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.
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
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