Regulatory Considerations for Hospital-Based 3D Printing

There is a shift happening in the medical device world where hospitals are now evaluating whether they may play a role in not just the use but also the manufacturing of medical devices.    Most of the work in this area today focuses on 3D printing-enabled, personalized surgery implements, be they anatomic models, surgical guides or even implants.  The regulatory system in the US was established in the 1970’s to regulate those marketing medical devices to the healthcare professionals who would use them to treat patients. First and foremost, for all of those involved is the patient’s safety and ensuring that devices made, regardless of where they are made, are safe for their intended use.  Today’s shifting landscape has left questions as to if and how hospitals may be regulated in the future should they embark on manufacturing medical devices themselves.  Stakeholders representing leading hospitals, the FDA and industry will come together in this panel to imagine what the future could look like for this evolving area.