How 3-D Printing Is Impacting Medical Device Design and Development

3-D printing technologies are all the rage. In the years to come, designers and manufacturers will be able to use 3-D printers to create a host of medical devices, tissues, and even organs. But here and now, 3-D printing is already being employed in low-volume applications and as a method for streamlining the manufacturing process, as Bruce Bradshaw, director of marketing at Stratasys (Minneapolis), explains in the following Q&A. On Tuesday, February 11, Bradshaw will highlight "The Next Steps In Rapid Manufacturing" as part of a conference track on "Accelerating Speed to Market through Effective Prototyping and 3-D Printing" at MD&M West in Anaheim, CA.

MPMN: What are some recent advances in rapid prototyping and how are they affecting medical device design, development, and manufacturing?

Bradshaw: There is lots of action in the 3-D printing world, much of which is taking place on the consumer end. Advancements in the rapid prototyping world include the use of fused deposition modeling (FDM) nylon material and Stratasys's Connex multimaterial jetting technology. Using these technologies, designers of medical devices can create parts and components--for example, a living hinge and gasket--in one print. A prototype using these 3-D components would not be cobbled together using duct tape to simulate an end product. Rather, using 3-D printing technology, the prototype would come very close to the end design.

At the manufacturing level, materials advancements--including ULTEM, nylon, and other materials--are now enabling manufacturers to print parts in small quantities. We call this production capability 'digital manufacturing.' For example, if I'm producing a medical device that includes knobs or enclosures, I can use 3-D printing to produce low volumes of this product ready for shipment to the end user.

MPMN: Why is low-volume production important for the medical device industry?

Bradshaw: Several manufacturers produce low volumes of medical devices and related components. Used in the body, biomedical applications are of growing importance. For example, a liver surgeon can take an MRI or CT scan of a patient and produce a one-up model of the liver using a 3-D printer using a clear, flexible material in which the tumor appears in one color and the bile ducts in another. Using this model, the surgeon will know exactly where to perform the procedure. In addition, it can help to reduce surgery times, minimize the amount of time the patient remains under anesthesia, and lowers costs.

In the medical device sphere, 3-D printing can be used to manufacture such devices as pill-dispensing products. In one case, this technology is now being used to print low volumes of such a dispenser. Because it would be cost prohibitive to produce the tooling to machine such a device, an FDM machine can be used to produce the enclosure and many other components. For such applications, 3-D printing is a much more agile, cost-effective way to manufacture some devices than is injection molding.

MPMN: How can rapid prototyping methods complement rapid injection molding?

Bradshaw: There is a hybrid way of using both 3-D printing and rapid injection molding to manufacture medical devices and components. What if I want to manufacture 100,000 parts within the next three months, but it will take two and a half months to receive the finished tooling from a supplier abroad and additional time to modify the tooling for my application? While I wait for the tooling to arrive, I can produce the mold using a 3-D printer and print very short runs of the part on an injection-molding machine. Known as 'bridge manufacturing,' this technique is now being employed by many companies to produce medical device components.

Statasys's Connex technology allows manufacturers to create molds that blend two materials. In the past, if I wanted to create a mold using a 3-D printer, some materials had limitations. A mold made from a high-temperature material would be brittle, making it incapable of withstanding the pressure of the mold machine. Alternatively, if I used a tough material that could withstand the pressure of the mold machine, it wouldn't be able to handle high temperatures. But now, we can blend two such materials, exploiting the best characteristics of each to create a high-temperature-resistant and tough mold using a 3-D printer.

Bob Michaels is senior technical editor at UBM Canon.