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.
Nice design!
