Expectations for Medical Innovations

Deleted by Del...argumentative.
(surely not )

C'mon Kitty---spit it out.

"Medical device sector" includes everything from CT scanners to bandaids. It includes 'devices' that are tried and true and maybe unlikely to be superseded by new innovations. And it includes devices that are untried and untrue - the hype about using MRI for dubious non-medical applications comes to read my mind. Maybe this is the "major breakthrough" syndrome referred to above. Or maybe the push towards non-medical and recreational applications and markets is spilling over from the general pharmaceutical trend in that direction, so the goal of R&D is no longer clearly medical.

Please cite this 'recent assessment' because as someone who has had a fiber optic probe inserted into into my ephemeral artery at the groin, snaked up into a tumor in my lung which then cauterized a bleeder with a laser all without anesthesia and was handed a DVD of the probes video that afternoon I doubt you have a clue as to what medical devices are capable of today.

http://www.emdt.co.uk/article/race-for-open-innovation

The problem in the US isn't lagging private sector innovation. It is the Geological time scale of the FDA and its mission and vision of saying "NO!" here is just one reference on this subject:

"If you've spent some time dealing with FDA, you've probably been on the receiving end of many, many questions or even a definitive "No" or two. In fact, some in industry are convinced that FDA has a well-hidden and busy "Department of NO." But with the right resources, plans, and advice, you can stem the tide of endless questions or potentially even turn a "No" into a "Yes." "

This is from an advert for a teleconference on how to deal with the bureaucrats from FOI teleconferences.

There is a need to protect the public from the snake oil and shabby operators, but a bureaucracy which requires "certainty" in an area where statistics can only establish correlation and not causality is in over its head- getting to yes in such a situation is a pretty tall order for the average fraidy cat bureaucrat...

<sorry del>

Milo

I'm not convinced the FDA is to blame here. What about their work on the Critical Path Initiative since 2004? FDA has taken a leadership role to try to address some general problems identified in the "Innovation or Stagnation" report 2004, to help industry to capitalize on scientific breakthroughs and speed the development of usable products and applications, and to improve the pre-clinical screening process, among other things.

In 2004, the failure rate of drugs in clinical trials was close to 90% - many of these rejected due to unacceptable levels of liver damage. But everyone in the business wants to get their product approved and to market ASAP. The industry can tolerate fatalities if the overall sales are more than the compensation. So, love em or hate em, the FDA is needed there to draw the line. It's just as common to hear complaints that the FDA is biased for the big corporations, and too easily approving bad stuff.

I'm surprised to hear you say that the FDA required "certainty", because afaik, for efficacy standards, they only ask for a small percentage better than placebo.

On the subject of statistics, you might be interested to see that they have sponsored development of Bayesian software for use in clinical trials - it's in the list of projects in their 2008 report.