3D Ops is doing something so new the FDA hasn’t regulated it (yet)
When is a 3D-printed heart like a cartoon flip book? Just as you can flip through static drawings in rapid succession to create animated movement, if you combine a sequence of MRI images in the right way, something different is created: a 3D image you can print.
That’s what Gig Tank company 3D Operations is doing. The company’s president, Daniel Hampton, spent years using 3D printing to create custom surgical tools based on scans of patient anatomy. He created 3D Operations to take the next step: 3D printing organs from the same type of 2D scans.
These organs would remain strictly outside the body. A surgeon might show a heart patient exactly what upcoming surgery would do using a 3D printout of the patient’s heart, complete with the defect to be corrected.
Once a particularly difficult or innovative surgery was done, the surgeon could reenact the operation on a 3D-printed organ—heart, brain, lungs, liver, anything—to educate other surgeons.
Or a medical device manufacturer could use a printed organ, complete with defect, to show surgeons how a new product could be used to correct the problem.
If education and product development were all 3D Ops’ products would ever be used for, the company would be almost ready to go to market. But here’s where it really gets interesting.
If a surgeon wants to use a 3D model based on actual MRI and CT data to study the patient’s anatomy and prepare for surgery, the company’s product might be considered a medical device and subject to approval by the U.S. Food & Drug Administration. Or not. What 3D Ops is doing has never been done, so the FDA doesn’t know how to regulate it.
“What they’re doing with this model is they’re getting inside and understanding your anatomy from a base level that they can’t do right now, because they can’t take your heart out and look at it—but now we can,” says Hampton.
“Based on your scan data we can, essentially, take your heart out of your body and hand it to a surgeon and say, “Here, this is what you’re going to see when you get in there.’”
The FDA considers anything used to treat or diagnose an issue to be a medical device and subject to review and approval. The question is whether it is possible that having a 3D model could hurt someone where having a 2D model would not.
“Could they misdiagnose you because of the model?” asks Hampton. “And what we say...is that the model is not used for diagnosis. The diagnosis is based on the MRI. When you use the model, you’re essentially practicing surgery so you know what you’re doing before you get in there. You’re not using the model to diagnose. You’re using the model to plan, and those are two completely different things.”
Hampton’s company is not the only one grappling with 3D printing in the operating room, but it’s the only one (as far as he knows) that’s making the FDA scratch its head. Other companies use 3D printing to create instruments used in surgery or artificial bones that are implanted. These things are clearly subject to FDA approval.
3D Operations is using software that is commercially available and already FDA-approved to convert 2D scans to 3D images that are viewed on 2D screens. The only difference is in the output. But it turns out there is a human element in the 3D conversion. As 2D files are prepared for 3D conversion, human judgment is needed to choose what gets printed from the entire visual field of the 2D scan. Hampton uses the flip book analogy.
“Say you have a cartoon flip book, and a tree that stays in the same place and you have a little guy running,” he says. “As I flip through, the tree never moves but the little guy’s running. So I’m looking at this one image within this entire cartoon and I’m saying, ‘OK, what of this is the guy, and what of this is the tree?’”
Or, in other words, is this blob on the MRI image part of the heart or part of the lung? With the software and the 3D conversion process already FDA-approved, there is nothing for the FDA to evaluate except the ability of Hampton’s company to distinguish guy from tree, or heart from lung.
“That’s the only thing that is variable in the whole system,” he says. “As far as I know there is no way [for the FDA] to approve the way something is done. It’s only the thing that exists at the end of the process.”
In the next few weeks Hampton will decide, based on input from regulatory specialists around the country, how to proceed. He could move forward on non-surgical uses without FDA approval or ask the FDA to decide whether his product requires approval. For now, it’s a puzzler.