3D Printing of Medical Devices - Reed Smith LLP

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets ..... and Drug Administration (FDA) has granted ...... She has a M.S. in.
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Letter from the Editors This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D printing technology has the potential to radically transform the way medical devices are used to treat patients and save lives, a potential that is already beginning to be felt. One can foresee numerous potential benefits to patients as this technological trend continues – but at the same time, unknown risks and consequences exist. What follows is an overview of what 3D technology is and how it is being used to print medical devices for patient treatment or use. In addition, an overview of a wide range of developing legal issues is provided, including:    

Regulatory Issues Intellectual Property Tort Liability Environmental Effects and Health Risks in the Work Place

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Insurance Issues Reimbursement Litigation

This is a truly collaborative work with contributions of a Reed Smith 3D Printing task force including chapter editors Jim Beck, Celeste Letourneau, Kevin Madagan, Todd Maiden, John Schryber, Tracy Quinn, and Gail Daubert. A special thank you to Reed Smith attorneys Matt Jacobson and Farah Tabibkhoei, who worked tirelessly on drafting, editing and compiling. We predict continued rapid change in the medical arena as the use of 3D technology grows. Even as this white paper was going to print, Aprecia Pharmaceuticals Company announced that the FDA granted approval for the first ever 3D printed drug tablet for use in the treatment of epilepsy. Aprecia’s proprietary 3D printing technology allows it to make porous tablets that rapidly disintegrate when taken with water, thereby aiding patients who struggle to take large, hard-to-swallow medications. As the legal environment surrounding 3D technology evolves, as well as the technology itself, this white paper will be updated to offer a comprehensive, up-to-date resource. We hope that 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles provides readers with valuable guidance as the medical use of this evolving technology continues. We welcome any comments or questions, which can be sent to [email protected] Thank you, Colleen Davies, Lisa Baird, Matthew Jacobson and Farah Tabibkhoei Editors

TABLE OF CONTENTS Page Introduction .................................................................................................................................................... 1 Overview of 3D Printing: What Is 3D Printing And How Does It Work? ......................................................... 2 3D Printing and Its Impact on Medical Device and Health Care .................................................................... 4 Regulatory Issues .......................................................................................................................................... 7 Intellectual Property ..................................................................................................................................... 12 Tort Liability ................................................................................................................................................. 15 Environmental Effects and Health Risks in the Workplace .......................................................................... 20 Insurance Issues ......................................................................................................................................... 22 Reimbursement Issues ................................................................................................................................ 24 Biographies of Editors and Authors ............................................................................................................. 27 Additional Reed Smith 3D Printing Task Force Members ........................................