Also, as an FDA certified medical device, the rough rule of thumb (that I was taught while on an internship) is ~5-7 times mark up on BOM+assembly cost. I thin

Also, as an FDA certified medical device, the rough rule of thumb (that I was taught while on an internship) is ~5-7 times mark up on BOM+assembly cost. I think the markup varies quite a bit more widely than that, probably along with device complexity. As someone who has been a member of the development teams for various complex FDA-regulated medical devices (think image-guided surgery), the markups I saw were more in the 10-15x range.