FDA Putting Methods in Place for 3-D Printers

Three-dimensional (3-D) printers are kinda changing the world.

It used to be that if you wanted something, you had to go to the store to buy it. But with 3-D printers you can just make it. The machine takes a digital design medical devicesand then sprays or squeezes a polymer material onto a platform and adds layer upon layer until a three-dimensional object is complete. The process can make toys, machine parts, and lately, even medical devices.

These printers have been used to make a windpipe for young child born with a weak trachea that collapsed. The printers also can fashion implants to replace parts of a skull, or make hip cups, the part of a hip implant that fits into the hip socket, reports LiveScience.

Since a medical device is a medical device, however it functions or is made, it still needs to be evaluated by the U.S. Food and Drug Administration (FDA). But the agency says it treats 3-D-printed devices the same way that it treats conventionally made medical devices. It’s just that these machines are something new for the agency to look at.

“We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used,” says Susan Laine, an FDA spokesperson. “In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device.”

To get FDA approval for the market, its manufacturer must do one of two things: prove that the device is equivalent to one already on the market for the same use, or go through the process to attain premarket approval. 3-D printers offer a new twist to the latter approach. LiveScience explains why:

[B]ecause 3D-printed products are made using a different manufacturing method than traditional medical devices use, they could require additional or different forms of testing. Two FDA laboratories are looking into ways 3D printing could affect the way medical devices are manufactured in the future.

These two labs are the agency’s Functional Performance and Device Use Laboratory and the Laboratory for Solid Mechanics. The former lab uses computer models to figure out how tweaks to a product’s design could affect its safety and performance with various patients. Understanding the effects of those adjustments helps FDA evaluate devices that are customized to an individual patient or group of similar patients.

The latter lab examines how different printing methods affect the strength and durability of materials used to make the medical devices. This examination “will help us to develop standards and set parameters for scale, materials, and other critical aspects that contribute to product safety and innovation,” FDA scientists wrote in a recent blog post.

The advantage of 3-D printing is that a device can be customized to fit a patient’s particular anatomy, say, for his or her dental or hearing-aid needs. The agency reviews each device submitted for approval, but it does not approve the specifically designed medical aid.

Medical device manufacturers would be well advised to have their products tested by independent laboratories for integrity, performance, and design. Polymers Solutions Inc. has special expertise in testing medical devices.

Source: “3D-Printed Medical Devices Spark FDA Evaluation,” LiveScience, 8/30/13
Source: “3D Printing,” YouTube
Image by Intel Free Press.