[sanarothe]

I have seen them called something like 'government affairs' - We have them in med device for various reasons. Current company is in market creation, so we have people on staff who build relationships and (ideally) change policy in VA, Medicare and other government health orgs, all as part of the fight against insurance non-authorization & non-coverage. US health insurance is evil and needs fixing, so in this case I think it is a positive.

Last company, megacorp, has a full-time guy in Brussels who does regulatory intelligence and represents the company in the legislative process.

I think EU MDR, the 2017 European medical device regulation, indicates there is probably some value in having meaningful input from the giant corporations in the relevant sector being regulated. The burden on med device manufacturers to get market access to the EU has become very high - the enforcement date of the regulation has been pushed back year after year because it's taking forever for companies to overhaul their technical documentation for this regulation (no grandfathering clause, everything state of the art), and taking forever to get review by notified bodies (not enough notified bodies, TON to review for every device family).

The result is that there are just fewer devices on the market. Companies are looking at their volumes vs the effort EU wants to maintain market access for something that's been available since 1985 and the choice is an obvious nope.

It seems like the regulation was created in a bit of a bubble. Perhaps if there were more stakeholders at the table who could say "Um this is a ridiculous hurdle and I'm going to drop from the market if you implement this" or "We don't want to be a notified for body EU MDR, the burden is just too high and costs don't work out"... maybe we wouldn't be in this absolute fi-esta.

(Source on market availability - https://www.medtecheurope.org/wp-content/uploads/2022/07/med...)