We don't have a law that says we can

Let's start this posting by saying that I work on implantable medical devices and the lives of people are indirectly affected by engineers like me. I understand that there must be rules and regulations regarding actions that are taken in regard to the quality and safety of the devices. People have been harmed due to poor judgement, poor product design, off-label usage, and even blatant stupidity. My issue is when our hands are tied from doing the obviously right things. The hallway comment of the day is "we don't have a law that says we can". To improve on the manufacturing process in such a way that improves quality is to admit to the FDA that there must have been a quality problem. Even if the improvement reduces the incidence of failure from 1 in 10000 to 1 in 500000, this is still a corporate shortcoming that must be dealt with harshly. How did we manage to drive Miss Daisy to the asylum? Medical innovation in our core products has come to a grinding halt because the FDA believes that (with enough rules and regs) that they can actually legislate quality. Actually, you can no more legislate quality than legislate morality. Quality comes from within the DNA of an organization, where there's absolute intolerance for defects.

Over the summer, I offered my services to one of our senators at possible risk to my job, because I think that this an issue that needs addressing if we're to continue to lead the world in medical innovation. I've received no reply whatsoever. Maybe ignorance of the problem (and possible solution space) is bliss. Since this is a senator that's from our state, someone that I've contributed to, and also on the Health and Human Services committee, I thought that I'd at least get a "thanks but no thanks", response ... nope. More likely it was her staff people that vetted me as some sort of crack pot, rather than an upper level engineer that develops strategies for product quality and reliability. In any case, if it's not me that helps in fixing the status quo, then there needs to be some forum for getting through this morass.

OK nation, this is today's request to become more rational.

P.S. Someone figure out how we don't move critical medical device manufacturing to China ... transparency on quality issues is not at all the Chinese corporate DNA.