Washington, D.C. – The purpose of this workshop is to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3D printing.
Additive manufacturing, also known as 3D printing, is a fast-growing manufacturing technique that builds devices from computerized blueprints or models, by layering material only where it is needed as if building with interlocking bricks. Traditional methods of manufacturing remove material from larger pieces by cutting, drilling, and carving to create a final part. Through additive manufacturing designers can alter products quickly for rapid prototype iteration or produce small batches of multiple product designs in each batch. The 3D computer models used to build each part can be created using traditional computer aided design techniques or they can be made directly from 3D image sources, such as computed tomography scans or magnetic resonance imaging. Designers can also use a combination of techniques. Consequently, 3D printers can create truly anatomically matched devices or surgical guides by utilizing a patient's own medical imaging.
Additive manufacturing is just beginning to enter mainstream use in medical devices. This technology unlocks new avenues for creativity and innovation for medical device designers. For example, it can facilitate the production of devices with intricate structures that were previously impractical or impossible. Current industry applications include using it as an alternative device production method for traditional components or as a primary method to create patient-matched devices. As the technology matures, additional capabilities may be incorporated into medical devices. FDA has begun to receive submissions using additive manufacturing for both traditional and patient-matched devices, and we see many more on the horizon. Industry forecasts project significant growth of additive manufacturing in both traditional and innovative environments by 2025.
Additive manufacturing may or may not present new questions depending on its use. However, there are technical challenges associated with the process from design to final product that need to be properly addressed in all cases to ensure patient safety and to promote innovation in a fast-moving field. Process verification and validation are especially important when devices are produced individually or in very small batches. By discussing and addressing these technical challenges through an open forum, FDA would like to foster innovation with a transparent process and shared expectations for stakeholders. Participants in the workshop will include researchers, scientists, and engineers involved with the research and development of products using additive manufacturing as one or more steps of the manufacturing process. The intent is to address scientific and technical challenges posed by additive manufacturing process but not address specific printing technologies or medical device types. The latter will still be covered by their respective standards and guidance documents. Ideas generated during this workshop may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices.
At this public workshop, participants will engage in open dialogue and discuss the following factors that contribute to additively manufactured medical devices.
Preprinting considerations, including but not limited to:
- Material chemistry
- Physical properties
- Part reproducibility
- Process validation
Printing considerations, including but not limited to:
- Printing process characterization
- Software used in the process
- Post-processing steps (hot isostatic pressing, curing)
- Additional machining.
Post-printing considerations, including but not limited to:
- Cleaning/excess material removal
- Effect of complexity on sterilization and biocompatibility
- Final device mechanics
- Design envelope
This is not an inclusive list. There will be discussion time and breakout sessions to bring up topics that are not listed.
The public workshop will be held on October 8-9, 2014, from 8 a.m. to 5 p.m. at the FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, Md.
Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 30, 2014, 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7 a.m.