What's up with getting FDA approval for my prosthetic?
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- Опубліковано 30 чер 2024
- In this video i explain what power and role the FDA has with bringing my partial hand prosthetic to market.
thank you to everyone who is supporting me on Patreon, you guys are awesome! and I really appreciate your support, let alone just believing in what I'm trying to do with my project.
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Amazon link for all the stuff I used for this project.
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Alumilite plat 25 silicone.
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finally a tic tok!
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It may sound backwards, but you should try to reach out to European medical companies instead of American, and then branch out to America after establishing your prosthetics in Europe. The European medical market isn't quite as profit-driven as the American, because of public health care; making companies more willing to invest in projects like yours.
As a bonus, many European countries have much cheaper processes than the FDA.
In any case, the world itself is richer for innovations like yours, so keep doing what you do!
I had a similar immediate idea: Reach out to the medical policy nerds, to find a reasonable country where it would be cheap to get approval (cheaper than the EU in general). So market there first and use it to leverage EU and then US investment/approval; possibly even as a collaboration with a technical university. [Probably NOT a "Third world" country with charitable funding, as approval there would not do much for leveraging up to US manufacturing.] Country language shouldn't be a barrier.
Thing is, you also don't get as much money either with doing such ventures, and the European countries with free healthcare are VERY stingy with lots of more advanced treatment options, even some medication and more complex surgeries...I think prosthetics like this would end up being backlogged and would be quite slow for needy people to get their hands on them in Europe, whereas in the US you could apply for one and get it immediately as long as your insurance (or you) can pay for it. US healthcare isn't bad (I know you didn't say this, but a lot of people often try to act like "free healthcare" means western European healthcare is somehow better...they're the same quality, but American healthcare you can get much more immediate access as well as greater access to more variety of medications and treatments)
@@aydointergalacticcorporati698 That is highly dependent on the specific country and their budgeting for health care. Medical companies themselves, though, are very profitable in Europe, even if not as obscenely profitable as American ones.
I got the feeling that the inventor here is more interested in getting this prosthetic out to those who need them, and getting reimbursed, rather than trying to become a millionaire over night.
@@aydointergalacticcorporati698 *to get their hand on them
You really underestimate how fucked up European MDR documents are. No wonder most European companies flee to the US or are bought up by them. On top of that, the US is arranging for faster approvals. There is no reason to go bankrupt by going to Europe first.
It's FULLY reasonable to seek and expect compensation for the device. I know a lot of UA-camrs give plans away, but those are almost always one week, first draft projects for the views. This device is a whole other animal.
As long as it has no software and/or wifi (, bluetooth, or other) connection, I am perfectly with it bring propietary
Bring it to Aus!
I love that you said "for the views" because it is so true! I am so annoyed by this aspect of most youtube projects which are so trash and toy-like because its all about get it done fast and dirty "for the views" and nobody makes things of quality and substance
@@artbyrobot1 indeed, it's apples to oranges: one is a content creator, the other is an inventor. Love the content creators, don't get me wrong, like Hacksmith and JLaser and Allen Pan etc.; but their end-goals are different 👍
@@lady_draguliana784 the first two you listed (never heard of the 3rd one) waste their talents on trash projects to such a vast degree of clickbait videos that I unsubbed from both and refuse to watch their stuff. It makes me SICK. Why can't they build something actually cool and innovative and useful to solve problems? That would be worth watching and you could really learn more. What they build might be "cool" to a 12 year old, but not a adult.
name something more iconic than 3 letter organizations and getting in the way or taking forever.
hopefully your designs go through, you do great work.
Despite the way bureaucracies work, the FDA does exist for good reason and they're part of the reason why food safety is actually pretty good in the US. Also, although American healthcare is a total shit-show, but there's at least some effort put into making sure medical devices won't cause substantially more harm than good.
That said, the barriers are prohibitive unless you're already a big corp with deep-pocketed backers, and that's probably stifled more than its fair share of potentially life-changing innovations.
@@OddlyIncredible on a base level they do operate successfully, given that common sense is pretty much dead in 2023. However, there's still plenty of items and medicines gated by the organization that has substantial backing.
They do serve a purpose but I do think that re-evaluation of items should be reoccurring to double check (given how much medical knowledge is obtained yearly)
I think you made a mistake there, DMCA isn’t 3 letters, neither is Nintendo.
Can't have the smaller guy do something genuinely good and useful for the world without some big organisation trying to either:
Take credit
Make money off of it
Or stomp it in the ground...
And to add to that...
What's just as bad is that when the developer of something genuinely good and useful for the world decides giving everything away for free isn't the best move because just maybe he _would_ like to make a _little_ money off the thing to recoup the _massive_ amount of time and effort he put into the thing, people tend to immediately shit all over him for it. It's a no-win situation. If it were me I'd be exploring the component-kit angle.
This is genuinely a great idea that could become life changing for a small niche of people. It is very difficult to navigate the financial and paperwork aspects of bringing it to market.
I think those hurdles are made to discourage big companies from putting out shoddy items at the drop of a hat and using consumers as lab rats while iterating on an item every week with questionable results. That and stopping any company willing to mass produce and import any item that people will pay for at bottom dollar prices, and bottom dollar quality *cough* China *cough* that will end up hurting people.
I would be willing to side with a government agency stopping that. It is an absolutely terrible rock and hard place to be between when a product like this could actually help people though.
@@Johnny-uy4iuI've studied it, and make no mistake, the FDA does their job terribly. The amount of people currently living in the US with an FDA approved device related morbidity or are currently at risk of developing morbidities related to their currently implanted devices, well it's in the millions.
The 510k process alone is incredibly flawed and in fact, it is the biggest companies that are responsible for the most pain. Be very careful with medical devices in the US
You definitely deserve to get paid for your labor this is an insane amount of work testing and iterating youve put into a super unique product. I hope the government stuff doesnt get in your way too badly
Fees just mean the barrier only exists if you aren’t rich… classic.
In my role as a biomedical engineer, I frequently contemplate the implications of the Orphan Product FDA clause. This regulation pertains to situations in which innovative medical products could greatly benefit a small population but may not be financially viable enough to justify navigating the complex FDA approval process. I would strongly encourage you to delve deeper into this matter.
Specifically, what I've observed in the realm of hand prosthetics is a multifaceted landscape. While it's a substantial field, the marketing and customization aspects-such as distinguishing between left and right hands, different sizes, or varying numbers of digits-inevitably narrow down the target demographic.
That shit sends my blood to boil.
Technology that is far superior to what we currently have always getting shut down cause it doesnt make money.
god help us.
God won't help you. You gotta take it into your own hands. Or prosthetics.@@UtubeH8tr
Unfortunately Office of Orphan Products Development only applies humanitarian use device designations to medical devices treating a condition that affects fewer than 8,000 individuals in the U.S. per year. There are approximately 30,000 US finger amputations per year. Perhaps, as you mention, treating every permutation of missing fingers as a different condition would qualify, but then each slightly different device would need to be independently approved.
@@DustinMaki1 There is no difference in the design. Assuming he reached the final version. It is for people with all four fingers cut, all on left or right hand. I would assume the majority of 30k lost fewer than 4 fingers. I would assume (with nothing to back it up) that 10%, or 3k, is a reasonable upper estimate for 4 finger amputees.
Also, do compensated people count?
And if they lost their palm, they would have surgery (at least in my country). And the device wouldn't fit anyway. So they shouldn't count either.
@@UtubeH8tr Profit is nothing more than a measuring device for economic projects. Do you get upset at scales and tape measures when they don't give you the answers you want? If something doesn't make money, that means that the project is not worth doing. It means it consumes too many scarce resources that could be better used elsewhere for different purposes. If something can't be done profitably, then it's actually not "superior" to the alternatives.
Now, if you want to be upset at the FDA for causing costs to be so high that the costs exceed the profit, that's a fair point and something to be upset about.
This is why I stitched new straps on a friend's thumb brace multiple times. The thing was maybe $4 worth of plastic and Velcro, but cost her $175, and would start to wear in a couple weeks. I can't imagine the profit margin on stuff like that.
At first look medical products have a stupid margin. But when you consider the insane cost of insurance and then add on license fees. The profit kind of goes away., not saying they aren't making money, just they have to, to afford the insurance.
In this case, shouldn't the insurance cover the stitching? I would return such a product (in my country).
I assume he means liability insurance for the manufacturer, to cover them in case they are sued by a customer. Not to insure the purchase of the device on behalf of the customer?
As a practicing prosthetist/orthotist, we warranty our devices. Especially for stitching that will only take a few minutes.
@@Tondadrd It was an off the shelf type of thing, made in some far away country. Her insurance wouldn't cover a new one for a couple months, they were $150 if she wanted to buy a new one, and the Velcro they used was worse than the cheapest stuff I could get at the local fabric store. The rigid part of it was totally fine, just the crappy straps had worn out. So I made some really nice new ones with industrial Velcro and nicer fabric. Better than it going in the trash.
Lemme just guess ahead of time. This is all gonna be related to money and how hes making cheap and really functional prosthetics to be "dangerous and unreliable"?
Exactly
If only the parts were available for non prostectic use...
Yes. Thats all its about. The fda has deals with manufacturers. He will never get approval. U dont need fda approval for a glove. Just that insurance pays for it. Accept cash. Maybe start ur own insurance company lol
Fda like the fbi and other agencies have orverdone theyr stay. They need to go.
Think of the children XD
Currently am working on a prosthetic product under very similar circumstances. It's very unfortunate to have such a restrictive validation process that can really only be done by massive conglomerates who often have a greater interest in squeezing money from vulnerable people rather than a desire to produce something that is useful and helpful.
The FDA needs their cut man. How else will they mooch off the people if you don't pay their exorbitant fees?
@@oldscratch3535 Wouldn't be extraction capitalism if every single hand in the process didn't squeeze every possible fraction of a penny from the previous pair.
side stepping the system. I'm all about it man, get after it. DIY kits for the masses. Some assembly required.
Suggestion: Instead of selling the design as a medical prosthetic, sell it as a module for mechatronics. Especially you should consider selling it to Toyota, last I heard from them, they bought all the MIT enterprise in charge of building the "Spot" and the rest of the MIT famous robots; they would likely be interested in mechanisms that can work and distribute the strength efficiently of a human hand, specially if it is in metal.
commenting on my wife's account... I've followed your channel and support your cause and am very appreciative of this video. it explains the ins and outs of trying to help in which ways I have been interested. my late mother had above the knee and I've been a carpenter, mechanic and welder. I have always wanted to see her walk again and help others like her. I'm glad to see the outcome of all your research because I've considered the same for others as a hobby.
Don't call it a medical device...it's just a wrench! No different than me using a hammer. I am missing my left hand byt the way.
It helps people tho
Show you can use it to hammer in nails. Problem solved. Now sell it as the “glammer” at local home project stores. Glove meet hammer.
@@mehoyminoy1326 as cute that that souhnds, those prison sentences were PER SALE! and so were the fines... WTH... they treat each sale as a separate felony
I was just about to type a message saying make it a kit (AR style) when you said exactly that. I hope you find a way forward- your design is phenomenal
It bites you would have to use that method just to get your prosthetics out as well as how most companies seem to just not want to hop in once they learn how much it cost to get things through.
Wish you the best of luck and hope it'll get traction eventually.
I did FDA drug and device submissions, and you're on point. It's a nightmare.
It would be fantastic once they start mass producing these things on conveyor line, how easily and quickly they could manufacture them. This guy took forever to make his, he deserves to sell these things and make a massive profit.
Dude I'm rooting so hard for you, you're my favorite prosthetic engineer
Firearm owners and collectors have been dealing with this bureaucracy for decades. We welcome you to the party. At least you won't have to worry about buying a product that they said was legal for 10 years, then overnight tell you you're a felon and can go to prison if you own it.
Although, now I'm wondering if the ATF would classify your hand as a machine gun b/c its a mechanical device? They once classified a shoestring as a machine gun. No, I'm not joking. What can you expect from an agency and government that says a 16" barrel is OK, but a 15.9" barrel? NYET, GO DIRECTLY TO JAIL.
Best of luck in the process. Your work is inspiring!
I like your energy and engineering and unfortunately I think you are right. All the best!
You're such a genuine guy, Ian. I just know you'll do what's best for everybody!
Really great prosthesis! Good luck!
You are hardcore Ian!!! Rooting for you. Stick it to the man!!
Hey Adam, I love watching your videos. Seems like the world wants us to expend the effort to make new stuff, then when it makes money they steal it from you. I think there is going to be so much variation in prosthetics that you won't be out of a job. I like the idea of kits, you make the hard points, joints, and winder, and the customer 3d fills to their body, the fit and size they want to have. Great video. Keep on making the best you can, and leave it to someone else to deal with the man.
Its a great thing youre doing, I wish you the best of luck
I hope you succeed in everything you set your mind to.
Indeed, that FDA fines are part of the price of any medical product because сompany risk insurance included in the price.
You have the best hand prosthetic project, if you do it in parts, then it will be much cheaper for the end consumer, many will buy it as a construction set only because of the price, not everyone has good insurance.. If the product is completely ready with all licenses, I think so too will be in demand regardless on the price, but there is a lot of investment and time.
Unrelated... But I gotta point out the sounds of the mech-hand when it's moving, that's so cool 😄
I wish you the best in making this become a real product.
Probably the only hand/arm para who has more hand gestures now than before. Glad you're making steps to provide this for the public. These prosthetics "look" amazing. If the right kind of hardware was introduced, some versions improved upon.... who knows... this might be the start of prosthetics that are BETTER and STRONGER than limbs.
Well, considering, it IS stronger in some sense, because if a sword came at you your prosthetic hand would be totally fine whereas your flesh hand would suffer lacerations.
Realizing your hand is actually better than a normal hand in some regards.... Amazing.
Edit: srry i didn't mean to say para. Paraplegic. Regrettably that's what someone I know has. Amputee* is the correct term.
I'd say that's more about durability than strength. We are still way way far from prosthetics that are as strong and accurate as real human hands. There are people who can do 1 finger pull-ups and their hands are still incredibly dexterous. Can you imagine trying to pick up a singular table salt crystal off the table with a prosthetic hand and crushing it between your nails? That's the dexterity of a real hand. Maybe in 50 or 100 years we'll get close, but it's still far away.
@@outandabout259 This is already stronger than a real hand, hands are limited by the weakest muscle/tendon running down the fingers. Which in most people is pretty weak. This prosthetic appears only to be limited by the strength the arm.
It's not accurate though that's not the point. You won't get anything even close to the dexterity of a real hand without a neural implant
This device is unbelievably impressive. Keep fighting!
This is Awesome and will help many people live better lives! I hope you get patented and approved for FDA. I can already imagine third party companies scrambeling to try and replicate your design right now. All best of luck to you sir
I think a breakdown of Technology Readiness Levels would be interesting for this channel - where do you think your devices fit in the scale?
Government is owned by big business. Big business doesn't like competition
It's always the cats at the end of the video that I'm looking forward to😆.
Hey, is the audio in this video full of static for other people?
Yes. Glad to see it's not just me.
It's quiet, but it's there.
rooting for u so hard rn
They are afraid of competition. This prostethic is great. More reliable than an myoelectric prostethic hand. This is an advance conventional prostethic hand that will change the ortopedic medical industri ❤️👍 Maybe try in the Scandinavian. Its different rules here. I think you will find a good partner here😊
wow great microphone quality
you deserve adequate comp my friend, am still of the belief that you make the most advanced arm prosthesis
I feel you pain, having worked on a 510K application's it feels like a giant money pit. Were you work harder every day to throw more money in. Also to BS EN 60601 for products in the UK! boy oh boy am I glad that i don't have to do that anymore. good luck with the materials that contact the skin that alone can be a nightmare. I whish you all the luck with this great endeavour.
your gestures are mezmerizingly lifelike with that prosthesis.
I'm curious - how many people are there for whom this design would work? it's a very specific build for a very specific amount of uh.. "remaining hand"
It feels like you need to talk with Jerry Rig Everything about his Not A Wheelchair project.
You rock!
I'm personally of the opinion that selling it as a "Novelty" kit is likely the best idea, as that seems like both the simplest, AND the easiest path to take. Working alongside a company of some persuasion is likely to be a good idea as well, but the chances of that happening are pretty slim if you ask me, the same issue that the FDA had with the "product" will likely apply. As someone with a vague understanding of the price of prosthetics and a pretty decent understanding of the price of materials and labor, I'd say selling it as a DIY kit would be fair at anywhere from $150-300 (This including the fact that there will likely be differing lengths and widths of hands for different people, so if you disagree, you can increase the total price pretty easily, to say $225-375 as an example). Looking forward to seeing how this all plays out :)
Your numbers are a tad off, just the printed components for my current build cost me $600 us. That doesn't pay to get them machined to tolerance, or the pins and chains, or the casting and layup of the sockets. A finished device will likely cost in the neighborhood of $4k-$5k. Which is a far cry from the $85k that ossur gets for one of their I digit devices
oooooooooooo, being that wrong on numbers is embarrassing, but good information to have. I also did my scaling math wrong, since I tried to do it mathematically instead of exponentially. Much appreciate the polite nudge of "Hey man, you've kinda goofed it" over some of the more abrasive interactions I've had about being wrong :)
This is yet another place where the government has not kept up with the pace of technology. The current capabilities for self prosthetic manufacture, or for rapid agile development of prosthetics, is being ignored by the government in favor of old and tired bureaucratic processes focused on developing a single product that is intended to be sold for decades. The current state of 3D printing, CNC machining, and microcontrollers means prosthetics could be improving every single week. The current regulations just can't keep up with this, and its niche enough that our currently ineffectual congress will not pay attention to it, and if they do its due to lobbying from large corporations who stand to benefit from keeping the process as it is right now.
I've been watching for a while. It's so cool to see all your progress. Hope to see other people with your hand soon.
Congrats.
Pretty sure the UK has a fast forward process for devices like this since our NHS is constantly overbudget and looking for new ways to save a ton of money on new ways to do stuff. One charity here I know of has successfully trialed 3d printed heart transplants quite rapidly, for example.
Real life Cyborg! Cool as hell man! You could go wild on the next design. Carbon fiber, LED's, add a laser, flashlight, remote, garage door opener, Apple watch, Swiss army. I know I'm exaggerating but you turned a disability into a gift! You are the future. You can take ideas and make them reality. That's so awesome!
I'm just here for the cats. Much love to you brother.
Personally, I'd sell it as a costume prop cosmetic addition.
Customers are advised against connecting spring A to anchor D, or any other steps that might accidentally result in a functional prosthetic. *cough*
Ian, get in touch with AvE (that's the name of his channel) for help machining metal parts (the "winder"?). That Canadian is looking for low volume COMMUNITY DRIVEN projects to CHOOCH on his CNC - FOR FREE. I bet he would be all in on this one!
Keep your stick on the ice.
he is subscribed to my channel. He and Jerryrigeverything.
@@missingpartsclub Great! Really hope the two of you can work together on this.
Oh - and yes, I agree that you should be compensated for your time and effort. Keep up the good work and I wish you the best of luck with everything!
I hope you'll eventually bring this product to market.
I'm trying! There are just so many obstacles. I'm still confident in the "DIY" workaround. But we'll see. I'm getting really close on the design. The fingers are final, I'm confident in the new winder, the gaffney is a prototype, and the gimbal is the same as the past 4 devices, so that should be good. Currently, I'm looking for funding to do 2 10-person trials. But trial funding is turning out to be more difficult than I expected. I'll eventually get it.
I'm sure you'll get it.
Once again, good work!
So much yellow tape and is and ts to dot and cross is such a drag. Some big company out there need to see this product and believe in it as much as we do.
I'd get so giddy if I saw someone walking around with a fully metal hand, i think i'd have to shake their hand
this is how big companies force innovation to die, by making sure they are the only ones who can actually bring stuff to market
Would you be able to make feet with toes section for those flat foot akward walking robots that boston dynamics and tesla brags about
Like the jerry rig everything "not a wheelchair"
If you are Class I, I think you only need to register. 510k is for Class II devices.
I think you could sell them as art pieces in the meantime lol, they are certainly cool enough
are these laws only that strict in usa or are they just as bad in other countries?
they tend to be just as strict, but slightly less being in bed with coperations and charging you thousands in regular, arbirary fees
You just have to Imagine this, someone who builds his prosthetic himself, because he needs it himself, and got good creativity and skill for building it. How will you make it better as a human who doesn't use it and just test his stuff on other people and makes it better based on secondhand ( pun not intended ) experience from them.
This just is probably the best mechanical device for people who only got a thumb left, period. As long as he just get money throw at him and goes get some help of mechanics and robotic specialist to just build a perfect electric one. This man is a opportunity for all amputees of his kind and I really hope some company's see it as just that!
For whatever good they may have once done or do the FDA has become something of a joke in my field. They're like an aging gate keeper who refuses to modernize but swings the door wide open for anyone jangling a nice bag of cash at them with a nod of their head. It's kind of like how the organic labeling has almost nothing to do with the food itself anymore.
On another point, of course you deserve compensation for your work! You've worked hard and brought us along for most of the ride and have inspired many people in the process. I want to see you succeed and be recognized for your effort fella!
I haven't browsed through all comments, but why not crowd fund, detailing each step in the process? I don't need the device, but I will help support it.
Did you tried to reach out the MiT lab ?
Excellent video! Unfortunately, yet another case of poorly thought-out regulations stifling innovations like your own. I wish you the best of luck in your efforts to bring your work to market!
"Poorly tought out"
That is the whole point of the regulations
@@hawoaliahmed6996 Well, I usually like to give the benefit of the doubt and assume ignorance or poor organization structure. But at the same time, you very well be right on that one. lol
@@plumpdolphin You shouldn't give benefit of the doubt because that's how the regulators keep getting away with it.
@@agentoranj5858 I see your point, and often times giving a charitable interpretation goes hand-in-hand with complacency. However, I see it that being kind with my words does not have to equal being complicit with the mistake, nor does it mean that I don't believe regulators have responsibility as well for how it is.
I just understand that there are a lot of factors trying to balance regulating large medical-tech companies and insurances, especially in a system as complicated and dis-functional as ours, such that they could have neglected to add provisions/consideration for smaller companies, boxing them out in the process. But whether they meant to do so or not, if it does not work well for the people and then I believe it must go. I just want to be polite in the process is all!
The ignorance seems to hit one way but never the other.
At a certain point you can only assume maliciousness.
I’d think the issue with this type of prosthetic, it would need to be completely customized to the user.
Out of the box set ups would definitely not work unless it was one designed for a complete loss of hand that functions on forearm twisting, raising and lowering to function.
"Get this man an arm!"
FDA and ATF are so similar its crazy
I wonder what the limitations for a partnership with a danish company would be
What kind of tolerances and volume are you needing just out of curiosity.
I'm curious if you could play guitar with such prosthetic :D
I think just pick a country that will give approval easily, then work with distributors in that country to sell your product. Many times people can just import the product for personal use into the US. As long as you don't directly market to US customers, you don't need to worry about it. Let the distributor do their thing, they know how to market to the US users without being considered marketing to US customers.
I don’t know if anyone’s said this yet, but rather than gathering the $30,000 for filing the paperwork, you might be better off lobbying congress to have non-surgically-attached prosthetics be made exempt to those requirements. It might be more work, but you’d be paving the way for biomedical engineers in the future.
0:14 yes sir based you are
If I'm getting a robot arm, I'm getting his
Try contacting FUTO organization and see if they would be willing to award a grant to you and creating this product based on their requirements. Like open source and customer rights like right to repair and no proprietary crap.
What if... - and you've probably thought of this before and perhaps not a viable solution... but what if it was modular, and you bought each part from a kit to suit your needs/requirements. A shopping list, you make each part to order as they user builds it. Would that allow you to sell and market it, almost like a l3go kit? The final prosthetic is your own creation. You provide help and support to build it (another revenue stream) Would that need approval? Start with a cheap 3d printed parts for the novice, something they can get used to and see if if works for them. As time moves on they upgrade parts and components for stronger, better ones. Maybe you need to trade mark it something, not sure on all that, it's just a shame others can't benefit from it globally.
This comment has been written to promote and help the video above!
We have a lot of people in Ukraine with such problems because of the war, try to find an opportunity to do something like this for them and maybe you will find customers.
Just a small devil´s idea.... How bout selling it as a "Costume" ? Would definitely work in my country. Here its common to sell chemical substances as "collector items" without any regulations. Same situation is definitely around EU.
Shark Tank? Even if you get on and they all pass, the exposure alone!
"Unless this is your first time watching one of my videos, then I'm sure you're aware that I'm based"
true
"Unless this is your first time watching one of my videos, then I'm sure that you're aware that I'm based." That's it, wrap it up lads, the president of the Missing Parts club has spoken.
Imagine a timeline where a prosthetic arm is as big of a touchy subject as a firearm. Yet here we are
That's epic and sad at the same time have you thought of 4th largest economy which have the lowest medical expenses. I have no idea just sharing
You could still sell it assembled as a toy or non-medical prosthetic for people to have 4 extra fingers.
:D kets make me happy after the depression that america just is.
Without knowing the all of the legal technicalities, it's not really a "prosthetic" because it's external, lightweight, and has little to no effect on the body. It's basically pair of hand shaped pliers. I'm surprised it's not possible to sell it under a different classification. If this needs FDA approval, any mechanical device that can be strapped to the body would need FDA approval.
I'm trying to figure out how its different from a pair of shoes. Its literally just something you fasten to an extremity. Are shoes prosthetic devices? No.
@@oldscratch3535 problem is the cost which Ian estimates to be around 4-5k usd in one of the other comments. Far cry from normal prices, but without insurance (and the medical device clause) almost no one can afford it.
I'm not a lawyer but couldn't you market it as a costume or hobby build that's unrelated to medical use? Because I could think of a few halloween costumes that would be fun to try and make with a hand like that. Victor from League of Legends comes to mind with his extra robotic limb.
you started great, but i think you missed the point, he wants to make his product available for the people who truly needs it
???? "Why not just market your invention as a prop"
@@c0quinha I think you missed the point. He's saying to just market it as a prop or hobby build. A person who needs it could still buy it.
4:43 he pretty much explains why here
"I'm sure you're aware that I'm based"
Yes I was in fact aware.
the land of the free
I've come with absolutely no knowledge but if the US is too difficult, what about the uk or eu?
Do you ever accidentally pinch the good hand with the robot hand?
Print it in stainless steel?
Give em hell!
Maybe you should apply under an EUA and then change anything you like and ignore all the rules?
Would it not be possible to go to other countries without such requirements ( as US have ) before going for US market ? This could give you good amount of data about how product would be received as well as money to invest in US market.
Not sure how it is in specific countries but taking in to consideration amount of subscriptions you have asking your "followers" to check in there own countries should work fine even if only 1% of them will respond.
We all want for you to succeed. You have done something that needs to be allowed to succeed as it is needed by lot of people.