3D printed prosthetics have been popularized in the news for providing custom fit prosthetic limbs for veterans, children and others in need. These remarkable innovations have helped many people. Last year, non-profit LifeNabled provided 35 patients in Guatemala with custom prosthetic and orthotic devices. 3D printing enabled them to cut time and cost while providing a high quality custom device.
Additive Manufactured medical devices include tools such as forceps, hemostats, scalpel handles, clamps. Other printed tools for medical applications include printed replicas of organs that can be made to assist with complex surgeries so that surgeons can practice on a model and 3D printed custom made prosthetics that create an exact fit for the user. For medical devices, AM has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation (called patient-matched devices) by using a patient’s own medical imaging.
The FDA (Food and Drug Administration) plays an important role in the adoption of Additively Manufactured medical devices. In 2017 the FDA issued “Technical Considerations for Additive Manufactured Medical Devices (Guidance for Industry and Food and Drug Administration Staff)” guidance for manufacturing 3D printed medical devices . The purpose of this guidance is to outline technical considerations associated with AM processes, and recommendations for testing and characterization for devices that include at least one additively manufactured component or additively fabricated step. Extol, a manufacturing technology company who prints orthotics and prosthetics, has recently obtained FDA registration for the contract manufacture of 3D printing medical devices. As more additive medical companies gain FDA registration of their products, the more widespread we will see AM used for medical applications. The FDA 510K premarket notification is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective for human use. For the 501K there is a cybersecurity guidance for medical devices with cybersecurity risk. This guidance should be updated to include additively manufactured parts. While the part itself may not have a cybersecurity risk, the manufacturing process does have risk.
Since 2020, AM vendors and users have rushed to manufacture PPE to alleviate shortages due to Covid 19. This use case of AM illustrates how practical and essential point-of-care additively manufactured devices can be in adapting and addressing urgent needs. The majority of 3D printed medical devices are printed locally. Point-of-care device manufacturing may raise additional technical considerations that are not addressed in the FDA guidance. There needs to be a robust process validation and acceptance protocol for these medical devices. This validation process must include cybersecurity considerations. Consideration has been given to validation with non-destructive evaluation (NDE) evaluation including CT scan, x-ray, ultrasound, etc. but not to quality issues related to cybersecurity intrusions.
Degrading trust in medical devices and tools, counterfeit medical parts and theft of IP related to medical devices could be a waste of time and money as well as dangerous to users. Cybersecurity risks could affect the reliability of the end product. Reducing the strength of a part through introducing defects and voids into the print could cause serious injury if a medical device fails while in use. Cyber attacks could also lead to patient information being stolen. The nature of patient matched devices means that some patient information is needed to create a customized medical device. AM cybersecurity in medical applications should be taken seriously and measures need to be taken to monitor cyber activity to ensure integrity of the printed part.
If you are interested in learning more about BISON and securing AM, please contact us at info@breakpoint-labs.com.