3D printing’s promise for medical devices

Don’t blink, because the world of healthcare packaging, particularly in medical devices, is undergoing dramatic innovation.

PERSONALIZED MEDICINE. Britain’s University of Central Lancashire is developing a 3D printer that can produce a tablet with precise drug quantities of meds for individuals. Here, student Katazyna Pietrzak holds a 3D-printed theophylline tablet made of 100% pharmaceutical-grade materials
PERSONALIZED MEDICINE. Britain’s University of Central Lancashire is developing a 3D printer that can produce a tablet with precise drug quantities of meds for individuals. Here, student Katazyna Pietrzak holds a 3D-printed theophylline tablet made of 100% pharmaceutical-grade materials

Although 3D printing (3DP) technology has existed for decades, its disruptive potential has moved it into the spotlight. Also referred to as additive manufacturing and rapid prototyping, 3DP is even moving onto the radar screens for consumers and hobbyists who can design 3D objects on their computer and print everything from tchotchkes to chocolate to jewelry. At a much more sophisticated end of the spectrum are 3D-printed skin and organs that not too long ago would have sounded like science fiction.

Somewhere in the middle of those two application ranges, 3DP offers real-world benefits for manufacturing and packaging applications. Think prototypes, sample packs, small-volume runs, replacement parts for equipment, and alternatives to producing molds and tooling that can allow multiple changes and adjustments made at much more reasonable prices before buying tooling for commercial production.

These points of discussion were raised during the Nov. 3 presentation at Pharma EXPO Intl., “Application in Additive Manufacturing/3D Printing.” The 90-minute presentation was led by Carl Dekker, President, Met-L-Flo, Inc., with presentations by Sheku Kamara, Director, Rapid Prototyping Consortium, Milwaukee School of Engineering, and Don Smith, Manager Engineering Technology Resources at Baxter Healthcare Corp.

Pharma EXPO, co-located with PACK EXPO International Nov. 2-5 in Chicago, is a joint venture of PMMI, The Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineering.

Smith offered two recent examples of how Baxter has employed 3DP in secondary packaging applications. One was to hold glass vials that present safety and security issues when shipping. Smith said the company brought in vendors to work with Baxter personnel and came up with more than a dozen ideas, using plastic, glass, and corrugated materials. He said the company went through several design iterations and included a living hinge on the plastic device it selected. “For these prototypes, additive manufacturing works well and allows us to make deep-pocketed parts that are then vacuum-formed for wider production.”

Another prototype Baxter developed via 3DP was for holding syringes in place so that a plunger device would not move. Parts were made quickly and within a month a tool was ordered for production.

Dekker noted that medical devices, such as MRI machines and CT scanners, represent equipment that would make good candidates for additive manufacturing, due in part to their apparent lower-volume production needs.

Dekker said that bottle applications would also work well for 3DP since multiple sizes, shapes, and colors could be made in limited quantities. Same for mold halves.

And while more materials—and more robust materials—are becoming available for additive manufacturing, Dekker noted some drawbacks in the technology, including variances in part quality—often challenges due to fragility issues, and differences in printing equipment. Additional costs during production can also detract from potential benefits.

Kamara pointed out two broad classes of 3DP machinery. One, he noted, was concept-molding equipment that offices might employ that require minor technical knowledge and cost under $300,000 in general. Mainframe machinery, meanwhile, typically carries price tags north of $500,000 and tends to require laboratory environments to run.

The MSOE director offered a primer on the seven different 3DP technologies, listing each of their advantages, disadvantages, uses, what materials they work best with, etc. He said users must know upfront what they want from 3D-printed parts—low costs, high throughput, softness/hardness characteristics, etc.—before determining which of the seven printer types would be most effective in meeting that company’s needs.

Q&A session takeaways
During the session, one attendee noted that his company makes more than 1,300 different bottle SKUs, with more introduced virtually on a weekly basis. His immediate question was, “Why not go to Walmart and buy a 3D printer to develop samples?”

That may work well, replied one of the speakers, but be cautious because part quality issues, testing, and meeting regulations might make it more economically effective to invest in a higher-quality unit.

Smith was bullish on the technology, however, noting that it helps in creating designs upfront, reducing costs and the design time cycles.

Dekker also suggested 3DP could reduce the amount of scrap generated during prototype development and even help improve line safety, both for workers and for parts. He cited an example of a facility he visited in which tubes were being placed on a metal rack, occasionally causing tube damage. A 3D-printed rack made of plastic, he noted, could alleviate the damage issue.

On Oct. 30, Stratasys Ltd., a global provider of 3D printing and additive manufacturing products, announced a collaboration with Worrell, a design and product development company, to accelerate medical device development through the use of 3D-printed injection molding. The aim is to provide cost savings for 3D-printed injection molds and greatly reduce product development cycles.

A press release on the collaboration quotes Nadav Sella, Senior Manager of Manufacturing Tools at Stratasys: “Worrell is a leading design firm with the expertise and infrastructure necessary to integrate injection molding and 3D printing within the product development cycle. In an industry where products have the potential to save lives, we want to use this collaboration to demonstrate how medical device manufacturers can bring their products to market significantly faster than ever before.

“Medical device manufacturers traditionally face two main obstacles in getting medical devices to market: tooling costs and the FDA regulatory process. Traditional tooling is both costly and time-consuming, as new molds must be created every time a prototype is refined before manufacturing. To reduce potential iteration risks and tooling costs, Worrell uses Stratasys’ PolyJet-based 3D printers to create injection-molding tools and then inject the same materials that will be used in a finished medical device, creating higher-fidelity prototypes.”

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