” said Claire Brown, director of quality-U.S. at Minnesota-based Precera Medical, which specializes in the precision manufacturing of complex, tight-tolerance components and assemblies for medical devices. “As designs continue to evolve to support minimally invasive procedures, they are introducing geometries and tolerances that challenge traditional machining approaches. Manufacturers are having to rethink how parts are programmed, fixtured, and produced to keep up.”

What is currently defining success is the ability to translate that innovation into processes that are stable, repeatable, and well understood. “It is not just about whether a design can be produced—it is whether it can be produced consistently, at scale, and with a level of process control that holds up under regulatory scrutiny,” she added.

Latest Trends 

“We continue to see advances in the 3D printing of medical devices, as well as the use of nanotechnology coatings on implants to enhance specific properties or functions,” said David Cabral, president and CEO of Five Star Companies, a Bedford, Mass.-based contract manufacturer (CM) of medical devices and implants.

Other trends are:

• Personalization is moving mainstream for certain use cases, even going beyond the most complex revision cases.
• Design-for-additive is maturing, with more implants being designed from the start to take advantage of AM design freedom, rather than simply “ported” from machined designs.
• Higher throughput and cost-down via more efficient printers, better post-processing, and more standardized, validated workflows.
• A stronger digital thread—medical device manufacturers (MDMs) want connected workflows that tie design decisions, manufacturing parameters, and quality evidence together for traceability and regulatory confidence.

A shift is also underway toward operationalizing personalization, with the intent of creating a growing and sustainable business from those efforts. “MDMs also want predictable throughput, auditability, and cross-team visibility,” said De Boodt. “They also expect more investment in the digital layer—for example, case management, cloud collaboration, and workflow automation are becoming as important as printers and materials.”

As implants grow in complexity alongside shorter timelines and more cost controls, MDMs are pulling their CMs into the design process earlier. Designs have reached the level of complexity where development and manufacturing cannot be treated as separate phases and must be considered together during design for manufacturability (DFM). 

“Decisions around tolerances, geometry, and inspection strategy directly impact whether a part can be reliably produced and validated,” said Brown. “There is also a clear increase in expectations around process understanding. It is no longer enough to show that parts meet print during development; customers want to understand stability, scalability, and risk.”

At the same time, timelines continue to tighten. More MDMs are pressuring their CMs to move quickly, without always fully accounting for what it takes to build a robust, compliant process. When this work is not done early in DFM (or worse, without DFM), it often shows up later as validation or production issues.

What MDMs Want

MDMs seek partners that have the resources to actively support the path from development through launch, rather than relying on multiple disconnected vendors. “For implants, we continue to see strong demand for metal-based solutions, growing interest in turnkey systems, and more emphasis on designs that reflect the realities of procedural use, manufacturability, and scale,” said David Hannah, chief technology officer for Bethlehem, Pa.-based EXALTA Group, a global technology contract development and manufacturing organization (CDMO) that serves the medical device industry. “They are looking for partners who can help them move faster with fewer surprises later in the program, but not speed at the expense of manufacturability or regulatory readiness. These collaborators are expected to support them from a design, clinical testing, and manufacturing standpoint through post-market surveillance.”

“MDMs ask for scale without chaos,” added De Boodt—”one source of truth, faster approvals, fewer handoffs, and a cost model that aligns with volume as they grow.” 

Topping the MDM wish list are:

• Shorter and more predictable lead times, especially when cases are patient-specific
• Repeatable quality and validated processes—not just “can you print it,” but “can you prove it, every time” 
• Design support for AM expertise, particularly around porous regions, fixation strategies, and build orientation tradeoffs
• Scalability—the ability to move from early cases into a routine, efficient production model without the workflow collapsing under volume
• Responsiveness—as programs move quickly and priorities shift, CMs and CDMOs must keep pace, without losing control of quality or delivery

What stands out the most is the expectation for stronger partnerships, not just execution. “MDMs are looking for suppliers that will engage beyond the print, identifying risks, asking questions, and helping guide decisions that impact manufacturability and validation,” said Brown.

Tech Advancements and Tools

New high-tech and high-speed machining equipment, with improved process control, is allowing implant manufacturers to produce complex geometries while holding tighter tolerances. Lasers are used more frequently in orthopedic implant production. Ultra-fast lasers are in high demand because of their speed and precision—for example, they can cut features as small as 0.0005 inches (13 microns) with high accuracy and no thermal damage. The ultimate setup for speed and reduced production costs is “lights out” manufacturing, which is a production method that relies solely on automation and robotics, with no need for human operators.

“We are also seeing advancement in how machining and inspection are used together,” said Brown. “More complex parts are being produced in fewer setups using multi-axis equipment, reducing variation but requiring stronger process understanding. There is more focus on using data earlier to identify issues before final inspection.”

For some orthopedic designs, machinists must be creative and take technology into their own hands. For some non-metal components, machining must be done without coolant or other contaminants. Due to the expansion/contraction properties of certain materials, some products must be machined out of tolerance to compensate for heating/cooling characteristics. For example, the material that Five Star Companies machines for shoulder implants is ultra-high molecular weight polyethylene, an implantable-grade polymer. During the machining process, coolants and other fluids cannot make contact with the material. As a solution, “our engineers developed a process utilizing cold air (<32°F), which results in the material contracting in size,” said Cabral. “After the machining process, as the parts warm to room temperature, the material returns to its original state, as it moves into dimensional and tolerance specifications as per the drawing/blueprint. It sounds strange, but this approach works and is based on our team’s extensive experiences with these materials.”

AM can support prototyping, fixtures, tooling, and selected development applications. “Advanced machining with automation remains essential because orthopedic programs demand precision, repeatability, and process control,” said Hannah. “We also see increasing value in digital inspection, process monitoring, and data capture because they help identify issues earlier and reduce scrap rates.”

AI applications expand continuously. AI is often used to automate what were previously manual and costly operations, such as image processing, planning, and patient-specific design. This reduces lead time, improves consistency, and brings down costs. AI can also better manage control variability in the workflow. AI-assisted segmentation and automation shorten lead times and improve consistency, especially when processing high volumes of cases.

Like many companies, Five Star is using AI for back-end marketing and administrative data generation, “but we are also now in the education phase of implementing AI for DFM options,” said Cabral.

This often includes combining AI and generative design, which are expanding how designs are iterated early in development, generating optimized geometries that may not have been considered otherwise. Many designs introduce complexity that is difficult to machine, inspect, or control at scale.

AI is also starting to show value in targeted areas such as process monitoring, data analysis, and programming support. “It helps identify patterns and improve efficiency, but is not replacing engineering judgment,” said Brown. “The ultimate value of AI is in supporting better decisions.”

Engineered Materials

Titanium alloys remain the workhorse for many load-bearing orthopedic implants, with AM adding value through porous structures and complex geometries. Ti-6Al-4V is central in orthopedic manufacturing and rapidly cannibalizing stainless steel, “but the discussion increasingly extends beyond alloy selection to surface properties, porosity, and coatings,” said Hannah. 

Polyether ether ketone (PEEK) has also been a mainstay for orthopedic and spinal implants due to its bone-like elasticity, radiolucency, and chemical stability. PEEK has high standing—particularly in patient-specific reconstruction use cases—because surgeons value its radiolucency and imaging compatibility.

Despite these mechanical and imaging advantages, conventional PEEK has long been associated with limited biological interaction. Its smooth, nonreactive surface can reduce early cellular attachment and lead to the formation of a fibrous interface rather than direct bone contact.

There is now growing interest in pairing established implant polymers such as PEEK with other materials and structures to support more advanced, patient-specific designs. By combining advanced material formulations and engineered porous architectures, “implants can be designed to support favorable bone-tissue responses by combining surface-exposed bio-ceramic phases with interconnected pore networks that facilitate tissue infiltration and vascular access,” said 3D Systems in a recent white paper.¹ “Recent advances in high-temperature additive manufacturing have made it possible to unite these two strategies in a single process—creating implants that are biologically active and structurally optimized for osseoconduction—a fundamental step toward next-generation polymer implants.”

New biomaterials, such as advanced metal alloys, polymers, ceramics, and nanocomposites, offer superior biocompatibility and mechanical durability, minimizing adverse reactions. Looking ahead, bioresorbables will be one of the most exciting trends in implant manufacturing. “The promise is temporary mechanical function followed by controlled resorption—very compelling in areas like bone regeneration and pediatric applications,” said De Boodt. “The challenge is, however, that bioresorbables raise the bar for predictable material behavior, process control, and validation across the full lifecycle of the device.”

More broadly, MDMs seek guidance from their manufacturing partners on how material choices affect their designs, structural characteristics, processing, validation, and long-term product performance. MDMs are especially interested in the consistency of incoming material, and how it behaves through processing, rather than just the selection of new materials. As materials continue to evolve, the more meaningful shift will be how they are applied and controlled. Understanding how material behavior impacts machining, stability, and performance is crucial to long-term success.

Industry 4.0 

Industry 4.0 impacts implant manufacturing by making the digital thread the core asset—especially for personalized devices. “The biggest gains are not just in machine connectivity,” said De Boodt—“they are also about connecting people, decisions, and evidence across the workflow.”

For personalized devices, he noted, that means moving away from disconnected tools—imaging software here, design tools there, spreadsheets and email approvals everywhere. “Fragmentation is the hidden killer of scalability because every handoff is a risk to speed, quality, and compliance,” said De Boodt. “That is why we focus on an end-to-end platform approach: segment, plan, design, collaborate, and manage cases in a single environment, with a clear audit trail.”

“Our latest machine purchases have wireless capabilities for program data transfer, optical monitoring, and tool failure technologies,” said Cabral. “These features create opportunities for real-time data collection on tool wear, process efficiencies, and product compliance. All are factors in overall quality improvements, cost reductions, and delivery outcomes.”

There is also increased interest in using AI for case management to maximize quality and efficiency. Cloud platforms connect engineers, surgeons, and case managers in a single real-time flow—from order creation and image transfer through planning, design, treatment, and follow-up—so cases keep moving and teams can scale appropriate volume. 

Also, more MDMs are trying to capture post-operative behavior of their patient through smart wearables. “So if you can lead these results back to your digital system, this data could be used to optimize planning for the next patients,” said De Boodt.

Instead of focusing on fully connected systems, an increasing number of orthopedic manufacturers are using Industry 4.0 to improve process visibility and control. “For example, we are seeing increased automation in handling and inspection to reduce variation, along with greater use of machine and inspection data,” said Brown. “AI is beginning to support inspection and predictive analysis, helping identify issues earlier.”

“For us,” said Hannah, “Industry 4.0 is useful when it improves process discipline. That includes better machine data, automated capture of inspection results, and tighter traceability between process inputs and finished-part outputs. In implant manufacturing, this matters because small shifts in process can create outsized problems later in finishing, inspection, validation, or supply.”

Challenges to Innovation

The majority of challenging customer requests can be solved by stepping back and looking at the broader system. “In practice, that may mean adjusting geometry, rethinking tolerances, redesigning an implant-to-instrument interface, revisiting inspection strategy, or changing the production route altogether,” said Hannah.

A major recurring challenge is dealing with compressing timelines while still maintaining quality and compliance. The most effective solutions De Boodt has seen combine:

• Digital-first workflows (segmentation, design automation, simulation) to reduce iteration time
• Standardized, validated manufacturing steps
• Transparent collaboration between the clinical and engineering teams so approvals do not become the bottleneck

“This is also where end-to-end platforms matter,” he added. “When planning, design, documentation, and handoffs are integrated, teams can move much faster without losing control.”

“Much of the innovation in our space comes from working through constraints, rather than introducing something entirely new,” Brown added.

For example, in one case, Precera Medical’s engineering team was supporting a component with long, extended features and very minimal wall thickness. As material was removed during the machining process, the part became increasingly sus-ceptible to movement, which made it difficult to maintain dimensional stability.

Rather than trying to compensate for that variation downstream, “we adjusted the machining strategy to retain additional material in critical areas during earlier operations,” she explained. “This allowed secondary processes to be completed while the part retained the structural support needed to remain stable. The remaining material was removed in a controlled final step, which helped the part maintain integrity and ultimately meet print requirements.”

Future Directions

An important shift over the last few years is designing the implant as part of a system, rather than an isolated device. This means considering geometry together with instrument interface, inspection access, cleaning, and scale-up requirements. “In many cases,” said Hannah, “the best design improvements are the ones that improve manufacturability, consistency, and usability without adding unnecessary complexity.”

Although the industry is always working on new materials and manufacturing processes, MDMs are focusing less on any single breakthrough technology and more about how to remove bottlenecks throughout the product lifecycle, which then speeds up time to market and reduces costs. One way this process can be assisted is by bringing critical testing closer to the product realization process. “At EXALTA, our in-house microbiology laboratory recently achieved ISO 17025 accreditation, which reflects this shift,” said Hannah. “By bringing validated testing capabilities such as bioburden, sterility, bacterial endotoxins, and related testing closer to the product realization process, we can reduce reliance on external labs, tighten feedback loops, and help customers move more efficiently through development, validation, and regulatory readiness.”

De Boodt believes the most meaningful breakthroughs will come from combining technologies, such as:

• More automation and AI to reduce manual effort and variability in planning and design
• Better simulation/digital twin approaches to predict outcomes and optimize manufacturability earlier
• Maturing bioresorbable applications, where AM-enabled complexity could unlock new treatment approaches—if materials and validation methods keep pace

Most of the real breakthroughs will come from the maturation of existing technologies, rather than inventing entirely new ones. “AM, data analytics, and more flexible machining approaches are all becoming more practical in a production environment,” said Brown. “The biggest impact will come from how well these tools are integrated and controlled, ensuring processes are not just capable, but stable and repeatable at scale.”

Reference
¹ tinyurl.com/odt260501

Top Constraints to Implant Innovation

Too many programs are still developed in sequence, with cost pressure driving decisions too early and validation, regulatory, and manufacturing strategies coming in too late

Workflow friction—Too many companies still use manual steps and disconnected tools between clinical intent, engineering, and manufacturing.

Scaling challenges—What works for 10 cases often breaks at 1,000 without automation and standardization; scripting is key.

Evidence burden and alignment—Aligning engineering design changes with regulatory expectations requires tight collaboration and disciplined documentation.

Regulatory concerns—Regulatory expectations require a high degree of confidence in how design and process will perform, which can make MDMs more cautious about introducing change.

Design freeze—Designs tend to become “locked” early, especially when validation planning begins; at that point, even small improvements can be difficult to implement without impacting timelines.

Time crunch—There is often pressure to move quickly through development, which can limit the time available to fully explore innovative design alternatives or optimize the manufacturing approach upfront.

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.