3D printing medical devices: industry unlocks new possibilities
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As momentum continues to build, medical device companies are ramping up their investment in 3D printing technology. Driven by a strong focus on innovation and improving patient outcomes, the adoption of 3D printing services is rapidly expanding across the sector.
According to GlobalData analysis, the medical 3D printing market is set to grow from a $2bn market in 2022 to $4bn in 2026 at a compound annual growth rate (CAGR) of 21%.
Also known as additive manufacturing, 3D printing can be used to create custom prosthetics, implants and surgical tools that meet the individual needs of patients. Bioprinting, although still in early stages, also holds potential to create custom tissues or organs for transplantation.
3D printing service Stratasys Direct has been a key supplier to the medical device industry for several years. However, its manufacturing facility in Tucson, Arizona only recently obtained ISO 13485 certification, a globally recognised standard for quality management systems in medical device manufacturing.
The manufacturer now plans to extend this certification to other facilities in Texas and Minnesota to accommodate increasing demand from medical device companies.
Stratasys Direct manufacturing engineer Amy Vaughn spoke with Medical Device Network at the 2025 MD&M West conference about how Strasys is advancing its medical 3D printing capabilities and why the technology could potentially replace injection molding in the future.
Before joining Stratasys Direct, Vaughn worked in silicone injection molding, and says she experienced firsthand the cost and design limitations in medical device manufacturing.
“I was the engineer on the production line, working directly with customers, explaining how much it would cost to produce all the sizes they requested for a product,” shared Vaughn.
“For instance, a doctor wanted a catheter designed for babies, but the cost of developing a mold became prohibitive, so we could only create one version. There's a limit to design flexibility because patients come in all shapes and sizes, especially when it comes to prosthetics, surgical guides, or thumb splints."
Traditional manufacturing methods can be limiting as they don't allow for the diversity of what medical parts need to be, explained Vaughn. "People are different sizes and have different needs. So that's where additive manufacturing fits in the medical field as it can produce customised parts that couldn't be developed before with traditional manufacturing methods."
While 3D printing has been widely adopted by the automotive and aerospace industries, the medical device industry is still discovering the technology’s potential, said Vaughn.
“I think many people in MedTech don't know what additive manufacturing can do. They don't realise 3D printers can print high details. Or they are not aware that PolyJet exists, and it can do entire prints and complex colors and geometries. They also don't know about digital light processing (DLP) or that the technology can print rubber. Often people still think the technology can only print rigid stuff. So, there is a challenge working with customers who just aren't aware of how far additive manufacturing has come.”
However, despite the growing advantages, there are still limitations. 3D printing remains slower than conventional manufacturing, particularly for large production runs.
“We haven't quite got it to a production level like molding,” conceded Vaughn.
“Injection molding is the big one for any medical device manufacturing company, and there's a huge initial investment with molding, but once you get past that, it can mold thousands and thousands of parts. But with additive it can allow for more iterative and customised work so when it comes to small batch parts, additive manufacturing is cheaper than injection molding.”
Nevertheless, Vaughn believes 3D printing could eventually replace injection molding. “The technology needs to get to the point where it can handle large batches,” she added. “It is good for small batch stuff, but in the future, it needs to be able to be as efficient as injection molding, where you can print out thousands and thousands of parts.”
And, what is required to make that a reality? Simply put, an investment in automation and R&D.
“That’s the direction I aim to take our facility,” Vaughn expressed. “We want to try to optimise the process and printers. Perhaps adapting operations so robot arms move parts off a printer, instead of having people manually remove them. That may be a future solution which increases efficiency. But if not that then R&D development to look at ways to improve the technology overall.”
"3D printing medical devices: industry unlocks new possibilities" was originally created and published by Medical Device Network, a GlobalData owned brand.
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