The global 3D-printed medical devices market is projected to grow at a compound annual growth rate of 17% from 2025-2030, driven largely by the growing confidence medical device manufacturers (MDMs) have in additive manufacturing (AM) technologies.¹ AM’s maturation is underpinned by advances in process control, regulatory acceptance, and scalable post-processing workflows. “Over the last five years, additive manufacturing has become one of the fastest-growing sectors in healthcare,” said Neil Glazebrook, vice president of 3D solutions for LabCorp 3D, a Boston, Mass.-based provider of innovative additive technology solutions, from prototype to scale. “Ranging from prosthetics to surgical guides, implants, and fixtures, 3D printing [3DP] is revolutionizing personalized medicine.”

AM has left the realm of R&D and is now a mainstream production tool in the medical device industry. It can consistently meet exceptionally challenging requirements for design and manufacturing—from stringent biocompatibility and sterilization to mechanical strength and regulatory compliance. “AM is increasingly viewed as a commodity complement to conventional machining, offering a parallel pathway for parts that push the boundaries of design and performance,” said Markus Reichmann, U.S. regional AM sales account manager for Lincotek Medical, a global provider of medical device development and manufacturing solutions for the spine, reconstruction, and extremities markets.

By adding AM technologies to the manufacturing mix, product development teams and manufacturing engineers gain a powerful new lever—the ability to design complex, patient-matched geometries, optimize for weight or porosity, and shorten iteration cycles. “In practice, AM augments rather than replaces traditional manufacturing methods—enabling innovation without sacrificing the reliability or high production volumes that conventional machining delivers,” added Mukesh Kumar, technology and R&D director for Lincotek Medical.

“AM is definitely moving from an ‘interesting prototype tool’ to a bona fide production method—especially for small, complex components where traditional machining or molding hits a wall,” added John Kawola, CEO for Boston Micro Fabrication, a Maynard, Mass.-based AM company that uses projection micro stereolithography to provide high-precision printing and tolerance solutions. “We see it most in surgical robotics, microfluidics, drug delivery, and emerging dental applications.”

Shon Anderson, CEO for B9Creations, a Rapid City, S.D.-based high-precision AM solutions provider that helps regulated manufacturers move from prototypes to production, agreed. 

“Additive manufacturing is moving through the awkward adolescence phase, growing beyond prototyping into validated, regulated production for select device classes,” he said. “Patient-matched components, supply-chain resilience, and point-of-care pilots are driving adoption, while expectations around design controls, process validation, and quality management continue to mature.” 

Latest AM/3DP Trends

A key trend is the integration of AM into the overall medical device workflow, moving beyond stand-alone printing toward fully validated, end-to-end processes. This shift significantly increases the usability and scalability of AM.

“For example, we have developed and submitted an FDA Master File for a 3D-printed lattice structure,” said Kumar. “At Lincotek, the AM process is de-risked by fully characterizing the lattice and validating the AM process output, even if there is natural drift in the process. Further, downstream steps such as powder removal and cleaning of machined AM parts allow MDMs to apply this structure to their own implants with far less regulatory burden. The result is a dramatic reduction in time to market, since customers can leverage pre-validated data rather than repeating extensive in-house testing.”

Other AM trends across the medical device industry include:

• Greater use of design for AM (DfAM) tools to enable more complex and performance-driven geometries
• Non-destructive quality control methods, such as computed tomography (CT) scanning, are becoming standard for reproducibility
• Validated depowdering and cleaning systems improve safety and consistency
• Binder jetting and other alternative platforms are emerging, especially for instruments and high-volume stainless parts
• Growing emphasis on digital traceability and regulatory readiness, aligned with FDA and ISO standards

Combined, these trends push AM toward becoming a fully industrialized solution—not just a prototyping tool, but a validated, regulated, and scalable pathway for bringing innovative implants and instruments to market faster. For example, the industry is seeing more cleared additive components and an expanding set of point-of-care use cases inside health systems. As standards continue to develop, MDMs are aligning with disciplined quality practices. “Just as important, ‘integrating AM’ now means far more than hardware, materials, and software—it includes workforce development and training, clear business-case/ROI modeling, upstream implications in design and risk management, and downstream realities in sterilization/packaging/labeling so additive parts travel cleanly across the enterprise,” said Anderson.

Miniaturization, lightweight design, and customization are also important trends—all of which depend on AM. Devices are becoming smaller, more precise, and increasingly tailored to specific applications or patient needs. “Additive manufacturing enables all of these advances—creating highly complex, functional parts that conventional manufacturing methods simply cannot produce,” said Nikolai Sauer, chief technology officer for Immenstadt, Germany-based Bosch Advanced Ceramics, a specialized contract manufacturer (CM) for additively manufactured technical ceramics, from single prototypes to full series production. 

The biggest trend Glazebrook has observed is the rise in personalized, patient-specific devices, “ranging from implants to dental applications and orthotics and prosthetics solutions,” he said. “There is also growing exploration of 3D printing’s role in logistics and delivery, including the use of drones.”

What MDMs Want 

MDMs want to use miniaturization and functional integration to pack more performance into less space. AM can also accelerate development cycles and shorten time to market. By removing the need for expensive tooling and fixtures, AM allows faster iterations during design and prototyping, enabling MDMs to launch products more quickly, at less cost. 

Another major request is the ability to create complex geometries—especially lattice structures—that cannot be produced via conventional methods. Customization is also a top priority, as MDMs increasingly seek patient-specific solutions that improve fit, function, and clinical outcomes. In addition, there is a strong push toward flexible manufacturing strategies. MDMs want partners that can manage diverse parts—across different product lines—while maintaining quality and regulatory compliance. “This flexibility is essential to maximize machine utilization while ensuring traceability and customer approval,” said Reichmann.

Managing this high level of diversity and flexibility typically requires DfAM, which is becoming a standard process in early R&D. “Digital traceability is also in high demand, including tighter process control, in-situ monitoring, and data capture for validation,” said Kawola.

MDM requests are diverse: biocompatible, sterilization-compatible materials with complete data packages, end-to-end process validation, turnkey traceability for submissions, and hands-on DfAM support to unlock cost, lead time, and performance gains, without compromising quality. “MDMs also want tight product lifetime management, enterprise resource planning, manufacturing execution system, and quality management system hooks so parts flow cleanly across the enterprise,” said Anderson. 

Always high on the MDM wish list are precision, scalability, and reliability. MDMs need components that can be customized and miniaturized but also produced at high volumes. “For surgical tools and diagnostic devices in particular, biocompatibility, chemical resistance, and the ability to withstand repeated sterilization cycles are essential,” said Sauer. “With ceramic additive manufacturing, we can deliver on all of these requirements—from prototyping to full-scale series production.”

“It might seem like an odd success, but the volume and throughput requirements for AM have increased so much that MDMs are starting to expect higher overall equipment efficiency in machine performance, as well as safer systems that reduce exposure to powder during production,” said Allen Younger, senior business development manager, medical, for AddUp Solutions, a Cincinnati, Ohio-based provider of metal laser powder bed fusion systems for the medical device industry. “The results are cost efficiencies that get more attractive with each new product introduction.” 

MDMs value the inherent cost-effective flexibility in production quantity that AM/3DP offers—especially in scale-up scenarios—compared to conventional manufacturing methods, which enables agile adaptation from prototyping to full-scale series production without the extensive retooling or lead times. 

“Design flexibility and faster turnaround are top demands,” said Glazebrook. “Price is always part of the discussion, but speed consistently takes priority.”

Additive Advances

AM machines keep getting better, with tighter optics, improved motion systems, and smarter process controls. At the micro scale, projection micro stereolithography (PµSL) makes features with tolerances that were previously “unmoldable” or “unmachinable,” while keeping builds stable enough for small-batch production. PµSL technology prints small parts rapidly, in biomedical plastics, with 2.0-µm resolution and ±10-µm accuracy at scale. The process also reduces the number of assembly steps required and supports product designs that speed assembly. Products made with PµSL include endoscopes, cardiovascular stents, blood heat exchangers, and lab-on-a-chip devices.

One of the biggest advancements in high-resolution AM processes is lithography-based ceramic manufacturing, which works by polymerizing a ceramic powder suspended in a photosensitive resin. “For example, we recently produced ceramic insulation sleeves for laparoscopic tools with a wall thickness of just 90 µm—and did so at industrial scale with more than 1,400 parts per print job,” said Sauer. “This shows how additive manufacturing is pushing the limits of precision while also proving scalability for series production.” 

Dissolvable molds (also called sacrificial tooling) are temporary molds created using 3D printing to manufacture complex shapes that are later dissolved or removed. This method is especially effective for producing hollow composite parts, as it simplifies the removal of the support material without damaging the final product.

“Dissolvable molds let you produce intricate elastomeric or multi-material geometries by printing the mold, casting the target material, and then cleanly dissolving the tooling to free features injection molding cannot reach,” said Anderson. 

Roller recoater technology is an AM process that uses a roller to apply a uniform layer of material, such as a powder or liquid, onto a substrate. Manufacturing advantages of roller recoater technology are consistent powder spreading, high accuracy, and the ability to produce parts with fewer support structures, leading to a better surface finish and faster build times.

“Our platform uses roller recoater technology to give customers a head start on surface expectations and fewer supports,” said Younger. “Recently, an MDM wanted to convert from several platforms to one. During the process, the company discovered it did not need as many supports, and the surface quality helped reduce the need for secondary machining. The design and production efficiencies are speeding new products to market.” 

There are no true “hybrid” systems (AM/3DP + Swiss turning/milling) that are available to the medical device industry. However, directed energy deposition (DED) is a process that does include hybrid systems—for example, the DMG MORI Lasertec series can deposit material (welding via DED) and then machine features in the same setup. This process has yet to take hold among MDMs and their manufacturing partners, who prefer powder bed fusion followed by post-processing computer numerical control, Swiss machining, and polishing, which are done as a separate, validated step. This separation is actually a strength for regulatory compliance, since each process can be validated independently.

Instead of seeking hybrid systems, more MDMs and CMs are creating hybrid workflows—for example, precision-machined shafts or housings combined with micro-printed end-effectors, manifolds, or connector features, sometimes followed by laser finishing. “A practical example,” said Kawola, “is a laparoscopic or robotic instrument where the stainless shaft is Swiss-turned and the jaw or micro-gripper geometry is 3D-printed to achieve internal channels or undercuts that cannot be otherwise machined.”

For metals, direct metal laser sintering still leads the charge in terms of material validations but competing technologies such as metal binder jetting are being used in more applications. “In plastics, both sintered powder and photopolymers have investments made, particularly in digital light processing-based photopolymers, where there has been increased interest in end-use materials designed for specific applications,” said Eric Utley, 3DP applications engineering manager for Raleigh, N.C-based Proto Labs, a rapid prototyping and production manufacturing company that serves the medical device industry.

Advanced software solutions enable very complex part designs using computational design techniques. “These, however, create very large file sizes for the CAD, and even just opening and reviewing them takes a strong graphics card,” added Utley. “Processing these CADs and slicing them into the layers for the printers to process can be very intensive.”

Materials and Methods

Material science in AM is evolving rapidly, with the focus shifting from simply making parts printable to enhancing their biological performance and mechanical reliability. Advancements in both metals and polymers are expanding design possibilities. “We’re now seeing everything from custom implants that keep patients active well into their 80s to specialized hardware designed for newborns,” said Glazebrook.

Advanced biocompatible and bioactive materials continue to be introduced. Titanium alloys such as Ti-6Al-4V remain the gold standard for implants but are now increasingly combined with surface treatments and coatings—for example, hydroxyapatite, HAnano, or TiNbN—to improve osseointegration, reduce wear, or add antibacterial functionality. For instruments, there is growing interest in stainless steels such as 17-4 and 316L processed through laser or binder jetting, offering cost-effective production of complex geometries for reusable surgical tools.

“We also see more work being done in porous and lattice structures, where both material properties and architectural design are engineered together to optimize strength while promoting bone ingrowth,” said Kumar. “Customers have approached us to explore these aspects while being within the design window of our master file. Of course, not everything can be commercialized, but the quest is real. This convergence of material and structural design is one of AM’s biggest advantages over conventional manufacturing.”

Considerable R&D investment targets bioresorbable and polymeric AM materials, increasing the viability of regenerative medicine and temporary scaffolds—though these are still at an emerging stage compared to metals. Biocompatible, sterilization-resistant polymers continue to improve—higher heat deflection temperature, better toughness, and stable translucency for fluid visualization. “We are also seeing interest in electrostatic discharge-safe, flame-retardant, and ceramic-filled systems for radio frequency, imaging, and wear-resistant micro parts,” said Kawola. “The direction is clear: application-specific materials with documented test data.”

Bosch Advanced Ceramics works with high-purity zirconia, alumina, and composite ceramics such as ATZ and ZTA, which combine toughness and hardness. Increasingly, compositions are being tailored for specific applications, such as optimizing dielectric properties for sensors or enhancing wear resistance for surgical instruments. “By combining these advanced ceramics with AM, we unlock new levels of performance that traditional processes cannot achieve,” said Sauer.

Ultimately, materials are driving innovation,” said Glazebrook. “Lightweight yet strong materials and custom formulations for dental and internal medical use are opening entirely new applications and use cases.”

Pushing the Limits

AM limits for medical devices are being pushed on multiple fronts—from new build platforms to integrated post-processing and validated coatings. The latest technologies enable micro-scale, production-grade parts (2-25 µm for features, ±10 µm for tolerances), without waiting months for tools. “Our teams work closely with MDMs to tune designs to the process, so the first printed parts aren’t just pretty—they’re measurable, repeatable, and ready for verification,” said Kawola.

Over the last five years, AM has become a true production technology, giving MDMs and their CMs new options for high-performance implants and instruments with validated quality, reduced lead times, and innovative geometries that were once impossible to make. Automation in powder handling, depowdering, non-destructive testing, and quality control all reduce operator variability and improve throughput. Digital twins and closed-loop monitoring can ensure consistency in real time, which is especially valuable for regulatory acceptance. Advances in surface functionalization continue to be announced. Coatings and surface treatments—such as TiNbN or bioactive layers—are being integrated directly with AM parts, enabling new ways to enhance osseointegration, reduce wear, or add antibacterial properties.

“The common theme across all these advances is industrial scalability—moving AM beyond today’s applications and establishing it as a core production method,” said Reichmann. “For MDMs, this will translate into shorter lead times, lower costs, and greater design freedom when developing the next generation of medical devices and instruments.”

Design techniques are catching up to the capabilities of the manufacturing process. “The AM industry is going through a maturation phase, and there are a growing number of upstream and downstream solutions that wrap around the printing itself, making the whole manufacturing process more robust,” said Utley.

Such techniques enable multi-material printing at the micro scale, smarter closed-loop control with inline inspection, more application-specific polymers (including bioresorbables and higher-temperature biocompatibles), and faster speed and scalability.

“For example, design teams can now combine five parts into one tiny, printable component with internal geometry that simply cannot be made any other way—and then carry that same geometry from prototype into regulated, low-volume production,” said Kawola.

The next generation of machines, equipped with more lasers and higher throughput, will accelerate production of customized products without sacrificing quality. The design freedom, biocompatibility, and durability that AM offers, when combined with these other attributes, “will be a powerful enabler for next-generation medical devices,” said Sauer.

“Without question, the single coolest thing in AM right now is accessibility,” said Younger. “It is no longer for the deepest pockets or those who might be most ready for market. We are certainly going in the right direction and will see more novel products with the availability of machines.”

“We’re still only at the beginning,” added Glazebrook. “Engineers have long used 3D printing for prototyping, but its real potential lies in production. The pace of innovation in the next few years will likely outpace the previous four decades combined, so stay tuned.”

Reference

1. tinyurl.com/mpo251191

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.