Public Workshop - Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing, October 8-9, 2014
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. 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.
- Date, Time and Location
- Federal Register Notice
- Webcast
- Transcripts
- Workshop Materials
- Agenda
- Contact Us
Date, Time and Location
This meeting was held October 8-9, 2014, beginning at 8:00 a.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
Webcast
Main Session 10/8
Breakout Session 1
Breakout Session 2
Main Session 10/9
Transcripts
Agenda
October 8, 2014 | ||
|---|---|---|
| Time | Subject | Name of Speaker |
| 07:30-08:00 | Sign in and Assemble | N/A |
| 08:00-08:10 | Opening Remarks | Steven Pollack, PhD, OSEL Director, FDA Matthew Di Prima, PhD, FDA |
| 08:10-09:10 | Perspectives on Pre-Printing Considerations | LCDR Michel Janda, FDA Martin Bullemer, Dipl.-Ing. EOS GmbH Electro Optical Systems Maarten Zandbergen, Global Services Manager, Materialise Andy Christensen, 3D Systems |
| 09:10-10:10 | Perspective on Printing Considerations | LT James Coburn, FDA Jon Cobb, Stratasys Ernesto Rios, Renovis Surgical Technologies, Inc. Scott J. Hollister, PhD, University of Michigan |
| 10:10-10:30 | Keynote Address | Bryan Sivak, CTO Health and Human Services |
| 10:30-10:45 | Break | N/A |
| 10:45-11:45 | Perspectives on Post-Printing Considerations | Matthew Di Prima, PhD, FDA Greg Morris, GE Aviation Bill Brodbeck, PhD, STERIS Corporation Tom Boland, PhD, University of Texas at El Paso |
| 11:45-12:30 | Clinical Perspectives on 3D Printing | Katherine Vorvolakos PhD & Irada Isayeva PhD, FDA Dr. James Yoo, Wake Forest University Axel Krieger, PhD and Dr. Laura Olivieri, Children’s National Hospital Peter Liacouras, PhD, Walter Reed National Military Medical Center |
| 12:30-13:30 | Lunch | N/A |
| 13:30-17:00 | Two Concurrent Breakout Sessions | |
| Room 1 13:30-15:15 | Materials Breakout Session | Christina Savisaar, PhD, FDA Martin Bullemer, EOS GmbH Tom Boland, PhD, University of Texas at El Paso John Slotwinski, PhD, Johns Hopkins University Applied Physics Laboratory (JHU APL) |
| Room 1 15:15-17:00 | Design, Printing, and Post Printing Validation Breakout Session | Joel Anderson, PhD, FDA Jon Cobb, Stratasys Maarten Zandbergen, Materialise Ernesto Rios, Renovis Surgical Technologies, Inc. Axel Krieger, PhD, Children’s National Hospital |
Room 2 | Printing Characteristics and Parameters Breakout Session | Jennifer Kelly, PhD, FDA Gerald T. Grant, DMD, MS, Walter Reed National Military Medical Center Scott J. Hollister, PhD, University of Michigan Severine Valdant Zygmont, Oxford Performance Materials Andy Christensen, 3D Systems |
| Room 2 14:40-15:50 | Physical and Mechanical Assessment of Final Device Breakout Session | Mark H. Lee, PhD, FDA Ruben Wauthle, Layerwise Edmund Loftus, Exactech Greg Morris, GE Aviation |
| Room 2 15:50-17:00 | Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session | LT James Coburn, FDA Ed Kanegsberg, PhD, BFK Solutions Jayanthi Parthasarathy, PhD, MedCAD Bill Brodbeck, PhD, STERIS Corporation Dr. James Yoo, Wake Forest University |
October 9, 2014 | ||
|---|---|---|
| Time | Subject | Name of Speaker |
| 07:30-08:00 | Sign in and Assemble | N/A |
| 08:00-08:10 | Opening Remarks | Matthew Di Prima, PhD William Maisel, M.D., M.P.H. |
| 08:10-08:25 | Materials Breakout Session overview | Christina Savisaar, PhD, FDA |
| 08:25-08:55 | Materials Breakout Session Q&A | Christina Savisaar, PhD, FDA Martin Bullemer, EOS GmbH Tom Boland, PhD, University of Texas at El Paso John Slotwinski, PhD, Johns Hopkins University Applied Physics Laboratory (JHU APL) |
| 08:55-09:10 | Design, Printing, and Post Printing Validation Breakout Session overview | Joel Anderson, PhD, FDA |
| 09:10-09:40 | Design, Printing, and Post Printing Validation Breakout Session Q&A | Joel Anderson, PhD, FDA Jon Cobb, Stratasys Maarten Zandbergen, Materialise Ernesto Rios, Renovis Surgical Technologies, Inc. Axel Krieger, PhD, Children’s National Hospital |
| 09:40-09:55 | Printing Characteristics and Parameters Breakout Session overview | Jennifer Kelly, PhD, FDA |
| 09:55-10:25 | Printing Characteristics and Parameters Breakout Session Q&A | Jennifer Kelly, PhD, FDA Gerald T. Grant, DMD, MS, Walter Reed National Military Medical Center Scott J. Hollister, PhD, University of Michigan Severine Valdant Zygmont, Oxford Performance Materials Andy Christensen, 3D Systems |
| 10:25-10:40 | Break | N/A |
| 10:40-10:55 | Physical and Mechanical Assessment of Final Device Breakout Session overview | Mark H. Lee, PhD, FDA |
| 10:55-11:25 | Physical and Mechanical Assessment of Final Device Breakout Session Q&A | Mark H. Lee, PhD, FDA Ruben Wauthle, Layerwise Edmund Loftus, Exatech Greg Morris, GE Aviation |
| 11:25-11:40 | Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session overview | LT James Coburn, FDA |
| 11:40-12:10 | Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session Q&A | LT James Coburn, FDA Ed Kanegsberg, PhD, BFK Solutions Jayanthi Parthasarathy, PhD, MedCAD Dr. James Yoo, Wake Forest University |
| 12:10-12:30 | Wrap-up Breakout Session Summary | Matthew Di Prima, PhD, FDA |
| 12:30-13:30 | Lunch | N/A |
| 13:30-15:00 | Discussion and Future Technologies | LT James Coburn and Matthew Di Prima, PhD, FDA |
| 15:00-15:15 | Closing Remarks | Matthew Di Prima, PhD, FDA |
Workshop Materials
- List of Questions (PDF - 244KB)
Contact Us
If you require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, susan.monahan@fda.hhs.gov.
For questions regarding workshop content please contact: Matthew Di Prima – Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 62, Silver Spring, MD 20993, 301-796-6300, Matthew.Diprima@fda.hhs.gov.