3D printing has emerged as a growing force in industries as diverse as retail, automotive, and food science. As the technology takes hold in the medical device market, it brings profound changes to product manufacturing — and to the pace of innovation. Arlene Chow, partner in the Intellectual Property, Media and Technology group at Hogan Lovells, says the rise in availability of 3D printed devices is already making an impact in the market.

“3D technology is incredibly disruptive, and I think we’ve only scratched the surface of how it will transform the medical services industry,” Chow says. “Traditionally, the cost of manufacturing has been a major barrier to competing in the medical device market. With 3D printing, that barrier no longer exists.”

But the technology’s biggest strength — the ability to easily create and distribute CAD files that serve as blueprints for 3D-printed devices — also poses a major challenge for device makers. 3D printing opens the door for “copycat producers” by making it far cheaper and easier to replicate devices, which means manufacturers must redouble their efforts to defend patents and guard their intellectual property.

“Even if clients have patent coverage or protection in relation to the medical device as a whole, there may not be claims specifically directed towards the component parts,” Chow says. “Under those circumstances, a user could generate a specific component of a medical device with 3D printing, and that would not constitute patent infringement. With this loophole, your everyday user can circumvent patent protection.”

Control of intellectual property captured in digital CAD files is also a concern. “This is very similar to what the music industry faced a decade ago, when record labels had to police websites that were providing digital music files to the public,” continues Chow. “Our clients now have to monitor the web to ensure their files aren’t being distributed publicly.”

To navigate these challenges, Chow says that companies should be evaluating their internal security measures. “Sound management of these files internally is the best bet to ensure that control of critical IP doesn’t fall into the wrong hands,” she says.

She also suggests that companies explore ways to maximize their patent protection. “Protecting ownership of all aspects of a 3D printed device is the real challenge for these companies,” she says of device makers. “We recommend building a web of patent claims that covers as many different aspects of a device and its manufacture as possible. That includes claims that cover component parts to those that cover the 3D printing of the device itself.”

“The technology is moving fast and it’s quickly outpacing the current patent framework that protects our clients,” Chow says. “Now is the time for them to be vigilant.”

Watch the video to learn more about 3D printing and the specific legal issues facing medical device manufacturers.

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