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Legal & Regulatory Considerations for 3D Printed Medical Devices

Roosevelt Strategic Council will host the 3D Printing for Healthcare Summit, on July 24-25, 2018, in Washington, D.C. The Summit will provide insight on an array of 3D Printing and healthcare aimed topics including, patient-specific 3D printing, permanent implants and prosthetics, anatomical modeling and surgical planning, device development, regulatory and legal considerations for printed devices, and more.

Washington, DC, June 20, 2018 --( The 3D Printing for Healthcare Summit, occurring July 24-25, will provide a full spectrum view towards 3D printing’s evolving role within the healthcare industry. Attendees at this 2-day summit will have the opportunity to share and discuss the practical applications of 3D printing technologies in a healthcare setting, current limitations and technological challenges, as well as near and future term applications.

Attendees at the summit will have the opportunity to meet, learn & network with over 100+ healthcare and additive manufacturing professionals during 16 senior-level speaker led sessions. 2 of these sessions will consist of innovative panel discussions.

One discussion of particular interest is titled, “FDA Guidance for 3D Printed Medical Devices & Legal/Regulatory Considerations,” where our invited panelists will provide high-level insight on how to navigate this technical guidance, provide insight on device regulatory approval, considerations on meeting 510(k) premarket sub mission, & much more.

Panel Moderator:

- Jennifer A. Prioleau, Division Counsel, HP Inc.


- Edward “Ed” Margerrison, PhD., Director, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, FDA
- Elizabeth FitzGerald, Director, Regulatory Intelligence, Right Submission
- Shailly Jariwala, PhD., Sr. Biomedical Engineer, Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Center for Rehabilitation Sciences Research, Uniformed Services University of Health Sciences

Additional speaker-led discussions at the summit include:

- Innovative 3D Printing Materials for Flexible, Durable Applications
Speaker: Dr. Cora Leibig, Founder and CEO, Chromatic 3D Materials

- Improving Surgical Procedure Efficiency and Safety through Patient-Specific 3D Printed Models
Speaker: Dr. Aalpen A. Patel, Medical Director 3D Imaging and Printing Laboratory, Chairman of Geisinger System Radiology, Geisinger Health System

- Leveraging Digital Biomanufacturing Processes to Create 3D Tissue-Like Structures
Speaker: William Whitford, Strategic Solutions Leader, Cell Culture, Bioprocess, GE Healthcare

- Driving 3D Printed Prosthetics Development to Improve Quality of Life for Patients
Speaker: Irene Healey, Founder, New Attitude Prosthetic Designs Inc.

- Advancing Surgical Training Capabilities with Virtual Reality and Medical Models
Speaker: Justin Barad, Founder/CEO, Orthopaedic Surgeon, Osso VR

- Leveraging Sophisticated Imaging and Modeling Capabilities for Improved Implant Success and Surgery Recovery
Speaker: Joseph Lipman, MS, Director of Device Development, Hospital for Special Surgery (HSS)

Seating is limited
In order to allow for actionable discussion and dialogue amongst speaker and attendees, seating will be limited. Register now to reserve your seat. Government Employees & healthcare providers attend complimentary. Those interested in participating in the 3D Printing for Healthcare Summit can visit Roosevelt Strategic Council’s website at

Anyone interested in learning more or sending questions, contact Morgan Colfax at, 201-266-0058.
Contact Information
Defense Strategies Institute
Morgan Colfax

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