Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 1 FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) ADDITIVE MANUFACTURING OF MEDICAL DEVICES PUBLIC WORKSHOP Thursday, October 9, 2014 FDA White Oak Campus 10903 New Hampshire Avenue Bldg. 31, Room 1503 Silver Spring, Maryland 20993 Reported by: Michael Farkas Capital Reporting Company (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 2 A P P E A R A N C E S Matthew DiPrima, PhD William Maisel, M.D., M.P.H. Christina Savisaar, PhD, DFA Martin Bullemer, EOS GmbH Tom Boland, PhD, University of Texas at El Paso John Slotwinski, PhD, Johns Hopkins University Applied Physics Laboratory (JHU APL) Joel Anderson, PhD, FDA Jon Cobb, Stratasys Jenny Jones, Materialise Ernesto Rios, Renovis Surgical Technologies, Inc. Axel Krieger, PhD, Children's National Hospital 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 Mark H Lee, PhD, FDA Ruben Wauthle, Layerwise Edmund Loftus Exatech (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 3 Greg Morris, GE Aviation LT James Coburn, FDA Ed Kanegsberg, PhD, BFK Solutions Jayanthi Parthasarathy, PhD, MedCAD Bill Brodbeck, PhD, STERIS Corporation Dr. James Yoo, Wake Forest University (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 4 TABLE OF CONTENTS AGENDA ITEM PAGE Opening Remarks Matthew DiPrima, PhD 8 William Maisel, M.D. M.P.H. 10 Materials Breakout Session Overview 17 Christina Savisaar, PhD, FDA 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) Design, Printing, and Post Printing Validation Breakout Session Overview 34 Joe Anderson, PhD, FDA Design, Printing, and Post Printing Validation Breakout Session Q&A 41 Joel Anderson, PhD, FDA John Cobb, Stratasys (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 5 TABLE OF CONTENTS (CONTINUED) AGENDA ITEM PAGE Design, Printing, and Post Printing Validation Breakout Session Q & A (Continued) Jenny Jones, Materialise Ernesto Rios, Renovis Surgical Technologies, Inc. Axel Krieger, PhD, Children's National Hospital Printing Characteristics and Parameters Breakout Session Overview 64 Jennifer Kelly, PhD, FDA Printing Characteristics and Parameters Breakout Session Overview Q&A 69 Jennifer Kelly, PhD, FDA Gerald. T. Grant DMD, MS, Walter Reed National Military Medical Center Scott J. Hollister, PhD, University Of Michigan (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 6 TABLE OF CONTENTS (CONTINUED) AGENDA ITEM PAGE Printing Characteristics and Parameters Breakout Session Q&A (continued) Severine Valdant Zygmont, Oxford Performance Materials Andy Christensen, 3D Systems Break Physical and Mechanical Assessment of Final Device Breakout Session Overview 91 Mark H. Lee, PhD, FDA Physical and Mechanical Assessment of Final Device Breakout Session Q&A 101 Mark H. Lee, PhD, FDA Ruben Wauthle, Layerwise Edmund Loftus, Exatech Greg Morris, GE Aviation Biological Considerations of Final Device: Cleaning, Sterility, and Biocompatibility Breakout Session Overview 124 LT James Coburn, FDA (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 7 TABLE OF CONTENTS (CONTINUED) AGENDA ITEM PAGE 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 Bill Brodbeck, PhD, STERIS Corporation Dr. James Yoo, Wake Forest University Wrap-up Breakout Session 165 Matthew DiPrima, PhD, FDA LUNCH Discussion and Future Technologies 164 LT James Coburn and Matthew DiPrima, PhD, FDA Closing Remarks 215 Matthew DiPrima, PhD, FDA (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 8 P R O C E E D I N G S OPENING REMARKS DR. DI PRIMA: Just covering a few housekeeping notes before we get started with today's program. You saw a lot of FDA people up interacting with everyone yesterday and I want to thank them for all the hard work they've done. And a lot of people you haven't seen They are the workshop staff as well as - our center’s liaison with them and they've done a lot of work on the logistics. And they've also done a great job of telling us what works and what doesn't work in terms of workshops. So if you would give them a quick round of applause; that would be wonderful. [Applause.] So from yesterday we had a few comments from the webcast. When giving comments from the audience, please approach a microphone otherwise the webcasting attendees can't hear you. And if everyone would please be a little bit more vigilant with stating your name and affiliation every time you speak. Again that would really help the webcast people. So a few other notes. We have room 1406 which is over by the restrooms available for luggage. So if you have some suitcases you'd like to drop off and not have in here, that is available. We are going to spend the morning doing some recaps of what was discussed in the break-out sessions with everyone here. Now we have invited and have participants from many different industries who have many different perspectives on this. We'd like to get as many of your views as possible and we -- along with hearing what you are doing, we also are really interested in sort of an ideal (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 9 world what you would like to have done. And along with that there are many different sort of device areas represented here covering Class 1 to Class 3 devices. It is very important to understand that FDA looks at all the devices for their risks. And we have existing device guidances for many specific devices. So we are going to look at a 3D printed device that is Class 1 very differently from one that is a Class 3. So I know there is a little bit of a concern about you know for implantable devices having the same level of concern for something that is Class 1. So you need to understand that we are looking at some general technical considerations but again a Class 1 device is going to be looked at much differently from a Class 3. So with that I would like to introduce our opening speaker. We have Dr. Bill Maisel. He is a Deputy Center Director and Chief Scientist here at the FDA and currently Acting Director of Office of Device and Valuation. [Applause.] DR. MAISEL: Good morning. You know it is really great to be here talking about Additive manufacturing 3D printing because it is really emblematic of the types of challenges we are facing as a device center but also as an industry. We have these amazing technologies, these disruptive changes and it really forces us to step back and think about the current models we have of scientific evaluation and engineering evaluation and regulation and think about how can we do this right. How can we strike the right balance and take the right approach. A couple of years ago, we being CDRH modified our vision statement. And the first line of our vision is that patients in the U.S. have access to high quality, safe and effective medical devices of public health importance first in the world. And the first in the world part is (866) 488 - DEPO www.CapitalReportingCompany.com © 2014 Capital Reporting Company Additive Manufacturing of Medical Devices Public Workshop 10/9/2014 10 somewhat aspirational but it really forces us and forces the community I think to think about how can we bring these really great technologies to the bedside as quickly as possible particularly for those areas where it has a meaningful potential impact on clinical outcomes and really to help patients and advance public health. And so we have been focused on certain strategies in certain areas in accomplishing that and getting good technologies to patients more quickly. One of them is to think about the regulatory science aspects, the tool standards and approaches we can use to assess the safety, effectiveness, quality, and performance of products. And in many respects being here today is our reach out to help us figure out the best approaches for doing that. And reaching out and collaborating and understanding the needs of the community and the health care providers and the patients is also another thing we've really made a conscious effort to do. And I think just having this workshop is emblematic of that. We've also established more formal areas and approaches to doing that. For example we have what we call our network of experts which are agreements with professional societies and organizations that allow our review staff to reach out more easily and more quickly to get input on what is going on in the community, to get other viewpoints and vantage points of some of the technologies and scientific issues that are going on. We're very public about that so if you go to our Website there is a network of experts Website. It lists more than 30 organizations that we currently have agreements with. If you are with an organization that you think would be a good candidate for the network of experts, there is information about how to contact us. Currently our staff has access to literally tens of thousands of experts around the country now that they can reach out to get input. So we are really trying to not regulate in a silo, not decide on our own what the (866) 488 - DEPO www.CapitalReportingCompany.com © 2014