I would agree it's not so much strictly hardware as strictly Big Co. But I don't think a clean separation between development and production necessarily leads

I would agree it's not so much strictly hardware as strictly Big Co. But I don't think a clean separation between development and production necessarily leads to a slow development cycle. I've worked for both federally regulated biotech startups and huge biotech companies, and you can definitely be agile and fast even in that space, as long as you're small.