The Food and Drug Administration (FDA) announced that it will be holding a public workshop called “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.”
The workshop is being held so that the FDA, medical device manufacturers, academia, and additive manufacturing companies can discuss the implications, challenges, and solutions of 3D printing in the medical field.
The Federal Register website states, “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.”
- Preprinting considerations, including material chemistry, physical properties, recyclability, part reproducibility and process validation.
- Printing considerations, including printing process characterization, software used in the process, post-processing steps (hot isostatic pressing, curing) and additional machining.
- Post-printing considerations, including cleaning/excess material removal, effect of complexity on sterilization and biocompatibility, final device mechanics, design envelope and verification.
The workshop will be held on October 8th and 9th, 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 20993.