“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.
There certainly are alternate technologies.
I have seen designs and functional samples of autoinjectors that use a compressed liquid that expands to gas, rotates a screw and pushes on the plunger system to expel contents.
Variables for injection time include needle ID, solution viscosity and volume to be injected. Typical water based solutions have injections times of <10sec.
More info has come out about this company...the reports said something about stock purchases linked to exclusive use in FED reimbursements and huge profits on the stock increase.
G