Additive manufacturing (AM), sometimes referred to as 3D printing (3DP), has allowed creation of geometries that were impossible to manufacture in the past. This includes nearly limitless, 3D structures that can be fabricated from a growing variety of materials, including metals, plastics, and even living cells.

AM/3DP’s benefits include the flexibility to customize shapes, boost the intricacy and complexity of manufactured products, elimination of assembly steps, reduced material waste, and the promise of “just in time” manufacturing capabilities.

“AM excels at producing intricate, organic, and lattice structures that traditional methods (e.g., CNC machining) struggle to create,” said John Ruggieri, senior VP of business development at ARCH Medical Solutions. “This is especially valuable in orthopedic devices like implants, where patient-specific designs or porous surfaces for osseointegration are required. For specialized or niche products like custom surgical guides, patient-specific implants, or limited-run components, AM eliminates the need for costly tooling and setup, making it more cost-effective for small batch sizes.”

In orthopedics, AM is commonly used to create personalized implants, devices, and instruments. It has also been used for preoperative planning and teaching both students and patients more about the procedures by way of customized surgical models.

Parts and devices manufactured through AM/3DP are made in a layer-by-layer manner. The technology can fabricate underhangs, overhangs, interconnected pores, spaces in the implant, and other features that aren’t possible with machining or molding. 

In order to further examine AM/3DP’s impact on orthopedic device manufacturing, over the last few weeks ODT spoke to more than a dozen experts in the field:

• Chris Beaudreau, VP of Orthopedics, Axial3D
• Ido Bitan, Product Director, Stratasys
• Chris Boothe, COO, Multi-Etch
• Sandy Boothe, CEO, Multi-Etch
• Antonio Giordano, CFO, Multi-Etch
• Mukesh Kumar, Technology and R&D Director, Lincotek
• Adam Lacy, Program Manager, Able Medical Devices
• Jake Marasco, VP of Sales and Operations, Westconn Precision Technologies
• Markus Reichmann, US Regional AM Sales Account Manager, Lincotek
• Pierfrancesco Robotti, Technology & Business Development Manager, Lincotek
• John Ruggieri, Senior VP of Business Development, ARCH Medical Solutions
• Nora Toure, Director of Medical Sales—North America, Materialise
• Gary Turner, VP, Additive Manufacturing, Ricoh USA

Sam Brusco: Which recent additive manufacturing technological or operational innovations have most benefited your medical/orthopedic device/component manufacturing business? How so?

Chris Beaudreau: One of the most impactful innovations has been the integration of AI-driven automation into the additive manufacturing workflow. We leverage AI-powered 3D medical imaging to streamline conversion of patient DICOM data into highly accurate 3D models. This eliminates the traditional bottlenecks of manual segmentation, significantly reducing processing time while improving consistency and precision.

Advances in biocompatible materials have also transformed additive manufacturing for orthopedics. High-temperature polymers like PEEK are now being used for rigid implants, offering superior durability and mechanical properties for long-term implantation. Meanwhile, flexible polymers are expanding applications into consumer-facing healthcare, such as patient-specific braces and wearable medical supports. Even biomaterials are evolving, enabling the development of substructures for grafts and direct tissue printing—bringing regenerative medicine closer to reality.

Improvements in high-resolution printing techniques are making anatomical models and implants more precise, enhancing their effectiveness for pre-surgical planning, device testing, and patient-specific instrumentation. By combining AI automation, next-gen materials, and advanced printing methods, we’re helping medtech companies scale patient-specific solutions efficiently while pushing the boundaries of what’s possible in personalized orthopedic care.

AI-driven automation and cloud-based additive manufacturing have transformed orthopedic device production, making patient-specific solutions more scalable, accessible, and efficient. Our AI-powered 3D imaging technology automates the conversion of medical scans into highly accurate, print-ready 3D models—reducing time, improving consistency, and enabling global access to personalized care.

By leveraging the cloud, we eliminate the need for on-site processing, ensuring seamless collaboration and faster turnaround times. Automating these complex workflows also frees up valuable resources, allowing engineers and clinicians to focus on higher-priority tasks like innovation, patient care, and surgical planning. This shift improves efficiency and makes personalized orthopedic solutions more widely available and cost-effective at scale.

Ido Bitan: We have unique solutions to benefit point-of-care and medical device companies. The Digital Anatomy Printer is capable of producing anatomical models that are not only accurate by the geometry, but more importantly, in the mechanical behavior of the model. They mimic the bio-mechanical behavior of a real organ to exercise, train, and research using these models instead of cadavers/animals.

They added the ability to actually perform a specific operation on a model as part of pre-surgical planning. Up to this point, pre-surgical planning with anatomical models was used for measuring, looking at different angles of an organ and proximal vessels and fitting of a surgical tool to the target organ. Now with the Digital Anatomy solution, one can actually perform the desired procedure on the model while receiving correct haptic feedback and mechanical performance as would be expected from the organ itself.

Chris Boothe, Sandy Boothe, Antonio Giordano: The greatly increased use of filament material in general and for medical devices in particular, has grown our business significantly. Nitinol (NiTi) filament has become very popular across the orthopedic and medical industries due to its strength and shape memory characteristics. The effect of Multi-Etch on Nitinol has been shown by academic researchers to have excellent and controlled performance on Nitinol wire, filament, and printed parts. Multi-Etch improves the overall surface of Nitinol parts by greatly reducing the amount of surface nickel and surface roughness, making the parts more implant ready.

Some commonly known issues with 3D printed devices are unfused and partially bonded particles; internal chambers and surfaces that cannot be reached with typical machining; and overall surface qualities that are rough and porous. We excel in solving all three problems in one application. When parts are submerged and etched in an aqueous solution of Multi-Etch, the etchant attacks and removes those unfused particles first, the solution reaches all surfaces through the structure of the part, and smooths the roughness of the surface in a very controlled manner. These are desirable etching requirements for orthopedic structures and cardiac stents.

Mukesh Kumar: Additive Plus is a new comprehensive process: management and implementation of the entire AM process taking care of every step of the creation, from design to support for regulatory approval through extensive depth of validations and Master File. This could include post-AM processes that involves machining, cleaning, packaging for sterilization.

Adam Lacy: In our contract manufacturing environment one of the primary uses of 3D printing is rapid prototyping of custom fixtures for secondary processing and inspection equipment. We’re taking advantage of the latest 3D printer technology to develop CMM and vision system fixtures to ensure repeatability and accuracy of inspection methods. For secondary processing like blasting, we use 3D-printed material for custom masking of parts requiring various surface finish requirements. 3D-printed fixtures are also used to store and transport oddly-shaped or fragile parts. The fixtures prevent parts from contacting during transportation, ensuring surface finish and delicate features aren’t damaged. This helps us keep scrap costs low, quality high, and deliver products to our customers on time in full.

We’ve embraced the use of 3D printing to help implement 5S and lean initiatives. If you walk around the shop, you will notice various 3D-printed items like custom tool holders, pin gage caddies, and pen and marker holders. With additive manufacturing, execution of custom 5S ideas is quick and cheap compared to producing them on a mill or ordering online.

As technology in the additive manufacturing industry evolves, we expect to see new materials emerging and higher resolution parts. Components provided by our customers with smooth high-resolution surfaces are more repeatedly fixtured and provide precise locations of datum-driven features without additional machining steps.

Jake Marasco: We see the largest advancements in powder-bed fusion systems for our industry on the software development side. Until recently, much of the design and manufacturing software used in AM has been trying to catch up to the capabilities of the machines. On the design side, we’ve seen advanced topology optimization software emerge, which allows for user-friendly and approachable ways to achieve implicit modeling of complex shapes and features. It allows customers to create repeatable and scalable design workflows quickly. On the operational side, we’ve seen the emergence of real-time build monitoring software, which provides more insight into and control of build quality—all while allowing us to monitor and reduce defects.

Staying at the forefront of software advancements has enabled us to collaborate with innovative and pioneering customers who want to push the current boundaries of device designs. By integrating these advanced topology optimization tools and real-time build monitoring solutions, the industry can offer design flexibility and production consistency that benefits all parties in the supply chain. These developments foster innovative product creation and raise the overall standard of manufacturing quality, leading to better patient outcomes across the industry.

Markus Reichmann, Pierfrancesco Robotti: The introduction of advanced materials and coatings such as biocompatible and bioactive materials has expanded application possibilities. Materials enhancing mechanical properties and supporting biological integration are particularly valuable. Improvements in process integration and overall manufacturing cycle are noteworthy. These include use of software streamlining component design for additive manufacturing (DFAM), validated de-powdering and cleaning processes, and non-destructive quality control methods.

These innovations allowed coated lattices to improve osseointegration and mechanical properties, leading to enhanced performance and better patient outcomes. AM increases design freedom and facilitates the production of highly customized geometries improving functionality and surgical outcomes. AM enables creation of multi-functional components with varying surface properties in a single process (e.g., areas with highly porous lattice, thin small pores, or solid sections).

Nora Toure: It’s difficult to single out one specific additive manufacturing technology, as we support all major 3D printing technologies and materials in-house. This versatility allows us to address a wide range of customer needs, from rapid prototyping to patient-specific implants. Additionally, advancements in AM software—particularly for design optimization and simulation—have been transformative. These innovations have enabled us to streamline workflows, minimize errors, and consistently deliver high-quality final products. As a result, we’ve become even faster and more efficient in providing tailored solutions.

These innovations have enabled us to design and manufacture orthopedic models with complex geometries and internal structures that enhance osseointegration simulations and mimic natural bone properties. Furthermore, the integration of advanced software tools has augmented our ability to perform detailed simulations and optimizations, ensuring our products meet the highest standards of safety and performance.

Gary Turner: Currently, printing. The industry continues to develop printers that are cheaper, faster, have a smaller footprint, minimize post processing, and are compatible with a wide variety of medical grade materials. This benefits our business, the end users, and customers.

The aforementioned innovations enable developing a distributed manufacturing model to bring production to, or close to, the point of care where space and utilities may be limited. A single machine can be leveraged to produce devices in various materials for multiple applications. More acute ailments and conditions where speed to device is critical can be addressed as well.

Brusco: Please describe a noteworthy orthopedic device/component additive manufacturing project and explain why it stuck out.

Beaudreau: One of the most impactful orthopedic additive manufacturing projects we’ve worked on involved complex patient-specific surgical cases where traditional imaging alone didn’t provide the full picture needed for preoperative planning. By leveraging AI-powered automation and cloud-based processing, we rapidly generate ultra-precise 3D models of a patient’s anatomy, allowing the surgical team and device manufacturer to collaborate seamlessly—no matter their location.

This project stood out because the integration of AI and additive manufacturing reduced planning time and ensured a perfectly tailored implant fit. This directly contributed to improved surgical precision, reduced OR time, and ultimately, better outcomes. It demonstrated how scalable, automated 3D solutions are changing the game for orthopedic device companies, making personalized care more efficient and accessible.

One of the biggest challenges we’ve seen in orthopedic device manufacturing is the inability to scale due to resource constraints and the time-intensive process of converting medical images into usable 3D data. A leading medical device company we worked with faced exactly this issue—they had the expertise to produce high-quality, patient-specific implants, but the manual segmentation, landmarking, and device design plus medical image processing creates a bottleneck, limiting their ability to serve more patients efficiently.

By implementing AI-powered automation and cloud-based workflows, we helped them drastically reduce the time needed to generate precise 3D models, cutting processing time from days to hours. This not only freed up valuable engineering and clinical resources but also enabled them to deliver personalized devices faster—significantly reducing time to patient. The result was a scalable, efficient workflow that maintained quality while increasing accessibility to patient-specific care.

Bitan: Medical device manufacturers perform surgical training sessions on newly developed tools utilizing cadavers/animals. It is common for learners to receive a “damaged” cadaver or animal that suffered from some abnormality (tumor, weak bones, etc.) that would essentially make the learner “take the bench” and watch someone else perform the operation instead of doing it themselves. The financial, as well as the personal disappointments, are major. You always know what to expect from a model. Once you have your design ready, every print would be similar.

Boothe, Boothe, Giordano: We have been working with a prominent lab and university in the UK that has designed and printed incredible 3D structures that will eventually be manufactured into implantable devices. This customer approached us with the problem of excessive roughness and porosity on their finished parts. They wanted to find a solution that was safe to use (hydrofluoric acid is not an option), biocompatible, and scalable. The goal and parameters were to etch their printed part, reduce the porosity by an acceptable percentage without sacrificing too much mass, keep hydrogen uptake as close to zero as possible, and be left with a formal Standard Operating Process (SOP) for production purposes. After working closely with our customer, we were able to deliver on all accounts.

Kumar: We’re now in full production with AM tibial trays, patellas, and cones. There has been extensive R&D to demonstrate feasibility of AM titanium femoral components with a porous structure. Such components can be coated with different technologies to assist with articulation (TiN, TiNbN, etc.) or with hard coatings for tribological applications. We think this will help OEMs address concerns from CoCr-based components and supporting cementless fixation, further enhancing patient care. 

This advancement is on the extensive experience of titanium alloy acetabular shells with a porous interconnected outer layer. This design provides high grip for primary fixation and possesses porosity and pore sizes allowing long-term secondary fixation. This design’s success is due to the ability to adapt the design for various components (tibial plates, shoulder implants, spine components, etc.). Success also comes from the combination of a wide range of sizes with high industrial flexibility and gold-standard clinical performance.

Lacy: We had a unique opportunity to work with a customer on an expandable multi-axis medical device made from 3D-printed metal. The geometry was not manufacturable without the use of additive manufacturing techniques. Not only was creative geometry a benefit, but the texture of the device was designed to promote osseointegration—which encourages bone growth around the device. This was a great experience for us to familiarize integrating additive manufacturing with machining and finishing processes.

Marasco: We’re seeing some really innovative customers achieving great results in the area of implantable devices that effectively blend both subtractively machined and additively manufactured components into a single device. Blending these two specialties is something we offer in the industry and allows us to achieve machined feature accuracy and tolerances and AM produced complex geometries.

Ruggieri: We leveraged cutting-edge additive manufacturing techniques to develop patient-specific pelvis and hip implants made from medical-grade titanium. This project utilized lattice structures to improve implant integration and reduce patient recovery times. The design included porous regions mimicking cancellous bone to enhance osseointegration, with denser outer layers for structural integrity. The project stood out due to the integration of patient-specific design capabilities, allowing for custom geometries tailored to individual anatomy. These implants were fabricated using electron beam melting (EBM), known for producing parts with high precision and superior surface finish, ensuring minimal post-processing.

The use of AM enabled us to transition from one-size-fits-all implants to patient-specific solutions, addressing variability in pelvic and hip anatomy and increasing surgical success rates. The porous lattice structure was only achievable via AM. This design enhanced bone in-growth and load-sharing, crucial for long-term implant stability and patient outcomes. The EBM process reduced waste compared to traditional machining and allowed for the simultaneous production of multiple implants in a single build, cutting lead times significantly.

This project brought together cross-functional teams from engineering, material science, and quality assurance to meet the stringent requirements of FDA approval, setting a benchmark for future AM endeavors.

Toure: One of the most remarkable orthopedic AM projects we’ve been involved in was a collaboration between Materialise and Mediimplantes (a Colombian company dedicated to designing, manufacturing, and distributing spinal implants), focused on treating complex spinal pathologies. In a particularly notable case, a patient with severe spinal deformities faced challenges that traditional implants and surgical methods could not effectively address.

By leveraging 3D printing, we created patient-specific surgical guides and implants tailored to the patient’s unique anatomy. This approach allowed for unprecedented precision during the procedure, ensuring accurate alignment and fit that would have been difficult to achieve with off-the-shelf solutions.

The ability to manufacture highly customized implants streamlined the surgical process, reduced the risk of complications, and improved the patient’s recovery. This project highlighted how 3D printing bridges the gap between engineering and personalized medicine, enabling transformative outcomes for patients who previously had limited options.

Turner: There’s currently little to no reimbursement of patient-specific, 3D-printed anatomic models. Medicare (CMS) and commercial insurance companies consider many factors in deciding whether to reimburse a medical device or not. 

One is its regulatory status; other considerations are clinical evidence and outcomes. In order to drive reimbursement for patients forward, there’s a great need for data that points to regulatory approved innovations. What we have been working on is collecting that data.

Ricoh USA, Inc. and Stratasys Ltd. have partnered on a groundbreaking clinical study aimed to evaluate the use of 3D printed models for orthopedic oncology. The study will assess the efficacy of patient-specific 3D printed anatomical models for preoperative planning and tumor excision in comparison to the current standard of care, which relies solely on CT or MRI imaging.

The trial is focused on anatomic model use in presurgical planning for bony tumor procedures in subjects aged 13+. The primary result we hope to see is a reduction in operative time. 

Other endpoints include a reduction in blood loss, positive margins, and adverse events. 

Insurance companies will recognize these outcomes as a cost-effective application of anatomic models, as they contribute to reducing costs per patient and more importantly improve patient outcomes. This study is expected to conclude at the end of 2025. We hope to gather insights on how this will potentially be a solution to the industry’s gaps in insurance reimbursement.