[sweetcherrypie]

Naloxone is the drug used to block the effects of opioids. LE carry them, but at the cost of $4500 for two injectors. The Narcan spray is slightly lest costly iirc. I'm a uni student working on designing an auto-injector that could be used instead (the medicine itself is very cheap) and potentially to administer epinepherine too (also a case of cheap medicine - expensive administration device).

I've made some progress but have no mechanical design experience. I'm not optimistic about the time period needed for FDA approval so I'm really doing it for the learning experience. I'd love some help!

[mv]

It is absolutely criminal that a <$20 drug can be sold for $4500... Auto-injectors have been a solved problem for decades, and there is nothing special about naloxone vs any other drug. Treating auto-injecting tech as different for each drug only helps drive up prices and keep out competition by making FDA approval very expensive.

I hope you are successful getting a generic auto-injector approved, but I don't think your biggest hurdle will be design or engineering.

https://www.nejm.org/doi/full/10.1056/NEJMp1609578

[DanBC]

> Auto-injectors have been a solved problem for decades,

And yet we still have stuff like this: https://www.judiciary.uk/publications/natasha-ednan-laperous...

>(3) In the Emergency treatment of anaphylactic reactions Guidelines for healthcare providers the preferred needle length is 25 mm for adrenaline injectors to access muscle in most people. I heard during expert evidence that Epipen needle length was 16mm - suitable according to the UK Resuscitation Council for “pre-term or very small infants”. The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe. An alternative autoinjector, Emerade has a 24 mm needle.

>(4) The dose of adrenaline in Epipen is 300mcg. The UK Resuscitation Council recommends a standard emergency dose of 500mcg. Emerade contains a dose including 500mcg. The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns.

[mv]

The Auto-injector's themselves are a solved problem and the device itself did not fail. However,

-For over 10 years, It well documented in literature that even in normal BMI women the needle is not long enough to reach muscle. https://www.ncbi.nlm.nih.gov/pubmed?term=15945556

- Prior to around 2003 IM and subcutaneous routes were both listed as valid treatments for anaphylaxis. (See https://www.aafp.org/afp/2003/1001/p1325.html)

-Depending on her weight 300mcg may be an appropriate dose for US guidelines (listed at 0.01mg/kg).

The listed issues may be from a company taking a 'one-size-fits-most' approach. They also do not update their product with respect to new guidelines and recommendations (new doses, new needle lengths, etc) Possibly to avoid further FDA approval processes? With such large profits and so little competition there is no incentive to innovate/update.

[CodeWriter23]

My suggestion, keep a journal about the process you go through (design, manufacture, ip, regulatory) and publish that when you’re done.

This whole area of portable medical devices is in serious need of disruption. Knowledgeable people should be able to enter into this area. Check out the insulin pump hackers if you haven’t already to get a peek at what is possible.

[grkvlt]

That USD 4500 for two is nonsense. In the UK, they are GBP 15.30 each, according to this report: https://www.sciencedirect.com/science/article/pii/S109830151...

[Balgair]

Sounds like a great project with a real need! Maybe consider the Ycombinator route, as it seems there is a niche you can scratch.

FDA typically takes ~10 years to get through (though this WILDLY varies).

Make sure to put your contact info in your bio so HNers have a way to contact you!

[subculture]

Today in California a person can walk into a Target Pharmacy and get 2 doses of the Narcan spray for less than $100, without a prescription.

[weisser]

Interesting. My email is in my profile.