Market research firm IDTechEx estimates that the global market for 3D-printed (additive manufacturing) medical devices will increase to more than $6 billion over the next decade. Medical device companies are actively pursuing intuitive ways to incorporate 3D printing into their business models for prototyping new products and even delivering personalized devices and treatments to patients.

In short, through additive 3D printing methods, virtually any individual shape that can be drawn on a computer and be translated into a real part that is produced orders of magnitude faster than through traditional manufacturing methods. As 3D printing technology continues to develop and become more refined, new use cases for it are emerging in the medical device space, often coinciding with trends in personalized medicine. 3D printing has the potential to streamline the way workflows and supply chains are organized, however, the stakes are a bit higher as the production cycle now starts and ends with the patient.

Applications of 3D Printing in the Medical Device Industry

Currently, 3D printing has been applied in specific but nonetheless notable scenarios. Improved polymer casts can be designed and 3D printed to align more naturally with a patient’s body structure while saving material, resulting in a lighter and more comfortable product. Hearing aids can be 3D printed with customized fits while considerably reducing manufacturing times. Other common use cases include finger splints, prosthetics, device part replacements, and even biomaterial production.

Organizations have begun to incorporate 3D printing to enhance their value propositions and offer cutting-edge personalized services. For instance, on September 6th, 2019, Bone 3D, a French manufacturer of personalized medical devices, acquired a Stratasys J750 3D printer to generate full-color, multi-material models and thus expand on its production of patient-specific surgical guides and surgical simulators

“Since its installation, it has quite literally transformed what we’re able to achieve and the speed with which we can do it,” explains Jérémy Adam, Founder and President of Bone 3D, in a recent 3D Printing Industry article,  “the J750 is now the tip-end of the spear for our business – both insofar as production of highly-realistic models, and R&D development.”

A major benefit of 3D printing medical devices stems from how it augments the back-and-forth design-to-delivery process. For example, if a patient is being assessed for spinal fusion surgery, surgeons are now able to send patient-specific data from a CT scan to a medical device maker, who can then design, 3D print, and test a physical spinal cage prototype within hours. Spinal cages are commonly embedded into patients to help vertebrae heal into a natural alignment. However, new 3D printing methods allow these cages to be designed with improved porous geometry that minimizes the amount of required material and improves the body’s ability to heal.

Scaling 3D Printing and Effects on Supply Chain

Understanding how 3D printing can fit into a medical device company’s supply chain is a complex challenge. On one hand, 3D printing can allow some manufacturers to bypass arduous import processes and instead digitally transmit a product design to domestic soil. On the other hand, 3D printing does reach an operational efficiency threshold when it comes to larger bulk manufacturing. Currently, 3D printing, like in the case with Bone 3D, is best suited for production in small batches which is why it has begun to be used for creating custom replacement knees or hips.

3D printing’s major effect on the supply chain is that it can increase the degree of distributed manufacturing and digitizing inventory which, in turn, can disrupt product lifecycles. For situations where it is applicable, 3D printing connects production more closely with point of use, transforming dynamics among suppliers, customers, and service providers.

If a medical device company is seeking rapid design and testing capabilities, it has the option to invest in building out 3D printing capabilities in-house. This path requires specific talent with the right skillset to implement, but lead times can be dramatically reduced. One advantage of developing in-house capabilities is that medical device companies can become less reliant on a supplier. However, for production-level output, many organizations could look to vendors such as Stratasys.

In general, rather than shipping raw materials or components, a supply chain could possibly shift to moving 3D printing materials and parts for final assembly or finished products for distribution. Even so, air cargo experts estimate up to 5% of all cargo could be produced with 3D printing, which only reflects a minor dent at this stage. While there are clearly ways 3D printing can make a supply chain more dynamic, it will likely be a few years before trucking and air cargo carriers see a major shift in volume attributed to 3D printing and additive manufacturing.

Medical device companies exploring 3D printing should consider a cost-benefit analysis to understand production advantages and limitations. Further, organizations should assess their quality procedures to ensure 3D printed products are compliant and in-line with regulations.

Can additive manufacturing differentiate your organization’s services? What systems must be in place to support 3D printing? How would 3D printing affect supply chain? At Clarkston, we are focused on helping life sciences companies innovate and explore new technologies. If you are interested in learning more about our experience in the medical device industry, please contact a steward.