rp1954 wrote:As for future availability in the US, anyone know how much the FDA new device regulations are a stumbling block like for foreign drugs, where years go by if ever ? NIH also stands for Not Invented Here.
I can comment on this to some extent as a medical device engineer for a company whose product is available in most of the EU, but not in the states. I'm probably biased...but my bias lies in the fact that I want to increase technology faster and the US system is designed against increasing technology. Increasing technology faster decreases safety, that's just simple math, but I think the overall good of technology outweighs the bad. On top of that I believe that if I make a decision and want something done to me and I've decided to release liability of the others involved I should be able to do that. Call me old fashioned, but I believe in liberty. I also do not place false trust that the FDA is going to keep me safe and therefore have no responsibility to make sure something someone does to me is the correct thing. The FDA just said trans fats are bad for you after papers since the late '60s have said the same thing (one of many examples). What's the saying fool me once shame on you fool me twice shame on me. Anyways...
FDA regulations are quite tough especially for new therapies/devices (stuff invented after 1976). It likely to get this approved in the states it would require a clinical trial. Clinical trials are incredibly expensive. Someone has to do the ROI calculations on whether to bring a tech like this to the states. I know right now many companies (even companies based in the US) are developing device purely for the EU because their regs are easier to work with. Then they hope to get acquired by a 'big guy' (J&J, Medtronic, etc...) to let them deal with the FDA. This is where the FDA actually hurts patients. Because the 'big guys' may already actually have a technology in the same space. It may not be quite as good, but good enough. So the 'big guy' isn't incentivised to develop/acquire new technologies because in the end they will just be cannibalizing the sales of their current technology. So US patients don't get access to the new technologies.
In a nut shell in the US the FDA focuses on both safety (does the thing harm the patient) and efficacy (how the thing works) and you need to prove both before allowed to market your thing. In the EU the regulators focus on safety. They leave the efficacy part up to the doctors judgment. Safety is a relatively easy thing to determine efficacy is much more challenging and typically requires large clinical studies. I'd say in Europe medical technology is 5 to 10 years beyond that in the states.
The even more frustrating thing is a technology could have been used for years and years in the EU and treated 10s of thousands of patients. The FDA could care less. The EU has similar adverse event reporting standards as the US does, so if a technology didn't work or doesn't work the FDA could find out, but they just don't care. They want to see a completely scientific study with controls. Which isn't a bad thing, but what data is better a couple hundred patient study with controls (where only the best patients are selected to enter the study) or the 10s of thousands of patients that have been treated in the EU with the same technology in a market release.
In the end the FDA is not in an enviable position, they get hammered in the media if they miss once. The fact they miss so little shows that industry really wants to do the right thing. Medicine is not a perfect science there will always be bad outcomes no matter what. Unfortunately the American public has gotten into their heads that if something goes wrong it's someone else fault and they must pay. So we get the system we ask for and will continue to pay more for less.
As far as going over seas to have stuff done...I would not hesitate. Germany is one place I'd go for a number of things. I went to Stanford to have my cancer removed because the surgeons at Stanford remove cancer everyday, the local guy does not have as much experience. There's a reason why everyone gets paid more when they have more experience, they're less likely to screw up and more likely to do things right. It's no different with doctors. The surgeons in other countries have been working with certain technologies years longer in some cases than their US counterparts, so I would expect them to be better.