The concept seems like magic—a few strokes of a printer and a prescription medication or a customized medical device is available at your fingertips. Yet thanks to additive manufacturing, more commonly known as “3D printing,” what seems almost unimaginable is indeed reality. The popularity and utility of additive manufacturing is rapidly increasing across countless industries. According to one report, the 3D printing industry grew to $5.165 billion in 2015, representing a 25.9 percent growth from 2014, (TJ McCue, Wohlers Report 2016: 3D Printing Industry Surpassed $5.1 Billion, FORBES, Apr. 25, 2016). The pharmaceutical and medical device industries are no exception, and are harnessing the power of 3D printing to make innovative medical advances and bring significant patient benefits. Nevertheless, the proliferation of 3D printing comes with a host of legal implications and uncertainties. As the use of 3D printing continues to expand and evolve in the pharmaceutical and medical device space, the existing FDA regulatory regime and traditional product liability principles will be challenged to adapt.
By Raymond Williams and Kristina Neff | The Legal Intelligencer