The field of 3-D printing comes with a new set of legal questions hospitals using the technology will need to consider, said Bruce Kline, a technology licensing manager who oversees patents for new technology developed at Mayo Clinic. For starters, he said the STL file printers use are a lot like MP3 music files, in that they can be protected under copyright and require licensing to use. Copyright violations can occur if a purchased STL anatomical model file for rare disease is illegally shared ...

The field of 3-D printing comes with a new set of legal questions hospitals using the technology will need to consider, said Bruce Kline, a technology licensing manager who oversees patents for new technology developed at Mayo Clinic. For starters, he said the STL file printers use are a lot like MP3 music files, in that they can be protected under copyright and require licensing to use. Copyright violations can occur if a purchased STL anatomical model file for rare disease is illegally shared with another institution that did not purchase the file from the vendor that created the file.

Under the law, if a device has a functional use it falls under patent law. If it is not functional, it falls under copyright law. Kline said most medical 3-D printing for educational models and complex anatomy evaluation currently falls under copyright. But, he said that will rapidly change in the coming years as customizable 3-D printable medical devices see wider use.

Additive manufacturing (AM) allows the creation of patient-specific devices at the point of care. Kline said an interesting fact is that these devices are FDA 510(k)-exempt if produced by a hospital instead of a medical device vendor. He said this blurs the lines between traditional vendor relationships, since the hospital can now become the manufacturer. However, if a hospital makes a device, it also becomes liable for it. He advised that it might be better for a commercial vendor to make the device for the hospital so the vendor assumes the liability of the device. Custom-made medical devices are also exempt under FDA regulations, Kline said. So, if a physician creates or modifies a device to meet the clinical needs of a specific patient’s anatomy, he said it is acceptable to use under current FDA rules. This may leave the door wide open for use of 3-D printed devices that are customized for each patient using their own 3-D imaging datasets.

It is possible printable device files may become available in the next few years to customize and print on demand. However, Kline said it will be much more difficult to enforce patents on these types of devices. He explained if someone makes one or two devices, there is no economical way for the creator of those device files to go after the user/maker of unlicensed copies of the device to claim lost profits.

(Source: https://www.dicardiology.com/)

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