Over the past few days, some of our e-NABLE members have been at the FDA Public Workshop: Additive Manufacturing Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.
A workshop focused on getting members of the FDA, medical field, educators, companies and inventors together to talk about the evaluation process and how 3D printed devices should be assessed.
One of our core members, Peter Binkley, attended and shares his thoughts below:
“I just arrived home from the FDA workshop on Additive Manufacturing of Medical Devices. Those of you who attended the Hopkins/e-NABLE conference may remember Lt. James Coburn from the FDA who attended and was a speaker. He is completely supportive of our efforts. He was one of the main facilitators of the workshop yesterday and today. He and his colleagues in attendance (Matthew Di Prima, PhD; John F. Gillespy, FDA Chief Regulatory Officer; Steven Pollack, PhD, Director of the FDA Office of Science and Engineering Laboratories; Katherine Vorvolakos PhD; Irada Isayeva PhD; LCDR Michel Janda; Christina Savisaar, PhD; Joel Anderson, PhD; Jennifer Kelly, PhD; Mark H. Lee, PhD) are quite aware that the impact of the FDA on the pace of innovation has not always been a positive one, and that actually following existing regulations would paralyze research in many sectors. The FDA culture today seems to be guided down the chain of command by a philosophy that they need to encourage change and growth if we are to survive as a nation and as a planet. They seem quite determined to remove, reform or ignore many existing regulatory barriers, especially for projects that have potential to really help people. During one of the breaks today, I happened to meet a project manager from the Children’s Hospital of Philadelphia whose team is being *funded* by the FDA to bring medical devices for children to the market.
My impressions of the FDA based on my first direct experiences with their personnel were incredibly positive, and I think our e-NABLE volunteers also made a good impression. I think they will be strong allies for e-NABLE as we move forward.
Mr. Goodman is quite ignorant about e-NABLE, and in particular its relationship with the FDA, and about the FDA in general. He uses our organization to malign the FDA, ignoring all facts surrounding our actual interactions with the people of that agency. Please do not criticize the FDA in its current administration, unless you have actual experiences and data to back your views. The FDA is actively reaching out to e-NABLE and has been nothing less than wonderful. Articles like Mr. Goodman’s only serve to harm the relationships the FDA is actively and constructively cultivating with business, educational institutions, non-profits, and the public-at-large.
More on the Workshop
The industry leaders at the workshop were as dry and theoretical as you can imagine. They seemed so determined to guard their trade secrets that all they offered were vague references to “proper settings and standards” without giving any practical numbers or figures. I heard complaints from more than a couple attendees that all we were getting from these “experts” was a sales pitch for products and services nobody could afford, and nothing in the way of actual sharing of information.
By contrast, the presentations by university researchers were incredible and incredibly informative, like: How to hack a 3d printer and an HP26 inkjet cartridge and print freaking human organs!! Something like a dozen major living organs and tissues, including composite tissues successfully printed (You need two or three inkjet cartridges for this. Search the trash can!), and 20 more to go!! Third degree burns? No problem! They can culture your skin cells and print some new silky skin directly onto your burn site! Are you kidding me, Wake Forest SC?!?
The breaks between discussions were amazing too, Jon Schull, Mohit Chaudhary, and I got to meet with some very cool and talented people, some of whom joined or will soon join e-NABLE and who may be instrumental in various future e-NABLE initiatives.
I’ll let them introduce themselves.”