Example of what happens when your medical device just plain doesn't work:

http://www.highbeam.com/doc/1N1-118387E2698885C8.html

Example of what happens when you give 'deal sweeteners' to get your device into a health care facility, or IDN (Integrated Delivery Network):

http://physicianlaw.foxrothschild.com/2009/03/articles/fraud...

Just a couple off the top of my head, many, many more just Lex/Nex it. Or probably better, if you are thinking about getting into this area, PLEASE, talk to your lawyer.

Punishments are generally so harsh because it is considered fraud. The defendants were selling software that didn't work. They either knew it did not work, in which case it is pretty much straightforward fraud, and God help them if someone dies. Alternatively, they did not know that the software did not work. In which case they committed fraud when they represented themselves to the health care organization that purchased the device as being qualified to make a determination as to the efficacy of the software or device. Again, God help them if someone dies.