Medical Manufacturers Gain Support from 3D Printing

Additive manufacturing/3D printing (AM/3DP) in the medical device industry is poised for explosive growth and continued development. Until recently, most AM/3DP had only been truly cost effective for prototyping or making smaller devices, such as splints, HIP cups, and spinal fusion cages. However, advances in printing technologies in recent years, combined with an ever-growing list of printable materials approved for medical use, make it more feasible and cost-effective to produce larger parts with AM/3DP.

Rapid innovation is driving AM/3DP growth. The 3D printing medical devices market, which was valued at $2.7 billion in 2022, is expected to reach $6.9 billion by 2028, growing at a compound annual growth rate of 17.1%, according to a recent report published by MarketsandMarkets.¹

“AM/3DP is becoming more prevalent for use in the medical device industry as these technologies improve and medical device manufacturers continue to innovate, and also invest in bringing AM in-house,” said Cody Bonk, sales engineer for Able Medical Devices, a Gwinn, Mich.-based medical device contract manufacturer.

This is especially true for metal AM. Medical device manufacturers (MDMs) were among the first to embrace metal AM, with a focus on making high-precision porous surfaces and geometries for implants that could not be made with conventional manufacturing. Over the past decade, the use of implantable AM-made products has skyrocketed. Although the first AM/3DP products spent lengthy periods of time getting clearance from the FDA, these types of AM-made components and devices are being released on a monthly basis today.

“Advances in printing technology, materials, and surface enhancements have given orthopedic OEMs the ability to quickly offer novel and advanced implantable solutions,” said Allen Younger, senior business development manager, Medical, for AddUp, a France-based joint venture between Michelin and Fives (with a U.S. facility in Cincinnati, Ohio) that provides multi-material production platforms for metal additive manufacturing systems. “Instrument and other medical device printing have become more prevalent due to the availability of higher print quality, larger build plates, multi-laser formats, and the use of fine powder printing.”

Common uses for AM/3DP today include printing medical education models that represent patient anatomy, patient-specific surgical instruments derived from imaging data, and metal implants and instruments with features impossible to fabricate using traditional subtractive manufacturing.

The COVID-19 pandemic accelerated AM/3DP innovation. During the height of the pandemic, “hospitals turned to additive manufacturing as a rapid response tool and used it to solve supply chain issues for supplies like face shields, masks, and diagnostic swabs,” said Gautam Gupta, senior vice president and general manager, Medical Devices, for 3D Systems, a Rock Hill, S.C.-based provider of additive manufacturing hardware, materials, software, and product-development services. “Now, they are integrating 3D printing technologies to print personalized devices, instruments, and anatomic models at the point of care. MDMs are evaluating ways to adapt their portfolios to this evolving approach to device design and production.”

Latest Trends

3D printing has grown beyond its initial role of prototyping to become a versatile manufacturing tool with seemingly infinite possibilities. Its versatility and precision have led to its wider adoption for several medical applications. “Advancements in biocompatible materials and regulatory approvals have accelerated the integration of 3D printing in medical device manufacturing,” said Shon Anderson, CEO of B9Creations, a Rapid City, S.D.-based provider of 3D printing hardware, software, materials, and services. “This shift ensures that safety and quality standards are met, fostering trust in AM’s use for critical healthcare applications.”

Not only is AM/3DP disruptive to the manufacturing approach for medical devices, it is also disruptive in managing the supply chain and mitigating its costs and risks. COVID-19 showed the importance of having resilient supply chains and how nearshoring or onshoring could reduce supply chain risk and make just-in-time production feasible for critical industries such as medical devices. Furthermore, by reducing the number of manufacturing steps by using AM/3DP, MDMs can reduce the number of suppliers and, thereby, reduce the overall turnaround time from placing the purchase order to putting parts on the shelf.

“AM is playing a pivotal role in enabling localized production, customization of complex medical devices, and expanding the manufacturing process from rapid prototyping to short-run production, spare parts, and manufacturing aids,” said Anderson—ultimately making it financially feasible to produce these products, especially when integrated with the Internet of Things (IoT) and automation.

There is growing focus on AM/3DP and point-of-care manufacturing in the hospital setting, especially for the personalization of surgeries. Steady advances in scanning technologies and AM methods are making this easier to accomplish. “Products can be produced on-site to conform to the unique intricacies of each individual patient and surgeons can mitigate the amount of time per procedure, size of incisions, and approach methods by using the increasingly popular virtual-reality approach for procedure preparation—all while providing a better level of healthcare for patients,” said Bonk.

What MDMs Want

AM equipment manufacturers seek to balance standardization for efficiency and consistency, the integration of validated materials for quality assurance, and the flexibility to offer customized solutions. MDMs and their contract manufacturers (CMs) are eager to minimize lead times and drive down costs, which is easier to accomplish with the use of additive manufacturing and its continuously improving capabilities. This includes standardization across validated workflows.

“Many MDMs are prioritizing the development and implementation of end-to-end, standardized workflows,” said Anderson. “This involves streamlining the entire process, from design to post-processing, to ensure repeatability—minimizing errors, reducing variability, and enhancing overall product quality.”

An important part of this process is the integration of validated materials into the design and manufacture process. “OEMs seek the capability to seamlessly integrate validated materials into their processes,” added Anderson. “Validated materials ensure that final products meet specific quality, performance, and regulatory requirements. Being able to work with a variety of certified materials is crucial for meeting diverse customer needs.”

Many MDMs are intent on having customized solutions that allow them to address specific challenges, differentiate their products, and meet the demands of specialized industries. For example, in recent years MDMs have been shifting demand from industry-agnostic 3D printers to industry-tailored additive production platforms, coupled with implementation that delivers assurance of results.

“B9Creations’ custom technology division, called B9[x], focuses solely on meeting industry- and customer-specific needs with tailored solutions, from hardware, software, and materials to services and lean, regulatory, and AM expertise,” said Anderson. “Over half the work we do is customized solutions that you will not find on our website.”

Device manufacturers look to their experienced AM partners to stimulate innovation within their portfolios. As a result, additive manufacturers are being asked to help accelerate the product development process and even help de-risk the investments required. “At 3D Systems, we’ve organized ourselves to exactly meet these challenges with the creation of our Application Innovation Group (AIG),” said Gupta. “The AIG is a team of engineers that has deep expertise in 3D printing processes as well as experience with medical device development. This team partners with device manufacturers from concept to commercialization of a product to expedite development and help ensure market success.”

Ultimately, MDMs want to work with trusted problem-solvers that are skilled at both AM and other traditional methods, such as CNC.

“More MDMs are seeking a trusted partner to produce the various components and assemblies that will mate with their 3D-printed parts,” said Bonk. “This will evolve as the printing technologies continue to improve in resolution and capabilities, but for now, we are seeing great value in being able to work with, or around, the limitations in additively manufactured parts by using traditional manufacturing methods.”

An Abundance of Materials

Advances in technologies and printable materials are making it possible for 4D printing to become the next big leap in AM/3DP. 4D printing is just like AM/3DP except it utilizes special materials that can change their form and function when subjected to specific external stimuli such as moisture, heat, light, or pH—for example, 4D-printed stents can be designed to adjust their shape in vivo.
“As additive manufacturing continues to develop, there will be more opportunities to utilize multi-material printers and printing methods for manufacturing different 3D and 4D products,” said Bonk. “More studies and data are becoming available every day that detail emerging printable materials and their resultant properties when produced with the constantly growing array of additive manufacturing methods.”

New materials for metal printing have been steadily advancing. A greater number of vendors have entered the medical device market, creating a more stable supply of titanium powder. Some of these providers also want to add unique alloys that are titanium- or tantalum-based for implants. “As titanium is now so mainstream, MDMs are less likely to seek novel alloys because the idea of starting a lengthy validation process, which would delay revenue opportunities, is not an attractive option,” said Younger.

In a new metals announcement, Los Angeles-based 3DEO recently released its 316L austenitic stainless steel. This fully austenitic, non-magnetic stainless steel (equivalent to UNS S31603) maintains excellent performance at room and moderately elevated temperatures, as well as excellent ductility and mechanical performance. It is also extremely corrosion resistant, making it ideal for applications that will experience harsh environments. There is also growing interest in applications for cobalt-chrome for large joint reconstruction.

Polyether ether ketone (PEEK) for spine and craniomaxillofacial applications is in high demand. An increasing number of MDMs are also interested in carbon fiber-reinforced PEEK material for plating applications in trauma and fixation due to its high strength and radiolucent properties. 3D-printable bioresorbable polymers such as poly(l-lactide) (PLLA), poly(l-lactide-co-glycolide) (PLGA), polydioxanone (PDO), and poly(caprolactone) (PCL) are of interest for providing mechanical support and facilitating healing without leaving a permanent implant—for example, as patient-specific bridging of large bone defects to achieve bone recovery.

Researchers at Penn State and the University of Texas-Austin have received a $2 million grant from the National Science Foundation to study the 3D printing of smart devices using multiple materials. “The project allows us to collaborate at the exciting intersection of advanced manufacturing, soft materials, and adaptive structures,” said project co-lead Mary Frecker, professor of mechanical engineering at Penn State. The researchers hope to print smart devices that can change shape to accommodate shifting requirements, fabricating them in a single AM process and customizing each device in an approach that ensures manufacturability.²

New Systems and Technologies

AM systems do not have to be new to be advanced—sometimes small improvements in AM equipment can have big impacts on accuracy and quality. For example, B9Creations has taken a fundamentally different approach to address the root cause of inaccuracies in AM that result in fleet-wide dimensional variation under 25 µm to 50 µm between CAD and 3D-printed parts across thousands of printers.

“We have developed technology that exceeds precision manufacturing tolerances to set up qualification processes with consistent output across printer fleets, unlocking scaled manufacturing disruption,” said Anderson. “The methodology ensures validated part repeatability that consistently meets demanding dimensional requirements. By making dynamic, real-time adjustments while printing, the highly measurable, layer-by-layer, in-situ quality controls result in validated part repeatability that hits dimensional requirements for each layer on each run.”

Accuracy is also the driving force with 3D Systems’ DMP Flex 350 dual-laser system that can print in 90-micron layer thicknesses due to high-wattage lasers while maintaining mechanical properties and surface resolution and accuracy. “Because we can use our DMP platforms to 3D print in both titanium and cobalt-chrome alloys, they generate a lot of interest within the industry for applications in total joint replacement,” said Gupta. “Oqton’s industry-leading 3DXpert software utilizes sophisticated support strategies that minimize the post-processing of the printed parts, thereby reducing the overall cost of the part. 3Dxpert also has unmatched credibility, with dozens of FDA-cleared and CE-marked devices that utilize this software to integrate complex bone ingrowth porous structures to improve the overall performance of the device.”

Recognizing the demand for precision and affordability in microscale 3D printing, B9Creations developed the B9 Elite Micro, a micro 3D printer engineered to deliver the precision and capabilities of high-end micro 3D printers at a fraction of the cost. This innovation enables customers to create intricate, micro components with unparalleled accuracy, opening up new possibilities in fields where precision is paramount.

Boston Micro Fabrication (BMF), another leader in microscale 3D printing, utilizes its Projection Micro Stereolithography (PµSL) technology to 3D-print true microstructures with ultra-high printing resolution (2 µm~50 µm) and printing tolerance (±10 µm~±25 µm). This system rapidly prints small parts biomedical plastics, and with 2 µm resolution and ±10 µm accuracy at scale.³ Medical applications for BMF’s PµSL technology include parts for endoscopes, cardiovascular stents, and blood heat exchangers. PµSL technology has also been used to 3D-print a spiral syringe needle for minimally invasive surgery, a valve for a gene sequencer, and lab-on-a-chip (LOC) devices.

Even though much of the AM news is focused on micro and even nano 3D printing, important advances are also being made in size, precision, and repeatability in large-scale manufacturing environments. For example, B9Creations recently introduced the MPro 3D printer—a large platform that provides an expanded design space without sacrificing accuracy and resolution. One of the disruptive applications of 4D printing is computational folding, where objects that are larger than the build plate for printers can be compressed and printed as only one part. Since 4D-printed objects can change shape, objects that are too large to fit a printer can be folded, 3D-printed into their secondary form, and then later unfolded to their full size.⁴

Engineers are challenging AM machine manufacturers to do more to reduce the need for supporting the part during the build sequence. Some have built nests on the build plate so the part can be quickly removed after printing. “We used to have to support every down-facing surface of the model so that there would be no chance for failure,” said Younger. “Using a minimal support relationship and these small nests to attach parts to the build plate have been a tremendous savings in time and labor.”

Another AM advance is the ability for printers to make articulating or expandable implants. The most recent trend in spinal implant technology is to use a minimally invasive device that can be inserted and then manipulated to expand when it is in place. Normally, this is a very complicated process using conventional manufacturing; the engineer must take multiple pieces with fine tolerances and build them as an assembly. However, AddUp printing technology eliminates the need for manufacturing separate pieces. “We can generate the implant with a single print and allow designers to have the porous surface on their expandable product without the additional machining steps, which significantly reduces lead times,” said Younger.

Spectrum Plastics Group, a DuPont Business headquartered in Wilmington, Del., that provides medical component and device contract manufacturing services, has developed its own Spec+Additive Manufacturing proprietary AM technologies for manufacturing high-precision, medical-grade tubing (single and multilumen tubing) that is not extrusion-based—a first in the industry.

This unique AM process can create a full-length multi-lumen tube to specification in a single day—“in comparison,” said Tyler Stark, senior director of additive manufacturing and innovation for Spectrum Plastics Group, “with the standard extrusion process, it can take up to three or more die iterations and weeks before refining a prototype multi-lumen extrusion. Spec+ simply prints the entire extrusion profile out of the first shot of designated material.”

Moving Forward

Many MDMs are not fully aware of the broad range of capabilities (and possibilities) that AM/3DP offers. For example, it is a common misconception that AM/3DP is only feasible and cost effective for small, basic implants.

“AM/3DP methods are improving and producing a staggering range of surface features and roughnesses, augmented material properties, and complex geometries—all from an expanding list of printable materials,” said Bonk.

The FDA has been very supportive in enabling manufacturers to utilize AM technologies. The number of predicate devices that exist helps shorten the time to market. The FDA continues to offer guidance documents such as “Patient-Matched Guides to Orthopedic Implants” and “Technical Considerations for Additive Manufactured Medical Devices.” “Clearance for a new product is by no means easy, but the regulatory pathway has been paved with many successes,” said Younger.

As demonstrated by the FDA and the AM community, a willingness to share data, insights, and expertise is the best way to advance AM innovation and adoption. For example, some AM equipment manufacturers are collaborating with regulators and standards committees to set recognized consensus documents that provide information and know-how for additive manufacturing. This will help to ensure safety and reliability across the industry.

“To be successful in healthcare, additive manufacturers must establish and maintain a partnership with regulatory agencies, build a comprehensive understanding of the key factors driving the clearance of devices, and understand common pitfalls to avoid,” said Gupta. “Our role is not simply to help navigate the regulatory process, but also to work with regulators to help define parameters for using AM as a way to fabricate better medical devices that improve patient outcomes. We continue to work together to solve challenges regarding reliability of hardware and software used to design and 3D print devices, as well as establish workflows for delivering patient-specific instruments and implants.”

AM is much more than a novel way to prototype or a fleeting trend in device production; it is a well-vetted approach medical device designers and manufacturers can leverage to fabricate next-generation products. “The technology continues to improve and evolve such that it will become a manufacturing tool used to fabricate approximately 25% of all medical devices in the next five to 10 years,” stated Gupta.

“AM/3DP has been accomplishing the impossible for quite some time,” added Younger. “The challenge for engineers and designers is to look at what technology can do today that was not possible even a few years ago. Go back to your file history and pull out the design that everyone told you was not printable. Give it a shot. For example, we are working with clients today that had put projects on hold because internal supports could not be removed. Now, however, being able to print without the need for supports may bring you much closer to a manufacturable product than you may think.” 

Addressing Powder Exposure One of the biggest safety risks for operators and technicians during additive manufacturing is powder exposure. The chances of powder inhalation or explosion is a constant EHS talking point, which cannot be fully mitigated using personal protective equipment. To reduce these risks, AddUp’s FormUp 350 technology uses several safety-enabling technologies, including an autonomous powder module. “The user loads powder into the machine in an inverted glove box and the powder remains in the machine for life,” said Allen Younger, senior business development manager, Medical, for AddUp. “We use on-board sieves and a herding filtration system to almost completely eliminate any user contact with the powder, greatly reducing the chances for powder-related incidents.”

References

1. tinyurl.com/yzsme6vh
2. tinyurl.com/yckrswn3
3. bmf3d.com
4. tinyurl.com/4nwxf4a4

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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.