By Sean Fenske, Editor-in-Chief
 
The use of additive manufacturing (AM) in the medical device development space has exploded and interest only continues to increase. As such, many suppliers are hoping aboard the AM bandwagon, offering a variety of services but at different levels of expertise. When you have so many choices, but can’t be sure of who is the expert, finding the right partners can be challenging.
 
The applications for AM have primarily been focused around prototyping, but it has presented with challenges. For example, some materials used for prototypes aren’t used for final production parts. Or secondary services aren’t as accurately reflected in a prototype version as they might be in the final part.
 
With this in mind, it’s imperative for medical device makers to find an AM partner with whom they can collaborate and gain real feedback on what capabilities are for “real” production and what is just in the prototype stage. To help clarify what OEMs should be seeking in a supplier, Tyler Stark, senior director of additive manufacturing and innovation at Spectrum Plastics Group, responded to a number of question around this topic in the following Q&A.
 
Sean Fenske: How has additive manufacturing advanced in the medical device manufacturing space in terms of how it’s being used and the applications for which it is indicated?
 
Tyler Stark: Additive manufacturing is a rapidly advancing field in the medical device manufacturing space as new technologies, equipment, and specialized materials continue to enter the market. There are many benefits of additive manufacturing over traditional manufacturing methods (e.g., machining, injection molding, and extrusion). For instance, one of Spectrum’s additive manufacturing capabilities and services includes the ability to utilize customer-specific medical-grade materials for a wide range of medical applications. Spectrum’s rapid prototyping capabilities can also allow medical device companies to accelerate product development and make informed decisions faster.
 
Fenske: What challenges are still being overcome by additive manufacturing suppliers?
 
Stark: Many in the industry are challenged with non-functional or prototype-only parts as a result of additive manufacturing. Spectrum has developed technologies that allow end-use parts out of the same production materials commonly used in tubing and catheter manufacturing. Unlike many other suppliers, Spectrum uses Spec+ additive manufacturing technologies to process all medical-grade thermoplastic materials. These include nylon, Pebax®, polypropylene, polycarbonate, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), PEEK, polyetherketone (PEK), high impact polystyrene (HIPS), urethanes, and custom materials.
 
Fenske: Are materials shortages impacting the capabilities for additive manufacturing for medical devices?
 
Stark: For unique materials or materials with specific additives not commonly used in traditional methods, lead times for those materials have become increasingly long. However, material shortages have minimal impact on us. We have more than 50 standard materials in stock for our additive manufacturing processes with the ability to start printing immediately.
 
Fenske: With the growth of additive manufacturing as a component fabrication technology, what should medical device manufacturers seek in a supplier?
 
Stark: Medical device manufacturers should seek a supplier who can think like both a design engineer and manufacturing engineer in taking iterative additive manufacturing through a seamless transition to high-volume manufacturing. The greatest advantage of additive manufacturing is the design freedom it provides medical device engineers. Spectrum’s additive manufacturing capabilities allow medical device engineers to select from a wide range of medical-grade plastics, with specifically engineered material characteristics and design components, for multi-material and multi-dimensional builds.

Quick-turn prototyping is also essential in medical device manufacturing today. Time to market is a top priority for medical device manufacturers—delivering functional prototypes into the hands of all stakeholders as soon as possible allows for more informed decision-making and a shorter time to market. Additive manufacturing also does not require the expensive set-up and tooling that traditional injection molding or CNC machining requires. This makes it easier to access bridge tooling to test short runs before making expensive investments in tools, and ultimately, makes the transition to high-volume manufacturing seamless.
 
Fenske: What capabilities differentiate an additive manufacturing supplier, such as Spectrum Plastics, to make them an attractive option for medtech OEMs?
 
Stark: Spectrum has developed its own proprietary additive manufacturing equipment and processes for creating unique components and devices with complex tolerances, geometries, and features. This technology allows for greater capabilities such as high-precision, medical-grade materials, and additives that are biocompatible, traceable, and certified. We can create components for medical devices (e.g., catheter tip and hubs, micro parts, custom profiles, handles, and tubing) in as little as three to five days instead of weeks or months. Our customers design it and we print it. Spectrum also offers micro 3D printing, with walls as thin as 0.006 in. in some cases, and parts or dimensions so small, they are often difficult to see with the naked eye.
 
Fenske: Are there unique offerings within the additive manufacturing space that Spectrum Plastics offers to separate them from other supply partners?
 
Stark: Spec+ additive manufacturing technologies allow us to turn out a full-length single or multilumen tube to exact specifications in a single day (in comparison, with the standard extrusion process, it can take up to three or more die iterations and weeks before refining a prototype extrusion). With our new technology, our team can simply print the entire extrusion profile out of the first shot of designated material—a feat traditional extrusion processes cannot accomplish.
 
Spectrum also specializes in micro 3D printing with features and geometries so small, they are changing how medical devices are designed. Micro additive manufacturing consists of parts as small as 0.06 in. in diameter, with lumen sizes down to 0.01 in. or smaller. Spectrum engineers are designing miniaturized, complex components (e.g., hubs, luers, dilator tips, connectors, and inserts).
 
Third, Spectrum offers the ability for multi-material in the same print. For instance, we can have Pebax® 25D and Pebax® 63D all in the same print for a new deflectable sheath. We also have the ability to simulate overmolded and insert molded parts, creating functional prototypes that mimic the production configuration.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Stark: Spectrum continually innovates new methods, technologies, and solutions, particularly with our Spec+ additive manufacturing. Our methods for tubing and catheters in development are cutting-edge technologies that differentiate Spectrum from other medical device manufacturers, as well as help define additive manufacturing methods for the future.
 
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