By Rich Bailey
3D Operations, currently a participant in Chattanooga’s Gig Tank 2014 startup accelerator, has developed a business around converting 2D medical scans—MRI and CT images for example—into printable 3D files and printing hearts for surgeons. Think of a heart, complete with the defect that’s causing problems, that might be used in education, product development or presurgical planning.
It’s that last one that raises interesting questions. The scanning technology and the 3D conversion software are FDA-approved, but using them to prepare for surgery is new.
“The product is developed, all of the workflow is already there. The issue is if we are directed to get a 510k, what are we 510k-ing,” says company founder Daniel Hampton. A 510k is the FDA’s protocol for evaluating a “medical device.” But is this a medical device? “Essentially, at that point, it’s how well do I take the image that’s on the screen and turn it into a 3D model. So you’re essentially 510k-ing me and my training. I don’t know that that’s ever been done.”
I reported on my conversation with Hampton in Chattanooga Pulse.