Transcripts Added to Public Workshop – Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing, October 8


Date, Time and Location

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  • 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

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    Webcast

    Main Session 10/8

    Breakout Session 1

    Breakout Session 2

    Main Session 10/9

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    October 8, 2014
  • October 9, 2014
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    LCDR Michel Janda, FDA
    Martin Bullemer, Dipl.-Ing. EOS GmbH Electro Optical Systems
    Maarten Zandbergen, Global Services Manager, Materialise
    Andy Christensen, 3D Systems09:10-10:10Perspective on Printing ConsiderationsLT James Coburn, FDA
    Jon Cobb, Stratasys
    Ernesto Rios, Renovis Surgical Technologies, Inc.
    Scott J. Hollister, PhD, University of Michigan10:10-10:30Keynote AddressBryan Sivak, CTO Health and Human Services10:30-10:45BreakN/A10:45-11:45Perspectives 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 Paso11:45-12:30Clinical 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 Center12:30-13:30LunchN/A13:30-17:00Two Concurrent Breakout SessionsRoom 1
    13:30-15:15Materials 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
    15:15-17:00Design, 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 SystemsRoom 2
    14:40-15:50Physical and Mechanical Assessment of Final Device Breakout SessionMark H. Lee, PhD, FDA
    Ruben Wauthle, Layerwise
    Edmund Loftus, Exactech
    Greg Morris, GE Aviation Room 2
    15:50-17:00Biological 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
     

     

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    List of Questions (PDF – 244KB)

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    [email protected].

    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, [email protected].

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