As with any other type of manufacturing process for medical devices, additive manufacturing (AM) requires a specific and careful approach during the design and production-approval phases. When the proper steps are taken during the early stages of development, AM can serve as a powerful production resource. But success does not happen automatically. As Carl Douglass describes it, the pathway to appropriate AM requires calculated “intentionality.”

“When properly designed and manufactured, additive manufacturing parts can be produced with high precision and tight tolerances,” said Douglass, president and CEO of DI Labs, an AM technology company based in Willmar, MN. “It takes some development to dial in the process and controls, but it is very much possible to produce high-quality components.”

A full-scale production resource

When utilized appropriately today, AM has the potential to be a full-scale production resource, a “superpower” of sorts that can better enable rapid design iterations, more freedom of design elements, solutions that are tailored to device function, and on-demand manufacturing. And yet, in most instances today’s manufacturers are not considering AM as a production resource early enough in their product’s design cycle. “There is no doubt that additive manufacturing adds the most value when it’s considered as a resource on day one of the design stage of the program,” said Douglass, who will be addressing this topic during his session, Leveraging Additive Manufacturing for Medical Devices from Concept Through Production, at Advanced Manufacturing Minneapolis in October. Taking the day 1 approach to AM also enables design teams and manufacturers to problem-solve in new and unique ways because of the freedom associated with the technology that is absent from traditional methods, said Douglass. Additionally, recognizing the limitations and constraints of AM early on helps to ensure the method is selected for the most appropriate applications.

Steep learning curve

As Douglass sees it, AM is not the solution to every manufacturing challenge that exists today. “There are cases where the technology excels and others where it is not well suited,” he said. “Additive manufacturing has the potential to transform solutions when it’s considered as a manufacturing resource early in the design process, and we’ll continue to see radical innovations by designing products to take advantage of its strengths. But additive manufacturing is not easy to adopt for all production applications. It requires time and testing to adapt traditional design standards for the manufacturing method. Maximizing its benefits also requires significant learning to understand the potential gains in design, manufacturing, and assembly efficiencies.”

AM can also be an excellent manufacturing resource for complex low-volume components and sub-assemblies that can be consolidated to reduce assembly complexity. As it pertains to plastics, Douglass said AM is a legitimate manufacturing resource for volume production. “The largest volume we’ve produced of a single part was around 100,000 units for an aerospace component that could not have been machined or molded due to the geometric requirements,” he said. “While this is a unique case, it’s not uncommon to additively manufacture parts in the thousands and tens of thousands.”

Within the medical device industry, the digitization of physical products is unique to AM, according to Douglass. “The ability to manage physical products as digital portfolios and produce products on-demand is a superpower,” he said. “This isn’t to suggest products should consistently change, because regulatory requirements will prohibit this to a certain degree. But with additive manufacturing we have so much more flexibility to re-apply core product technologies from one market segment to another simply by re-imagining the product housing and physical interaction.” As an example, he suggests that re-deploying an air-quality device from an industrial market segment to healthcare might be as simple as repacking the electronics and revising the firmware, rather than re-imagining the device from scratch. “Digitization of physical components opens the door for massive transformational innovation,” he said. “Because there is no tooling or unique part-specific code for additive manufacturing, there is no additional manufacturing overhead for having unlimited versions of the same component. This enables opportunities for niche products and patient-specific solutions to address specific medical conditions, ergonomic requirements, and body shapes.”

AM: The ‘grown-up’ 3D printing

Although AM and 3D printing have been used as interchangeable terms for some time, Douglass says that more colleagues today are beginning to consider AM to be a “grown-up” and broader version of 3D printing. “It’s all about scale, repeatability, and quality,” he said. “Traditionally, 3D printing is a low-volume resource for prototyping and typically refers to the printing itself and the immediate steps before and after. Additive manufacturing is more than the printing operation itself; it’s a matter of the entire workflow from digital to printing, post-processing, finishing, and quality inspection. It captures the entire end-to-end workflow and represents a robust set of steps and process controls.”

AM also enables prototyping at a much larger scale than basic 3D printing and ultimately can expand into full clinical studies, Douglass said. “Because the geometries can be iterated and produced on demand, lessons learned can be applied to component designs for production in just a few days. The material streams and process controls allow for traceability and biocompatibility so that we can ensure and trace compliance.”

With additive manufacturing it is also possible to produce production components that are nearly indistinguishable from injection-molded parts. Achieving this level of quality, especially during clinical trials, can result in much greater confidence from clinicians and doctors because the parts look and feel like mass-produced components, said Douglass. “3D printed parts traditionally do not inspire confidence,” he said. “But the transition to additive manufacturing is not an overnight accomplishment. The longer that manufacturers wait, the further they’ll be behind the innovators who are learning to maximize its strengths today.”

Article Source: MDDI