Re:EpiPen Price Rise Sparks Concern for Allergy Sufferers
by chiph on Monday August 22, 2016 @10:14PM
(#12340914)
I haven't worked with this class of medical device, but I expect the major cost of the unit is in the approvals and lawsuits.
So far as the pen itself - They've got some injection-molded plastic, where the mold costs are amortized across the production lifetime. A needle + syringe, which are probably subcontracted from Becton Dickinson. A spring. A printed label. And the medication itself (probably the #2 cost).
The assembly of the above all had to conform to the FDA's Good Manufacturing Practices rules. Every part & ingredient had to have trace-ability to their source. With documentation thereof.
When we got our device approved (in a looser classification than this) we had to get UL approval ($50k per test, per device, per test-run), and we had 3 people on staff whose sole purpose was navigating the FDA paperwork and their approval process. I never heard what that cost was, but it was substantial. And then we had an IP attorney, and corporate defense attorneys to respond to the inevitable lawsuits.
So far as the pen itself - They've got some injection-molded plastic, where the mold costs are amortized across the production lifetime. A needle + syringe, which are probably subcontracted from Becton Dickinson. A spring. A printed label. And the medication itself (probably the #2 cost).
The assembly of the above all had to conform to the FDA's Good Manufacturing Practices rules. Every part & ingredient had to have trace-ability to their source. With documentation thereof.
When we got our device approved (in a looser classification than this) we had to get UL approval ($50k per test, per device, per test-run), and we had 3 people on staff whose sole purpose was navigating the FDA paperwork and their approval process. I never heard what that cost was, but it was substantial. And then we had an IP attorney, and corporate defense attorneys to respond to the inevitable lawsuits.