FDA To Host Public Workshop for Medical Additive Manufacturing

New medical devices built or prototyped using additive manufacturing (AM) are showing up all the time. AM offers solutions for a number of health problems and is becoming an increasingly effective tool for doctors and surgeons.

In order to assist manufacturers employing AM for medical usage, the Food and Drug Administration (FDA) will host a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.” The workshop will take place at the FDA’s White Oak Campus in Silver Spring, MD on Oct. 8 and 9, 2014.

According to the announcement, the workshop is meant to:

“… provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

Topics to be covered by the workshop include (but aren’t limited to):

• material chemistry
• physical properties
• recyclability
• part reproducibility and process validation
• printing process characterization
• software used in the process
• post-processing steps (hot isostatic pressing, curing)
• effect of complexity on sterilization and biocompatibility
• final device mechanics
• design envelope
• verification

Along with an open exchange of ideas, the goals of the workshop are to:

• Develop a more complete understanding of the technical challenges and solutions in additive manufacturing across a variety of materials and printing technologies that will affect safety and effectiveness of medical devices.
• Create awareness of these technical challenges and collaboratively develop solutions and best practices to ensure the performance and reliability of these devices.
• Create a forum for open dialog among stakeholders to share lessons learned and best practices for overcoming the technical challenges presented by additive manufacturing.
• Promote innovation in technology and processes to ensure and improve device performance and reliability.
• Coordinate future collaborations in the development of educational materials, standards and guidance.

Registration for the event is free, and on a first-come, first-served basis. Attendees are asked to sign up online no later than September 30. The FDA recommends registering early as space is limited. The workshop will also be streamed live online.

Below you’ll find a video about a medical AM technique that has already received FDA approval.

Source: Federal Register