The American Banknote Corporation (ABCorp) has announced the registration of its Center of Excellence with the U.S. Food and Drug Administration (FDA).
ABCorp’s Additive Manufacturing Center (AMC) is said to be packed with the MJF and binder jet systems needed, to engage in prototyping and ‘bespoke production’ applications. Effectively, having been registered with the FDA, the site is now green-lit to offer services to medical manufacturers on a wider scale, providing them with a potential means of reducing their products’ times-to-market.
ABCorp’s expanding horizons
ABCorp’s printing roots can be traced right back to its formation in 1795, when it was tasked by the newly-established First Bank of the United States with creating a counterfeit-proof currency for what was then a young USA. Since then, the firm has gone on to develop a broad portfolio of products and services that facilitate transactions around the world.
Continuing its focus on payment security to this day, ABCorp’s offering now revolves around the manufacture and personalization of contactless credit cards, as well as short-run 3D printing services. In addition to part production, the company also offers to help clients in the automotive, aerospace, consumer, and robotics sectors achieve their design, engineering, scanning, and reverse engineering goals.
Over the last year, ABCorp has continued expanding its capabilities as a means of better meeting these users’ needs, first installing a SolutionIX C500 light scanner and Girbau DY130 part dying unit, then acquiring Desktop Metal’s Shop System.
In terms of printed part compliance, the organization has also amassed a long list of certifications, including ISO, Intergraf, HITRUST and PCI accreditations, which cover issues ranging from product standards, security and risk management to credit card production, and it can now add FDA registration to its already-impressive regulatory collection.
Opening new medical avenues
Based in Boston, ABCorp’s 125,000 square foot AMC was refurbished as recently as November 2021, and now features a number of cutting-edge 3D printing technologies. Amongst these, the facility is known to be fitted with HP Jet Fusion 5210 and full-color capable Jet Fusion 580 3D printers, as well as Desktop Metal’s Production System and AMT’s PostPro3D smoothing machines.
On the material front, this means that the AMC’s engineers are able to produce parts from HP’s 3D High Reusability PA 11, PA 12, CB PA12, and PP polymers, in addition to BASF’s Ultrasint TPU01, and the 174PH and 316L stainless steels.
In practice, ABCorp’s growing 3D printing capabilities have already enabled it to start offering full-color prototyping, short-run part production, industrial dying, and post-processing services to customers. However, the highly-regulated nature of the medical industry means that clinical devices need to be produced under specific conditions, something that can prevent suppliers from accessing a lucrative market.
With this in mind, the company has now registered its AMC as an FDA manufacturing facility, allowing it to provide services to all major medical device production firms handling Class I, II, and some Class III products.
Following the move, ABCorp has therefore become able to produce everything from devices deemed likely to present minimal potential for harm, right up to a limited number of implants, but for now, the firm continues to market its services as a prototyping and low volume production tool, that enables users to “obtain superior medical devices, achieve a faster ‘go-to-market’ and realize a lower cost structure.”
“ABCorp has a history dating back 225+ years, providing essential critical goods & services to world-class companies and federal, state, and local government agencies,” said Neil Glazebrook, VP of 3D Solutions at ABCorp. “Additive manufacturing, including 3D printing, offers our clients complete design freedom and is nothing less than transformative for the medical device industry.”
The FDA’s all-important approval
When it comes to marketing 3D printed medical devices in the United States, manufacturers must first make sure they’re FDA-compliant, and gaining approval from the agency is often seen as a major step towards their commercialization.
In July 2021, for instance, Desktop Health acquired the rights to Phonograft 3D bioprinting, a technology that its creators are currently seeking 510K FDA clearance for. The process is designed to yield soft tissues that expedite the regeneration of the human eardrum, and it’s believed to have future potential cardiovascular and neuronal applications as well.
It’s not just US-based firms seeking FDA accreditation either, as Chinese pharmaceutical firm Triastek also gained Investigational New Drug (IND) approval from the agency last year. The certification was awarded to its first 3D printed drug product, T19, a system specifically developed to deliver medication to rheumatoid arthritis patients in pre-set cycles.
More recently, the FDA itself has issued a call for feedback on a new regulatory framework it’s creating to ensure the continued quality of 3D printed medical devices. Instead of serving as guidance, the organization is hoping that its initial discussion paper generates responses from industry experts, which it can then use to shape future regulation.
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Featured image shows a sign outside the FDA’s headquarters. Photo via the University of Oxford.
