Cool project, but the $42,000 prosthetic probably has only $50 in materials as well, the expensive part is the engineering, fitting, and assembly. Not really a fair comparison.
Models like this are quite exciting - assistive devices and prosthetics are incredibly expensive due to low volume and customisation requirements. This is preventing innovation and production of new devices and technologies.
They are also (rightly) highly regulated. A next step is trying to figure out how to maintain quality and safety in these kinds of DIY projects.
I'm curious, why "rightly"? I use all kinds of assistive devices. You probably know them by the names "metal tongs", "gloves", "ice axes", "crampons", "shoes", and so on.
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.
Possibly I am using a jargon term that you aren't familiar with - assistive devices have a special meaning in this kind of context. They are designed and marketed to give renewed function or rehabilitation to someone with some impairment (http://en.wikipedia.org/wiki/Assistive_technology).
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'm familiar with the term. My argument is that the fact that device X is fixing an impairment should not make a difference vs a device that augments me. Tongs let me flip things on the grill without burning myself. If everyone but me had fireproof skin then that would be an 'assistive device', yes? My rock climbing shoes give me grip on the rock - is that not correcting an an impairment in some sense? I use stools to correct for my relatively short height - people fall off stools every day. Shall we require stools to cost $20K, complete with stabilization arms, railings, and a safety harness? My keyboard & mouse bothers my carpal tunnel. Would you like to have to pay $10K (say) for a keyboard? Artifical legs can cost over $100K, yet people get by hobbling around using a stick for support. IMO, it's madness to regulate at this level.
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.
So how much regulatory tax would you think is acceptable to add to a $50 hand? A few thousand?
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.
Ice axes and crampons are generally certified by the UIAA [1], but this certification is not legally binding -- it's just that consumers won't buy products that aren't UIAA-certified.
Yes. I mentioned climbing on purpose, because of the standards. In reality, you can go to the hardware store and buy things like bolts and rings, and people do that. Others buy certified versions, which is probably a bit smarter. But in the end it is personal responsibility. And the certification is not that onerous. I can buy a locking biner for $15 or so dollars, a sling for $5, a very high tech rope for $150, shoes for $60, and so on. I have no doubt economy of scale is working here - more carabiners are made and sold vs prosthetic arms. But in the end I have a lot of choice - I can use $5 cheapo sunglasses at altitude, or spend $300 for high end versions. I can spend $100 for a benchmade knife, or $3 at Walmart. My life, my risks,my choice.
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 $3800 orthopedic, medical grade, hypoallergenic pillow? Nah.
"...regulated as Class I (exempt) medical devices."
As long as the new device, "...is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology."
This means that most prosthetic devices are not explicitly regulated and are free from regulatory overhead in nearly all cases, especially the 3d-printed ones. While one can speculate on why they chose not to regulate these I think we can assume it's because ostensibly there's no danger to the end-user.
I had the privilege of seeing Dean Kamen speak last year about the DEKA arm. One of the things he lamented was that the FDA had to decided not to classify the arm as Class I, and as such it was getting caught up in drawn out regulation when there were people he felt it could help right now.
Thanks for the link. The DEKA arm is a great piece of tech.
I could speculate that because it relies on new tech and new research into prosthetic devices that the didn't just rubber stamp it.
Part of what the FDA does is safety, and the other part is validating the claims that a device or drug manufacturer makes. It's probably for this reason that they imposed additional regulatory validation. Because a cyborg arm? That HAS to be SCI-FI, right? ;)
I think it's fairer than you state. The end results is that both cases give you a usable prosthetic, one at 50$, another at 42000$.
Both required engineering, fitting, assembly, but one was done using volunteers time and a new technique, while the other was built part of a lucrative activity using a different technique.
They will serve the same purpose to the end-user, and the end-user will either pay 42k$ or 50$.
Really? So the Linux Kernel, Postgres, etc. haven't been able to scale? The only barrier that has been preventing an Open Source, volunteer run, approach from working in the physical world vs the software world has been the higher cost of entry due to materials and the machines you need to manipulate those materials. It's been pretty clear that those costs are coming down, both with 3d printing and electronics (raspberry pi, arduino, etc.) Volunteer time is just a function of how many committed people you can get together, software has proven it's most definitely possible to do this on a massive scale.
And companies that want to take advantage of freely available volunteer run hardware/physical projects wouldn't want to commit their own resources to improve them for their needs? I don't see anything about this model that wouldn't directly translate into these sorts of projects. Why exactly couldn't physically based open source projects have both paid and non-paid volunteers, just like software projects do?
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.
None of those are all volunteer organizations. There are plenty of old mostly volunteer organizations and a few large but short term ones. But, without a core of paid workers organizations don't last.
> They are also (rightly) highly regulated. A next step is trying to figure out how to maintain quality and safety in these kinds of DIY projects.
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.
I broad terms I agree that there's probably too much regulation on medical devices in general. There are a variety of areas where there can be considerable stream lining or reduction to the net benefit of all parties involved.
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.
"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."
It's a myoelectric, so the BOM cost is likely higher than $50.
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.
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.
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.
"the expensive part is the engineering, fitting, and assembly. Not really a fair comparison."
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.
The thing about the 3-D printed ones though is that it seems like it would be easier to design and manufacture more 1-offs, customized to the needs and abilities of the user; whereas the more traditional prosthetic device will be designed, necessarily, for more general usage. The one fits the needs of an individual; the other only kind of fits the needs of the individuals in a group. I would say for this reason alone, 3-D printing is a very exciting advance.
one of biggest costs is regulations, medical devices which this would fall under are are heavily regulated industry. The liability bill is enormous, let alone the costs of technology behind it.
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?
Models like this are quite exciting - assistive devices and prosthetics are incredibly expensive due to low volume and customisation requirements. This is preventing innovation and production of new devices and technologies.
They are also (rightly) highly regulated. A next step is trying to figure out how to maintain quality and safety in these kinds of DIY projects.