by Sheila Gretsch Payzant, Senior Regulatory Specialist
The use of three-dimensional (3D) printing to create medical devices is on the rise and manufacturers are embracing the technology. The Food and Drug Administration (FDA) responded with the recently released guidance, “Technical Considerations for Additive Manufactured Medical Devices.” It provides initial thoughts regarding this emerging technology and manufacturers intending to market 3D devices in the US should understand FDA’s concerns related to the technology.
What is 3D Printing Technology?
3D Printing is a type of manufacturing that uses instructions in a digital file to create an object. The 3D printer deposits or fuses materials in layers based on the instructions given from the digital file. Materials most commonly used in 3D printing of devices include powder versions of ceramics, plastics, and metal. More recently, the 3D-printing technology has been expanded to include using human tissues and components to create medical devices.
Regulatory Challenges of Using 3D Printing
Due to the distinctive capabilities of 3D printing, there are several unique regulatory challenges or risks that manufacturers of 3D-printed devices encounter that traditional device manufacturers do not.
Customization of 3D printed devices introduces a new complication for manufacturers in drafting a design control plan that will meet FDA’s requirements for consideration of clearance or approval of the device made with this technology. Design controls (i.e., a system that evaluates user needs; design inputs, processes, outputs and validation) are required by the FDA for the manufacturing of medical devices. These controls are required at all stages in the development of the device. By establishing a robust design control system, the manufacturer has a structure for identifying potential design flaws, and verification and validation of design performance (e.g., via repeated review of the design). However, the build processes and customization used in 3D printing present challenges in meeting the quality assurance requirements.
One challenge inherent in making patient-matched devices is that all of the steps in conversion of the image file are performed every time a device is created but specifications for each device are unique. In other words, critical attributes of the specific device, and the efficacy criteria of the final device must be validated as part of the software workflow to ensure the performance of the finished device for the individual patient.
These are just two of the main challenges for 3D-printed device manufacturers. For more insight and information, read the full RCRI Whitepaper.
If you have questions about creating the appropriate regulatory strategy and quality system for 3D manufacturing, contact Samantha Thrun at firstname.lastname@example.org or 952-224-2260 to be put in touch with an RCRI expert.