Several times over the past few weeks, in completely unrelated situations, 3D printed prosthetics have come up in conversation.  And I think the whole idea is really exciting.  If you’ve not seen these prosthetics, they typically look something like the photos below.

These don’t look like real hands.  No one’s going to miss that they’re prosthetics.  They come in all sorts of colors and they look robotic.  They don’t employ the absolute top of the line technology.  They’re relatively simple devices that can handle basic functions like gripping a ball.

And they’re cheap and easy to make.  Right now, a magnet school in Durham is making several of these prosthetic hands for kids across the country.  Yep, 17 and 18 year olds in public schools are making these and giving them away to kids who need them.  For free.

Of course, they aren’t free to make, but they don’t cost much.  The 3D printers cost several hundred dollars, and the materials for a basic prosthetic hand cost around $30.  But with fancy prosthetics costing tens of thousands of dollars, this looks like a pretty good deal to me.

Just think of the possibilities.  What if poor kids could get an arm for $50?  What if kids could get new arms hands easily and inexpensively as they grow?  Every parent knows how fast kids outgrow shoes, which is why parents tend to buy cheap ones for their kids, especially when they’re in the middle of growth spurts.  What if you could do the same with a prosthetic hand or foot?  Surely that would be a great thing for a lot of kids.

Adults don’t outgrow their limbs like kids do, but they might like the idea of having a cheap prosthetic that they don’t have to worry so much about damaging while playing sports or canoeing with the kids.  And for adults who are just trying to make ends meet, a less expensive option might be welcome.

And if we think outside America, the possibilities are even greater.  There are people all over the world who live in war-torn countries full of landmines, where people regularly lose limbs.  It’s terrible and tragic, and providing affordable prosthetics could absolutely transform many people’s lives.

And so, over the past couple weeks as I’ve been hearing more and more about these 3D printed prosthetics, I’ve gotten more and more excited.  This is amazing and wonderful technology, and it could really help so many people.

And then this morning I read a piece on the FDA’s blog, and my heart was filled with despair.

3-D printing is fast becoming a focus in our practice of regulatory science – that is, the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.

Because clearly what this exciting, innovative field needs is some FDA regulation.  I’m going to go out on a limb here and guess that, as the FDA starts to stick its nose into this, these sorts of prosthetics will get more expensive.  It will become more difficult for kids in schools to make hands and distribute them to kids in need.  It will become more difficult for designers and programers to create new designs and try out creative ideas.  And all those dreams I have of getting prosthetic limbs to people who need them but can’t afford them will become less easy to realize.

Without regulation, no one’s being harmed by these prosthetic limbs.  Quite to the contrary, people who would otherwise go without, now have hands and feet.  The technology is evolving rapidly, the prosthetics are getting better, and the costs are dropping all the time.  I’d love to see that continue.  Sadly, I fear the greatest threat is unnecessary and burdensome government regulation.