3D printing is a transformative technology that has the potential to disrupt manufacturing and distribution flows. The recent announcement that the U.S Food and Drug Administration (FDA) has approved the use of a drug in a 3D printed pill for human use has brought us closer to being our own home pharmacies. SPRITAM, a drug for treating epileptic seizures, is the poster child for 3D printed pills as its “manufacturer” — Aprecia Pharmaceuticals – has announced that it will use MIT’s 3D printing ZipDose Technology platform to manufacture it. Moreover, the 3D printed version of Spiritam is printed in a porous form that dissolves quickly, making it easier to swallow.
When compared with mass produced medicine, 3D printing opens up a huge opportunity for personalized medicine, as each pill can be made with the right concentration that corresponds to an individual’s unique needs. However, the use of 3D printing technology also promotes a particularly thorny problem. The 3D printer is guided by a digital file that provides instructions on just how the object should be produced. Since people’s lives depend on getting the right medicine, it is essential that these digital files are protected robustly. This is important not only for the patient taking the medicine, but also for the pharmaceutical company to protect its intellectual property and reputation.
When bad actors gain access to a file for 3D printed medicine, the already serious problem of forging pharmaceuticals becomes even easier. Equally easily, a bad actor can tamper with the file so that it contains less medicine than the dose on the label, or even manufacture the “medicine” from cheap inert materials. Also, with access to hacked files for creating 3D printed pills, harmful substances from “designer drugs” are a continuing problem for health and police authorities., can be indistinguishable from real medicine.
To avoid these issues, it is important that the 3D printer be secured from both physical and cyber-attacks. While locks and fences can protect against physical threats, protecting against cyber attacks is far trickier.A trust management platform is needed to give both the medical and patient communities the confidence that the printed medicine is indeed the exact medicine that is prescribed. A trust management platform relies on security mechanisms such as encrypting the link between the 3D printer and the services feeding it 3D printing files and other information. However, this still doesn’t solve a other difficult problems of how to verify that the 3D printer is authorized to print the pill, whether it is the one prescribed by the patient’s health care giver, that it hasn’t been modified, intercepted, or if the hardware or software has been compromised.
These problems aren’t unique to 3D printing. They are very similar to issues that have plagued other major industries whose business is based on appropriate access to intellectual property. DRM, a technology introduced for managing copyrights for media and entertainment has been in commercial use for nearly two decades and is now protecting billions of dollars’ of intellectual property on a daily basis. This technology is proven and is used by major corporations to protect their intellectual property distributed daily to millions of connected devices across the globe.
At its core, a file is nothing but a collection of bits, whether it’s a file containing the latest Hollywood movie or instructions on how to create a 3D printed pill. Content protection technologies already verify that a file a) originates from an authorized source, b) the device it is being used on is authorized and c) that the file is protected from unauthorized access and modification. These same features are equally useful for a 3D printer file as they are for a movie or game file.
While the file needs to be protected, it is also important that the software on the device is protected as well. An example of a potential problem is a bad actor with access to the software could reverse engineer in it a manner enabling them to extract keys hidden in the software. These keys could then be used to get access to the file. Intertrust offers whiteCryption, a solution which protects the software code from this and other attacks bad actors and is already being used on IoT devices.