342 karma · joined December 23, 2011
Same for me. I've been in the medical device industry for 15+ years now and came from "tech". What a lot of techies under/don't appreciate is that the medical device industry is heavily regulated and moves at a muuuch slower pace than other technologies.
There are lots of regulatory and quality/testing hurdles that you must clear (namely verification and validation testing, in addition to your 510(k) clearance or approval, if PMA) before you can market and sell your device.
I tell customers, on average, a Class II medical device project can take 18-24 months and cost $3M to 4M, minimum.
25 years later, jerry thinks the company has lost its independence? the independence was lost before the ink dried on the sales agreement. unilever never cared about their social mission, period. they've been "dealing" with it since the acquisition.
why not take the sale proceeds and pursue other social missions? btw, phish food is my favorite flavor! <3
* https://www.healio.com/news/pulmonology/20250518/platform-li...
- Certain states have serialization requirements and registration once a firearm is assembled (the slide is connected to the frame).
- Many states require a permit to conceal carry but may only require a driver’s license to purchase (meaning you can own but not conceal without a permit).
- If a store posts signage saying firearms are prohibited, you legally can enter, however you can be trespassed if they discover you possess a firearm. This is generally not a criminal charge, unless your firearm is possessed illegally or another violation has taken place.
- A “suppressor” (the more correct and accurate term) is purchased from an FFL and transferred to the buyer via an ATF Form 4 (not a Form 1). Additionally, certain states do not allow the possession of a suppressor, regardless of the legality at the Federal level. FFLs don’t generally manufacture suppressors, they sell them.
anything can be a "weapon of war" if desired. actors are using broken up bike chains for shrapnel in IEDs. is my huffy a weapon of war? :/
either way, very fascinating experiment. i look forward to hearing about the results!
additionally, product testing != human trials. they are two very different things.
final product testing is called "design verification and validation" (aka dV+V) where a statistically significant number of devices are tested against several different categories.
human trials can run the gauntlet from a small IDE studies to phase I through IV.
the drug approval process is MUCH different than the medical device process.
it's frustrating that the article uses the term "approve" which is specific to PMA devices (class III), whereas class II devices are "cleared" by the FDA.
- a medical device executive
once you appreciate the dance that all functional teams perform in an organization, you'll experience true success.
a few to check out are Dieselcreek, I Do Cars, and Watch Wes Work.
one time i gave a friend some advice and he did the exact opposite. oh, the satisfaction! xD