I can see regulation as soon as you are penetrating the body - screwing something in, surgery to make an attachment point, and so on, but otherwise? Don't make people's lives even harder because you think you can think and make decisions better than they can.

I'm making generalisations that may extend beyond this particular device for this particular user because its an entire field that isn't well serving its users at the present time. Implementation far lags technology because business and operations models don't exist to promote the development of these technologies. The kind of approach article is suggesting is promising, but not a complete solution.

The reason why regulation is needed is that the people making/designing/marketing the device have by doing so made an appeal that they are an expert.

Often, failure of these devices have far higher consequences than failure of typical consumer devices (maybe ice axes and crampons are also in this category!). Its the same reason why doctors need to be licensed to practice, whether it be for open heart surgery or to diagnose someone with a runny nose.

Probably assistive devices (and medical technologies in general) are over-regulated now, but that doesn't mean the solution is no regulation.

I agree that there is gray area, but these are people with very real needs that are finally being addressed in a cost effective way ($2000 or less!). There is a world of difference between open heart surgery and uninvasively strapping something on the end of my arm.

How about a simple disclaimer - not to be used in safety critical applications - and let people have their $50 hand? When people start selling hands with bigger promises that have more grave consequences, dial up the regulation on those.

[1]: http://www.theuiaa.org/safety-standards.html

In the end it doesn't matter much if my prosthetic finger breaks - I'll just print a new one. Could I get a rash if I use PVC plastic vs some bioplastic? Sure,but I can also get a rash from the $5 sneakers from Walmart. Is medical grade stainless going to be better than something I get from Home Depot? I would imagine so, but I buy all my metal from Home Depot and the like, and I have yet to suffer any real consequences from that. I have a stiff neck from the $10 pillow from BB&B - shall I buy a $3800 orthopedic, medical grade, hypoallergenic pillow? Nah.

http://openprosthetics.wikispot.org/Federal_Regulation_of_Pr...

"...regulated as Class I (exempt) medical devices."

As long as the new device, "...is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology."

This means that most prosthetic devices are not explicitly regulated and are free from regulatory overhead in nearly all cases, especially the 3d-printed ones. While one can speculate on why they chose not to regulate these I think we can assume it's because ostensibly there's no danger to the end-user.

Video demo of the updated, 3rd-generation DEKA arm. http://youtu.be/auetIxOaSe8

I could speculate that because it relies on new tech and new research into prosthetic devices that the didn't just rubber stamp it.

Part of what the FDA does is safety, and the other part is validating the claims that a device or drug manufacturer makes. It's probably for this reason that they imposed additional regulatory validation. Because a cyborg arm? That HAS to be SCI-FI, right? ;)

Both required engineering, fitting, assembly, but one was done using volunteers time and a new technique, while the other was built part of a lucrative activity using a different technique.

They will serve the same purpose to the end-user, and the end-user will either pay 42k$ or 50$.

Consider this; at what point was the first person hired to work on the kernel? At what point were there a majority of patches submitted by paid workers?

^And then consider that up until that point, it was all unpaid. Just... think for a while, just think please.

Publicly funded research may also contribute to open source, 3d printed prosthetics.

I can see why medical devices like pacemakers or implanted replacement joints need more regulation, but I don't understand why a prosthetic needs more regulation than other consumer products like gloves or eyeglasses.

That said, the myoelectric device at a minimum falls under some level of regulation since it is a biopotential device. The moment you start measuring potentials on the human body, you add the risk of injecting current across the human body - obviously bad. If you wanted to ensure that the myoelectric device was safe, you would at a minimum ensure that a) sufficient isolation between the sensory and actuator circuits b) a safe sensory circuit. Now, while doing that is probably relatively trivial to actually design, you do need to verify it.

So, once again, I agree that there's probably too much regulation piled on, but there is a good reason to regulate/verify in some form or way at least the myoelectric device.

More generally, notice that the examples that you and sister component pointed out are relatively simple, especially compared to a prosthetic hand. Complexity in itself can cause the need for regulation.

Oh, and on the side, you may find this document with regards to impact resistant and safety glasses (http://www.fda.gov/medicaldevices/deviceregulationandguidanc...) a fun read =P.

If you read Robohand's FAQ, to build a proper medical grade hand will cost $2,000.

http://www.robohand.net/faq/

"To print the fingers with the knuckle block and hinges for a Robohand costs around US$5.00. To make a proper Robohand, which includes medical Orthoplastic, stainless steel hardware, tools, Velcro, plus the time it takes, costs US$2000.00."

Also, as an FDA certified medical device, the rough rule of thumb (that I was taught while on an internship) is ~5-7 times mark up on BOM+assembly cost.

The -real- amazing thing about this is the idea that we can use far cheaper materials with much lower safety margins, since we can then just reprint individual components that break - remember the price of the materials isn't the bulk cost of material, its the price it takes to shape them, which is quite high for traditional methods, for low run parts like prostheses. What's going to be amazing is the combination of newer myoelectric devices, with these new manufacturing/design approaches, that -should- enable intermediately priced prosthetic.

Of course, the biggest cost saving comes from not being an FDA approved device at all.

I think the markup varies quite a bit more widely than that, probably along with device complexity. As someone who has been a member of the development teams for various complex FDA-regulated medical devices (think image-guided surgery), the markups I saw were more in the 10-15x range.

Agree. It's headline grabbing for sure. But when you really boil something down the actual material cost isn't always that big factor in the final product cost, in low volume quantities at least. [1]

There are overhead costs (some of which you have already highlighted) [2] that are necessary in running an actual company that makes products. These costs are not always visible or obvious.

[1] An example might be comparing the cost of a low volume production car such as the Porsche 911 Turbo S to a high volume car like a Honda Accord.

[2] I would also add legal and insurance costs which, with a device like this, are almost certainly not trivial.

There's R&D for the $50 arm too. They didn't just download the code and print plans from Github.

Justifying a fourty grand pricetag based on R&D costs is absurd in the face of this competing arm (which we should note is not actually $50, just $50 to replace plastic printed components).

The point is that the price difference is several orders of magnitude, and R&D was independently conducted by both groups, therefore R&D cannot justify the price difference alone.

anecdotal, a friend with an artificial leg needs it replaced every few years because of wear and tear on it and him. The fitting, maintenance, as well as physical rehab, is an ongoing costs. Hands don't experience the wear and tear that legs would so I wonder how 3d printed legs would hold up?