Authors: Celeste A. Letourneau Colleen T. Davies Farah Tabibkhoei Gail L. Daubert James M. Beck John W. Schryber Kevin M. Madagan Lisa M. Baird Matthew D. Jacobson Todd O. Maiden Tracy Zurzolo Quinn

Type: White Papers

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
  • Insurance Issues
  • Reimbursement
  • Litigation

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.

Download the PDF below to read the full whitepaper.