Medical Devices

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

This meeting will be 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

The workshop will also be available via webcast.

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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
Jenny Jones, Corporate Medical Quality 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
Jenny Jones, Corporate Medical Quality Manager Materialise
Ernesto Rios, Renovis Surgical Technologies, Inc.
Axel Krieger, PhD, Children’s National Hospital

Room 2
13:30-14:40

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
Jenny Jones, 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

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Registration to Attend the Workshop

As of September 30, 2014, online registration is now closed.

Space is full, on-site registration will not be available.

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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.

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Page Last Updated: 09/30/2014
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