Nancy Hairston likes to think her medical mission to Ukraine was guided by kismet.

As the country’s conflict with Russia surpassed its 10-year milestone, Hairston felt an undeniable urge to help its victims. She voiced her desire to a MedCAD board member, who happened to be meeting with ophthalmologist and oculoplastic/orbital surgery specialist Jorge Corona, M.D., shortly after that conversation.

During his meeting with the board member, Dr. Corona mentioned an upcoming trip to Ukraine to perform facial reconstruction surgeries for war-injured soldiers and civilians. The board member connected Dr. Corona with Hairston—MedCAD’s president and CEO—and the pair met after the doctor returned from his trip.

Upon meeting the surgical team accompanying Dr. Corona on his Ukraine trips, Hairston began planning her company’s involvement in the next medical mission. Late last year, she turned her desire to help the Ukrainian people into action, joining Dr. Corona on his latest mission with custom implants produced by MedCAD, a Dallas-based designer/manufacturer of patient-specific implants, including craniomaxillofacial (CMF) and lower extremity reconstructions.

“We arrived today in Kyiv at noon and went straight to the hospital to meet the team of surgeons, residents, and new patients,” Hairston’s wrote in a diary adapted from text messages, voicemails, and video calls with the U.S. MedCAD team. “We were also able to meet patients we did implants for in previous missions, and I met one guy who is six months into his recovery. His whole cheek and eye were damaged, but he looks good, and he’s getting through it…a lot of the patients speak at least some English, and they’re so appreciative of what we’re doing here, and they tell us that. There are also lots of hugs.”

Those hugs gave Hairston a brief respite from the stark realities of war—truths measured in crushed cheekbones, fractured jaws, splintered facial fragments, and missing eyeballs. 

Such battlefield (and civilian) injuries would have been next to impossible to repair a mere quarter century ago. But the advent and subsequent steady growth of additive manufacturing (AM)—often (erroneously) referred to as 3D printing—has revolutionized orthopedic implant design and fabrication, begetting customized prosthetics, better material biocompatibility, improved surgical precision, and faster postoperative recoveries. 

3D printing (or AM, depending on user definition) was instrumental in repairing the bodily damage suffered by Ukrainian soldiers and citizens. Leveraging 3D Systems’ direct metal printing technology, MedCAD’s additively manufactured titanium alloy implants were used to reconstruct mutilated cheekbones and jawbones and replace missing parts of the skull and orbital floor (the lower portion of bone surrounding the eyeball).

“These war injury cases are different from what we work with on a daily basis. The blasts can severely damage vessels, and there is often shrapnel left in faces,” Hairston observed in her diary. “We did three really intense cases the last three days, fibula reconstructions of the mandible and the maxilla. It’s not just the bony anatomy that’s affected by these injuries, it’s multi complex systems. The blasts cause soft tissue damage, so it takes tremendous skill and patience for the microvascular surgeon to connect arteries and veins for the harvested bone and tissue. Going to the hospital, seeing these patients…I mean the kind of injuries, it’s heartbreaking.”

The injuries may indeed be heartbreaking, but Hairston found solace in witnessing modern medicine—specifically AM (or 3D printing)—restore physical war wounds. 

Trauma injury restoration is just one of the many medical marvels championed by 3D printing/AM. The technology has evolved over the last 25 years from an experimental tool to a key component of orthopedic device development and manufacturing.

For perspective into this fast-growing manufacturing sector—particularly the market forces driving AM/3D printing’s growth, AI’s role in implant design, and remaining barriers the technology must still overcome—ODT spoke with a handful of specialists over the last several weeks. Insight came from:

• Antonio Giordano, chief financial officer at Multi-Etch
• Brian R. McLaughlin, co-founder/CEO of ALM Ortho Inc.
• John A. Ruggieri, senior vice president, Business Development, at ARCH Medical Solutions
• Corey Seacrist, manager, sales/marketing at Poly-Med Inc. 

Michael Barbella: What market forces are currently shaping the orthopedic 3D printing sector and what factors are driving them?

Antonio Giordano: Demand for 3D printed orthopedic products is strong. Many great companies are all competing to create and bring to market revolutionary products to better the lives of the people using these products. The competitive nature of companies using more capable printers and the never-ending evolution of filament and composites to print with is driving incredible innovation. 

Brian R. McLaughlin: Several forces are converging at the same time. First is clinical demand for better fixation and longevity, especially in complex revision cases and in anatomies where standard implants do not perform well, which is driving wider acceptance of porous and lattice-based designs that can promote osseointegration. Second is the cost and supply chain pressure on hospitals and OEMs, which is pushing manufacturers to reduce instrument complexity, consolidate assemblies, and shorten lead times, all areas where additive manufacturing can remove steps and parts. Third is the maturation of reimbursement and clinical evidence, where more published outcomes and clearer clinical indications are making it easier for surgeons and value analysis committees to justify adoption. Finally, the market is being shaped by consolidation and specialization. Big OEMs continue to acquire or internalize additive capability, while a growing ecosystem of focused partners is emerging around design for additive, post-processing, validation, and quality systems, which lowers the barrier for smaller innovators to build clinically meaningful products.

John A. Ruggieri: The orthopedic 3D printing sector is being shaped primarily by three key market forces: the demand for patient-specific solutions, the need for advanced implant geometries that enhance biological performance, and the push for faster development and innovation cycles. There is growing demand for implants that are tailored to individual patients’ anatomy. Additive manufacturing enables highly accurate anatomical matching, allowing for improved implant fit, enhanced surgical precision, and better functional outcomes. Equally important is the ability to design and manufacture complex lattice and porous structures that promote osseointegration while maintaining optimal mechanical properties. These architectures allow precise control over stiffness, porosity, and load transfer, reducing stress shielding and improving long-term implant stability. Such capabilities are not achievable through conventional manufacturing methods. Finally, additive manufacturing enables rapid prototyping and iterative design, allowing engineers and clinicians to quickly validate concepts, refine designs, and accelerate product development. This capability is transforming how orthopedic implants are designed, tested, and brought to market, enabling faster innovation while maintaining high standards of quality and regulatory compliance.

Corey Seacrist: Manufacturing orthopedic medical devices via 3D printing has unlocked design space inaccessible to traditional manufacturing methods. Specifically, 3D printing allows for the creation of porous implants that facilitate tissue ingrowth, in this case, bony ingrowth. This has been used most notably in 3D printed titanium interbody fusion devices as well as pedicle screws more recently. The pace of 3D printed absorbable implants has lagged compared to nonabsorbable counterparts, partly due to the lack of materials that exhibit sufficient stiffness and creep resistance. Two examples of cleared products with limited use are Dimension Bio’s (previously Dimension Inx) CMFlex Synthetic Bone Graft comprised of hydroxyapatite particles and polylactide-co-glycolide (PLGA) polymer and Osteopore’s polycaprolactone (PCL)/β-tricalcium phosphate (TCP)-based craniomaxillofacial implants. Poly-Med’s Lactoprene HMX can be combined with bioactive ceramics such as β-TCP or hydroxyapatite to create porous 3D printed constructs that exhibit significantly higher stiffness than standard PLLA and PLGA- based absorbable biomaterials.

Barbella: How have recent advancements in materials science accelerated the use of 3D-printed implants?

Giordano: The longer materials are in the marketplace, the more time manufacturers have to perfect their techniques and produce viable implants that get better with every version change. As materials advance, techniques in printing that were not possible within the past few years become possible, allowing designers to create never-before-seen designs that continuously improve final products. 

McLaughlin: The biggest acceleration has come from improved control and repeatability of titanium alloy performance and surface architecture at scale. In the EBM world specifically, the combination of stable Ti 6Al 4V powder supply, tighter chemistry controls, and better understanding of microstructure and fatigue behavior has made it easier to design devices that are not just biologically attractive, but also mechanically predictable. On top of that, there is a growing material science toolset for correlating porosity, strut thickness, and surface morphology to stiffness, load transfer, and bone response. That is important because the goal is not just to print a porous surface; it is to engineer an interface that achieves fixation without creating stress shielding or early loosening. We also see progress in post-processing science, for example, HIP, heat treatment, and surface conditioning workflows that preserve device functionality while improving fatigue performance and cleaning outcomes, which is critical for regulatory and clinical confidence.

Ruggieri: Improvements in powder quality, including tighter control of particle size distribution and alloy chemistry, have led to more stable printing processes and more consistent mechanical properties. Higher-quality powders reduce defects, improve part strength, and make production more repeatable, which is essential in a regulated medical environment. Advances in post-processing, particularly heat treatment and hot isostatic pressing (HIP), have further improved implant performance. These steps help eliminate internal porosity, reduce residual stresses, and refine the microstructure, resulting in better strength, ductility, and fatigue resistance. As a result, 3D-printed implants can now reliably meet the demanding performance requirements of load-bearing orthopedic applications.

Seacrist: Our team of material scientists has developed Lactoprene HMX as a novel material within our Lactoprene biomaterial portfolio that exhibits a Young’s modulus up to 2.2X higher than PLLA and PLGA 8515, and up to 1.5X higher than PEEK in injection molded formats. Additionally, we observed similar increases in stiffness for Lactoprene HMX in 3D printed formats. Our team has also shown that Lactoprene HMX exhibits significantly less creep than PLGA 8515 in static creep testing and is 2-3 times more resistant to failure compared to PLLA.

Barbella: What role does AI or advanced modeling play in optimizing implant design?

McLaughlin: AI and advanced modeling are increasingly used as design acceleration engines and as decision support. In practice, the highest value is in three areas. One is topology optimization and lattice parameterization, where you can rapidly explore thousands of design variations to hit stiffness targets, maximize porous surface contact, and keep peak stresses away from high-risk zones. The second is simulation-driven design, using FEA and fatigue modeling to predict how a lattice-backed construct will behave under physiologic loads, including micromotion at the bone interface. The third is manufacturability and process robustness, where AI models can help anticipate distortion, support strategy, thermal behavior, and build variability so the design is more repeatable on the manufacturing floor. For a company like ALM Ortho, the main point is that AI and modeling reduce iteration cycles and de-risk design decisions earlier, before you spend time on expensive validation builds and mechanical testing.

Barbella: What challenges/barriers must still be overcome to increase 3D printing technology’s use in orthopedic design and/or manufacturing?

Giordano: While printing technology has come so far in the past decade, we believe there is a lot of room for improvement. Many parts today, regardless of initial material, come off the printers with surfaces that are too rough, structurally compromised, and can have partially fused particulate. It’s a delicate balance between machine capability, programming, modeling, and the constant innovation of the materials being fed into the machines. New materials and new designs then require brand new testing and new obstacles. 

McLaughlin: The biggest barriers are still standardization, validation burden, and cost transparency. Additive is capable, but the industry still needs broader alignment on how to qualify porous structures, how to validate cleaning for deep lattice geometries, and how to establish equivalence when you change a parameter, a powder lot, or a post-processing step. Another barrier is education and workflow adoption in the hospital environment; surgeons may love the biology of porous implants, but committees care about evidence, revision rates, and total cost of care. A third barrier is capacity and supply chain maturity; many additive workflows are still concentrated in a small number of specialized facilities, and scale-up requires robust training, redundancy, and consistent QMS execution. Finally, design discipline is a barrier; additive can tempt teams into overly complex geometry that is hard to inspect, hard to clean, or hard to validate, so design for validation is just as important as design for print.

Ruggieri: Despite major advances in additive manufacturing, post-processing remains one of the most significant barriers to broader adoption, particularly from a cost, scalability, and production efficiency standpoint. Operations such as support removal, surface finishing, heat treatment, and inspection are still largely manual and time intensive. Greater automation across these steps will be critical to improving throughput, reducing variability, and lowering overall manufacturing costs. Another key challenge lies in achieving tighter dimensional tolerances and improved geometric consistency, especially for complex implant geometries and lattice based designs. While additive manufacturing allows design freedom, maintaining precise dimensional control across builds and machine platforms remains an area for continued development. Finally, effective powder removal from porous structures remains a challenge. Complex internal geometries, while essential for promoting osseointegration, can trap residual powder, complicating cleaning and inspection processes. Advancements in automated depowdering technologies will be essential to ensure both manufacturing efficiency and clinical safety. From a regulatory standpoint, the landscape is also evolving. As additive manufacturing becomes more widely used in medical devices, the FDA is becoming increasingly experienced and more specific in its expectations for 3D-printed implants. As more clinical data becomes available, submission requirements are being refined to address additive-specific risks and considerations. While this ultimately strengthens patient safety and industry standards, it also increases the technical and documentation burden on OEMs developing and submitting new products. 

Barbella: What recent additive manufacturing innovations have most impacted your orthopedic device manufacturing, and in what ways?

Giordano: Innovations have been driving consistent growth in our markets. The more complex shapes and structures that are created end up creating a lot of value for our product. We specialize in providing an aqueous etching solution that is repeatable and adaptable to hundreds of shapes, geometries, interior channels, and materials. We work hand in hand with our customers through the testing phases through live manufacturing.

McLaughlin: From the EBM perspective, improved process control and standardization across the workflow has had the largest operational impact, not one single “silver bullet” machine feature. Good powder handling discipline, more mature parameter sets for lattice builds, and tighter control of post processing has improved repeatability and reduced scrap. Lattice realism has also increased, meaning we can design interfaces that are more bone mimetic while still being manufacturable and cleanable. One the production side, digital traceability and quality tooling has improved, linking build data, powder lots, post process cycles, and inspection results into a cleaner DHF and DMR story, which matters in orthopedics, where validation and documentation are not optional. For ALM Ortho specifically, the ability to reliably print clinically relevant porous structures with EBM and then industrialize the downstream cleaning and inspection is what turns additive from an R&D method into a scalable manufacturing capability.

Ruggieri: One of the most impactful innovations in our orthopedic manufacturing operations has been the advancement of layer-wise process monitoring and imaging technologies. These systems provide high-resolution visualization of every deposited layer, enabling detection of defects and anomalies during the build process. This capability fundamentally changes how quality is managed. Instead of relying solely on post-build inspection, we can now identify process deviations as they occur, allowing for immediate intervention and improved build stability. When defects are detected, layer-by-layer imaging enables detailed root cause analysis, helping us understand whether issues originate from powder behavior, thermal conditions, or recoater interactions. From a production standpoint, this has led to reduced scrap, improved process robustness, and enhanced traceability, which are all critical for meeting the stringent quality and regulatory requirements of orthopedic implant manufacturing.