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 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

Back to Top Arrow


Webcast

Main Session 10/8

Breakout Session 1

Breakout Session 2

Main Session 10/9

Back to Top Arrow


Transcripts

Back to Top Arrow


Agenda

October 8, 2014

TimeSubjectName of Speaker
07:30-08:00Sign in and AssembleN/A
08:00-08:10Opening RemarksSteven Pollack, PhD, OSEL Director, FDA
Matthew Di Prima, PhD, FDA
08:10-09:10Perspectives on Pre-Printing ConsiderationsLCDR Michel Janda, FDA
Martin Bullemer, Dipl.-Ing. EOS GmbH Electro Optical Systems
Maarten Zandbergen, Global Services Manager, Materialise
Andy Christensen, 3D Systems
09:10-10:10Perspective on Printing ConsiderationsLT James Coburn, FDA
Jon Cobb, Stratasys
Ernesto Rios, Renovis Surgical Technologies, Inc.
Scott J. Hollister, PhD, University of Michigan
10:10-10:30Keynote AddressBryan Sivak, CTO Health and Human Services
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
11:45-12:30Clinical Perspectives on 3D PrintingKatherine 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
12:30-13:30LunchN/A
13:30-17:00Two Concurrent Breakout Sessions
Room 1
13:30-15:15
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)
Room 1
15:15-17:00
Design, Printing, and Post Printing Validation Breakout SessionJoel Anderson, PhD, FDA
Jon Cobb, Stratasys
Maarten Zandbergen, 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 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
14:40-15:50
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
15:50-17:00
Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout SessionLT 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

TimeSubjectName of Speaker
07:30-08:00Sign in and AssembleN/A
08:00-08:10Opening RemarksMatthew Di Prima, PhD
William Maisel, M.D., M.P.H.
 
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, Johns Hopkins University Applied Physics Laboratory (JHU APL)
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
Maarten Zandbergen, Materialise
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 Kanegsberg, PhD, BFK 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 TechnologiesLT James Coburn and Matthew Di Prima, PhD, FDA
15:00-15:15Closing RemarksMatthew Di Prima, PhD, FDA

Back to Top Arrow


Workshop Materials

Back to Top Arrow

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.

Back to Top Arrow

Page Last Updated: 12/02/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.