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Comment by lkrubner | Hacker News Reader

This sounds like it will be an absolute disaster:

"This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick."

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Having been in the Medical Device industry for the past 20 years, I read the article thinking I was going to disagree with you completely. Now I'm not so sure.

This is farther than I would have expected the FDA to go. I can see releasing a device without full clinical trials, because those can be extremely difficult to set up and can create very long delays. Imagine having to find a large enough number of people with just the right disease state and who consent to be part of the group, then getting the right control groups, building relationships with labs and hospitals in the right places, etc.

But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with. There's lots of precedence: nobody ships their devices off to the FCC for emissions testing, there are independent labs that sign off on that. Likewise companies such as UL that set safety requirements, have been around for decades. But as much as we bitch about the hoops we have to jump through to keep the FDA happy, I think deep down we're all glad they are there to do the job and keep us honest.

The moderating influence is that device manufacturers as a group are generally extremely, repeat extremely, conservative. The Quality Assurance engineers are generally a brick wall that have to be completely appeased before they will allow anything to be released.

"But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with."

This is exactly what happens in Europe, though. And it's one of the reasons we generally release products there first.

Sounds like a relatively biased article.

"Breakthrough therapy" designation already exists for drugs. The FDA identifies those drugs that have shown promising results in early trials for diseases where there are few treatments.

The reason this is being done is because the choice isn't between an untested treatment and a tested treatment, it's a choice between an untested treatment and death. Why shouldn't physicians/patients be given an opportunity to try out a therapy when no alternatives exist?

Obviously (and the FDA already does this), the risk/benefit should be carefully analyzed. It makes no sense at all to allow a device on the market with little data if it doesn't provide a substantial benefit where none currently exists.

Concerning the follow-up trial that the FDA requires of manufacturers: I'd have no problem at all if the FDA provided "temporary approvals". You're device/drug looks promising, so we'll approve it now, but you need to run a full trial to provide the needed data. That trial will take 2 years to conduct and readout? Great, you now have a 2-year temporary approval and if the data doesn't show up, we pull your device/drug off the market.

> Sounds like a relatively biased article.

It's an op-ed. The entire point is that it's biased.

>This sounds like it will be an absolute disaster:

It does; but isn't the status quo also an absolute disaster?

No, IMHO. The status quo is an attempt to walk a knife-edge ridge with cliffs on both sides. There are failures on both sides, and different people getting burned by the failures on each side. Both groups decide that the status quo is an absolute disaster, but disagree on which direction the disaster is.

Your statement seems to be a bit self-contradictory, or else I've read it wrong. So you agree that the status-quo is bad, but you think that almost anything else would be worse?

I notice in another reply ITT you stated that you were once employed in engineering medical devices and left that line of work because of the "horrible environment". That's another anecdote I'd use to support my opinion.

> So you agree that the status-quo is bad, but you think that almost anything else would be worse?

I think the status quo is a trade-off between too easy and too restrictive. Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other.

Re the horrible environment: It was horrible in that we didn't (at the time I was there) have much automation to handle the FDA documentation requirements. (Don't think the standard "document your code" here; FDA requirements are much more than that.) The result was a mass of manual paperwork for the software engineers, which (at least for this one) is a horrible environment to work in. It got better after I left, as they got more tools to help them.

> That's another anecdote I'd use to support my opinion.

But I don't see it as supporting your opinion, and I'm the guy it happened to.

>Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other.

Your statement I just quoted above is FUD. I'm not arguing that the OP link describes the best way to reform the FDA, but I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process.

>But I don't see it as supporting your opinion, and I'm the guy it happened to.

But it's my opinion. You get to make and have your own opinion, but not mine.

Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements.

A lot of assumptions are being made here, but your anecdote isn't dissimilar from other ones that I have heard, and negative anecdotes are in the majority WRT this field. Overriding conclusion is that better engineers are avoiding or leaving the field; leaving those jobs for less-capable candidates and driving costs up.

> I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process.

I never said that there is no room for improvement. I said that changing things so that devices are released faster almost certainly means that some number of devices get released that are unsafe. Changing things so that devices that are released slower almost certainly means that some other number of devices get held back that would have been safe. I take no strong position on where we are in relation to the optimum spot. My personal opinion is that the FDA was in about the right spot about 6 years ago, but I am not dogmatic about that opinion.

> Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements.

Thanks. I'd like to think that, too. But it's also possible that an engineer whose temperament was to move too fast and not careful enough found that he was in the wrong environment.

Right. Then the FTC/BCP will swoop in with massive $$$ lawsuits over unsubstantiated claims.

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