The “old” design of the epi pen is obsolete.
These injectors are driven by springs and plastic parts.
Older designs had springs that did not always deliver the required force to make the plunger move inside the syringe cartridge inside the injector.
Auto-injectors function because the spring energy expels the contents of the syringe into the body.
The FDA has imposed tighter and tighter regulations on “combination” products that combine an injectable product with a device that allows delivery of the drug.
These combination rules require the creation and maintenance of “Device Design and History Controls” that provide documented evidence of validation for the product.
I have been in Pharma for almost 40 years and regulations just get harder and harder to achieve. The amount of $$$ that we in Pharma spend to meet FDA and other world regulatory rules is often prohibitive. If a company cannot absorb the cost, the pass it on in the piece price of the unit.
Finally, the reimbursement schedules for devices is another regulatory maze that prohibits competition as most companies will stop making the product instead of putting millions of $ into an old product.
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“I have been in Pharma for almost 40 years and regulations just get harder and harder to achieve.”
I know nothing about pharma :-). Absolutely nothing :-).
Is there some kind of minimum velocity a medication must enter the body (i.e. mL/seconds)?
If not, I can’t see why a micro-electromechanical delivery system can’t do the job (I’m an EE). There are lots of different technologies out there (check out MEMS if you are curious) where, under a simple microprocessor’s control, deliver the medication. It’d probably be cheap enough to put redundant MEMS systems in the pen given the task of the pen and it’s life saving properties.
The only drawback is that it might not deliver the medication at a fast enough rate into the body (though that can be addressed).
What’s slick about MEMS is that you can integrate the digital control onto the same die as the mechanical system. This translates into a huge cost savings manufacturing the control system. Moreover, they’re a heck of a lot more reliable.
I’d have to dig into the problem more, but I can’t see, offhand anyway, why this medication can’t be delivered electromechanically in a simple pen form.
The military has been using auto-injectors for decades for things like atropine. If it’s good enough for them it should be good enough for civilians.
I think the Israelis make an auto-injector that was submitted to the FDA for approval. I wonder what’s happening with that?