How the FDA regulates 3-D printed devices

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Oxford Performance Materials, a Connecticut-based biomedical firm, earned approval this month from the Food and Drug Administration to commercially distribute 3-D-printed, patient-specific facial implants. But it wasn’t the first time a company created a medical device using a 3-D printer — in fact, more than a year before, Oxford got FDA’s okay to 3-D print a cranial prosthetic to replace 75 percent of a man’s skull.

Doctors and medical manufacturing companies are increasingly teaming up to use 3-D printing to lower the cost of life-changing, personalized medical devices, which is currently a major focus at the FDA. The trend raises interesting questions about how the FDA will regulate an endless continuum of customizable devices and make sure the benefits always outweigh the risks. The scientists behind the regulation of 3-D printed devices with the FDA, however, said it’s not much different than managing a normally-manufactured item.

“We are regulating 3-D printed devices the exact same way we regulate non-3-D printed devices,” said Matthew Di Prima, a materials scientist with the FDA. “During the review process we have a few additional questions about how the manufacturing process could affect device performance. But right now there’s no difference in regulation.”

Generally when a company produces medical devices, they have a few general sizes. With 3-D printing, however, “we now sort of have a possible continuum of sizes,” Di Prima said. Now, when a company or a sponsor requests a bone plate or a knee tray or a device with specific size limitations, Oxford matches it to the individual, Di Prima said.

With 3-D printing, though, comes the freedom to produce just about any and every three-dimensional image you can design on a computer. And like the widely-publicized ability for people to print things like guns, there’s always the concern that printing a medical device — something surgically inserted into someone’s body — could go horribly wrong if not closely monitored.

But James Coburn, an FDA mechanical engineer, said there are safeguards in place to prevent any negligence, or worse, from happening.

“We typically ask manufacturers to put safeguards on their products so you can’t go beyond the design space, so that when you’re patient-matching a device to someone, it will tell you when you have exceeded that limit and won’t let you push beyond it,” Coburn said. “So if somebody does try to go beyond that limit, they really have to circumvent the safeguards that are put in place, and sometimes that is a feasible option if you’re a very specialized institution and sometimes that’s something you can do with emergency use authorization. But in a general sense, we ask manufacturers to limit that to the design space that they’ve tested.”

The biggest benefit of 3-D printing medical devices might not be printing something from scratch but rather the ability to further tailor a standard-sized piece. “A lot of these devices are traditional-sized devices, but they’re using 3-D printing to create a shape or surface texture or some other feature they couldn’t do with other manufacturing,” Coburn said. “It’s just another manufacturing process” that’s added to standard devices.

The FDA has seen companies hoping to produce an array of different medical devices, like orthopedic, neural and dental pieces, but none too different from what manufacturers already make. So what then is all the rage?

“It all comes down to the freedom the manufacturing technology gives you,” Di Prima said. “Because you can sort of make something that you’ve drawn without really worrying about how complex it is. You can now print directly onto an orthopedic device, which improves the mechanical adhesion,” he said. “It’s now economic to build for individualized or patient-specific devices. Hopefully 10 years down the road we’re going to have truly-personalized medical devices, and it’s not just a few devices, but maybe a majority of devices matched to a patient to better fit their anatomy, better fit their lifestyle, how they want to move — we can really do a lot to get increased performance.”

Despite all the interest that surrounds 3-D printing and its ability to connect normal people to manufacturing, Coburn said when it comes to printing something like a working medical device, it’s not as simple as is sounds.

“In the news articles and on the web it all seems very easy and sexy, but it takes a lot of knowledge and design experience to actually make a viable 3-D printed product,” he said. “You can print a figurine or something pretty easily, but to know enough about your printer and about your design to make a viable medical device takes a lot of experience and know-how. So it may not be quite as simple as it sounds. Even though there is a lot of freedom, the people still have to know a lot to utilize that.”

The FDA will host a workshop in October to further discuss the technical considerations in 3-D printing and build best practices.

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3D Printing, Department of Health and Human Services (HHS), Departments, Food and Drug Administration, Government IT News, Innovation
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