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.

A brain printed by 3D Operations

A brain printed by 3D Operations

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.