An In-Depth Drive Into The Use of 3D Printing For Medical Technology

Jun 15, 2018 1:30pm – 4:30pm

Andrew Campbell
Faegre Baker Daniels LLP (Indianapolis, IN)

Kenneth Church
NScrypt (Orlando, FL)

Paul Gadiock
Senior Attorney
Arent Fox LLP (Washington, D.C.)

With recent major medical breakthroughs utilizing 3D printing technologies, complicated business and legal challenges have arisen. Points of discussion for this in-depth session will focus on:

  • 3D Printed Medical Devices:
    • Exploring the pathway for approval created by the current FDA standards for 3D printed medical devices
    • Risks involved in custom printing a medical device to fit a patient with an abnormality
    • Discussing the strategies used by hearing aid and dental implant companies in overcoming challenges
  • 3D Printed Pharmaceuticals:
    • Reviewing the FDA’s approval of Levetiracetam
    • Understanding the risks in tailoring pharmaceuticals through 3DP
    • Protecting against counterfeit 3D products
  • 3D Bio Printing:
    • Ethical considerations resulting from the use of 3DP organs
    • What are the risks in bio-printing allowing for the creation of organs to advance drug testing?
    • Ensuring the 3DP medical models used to practice surgery are accurate
  • Avoiding the risks:
    • What are the liability, negligence, and medical malpractice risks involved?
    • Must a hospital set up a separate manufacturing entity when printing drugs/devices for liability purposes?