Manufacturers of orthopedic implants were early adopters of metal additive manufacturing, and the industry continues to take full advantage of the technology. Indeed, SmarTech Analysis, a market research firm specializing in additive manufacturing, estimates that by the middle of this decade, 3D-printed metal orthopedic implants will generate more than $1 billion in revenue, particularly for knee reconstruction, spinal fusion and devices for fixing fractures.

This is not news to Jeff McCaulley, CEO of Avalign Technologies Inc., a Chicago-area manufacturer of orthopedic implants, surgical instruments, and medical instrument cases and trays. McCaulley has long been an advocate of metal additive manufacturing, especially electron beam melting (EBM), for making orthopedic implants.

“Orthopedic OEMs are increasingly [working] with contract manufacturers that have comprehensive capabilities and the capacity and resources to scale up. At Avalign, we’ve built one of the most complete portfolios, covering virtually every component and every step in the value chain of orthopedic manufacturing,” he says. “We are one of only a few companies that can design, develop, manufacture, and deploy every aspect of implant and instrument systems—including entire programs—in collaboration with our OEM partners. This is very compelling in our industry.”

In February 2021, Avalign acquired Slice Manufacturing Studios in Akron, OH, to become its center of excellence for additive and advanced manufacturing. Slice, now known as Avalign Additive and Advanced Manufacturing, is a full-spectrum additive and subtractive manufacturing studio. The 40,000-square-foot facility offers a variety of services, including design, prototyping, mechanical testing, regulatory compliance, final production, sterile cleaning and packaging.

EBM is a key process at the facility. In EBM, metal powder is placed in a bed under a vacuum and fused together with heat from an electron beam. The powder feedstock is typically pre-alloyed, as opposed to a mixture of individual metals.

Like other additive manufacturing technologies, an EBM machine reads data from a 3D CAD model and lays down successive layers of powdered material. These layers are melted together using a computer-controlled electron beam. Since the process takes place under vacuum, it can be used to make parts from reactive materials with a high affinity for oxygen, such as titanium, which is often used for medical implants.

EBM produces fully dense metal parts directly from metal powder with characteristics of the target material. In contrast, parts made from competing metal additive manufacturing technologies, such as selective laser sintering (SLS) and direct metal laser sintering (DMLS), require additional thermal treatment after fabrication. That’s because sintering forms a solid mass of material without melting the metal powder to the point of liquefaction. Compared with sintering technologies, EBM typically has a faster build rate due to its higher energy density and scanning method.

EBM Drives Growth for Maker of Orthopedic Implants

EBM at Avalign

Avalign currently runs 11 Arcam EBM Q10plus systems from GE Additive, one of the largest such fleets in the world. Two of the machines are used to make prototypes, fixtures and tools. The remaining systems are dedicated to making various implants.

The Q10plus v2.0 has a build area 200 millimeters wide, 200 millimeters deep, and 180 millimeters tall. The Q10plus v2.1 has a build area 200 millimeters wide, 200 millimeters deep, and 2000 millimeters tall.

The machine is equipped with cameras for precise, automatic calibration and monitoring of part quality. A powder recovery station is available to support low-volume production. Software analyzes the performance of key machine and process subsystems, such as vacuum, beam, powder distribution and auxiliary units, such as the chiller.

For orthopedic implants, the build area of the Q10plus enables optimal stacking of common implant types. The build chamber is designed for easy powder handling and fast turnaround times.

“The Arcam platform is uniquely qualified for manufacturing large joints, which is not easy with a [laser-based] platform. With the Q10plus, you can nest your products and stack them on top of each other so that you can best use the time and the powder that’s in the machine. It saves us time; it saves us and our customers money. It’s just a very good process for our customer base,” says Allen Younger, business development and product specialist for additive manufacturing at Avalign.

“[That makes us] appealing to those who have already accepted that EBM is the best technology for their product, and they’re looking for a contract manufacturing organization that can scale. We are also finding, however, that customers that were once predisposed to [using laser-based additive manufacturing technologies] are increasingly seeing the value of EBM,” he continues.

That said, Avalign employs laser-based additive manufacturing technologies, as well. Avalign does not see EBM and laser-based technologies as competing with each other; rather the company wants to offer the best tool for each application each time. Still, Avalign believes EBM is the best option for manufacturing most large joint implants and certain categories of spinal implants. Such parts come out of the machine nearly complete, which saves time and money.

As good as both technologies are, skilled engineers and technicians are needed to get the most out of the equipment.

“From the beginning, we’ve encouraged our teams to embrace complexity, because that is where additive manufacturing really differentiates itself from subtractive manufacturing,” says McCaulley. “There are no additional costs for making a difficult-to-manufacture part. We tell our customers to remove all their constraints, unleash their imagination for solving the most complex clinical challenges, bring them to us, and we’ll print it! From a design perspective, engineers are becoming more daring and confident with their designs and run out of their studios telling us ‘I can make this three, four or five different ways!’ It’s amazing to watch.”

Avalign also works closely with engineers from GE Additive. “We often have the GE Additive team on site, challenging us to do more together, and sharing ideas on how we can push the envelope to better serve our customers,” says McCaulley.

Industry Acceptance

In the United States, the Food and Drug Administration has its own Additive Manufacturing Working Group, and with a better understanding of the technology and its use, many approvals for new orthopedic applications now take only months, rather than years.

That’s exciting news. While orthopedic implants represent some of the most successful medical devices in modern medicine, additive manufacturing has the potential to usher in a new generation of designs.

“There are a lot of things that indicate this market is only going to grow,” says McCaulley. “It’s a question of how much faster orthopedic OEMs, contract manufactures like Avalign, and the additive machine manufacturers like GE Additive can continue to innovate. The promise of personalized implants has long been seen as the end game. While 3D-printed, patient-specific implants are not yet approved by the FDA, the potential is promising and could greatly propel the growth in additive manufacturing for orthopedics.”

Additive experts are beginning to enter operating theaters to guide surgeons—a development indicative of the collaboration throughout the additive value chain between healthcare professionals, device and implant designers, contract manufacturers, and machine OEMs.

“I’m quite excited about what’s happening in orthopedics today. Some of the applications are just phenomenal, but I’m even more excited about what we can expect for patients in the future and especially about our role in the value chain,” adds McCaulley.