OEMs without 3-D printers of their own can take advantage of the technology by working with an outsource partner that offers additive manufacturing capabilities. 

Bill Camuel

Three-dimensional (3-D) printing has been widely recognized for its potential to build complex designs, shorten lead times, and improve manufacturing efficiencies in a number of industries. For medical device manufacturing in particular, where speed-to-market can affect not just companies’ bottom lines but patients’ health, these benefits are especially important.

With 3-D printing (also known as additive manufacturing), it’s possible to reduce the design and build time for medical devices significantly. OEMs can quickly design, build, and test parts without being encumbered by the manufacturing restrictions associated with more traditional methods of production.

But not every OEM is well versed in this emerging field. For medical device companies with limited knowledge of additive manufacturing and those that don’t have the resources to invest in 3-D printing equipment of their own, outsourcing production to a service provider with additive manufacturing capabilities is a good way to take advantage of the technology’s many benefits. Service providers with a full range of 3-D printing equipment and engineering expertise can foster innovation and help bring innovative medical device designs to life.

Contract partners with 3-D printing capabilities can help bring OEMs up to speed on additive manufacturing and ensure their designs are optimized for the process. Whether an OEM is testing prototypes or needs fully functional parts, these service providers can lend a helping hand at every stage of production.

However, to effectively outsource additive manufacturing of a device, OEMs must first understand 3-D printing processes and how they can be of benefit at various stages in the product development cycle.
Choose the Right Process and Materials

While 3-D printing is a popular buzzword, many people don’t realize it encompasses several different additive processes, each with their own unique build methods and materials to consider. When consulting with a service provider, it is important for OEMs to clearly define the part’s intended application so the service provider can guide them to the best additive manufacturing process and corresponding materials for the project.

For highly detailed concept and surgical models, technologies such as PolyJet and stereolithography build in extremely fine layers to capture intricate features and provide unmatched realism. The Texas Cardiac Arrhythmia Institute, for example, relies on additive manufacturing to quickly produce realistic, detailed heart models from patient CT scans. These models help doctors better prepare for surgeries by giving them critical insights into a heart’s structure and improving patient safety and the efficacy of the procedure.

But additive manufacturing is not only used for concept modeling and prototyping. As 3-D printing technologies and materials continue to improve, more medical device companies are turning to additive manufacturing to produce functional end-use parts. Processes like Fused-Deposition Modeling (FDM) and laser sintering use engineering-grade thermoplastics and nylon materials, while Direct Metal Laser Sintering (DMLS) utilizes a variety of metals to build more complex parts with additional durability. All three of these processes have the strength required to produce surgical tools and devices that endure repeated use and exposure to high-heat sterilization methods. They can also be used with biocompatible materials that safely interact with the human body.

One instance that required producing durable, biocompatible parts involved a device used to treat cardiac arrhythmias. Using a biocompatible FDM polycarbonate, the OEM worked with a contract partner to produce a version of the device for use in clinical trials. In the end, the finished product was used to successfully complete the trials, and the OEM also turned to additive manufacturing to produce the device in low volumes in order to launch the product on time.

Expand Designs and Build for Function

Another major advantage of producing parts with additive manufacturing is the ability to create designs that increase functionality. In traditional manufacturing, engineers are limited to a strict set of rules to design for manufacturability. Parts have to be designed with uniform wall thicknesses, and intricate features like holes and undercuts can be difficult, if not impossible, to include.

None of these components are an issue with additive manufacturing. Because parts are built one layer at a time from the ground up, designers have the ability to create complex geometries and consolidate assemblies into a single part.
A contract service provider with 3-D printing expertise can consult with OEMs to optimize their designs to take advantage of the additive process and allow them to manufacture their devices more efficiently.

Validate the Design

A key component of the product development process for medical devices is testing prototypes to validate designs and prove efficacy and safety. Clinical trials can reveal critical design updates—for example, a particular geometry or material—that must be altered before the product can be approved for use. Design changes after trials can result in expensive tooling modifications, which in turn can lead to production delays.

Because additive manufacturing builds parts from the ground up, layer by layer, no tooling is required. Therefore, if a clinical trial reveals a design flaw, OEMs can simply update the 3-D computer-aided design file and send it to the service provider to print new parts.

Kablooe Design, an industrial and medical device design firm, turned to additive manufacturing for the production of components for a device used in a minimally invasive procedure to treat enlarged prostates. The combination of additive manufacturing’s design freedom and material options allowed for rigorous testing of the device, which revealed design flaws that needed to be corrected prior to full production. Thanks to additive manufacturing, Kablooe Design was able to make these changes quickly and efficiently while avoiding the capital investment in tooling for functional testing.

Find the Ideal Quantity

While tooling and injection molding make sense for quantities in the tens of thousands, smaller numbers of complex parts that can’t be built with traditional methods are more cost effective when produced with additive manufacturing because no tooling is required. Whether it is used to create devices used in clinical trials, for surgical models, or to produce large devices in low volumes, additive manufacturing can quickly produce customized parts on demand.

Additive manufacturing is also often applied as a bridge to production. A medtech startup might have a brilliant idea for a new device but lack the financial capacity to produce the tooling necessary for full-scale production. Additive manufacturing can solve this challenge by enabling the building of functional parts out of durable, certified materials without accruing tooling costs. This allows the company to verify final designs, raise capital, and even sell some products before eventually resorting to tooling for larger quantities.

Achieve an Exceptional Finish

A service center can provide secondary operations to further improve a part’s functionality and aesthetics or help meet tight dimensional tolerances. Utilizing these techniques can give parts the same look and feel of those manufactured through traditional methods, such as injection molding, while realizing the added benefits offered by additive manufacturing.

Secondary operations have proven popular for end-use parts in particular, which are becoming increasingly common as manufacturers look beyond prototypes when using additive manufacturing. Techniques such as media blasting and polishing enhance surface finishes, while painting and priming provide parts with a protective layer.

Whether an OEM requires a concept model, prototype, or end-use part, service providers with 3-D printing capabilities have a number of finishing methods that are suited to the application. Consulting with their project engineers can help determine how these secondary operations can best enhance parts to meet a project’s needs.

Additive manufacturing is opening up new possibilities for the medical device industry. Like any new technology, it is only beneficial if companies know how to properly take advantage of it. Working with a service provider that has 3-D printing capabilities and expertise can help OEMs better understand the various processes and materials to achieve the full benefits of additive manufacturing and to start innovating sooner.

Bill Camuel is project engineering manager at Stratasys Direct Manufacturing, the combination of three additive manufacturing legacies—Harvest Technologies, RedEye and Solid Concepts—and a total solutions provider of 3-D printing and advanced manufacturing.