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 (Tentative)

October 8, 2014

TimeSubjectName of Speaker
07:30-08:00Sign in and AssembleN/A
08:00-08:10Opening RemarksTBD, FDA
08:10-08:30Intro to workshopTBD, FDA
08:30-09:30Perspectives on Pre-Printing ConsiderationsLCDR Michel Janda, FDA
Martin Bullemer, EOS GmbH Electro Optical Systems
TBD, Materialise Belgium
Andy Christensen, 3D Systems
09:30-10:30Perspective on Printing ConsiderationsLT James Coburn, FDA
Jon Cobb, Stratasys
Ernesto Rios, Renovis Surgical Technologies, Inc.
Scott J. Hollister, PhD, University of Michigan
10:30-10:45BreakN/A
10:45-11:45Perspectives on Post-Printing ConsiderationsMatthew Di Prima, PhD, FDA
Greg Morris, GE Aviation
Bill Brodbeck, PhD, STERIS Corporation
Tom Boland, PhD, University of Texas at El Paso
11:45-12:30LunchN/A
12:30-13:30Clinical Perspectives on 3D PrintingDr. James Yoo, Wake Forest University
Axel Krieger, PhD and Dr. Laura Olivieri,
Children’s National Hospital
TBD, Walter Reed National Military Medical Center
13:30-13:45Explain Breakout SessionsMatthew Di Prima, PhD, FDA
13:45-17:00Two Concurrent Breakout Sessions
Room 1
13:45-15:15
Materials Breakout SessionChristina 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)
Jason Rolland, PhD, EIPI Systems
Room 1
15:15-17:00
Design, Printing, and Post Printing Validation Breakout SessionJoel Anderson, PhD, FDA
Jon Cobb, Stratasys
TBD, Materialise Belgium
Ernesto Rios, Renovis Surgical Technologies, Inc.
Axel Krieger, PhD, Children’s National Hospital

Room 2
13:45-14:45

Printing Characteristics and Parameters Breakout SessionJennifer 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
14:53-15:53
Physical and Mechanical Assessment of Final Device Breakout SessionMark H. Lee, PhD, FDA
Ruben Wauthle, Layerwise
Edmund Loftus, Exactech
Greg Morris, GE Aviation
Room 2
16:00-17:00
Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout SessionLT James Coburn, FDA
Ed Kanesberg, PhD, BFK Cleaning solutions
Jayanthi Parthasarathy, PhD, MedCAD
Dr. James Yoo, Wake Forest University

 

October 9, 2014

TimeSubjectName of Speaker
07:30-08:00Sign in and AssembleN/A
08:00-08:10Opening RemarksMatthew Di Prima, PhD, FDA
08:10-08:25Materials Breakout Session overviewChristina Savisaar, PhD, FDA
08:25-08:55Materials Breakout Session Q&AChristina Savisaar, PhD, FDA
Martin Bullemer, EOS GmbH
Tom Boland, PhD, University of Texas at El Paso
John Slotwinski, PhD, JHU APL
Jason Rolland, PhD, EIPI Systems
08:55-09:10Design, Printing, and Post Printing Validation Breakout Session overviewJoel Anderson, PhD, FDA
09:10-09:40Design, Printing, and Post Printing Validation Breakout Session Q&AJoel Anderson, PhD, FDA
Jon Cobb, Stratasys
TBD, Materialise Belgium
Ernesto Rios, Renovis Surgical Technologies, Inc.
Axel Krieger, PhD, Children’s National Hospital
09:40-09:55Printing Characteristics and Parameters Breakout Session overviewJennifer Kelly, PhD, FDA
09:55-10:25Printing Characteristics and Parameters Breakout Session Q&AJennifer 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
10:25-10:40BreakN/A
10:40-10:55Physical and Mechanical Assessment of Final Device Breakout Session overviewMark H. Lee, PhD, FDA
10:55-11:25Physical and Mechanical Assessment of Final Device Breakout Session Q&AMark H. Lee, PhD, FDA
Ruben Wauthle, Layerwise
Edmund Loftus, Exatech
Greg Morris, GE Aviation
11:25-11:40Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session overviewLT James Coburn, FDA
11:40-12:10Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session Q&ALT James Coburn, FDA
Ed Kanesberg, PhD, BFK Cleaning solutions
Jayanthi Parthasarathy, PhD, MedCAD
Dr. James Yoo, Wake Forest University
12:10-12:30Wrap-up Breakout Session SummaryMatthew Di Prima, PhD, FDA
12:30-13:30LunchN/A
13:30-15:00Discussion and Future TechnologiesTBD, FDA
15:00-15:15Closing RemarksMatthew Di Prima, PhD, FDA

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Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on September 30, 2014. 

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.

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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: 09/03/2014
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