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Home Medical Manufacturing

Medical Manufacturing

by Melissa Donovan

Additive manufacturing (AM) has long maintained an important position in prototyping, but it continues to work on scaling up to meet full manufacturing needs. This is seen across all the verticals it touches. Medical manufacturers are doing their part to fuel advancement, relying on three dimensional (3D) printing technologies for a number of reasons.

Above: Accurate visual representation of pathologies are achieved with full-color 3D printing from Mimaki.

“AM or 3D printing has empowered medical manufacturers to innovate faster, reduce costs, and deliver superior, patient-centered solutions. Customization, rapid development cycles, cost efficiency, and advancements in materials make AM highly effective,” says Rajeev Kulkarni, chief strategy and marketing officer, Axtra3D.

Creating prosthetics and surgical tools or engineering biological structures like tissue, powder bed fusion (PBF) technologies including selective laser sintering (SLS) and selective laser melting (SLM) in addition to vat polymerization methods such as stereolithography (SLA) are commonly used.

Key Reasons for Usage
3D printing is particularly advantageous for manufacturers of medical products thanks to the technology’s ability to cost-effectively produce items in runs as low as one. In the medical field, customization is highly favored.

Simon Leitl, director development, Freeformer at ARBURGadditive, believes 3D printing is an established process in medical technology, and its importance grows every year. “Examples include customized protheses and implants, as well as anatomical models with comparable properties for surgical preparation and training to help reduce risk. 3D printing also improves the time to market for the development of new products.”

“AM propels innovation across the medical field, especially as the trend of miniaturization drives the industry to seek new ways of developing smaller products. The technology has helped product designers and engineers overcome longstanding pain points during prototyping. As a highly regulated industry, high precision and accuracy are required, which makes micro 3D printing an ideal manufacturing method,” says John Kawola, CEO, Boston Micro Fabrication (BMF).

As technology advances it’s becoming more accessible, affordable, and reliable, which in turn extends it past prototyping, shares John Anderson, medical marketing manager, Formlabs. “These technologies now address critical challenges including enabling personalized healthcare solutions, reducing overhead and operating costs, and allowing medical device companies to adopt more agile development approaches.”

“AM has really made a mark in the medical industry over the past few years. Opening up doors that allow for the creation of custom parts like implants, prosthetics, orthotics, and surgical tools with incredible precision. The ability to quickly and cost-effectively produce items tailored to specific patient needs is a huge benefit and probably the most impactful factor to AM’s growth in the medical industry,” explains Jeff Enslow, head of marketing, Impossible Objects.

A key use of AM in medical is customization for patient-specific care, agrees Kulkarni. “Manufacturers like Open Bionics produce lightweight prosthetics tailored to individual anatomies, while Align Technology fabricates millions of Invisalign aligners based on unique dental scans. Surgical guides use AM for precise anatomical fit to assist in complex procedures like orthopedic and cranial surgeries, improving patient outcomes and addressing niche market needs.”

A subsidiary of medical is dental, which AM also touches. “Dentists use printers to create models of teeth and jaw lines, which help them design treatment plans or surgeries. Or 3D printers can also be used to make custom retainers or aligners, which are things patients would get into direct contact with. AM is very useful when you have to make low quantities of different products, which is exactly what’s happening with retainers and aligners. 3D printing can make dental technicians’ jobs easier and the result more precise as well,” notes a representative from Craftbot.

Cost also makes AM advantageous. “By minimizing material waste and eliminating tooling, AM reduces costs. Stryker uses it to create titanium implants with intricate internal structures that are otherwise cost prohibitive. Biocompatible materials like PEEK and nylon are utilized efficiently, making low-volume, high-complexity devices feasible,” admits Kulkarni.

All in all, “many labs and point-of-care facilities embrace 3D printing, enabling the creation of personalized, complex, and patient-specific devices, implants, and anatomical models,” states Matthew Stark, 3D segment manager, Mimaki USA, Inc.

Methods of 3D Printing
PBF and vat polymerization technologies are used to manufacture medical parts and tools. The method used depends on the goals of the intended final product and whether plastic, metal, ceramic, or some other material is necessary.

PBF technologies include SLS, multijet fusion (MJF), direct metal printing (DMP), and SLM. “SLS technologies—like the Formlabs Fuse 1+ 30W—offer cost-effective batch production of functional plastic devices such as surgical cutting guides, orthotics, prosthetics, and surgical tools. While MJF allows for multi-color and multi-material parts, its higher costs and reduced durability can limit its use in certain medical device markets. Metal technologies like DMP and SLM are critical for producing precision metal components such as titanium and cobalt-chrome implants,” says Anderson.

According to Enslow, SLS, SLM, and direct metal laser sintering (DMLS) are popular because they can produce detailed, lightweight, high-strength parts using materials suitable for medical applications. These methods work well for creating complex shapes and maintaining precision.

“SLS is valued for its strength and durability, commonly used in orthotics, prosthetics, and surgical tools. It allows for production of complex, lightweight structures without the need for support materials. SLM is crucial for producing metal implants, such as titanium cranial plates and hip implants. The process ensures precision, biocompatibility, and the ability to create intricate geometries,” adds Kulkarni.

There are limitations to SLS, SLM, and DMLS, specifically in speed and cost, which makes room for disruption from other technologies, continues Enslow. For instance, composite-based AM (CBAM) printing methods offer faster production speeds and cost-effective strong, lightweight materials, which could appeal to manufacturers looking to scale up and innovate. Impossible Objects offers the CBAM 25 printer.

Vat polymerization technologies including SLA, digital light processing (DLP), and liquid crystal display (LCD) are also a consideration. “These enable the production of high-resolution, precise parts from a range of biocompatible and sterilizable materials,” says Anderson. SLA printers like Formlabs’ Form 4B and Form 4BL are recognized for producing detailed anatomical models, medical device prototypes with tight tolerances, molds, tooling, patterns, and functional end-use parts.

BMF’s projection micro stereolithography (PµSL) technology falls under the DLP category. “The PμSL technology leverages light, customizable optics, a high-quality movement platform, and controlled processing technology to produce ultra-high resolution, micron-scale parts. The technology is able to reach tolerances and precision levels that other 3D printing, including SLS, is not able to achieve. Many medical devices, particularly those used in laparoscopic procedures, are intentionally designed with miniaturized features. Our technology is a great fit in these scenarios,” shares Kawola.

“SLA is known for its high precision and smooth surface finish, it is popular for creating dental models, surgical guides, and anatomical models. Its ability to work with biocompatible resins makes it ideal for dental, audiology, and other medical applications,” says Kulkarni. Hybrid systems combining multiple methods, such as Axtra3D’s Hi-Speed SLA with TrueLayer technology, are poised to optimize speed, precision, and material compatibility.

Ceramic 3D printing, which uses processes like DLP and SLA, is a new to the medical industry, according to Norbert Gall, head of marketing, Lithoz. However, it’s been proven that “DLP merges the best possible scalability and the highest possible precision with production efficiency. Up to 100 such printers can be synchronized to produce millions of parts at industrial scale.”

“The ultra-precise resolution of ceramic printing combined with highly efficient material use have paved the way for an entirely new generation of durable medical devices with the excellent material properties of ceramics,” adds Gall.

Similar to injection molding, but without the need for a mold, Arburg Plastic Freeforming (APF) is another method used in medical environments. “Extrusion-based processes such as APF are used for implants, orthoses, and surgical instruments. We continuously develop APF, which can be used to process original plastic granules, with a focus on build rate and surface quality,” says Leitl.

Top Manufactured Items
Currently, surgical tooling and prosthetics make up a large percentage of what is manufactured via 3D printing in the medical field.

According to Anderson, over 90 percent of the top 50 medical device companies integrate 3D printing into their workflows across nearly every area of medicine. “One advantage of 3D printing is its ability to produce devices that were previously impossible or prohibitively expensive to produce, through conventional manufacturing. Thanks to 3D printing, these devices are now finding a critical place in improving patient outcomes for applications like cancer treatment, joint replacement, and craniomaxillofacial surgery.”

Multi-feature surgical tools are a popular item manufactured in this space using AM. “Apart from minimal material waste in production, the magic lies in both the multifunctionality of these tools, which can be produced in just one single step, and the miniaturization made possible by the use of premium projection systems. Wall thicknesses of 90 µm have been achieved for a ceramic sleeve used in a laparoscopic tool. In serial production, 1,400 such sleeves can be fit on one build platform of a Lithoz lithography-based ceramics manufacturing printer. That opens up a completely new dimension of perfectly repeatable high-precision serial production,” explains Gall.

Medical companies could use CBAM technology like that from Impossible Objects to produce components like structural prosthetics or surgical tools that can be heat sterilized. “This approach allows for both durability and the flexibility needed for medical applications,” says Enslow.

Scopes are a surgical tool created via AM. Kawola says BMF’s micro 3D printers are involved in the production of “novel, single-use scopes for endoscopic procedures across clinical domains from cardiology, urology, peripheral vascular, and laparoscopy. The scopes require a high level of precision and detail, and traditional 3D printing tools could not handle the scale and accuracy required for the components.”

Kulkarni cites the adoption of AM by dental and hearing aid manufacturers as widespread and impactful. “Companies like Align Technology produce millions of Invisalign aligners annually, meeting the growing demand for precise, patient-specific solutions. Other popular applications include 3D printed dentures, surgical guides, veneers, crowns and bridges, and splints, all of which enhance accuracy and efficiency. In the hearing aid industry, nearly 90 percent of custom devices are now 3D printed, demonstrating the technology’s transformative role.”

Axtra3D’s Hi-Speed SLA technology is advancing the industry further by enabling the production of true silicone medical devices and audiology parts, significantly reducing costs and accelerating time to market.

AM is used is what FELIXprinters refers to as “bioprinting,” which is “enabling the development of functional biological structures, accelerating breakthroughs in regenerative medicine, drug testing, and tissue engineering.”

FELIXprinters has manufactured items under this category like 3D printed organoids, custom skin grafts, and vascularized tissue engineering. “By combining cutting-edge biomaterials with high-precision printing, bioprinting paves the way for future organ transplantation and personalized regenerative therapies,” cites a representative from FELIXprinters.

“Looking ahead, advancements in bioprinting for tissue and organ development may shift focus toward regenerative medicine. Additionally, wearable health devices and innovative drug delivery systems are emerging as high-growth areas. However, staples like prosthetics, implants, and surgical guides will remain essential due to ongoing demand for personalized, precision-driven solutions,” adds Kulkarni.

An area of high interest is the orthopedic implant market. “Before selecting an implant, surgeons rely on sizing trays to determine the correct implant size. These trays represent a significant cost burden for manufacturers. Many companies are shifting to a more cost-effective solution—3D printing single-use sizers and trials. This approach not only reduces overhead costs but also streamlines the process for surgical centers by reducing inventory and the demand for central sterilization,” shares Anderson.

“There have been many advances in materials and material properties for medical device manufacturing and it is assumed that 3D printing will be a major solution for many personalized medical applications,” foresees Stark.

Requirements to Consider
Users should look for AM solutions that offer precision, reliability, and material variability.
Gall says exact reproducibility and perfect precision are key requirements. And this challenges providers of printing systems to strive to reach those standards with new technology introductions.

“Precision and repeatability are non-negotiable in the medical world. Materials need to meet high standards for biocompatibility and sterilizability. Beyond that, manufacturers are always looking for ways to speed up production and control costs,” admits Enslow.

Material versatility is important. “The ability to work with a broad range of materials is critical, as the medical industry demands a variety of customized products. Materials such as resins, ceramics, metals, and elastomers are used to meet specific needs across dental, orthopedic, and prosthetic applications,” explains Kulkarni.

The materials need to offer strength and durability. “Many medical devices—particularly implants—require materials that are strong and durable. Titanium and PEEK are commonly used for implants due to their lightweight, yet robust properties. The printer must support materials that mimic the mechanical properties of human bone or tissue to ensure long-term functionality,” continues Kulkarni.
The trend of miniaturization is popularizing micro 3D printing, making it more attractive to those in the medical field. “In some cases, it’s the only option that’s able to manufacture micro-sized parts with the ultra-high precision and accuracy required. Looking ahead, I expect that micro 3D printing, along with the introduction of new materials, will be essential to many life scientists seeking to advance medical innovation,” suggests Kawola.

Small details and thin parts are commonplace in this industry. Anatomical models need to be replicated accurately to showcase the structures and pathologies of individual patients. “Some physical details are difficult to replicate with many 3D technologies, but through inkjet 3D printing, these fragile structures can be encased within clear resin or enlarged to prevent breakage,” advises Stark.

Leitl lists other requirements of importance such as, “the 3D printer must be suitable for use in grey respectively clean rooms, be able to process biocompatible materials, and be easy to operate and maintain. Another important requirement, especially in medical technology, is the recording and documentation of process data.”

Post processing and surface finish should also be considered. “Given the stringent requirements for the surface finish in the medical industry, 3D printers must provide an excellent finish or reduce the need for extensive post processing,” recommends Kulkarni.

In conclusion, “when selecting a 3D printer, medical device manufacturers need to consider several important factors, including the intended application, build platform size, print speed, reliability, and available materials. The properties of the materials are also crucial; factors like skin or tissue exposure, flexibility, durability, and compatibility with disinfection and sterilization methods should all be evaluated,” suggests Anderson.

Scaling Up and Out
AM continues to grow beyond surgical tools and prosthetics in the medical field. Material advancements as well as the technology itself allows for monumental change in how medical products can be made, whether it’s customization for patient-specific care or scaling up to create multiple iterations of a tool or tray. In addition, the future of 3D printing and its association with bioprinting is something to watch.

Apr2025, Industrial Print Magazine

additive manufacturing, AM, 3D, 3D Medical

 

Apr 24, 2025Cassie Balentine
Intelligent Corrugate Printing
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