Edit: Hi all, it seems like the general consensus is that this is a dangerous product. I really believed that I was making something helpful but that may not be the case. I have decided to take down the listing from Cults3D. Thank you for your feedback.
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Design looks slick and I’m glad it’s solving a problem that you have, but as someone who works in medtech I have to say - actually selling this as a product would probably be classed as a “Bold Move”.
The product you are marketing is controlling the dispensing of a drug, so is pretty unambiguously a Medical Device. The details vary by country and exactly which category this ends up in, but you are almost certainly required by law to seek approval from the regulators for any jurisdiction that you are marketing this product in. I’m not totally clear if “selling designs to produce a Device” would attract the same level of scrutiny as “selling a Device”, but generally I’d recommend not screwing with the FDA.
Also, I would be extremely concerned about germs and things getting into the layer cracks. FDM printing is okay for single-use, but they can’t be cleaned properly for prolonged use.
Somebody catching something because they took their medecine from an inhaler that’s been floating around in their purse/pocket/backpack… is going to prove problematic. I know that medical devices require strict testing in the US.
Still it’s a remarkably slick device. I’m just not sure FDM printing is the way to go here.
I agree. Admittedly I haven’t dealt with the legal side in years and never outside my own country. But definitely talk to a specialist lawyer or other expert about it. Because of the oral application it might not even be the lowest level of medical device anymore. And with that comes a multitude of regulations. From durability to material to production environment.
I like the idea and as someone who had to use a dispenser in my youth, I appreciate the smaller profile of it.
FWIW, resin may be better.
But I definite, OP should chat with somebody that knows more- I just know enough to say that much.
Isn’t the type of plastic used in resin prints relatively toxic?
Frankly, I’m not sure there’s a good alternative to traditional manufacturing (injection molding or whatever) for this application.
It depends on the resin, there is resin that are food safe or even biocompatible
There are medical grade resins
I’ve not used them, and I’m not an expert, but I assume there’s a way to make them safe for an inhaler.
Best case scenario might be if OP can work with an existing company to produce this design, with the right materials and approvals
I had to go through the regulations regarding plastic packaging and delivery systems of drugs for work and, yeah, you would have to go through a lot of testing and certifications for it to FDA compliant, especially for a inhaler.
Hey, thanks for your input, I agre e with you for the most part. I agree that it would be a different matter if I were selling the inhalers themselves, but I just put up the files. I made something I thought was cool and posted it so others could make it too. I’ve tested it exhaustively and believe it isn’t dangerous but dont necessarily have the means or inclination to pursue production on a commercial scale that would require some sort of regulatory intervention.
That said, I have included a disclaimer in the description mentioning this. Thank you.
Despite your extensive testing I would strongly advice against using it, due to things you might not be able to detect. A main concern is what we call leachables, molecules that can, well, leach from the material to the product (such as plastifiers, melting agents, etc). Since you are spraying the substance straight to your lungs, the danger level is maximum in terms of contaminants (the regulation regarding extractables and leachable actually started with Metered Dose Inhalers) and I doubt that a plastic designed to melt easily is really fit for this kind of applications. In the industry you would have to track the components of the raw materials and conduct several tests on each part of the device, to insure that it is below accepting doses. And then you would have to account for the sterility aspect of 3D prints…
That being said, very nice design though!
Edit: it is quite similar to why you should use ‘microwave OK’ plastic only (but in your lungs and with another kind of plastic)
I think that would be a defensible position if you weren’t selling the files. The distinction between “purchased a physical product that someone manufactured” and “purchased the designs and fabricated a physical product to the designers spec” is pretty semantic.
A safety disclaimer is a good step, but (in my opinion) once money changes hands you become a manufacturer and take on the responsibility to ensure the product you are selling is safe
Hi all, it seems like the general consensus is that this is a dangerous product. I really believed that I was making something helpful but that may not be the case. I have decided to take down the listing from Cults3D. Thank you for your feedback.
Smart move, for real. It sucks because I can see that this is something you made to solve a personal gripe, but you do not want the liability that selling this comes with.
Apply for a patent and sell the rights to manufacturers who can make something safe to use. That is a really slick demo video.
Nice print, but is this not in the same league as 3d printing for food stuffs? As in it’s not hygienic and not possible to sterilize? Those ridges are bacteria breeding grounds!
Yeah, this seems like a really bad idea.
Indeed not in the same league. It’s next level.
FDA open up!
POSTING AS MOD:
I don’t think medical is a good idea, and I don’t like that this is posted as a product for marketing. I like the design in general.
I think it is healthy to respectfully discuss the implications of this type of application. I also would prefer citations for anyone feeling strongly about any angle of this discussion.
My policy for moderation is to tread lightly. I’m just another hobbyist user like yourself. This place belongs to y’all. If this community post (OP) votes into the negative, hours from now, I’ll remove it.
Sorry for the unexpected negativity. I know that can feel discouraging. I like the design ingenuity, and I genuinely hope that you will continue to design and post about them. My comment as mod was because someone flagged this as violating rules… but those are more like strong guidelines. I don’t see this as being a serious medical danger but I’m no expert.
I dig the design, but I worry about something needing to move those parts while having an attack. I wonder if you could have it go back to its “ready” form with a spring/button or something so it’s easy to use in an emergency.
Nice design and great print dude. I wouldnt worry for myself too much, but I defo agree with others about health concerns. I wonder where are all “food safe” haters now haha (dont hate me, I love you all 😘). Its always funny to read stories for and against “food safe” printing, but since this is more serious than one-time-use cookie cutters everyone remains quite it seems. What is the difference, do you guys think cookie cutters, popcorn bowls or cups are less dangerous? Personaly Im not really concerned about my own health, but I think its unfair if you dont warn others about dangers and let them decide if they want to use it or not.
Like many others, Ive been printing respirator adapters in the begining of covid pandemic. Hospitals were moding respirators to use one device for 2 patients and that thing did more good than harm for sure in that life or death situation. I feel proud for contributing and I believe it actually did no harm (no prove), but it would be stupid to claim that adapters were safe even for one-time-use. There are so many laws, certificates, procedures,…that try to protect us from buying unsafe products made in garage by guys like me. In meantime, kids eat snow, suck dirty fingers, chairs and what not they pick from the ground and then we hear thats normal and it improves our immunity hehe
TLDR: think with your head, make your own decisions and dont listen to every guy on the internet 😉
Nice design!
I might be too late since you said you took down the post and I can’t find a link in the post. Couls you post a pic so people like me know what was the discussion about?
Hell yeah!
I have one that has a retractable mouthpiece that slides out when you twist the bottom. It’s great for portability, but the mouthpiece is very small as a downside.
Yup, I saw similar stuff online but didn’t like anything so decided to make this instead!
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I think that 3d printing is not food safe because of the layers.
One can decide for themselves if they want to take that risk, but commercially selling medical stuff with those issues would not be my cup of tea./e oops, replied to the Not instead of OP.
Yeah, the microcrevices and stuff already makes this a bit dicey, but the fact that this is technically a medical device?
You should, frankly, probably talk to a lawyer. There’s very likely some laws, regulations, and approvals you need to follow before you can sell something like this.
Yup, totally with you on that, but since it isn’t supposed to come in contact with food particles or such and can be washed, it’s not really something I’d worry about. Mouth contact is only with the outside of the mouthpiece which should be frequently wiped and washed, so I haven’t really noticed any build up or smell.
The problem is exactly that you can’t wash it. Prints have dips, bumps, and gaps, especially at the microscopic level. The perfect place for bacteria to find a home. Resin would be one thing, but filament can’t be made safe, not for food, and definitely not for medicine that goes into your lungs.
I get the concern with that, but Ventolin does not contain steroids and therefore does not attract bacteria. This inhaler body only works with Ventolin which only contains Salbuterol. It is not something attractive to bacteria.
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I think big pharmas got a new lawsuit cooking.
Jokes aside, good print, and awesome idea
Nah, this is a bad idea for the same reasons printing stuff to interact with food is a bad idea. Fdm printing leaves gaps that are perfect for bacterial growth and basically impossible to clean.
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