7 ms·

The F.D.A.’s Medical Device Problem

30 points by sethbannon 11y ago

lkrubner 11y ago
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."
- digitalneal 11y ago
  Right. Then the FTC/BCP will swoop in with massive $$$ lawsuits over unsubstantiated claims.
- refurb 11y ago
  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.
  - navait 11y ago
    > Sounds like a relatively biased article. It's an op-ed. The entire point is that it's biased.
- HeyLaughingBoy 11y ago
  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.
  - seehafer 11y ago
    "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.
- fnordfnordfnord 11y ago
  >This sounds like it will be an absolute disaster: It does; but isn't the status quo also an absolute disaster?
  - AnimalMuppet 11y ago
    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.
    - fnordfnordfnord 11y ago
      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.
      - AnimalMuppet 11y ago
        > 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.
reasonattlm 11y ago
The less FDA the better to my eyes. The incentives are broken, and the FDA is greatly slowing progress at a time when the potential to create new medicine is greater than ever before. Regulation is reason why we don't have the first fruits of the biotechnology revolution in the clinic today. The much-touted ballpark estimate of a billion dollars to produce a modern pharmaceutical from start to finish is about a decade old now - that figure is adjusted for today's diminished dollar value, eroded by inflation. You can replace "pharmaceutical" with any medical technology that is going to require a fair amount of original research and further tinkering in the laboratory to obtain the first working prototypes and the result is much the same. This large round number is the kitchen sink cost across a decade of work, including failed attempts and the opportunity cost of investment. The lion's share of the direct expenditures are imposed by regulatory requirements: trials, data, and more trials. It has long been my position that almost all of the work carried out in the US at the behest of the FDA to prove safety is unnecessary. In fact it is counter-productive, as the immense imposed costs on development shut out a great deal of the experimentation and small-scale initiatives needed for rapid progress. Much of what the FDA demands is not demanded by similar regulatory bodies in other parts of the world, and even their requirements are very onerous in comparison to the standards in place fifty years past, a time when medical development seems to me to have worked just fine. It is a question of balances and choice: it is better to err in favor of faster progress and informed patient choice, but that is very far from the present state of affairs. The result of an excessive and growing regulatory burden is that many potential medical technologies languish, are rejected outright, or are never developed at all, and patients suffer as a result. Our future health is determined by the pace of progress, and a slowdown across the board harms all of us considerably. Unfortunately that cost is invisible to the public at large and thus bureaucrats suffer very little as a result of the harms they cause by blocking progress. Meanwhile even comparatively small harms caused by an approved treatment that turns out to be overwhelmingly beneficial save for some negative effects for some people can snowball in the media to cause great damage to a career in the FDA bureaucracy. So you can see that the incentives are very much aligned with ever greater demands for proof and ever greater costs imposed on medical research and development. This is in fact what has happened over the past few decades, with the present result that in an age of radical progress and plummeting costs in the laboratory it is nonetheless the case that medicine is ever more expensive and the introduction of new applications of medical research has slowed down. This is well known and widely commented on, but so entrenched that this detrimental trend shows no signs of slowing. So, to return to the cost of developing a modern pharmaceutical product: estimated at a billion dollars (in today's dollars) ten years ago, the same approach results in an estimated $2.5 to $2.8 billion dollars now. Interestingly the bulk of that is apparently not due to the increased time required to run the regulatory gauntlet, but rather largely due to other increases in the demands of regulators: much larger trials and more data. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014... http://lifescivc.com/2014/11/a-billion-here-a-billion-there-the-cost-of-making-a-drug-revisited/ http://lifescivc.com/2014/11/a-billion-here-a-billion-there-... There is great frustration with this state of affairs, and it manifests with the creation of organizations such as Faster Cures and Tomorrow's Cures Today, none of which seem to be making much difference, sadly. The lobbying makes some people richer, and nothing changes as a result. In the end the only thing that is going to work is regulatory arbitrage - that the development goes to other parts of the world, and therapies are available there until the FDA is shamed into approving them because the people in charge look like clowns if they don't. This is exactly what happened for stem cell therapies; those available in the US today would still be held up in interminable trials and requests for more data without the fact that they have been widely available in overseas clinics for years. The pattern of activity in the FDA has nothing to do with safety and efficacy and everything to do with job security for bureaucrats.
msoad 11y ago
I know Apple Watch oxidometer and some health related software were disabled because FDA was not able to approve them fast enough
crisnoble 11y ago
As an insulin dependent diabetic I am consistently frustrated at how slow the medical device approval market moves. There is a reason that the most advanced insulin pump that I can buy 2015[0] looks like a pager from 1998, and it is not because the companies are moving too fast. I have been told that the reason all of the supporting software is so outdated is also because they are handcuffed by the FDA approval processes. I can see the author's point of view, but this is a rare case (for me personally) that I am not in support of more government oversight. [0] http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite http://www.medtronicdiabetes.com/treatment-and-products/mini...
- poke111 11y ago
  This is also a textbook case of what is seen vs. what is unseen. When someone dies from a treatment that the FDA has approved, that is a visible ("seen") tragedy. When people are suffering from ailments that could be treated more effectively if not for the FDA slowing things down and raising the cost of development, that is unseen. There's no single victim you can point to. But the latter is hard to quantify in the risk vs. reward calculation, and importantly no FDA bureaucrat will ever lose their job or be publicly shamed because of them.
  - cmdrfred 11y ago
    How the FDA handled the removal of CFC's from inhalers shows you clearly they are not on the side of the consumer. The slowness likely has something to do with incumbent companies not wanting to spend on R&D. http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much http://www.motherjones.com/kevin-drum/2013/10/heres-why-your...
  - WalterBright 11y ago
    This was all clearly laid out (with backing statistics) by Sam Peltzman in his 1974 book "Regulation of Pharmaceutical Innovation". The statistical result of the 1962 Amendments is that the beneficial effects of reducing the amount of bad drugs being released is far more outweighed by losing the beneficial effects of drugs being delayed or not being developed. But people only see the former.
fnordfnordfnord 11y ago
This ought to be called "experimental" medical devices for some probationary period pending large scale studies, and people ought to be able to buy and use them being informed that there is potentially some additional risk. A similar thing exists for general aviation aircraft for the same reasons.
icegreentea 11y ago
We were just talking about something like this this morning. My company makes diagnostic devices for hospital settings, and we were bitching about the lack of a middle road for introducing changes to devices. To somewhat oversimplify, either the change doesn't effect the function of the product, and in which case internal testing and documentation is all that is required, or it does 'effect the function' of the product, and you have to redo the entire 510k process - which is a crap load of money and time and effort. The result is that sometimes you end up releasing a suboptimal product, and NOW YOU CAN'T IMPROVE IT. Having some sort of intermediate level of testing/approval seems like it would be incredibly beneficial. That said, I'm obviously biased given all the frustrations I've been running into at work. Another thing that's super annoying is that the guidance document for weather or not a change requires a new 510k is woefully out of date and hilariously vague. It's from 1994 I think (so it doesn't deal with the concept of software very well), and the last time they tried to update it, they made it so specific that it got shouted down while in draft form. The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose. I honestly think that this is a net lose for everyone, both in terms of health outcomes, and total cost.
- seehafer 11y ago
  So much of what the House is trying to do here could be accomplished by making the FDA actually make some real guidelines and stick to them. Like you say, deciding whether not change X is a memo to file, a special, abbreviated, or full 510(k) is pretty much black magic because of how vague FDA is, so it basically comes down what your Regulatory VP is willing to live with, politically, inside the company. "The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose." I think the latter part of your larger players argument is most valid: it's not so much that the big guys have people in FDA who can give them informal reads, though that's true. It's that the big guys can take the hit of another year of delay when something doesn't go their way.
transfire 11y ago
Pure bunk. The oversight of the FDA on medical devices is one of the worst parts of the medical system. It is drowning in outdated equipment and limited supplies of over priced new equipment. The FDA exists to protect profits, not patients.
bwilliams18 11y ago
It seems to me like the biggest problem is implantable devices vs external devices. Anything that would require surgery to recall should have much more strenuous testing than something you could simply remove and replace without seeing a doctor. Especially because so many of these implantable devices end up in older people where the risks of complications from surgery go up so much.
- seehafer 11y ago
  But they do, and for the authors of this op-ed to try and insinuate otherwise is massively dishonest. Most implantable devices are what is known as Class III: the highest risk that FDA assigns. Accordingly, they go through the most stringent approval process, and they most definitely require multiple clinical trials.
seehafer 11y ago
I'm willing to accept to a large amount of honest disagreement of how much regulation is appropriate for medical technology. But articles like this, which twist the truth and drop so much context make my blood boil. Some examples: "Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials)" This is only true if the medical device in question is an update to an existing medical device that has extensive clinical data and use in the field. Sometimes that minor update is as minor as a software modification. "And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence" This is true because it's unethical to conduct major surgery on someone to give them a placebo, so we can't really blind the studies. They are definitely randomized and controlled though. "In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay." This is laughably untrue. I've in fact worked for two companies that received penalties for not being timely in postmarket surveillance. It might be true that FDA has never given a warning letter (which is their version of 'you've been a bad boy, no new products for you until you get your shit together) solely for postmarket reporting failures, but that's a much different claim. "When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses)." Wingspan was left on the market because for certain classes of patients it was a good treatment. FDA's action was appropriate. "But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices." This is the mechanism that Europe uses to approve all medical devices, not just changes, and it is not the nightmare scenario the authors make it out to be. The reason is that the regulatory middlemen have balanced incentives: they can't be too lax because when they get audited by the European Commission they can lose their license (and in effect go out of business). They can't be too strict because a manufacturer has 5 other companies they can do business with.
WalterBright 11y ago
I've proposed that legally consenting adults be allowed to take any treatment they want, provided that they sign an affidavit stating they understand that the treatment is not FDA approved. The flip side is that FDA approval would grant the drug maker immunity from lawsuits over deleterious consequences of the drug. Of course, the drug maker would not be allowed to make fraudulent claims in either case.

30 points by sethbannon 11y ago

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."

digitalneal 11y ago
Right. Then the FTC/BCP will swoop in with massive $$$ lawsuits over unsubstantiated claims.
refurb 11y ago
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.
- navait 11y ago
  > Sounds like a relatively biased article. It's an op-ed. The entire point is that it's biased.
HeyLaughingBoy 11y ago
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.
- seehafer 11y ago
  "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.
fnordfnordfnord 11y ago
>This sounds like it will be an absolute disaster: It does; but isn't the status quo also an absolute disaster?
- AnimalMuppet 11y ago
  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.
  - fnordfnordfnord 11y ago
    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.
    - AnimalMuppet 11y ago
      > 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.

reasonattlm 11y ago

The less FDA the better to my eyes. The incentives are broken, and the FDA is greatly slowing progress at a time when the potential to create new medicine is greater than ever before. Regulation is reason why we don't have the first fruits of the biotechnology revolution in the clinic today. The much-touted ballpark estimate of a billion dollars to produce a modern pharmaceutical from start to finish is about a decade old now - that figure is adjusted for today's diminished dollar value, eroded by inflation. You can replace "pharmaceutical" with any medical technology that is going to require a fair amount of original research and further tinkering in the laboratory to obtain the first working prototypes and the result is much the same. This large round number is the kitchen sink cost across a decade of work, including failed attempts and the opportunity cost of investment. The lion's share of the direct expenditures are imposed by regulatory requirements: trials, data, and more trials. It has long been my position that almost all of the work carried out in the US at the behest of the FDA to prove safety is unnecessary. In fact it is counter-productive, as the immense imposed costs on development shut out a great deal of the experimentation and small-scale initiatives needed for rapid progress. Much of what the FDA demands is not demanded by similar regulatory bodies in other parts of the world, and even their requirements are very onerous in comparison to the standards in place fifty years past, a time when medical development seems to me to have worked just fine. It is a question of balances and choice: it is better to err in favor of faster progress and informed patient choice, but that is very far from the present state of affairs. The result of an excessive and growing regulatory burden is that many potential medical technologies languish, are rejected outright, or are never developed at all, and patients suffer as a result. Our future health is determined by the pace of progress, and a slowdown across the board harms all of us considerably. Unfortunately that cost is invisible to the public at large and thus bureaucrats suffer very little as a result of the harms they cause by blocking progress. Meanwhile even comparatively small harms caused by an approved treatment that turns out to be overwhelmingly beneficial save for some negative effects for some people can snowball in the media to cause great damage to a career in the FDA bureaucracy. So you can see that the incentives are very much aligned with ever greater demands for proof and ever greater costs imposed on medical research and development. This is in fact what has happened over the past few decades, with the present result that in an age of radical progress and plummeting costs in the laboratory it is nonetheless the case that medicine is ever more expensive and the introduction of new applications of medical research has slowed down. This is well known and widely commented on, but so entrenched that this detrimental trend shows no signs of slowing. So, to return to the cost of developing a modern pharmaceutical product: estimated at a billion dollars (in today's dollars) ten years ago, the same approach results in an estimated $2.5 to $2.8 billion dollars now. Interestingly the bulk of that is apparently not due to the increased time required to run the regulatory gauntlet, but rather largely due to other increases in the demands of regulators: much larger trials and more data. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014... http://lifescivc.com/2014/11/a-billion-here-a-billion-there-the-cost-of-making-a-drug-revisited/ http://lifescivc.com/2014/11/a-billion-here-a-billion-there-... There is great frustration with this state of affairs, and it manifests with the creation of organizations such as Faster Cures and Tomorrow's Cures Today, none of which seem to be making much difference, sadly. The lobbying makes some people richer, and nothing changes as a result. In the end the only thing that is going to work is regulatory arbitrage - that the development goes to other parts of the world, and therapies are available there until the FDA is shamed into approving them because the people in charge look like clowns if they don't. This is exactly what happened for stem cell therapies; those available in the US today would still be held up in interminable trials and requests for more data without the fact that they have been widely available in overseas clinics for years. The pattern of activity in the FDA has nothing to do with safety and efficacy and everything to do with job security for bureaucrats.

msoad 11y ago

I know Apple Watch oxidometer and some health related software were disabled because FDA was not able to approve them fast enough

crisnoble 11y ago

As an insulin dependent diabetic I am consistently frustrated at how slow the medical device approval market moves. There is a reason that the most advanced insulin pump that I can buy 2015[0] looks like a pager from 1998, and it is not because the companies are moving too fast. I have been told that the reason all of the supporting software is so outdated is also because they are handcuffed by the FDA approval processes. I can see the author's point of view, but this is a rare case (for me personally) that I am not in support of more government oversight. [0] http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite http://www.medtronicdiabetes.com/treatment-and-products/mini...

poke111 11y ago
This is also a textbook case of what is seen vs. what is unseen. When someone dies from a treatment that the FDA has approved, that is a visible ("seen") tragedy. When people are suffering from ailments that could be treated more effectively if not for the FDA slowing things down and raising the cost of development, that is unseen. There's no single victim you can point to. But the latter is hard to quantify in the risk vs. reward calculation, and importantly no FDA bureaucrat will ever lose their job or be publicly shamed because of them.
- cmdrfred 11y ago
  How the FDA handled the removal of CFC's from inhalers shows you clearly they are not on the side of the consumer. The slowness likely has something to do with incumbent companies not wanting to spend on R&D. http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much http://www.motherjones.com/kevin-drum/2013/10/heres-why-your...
- WalterBright 11y ago
  This was all clearly laid out (with backing statistics) by Sam Peltzman in his 1974 book "Regulation of Pharmaceutical Innovation". The statistical result of the 1962 Amendments is that the beneficial effects of reducing the amount of bad drugs being released is far more outweighed by losing the beneficial effects of drugs being delayed or not being developed. But people only see the former.

fnordfnordfnord 11y ago

This ought to be called "experimental" medical devices for some probationary period pending large scale studies, and people ought to be able to buy and use them being informed that there is potentially some additional risk. A similar thing exists for general aviation aircraft for the same reasons.

icegreentea 11y ago

We were just talking about something like this this morning. My company makes diagnostic devices for hospital settings, and we were bitching about the lack of a middle road for introducing changes to devices. To somewhat oversimplify, either the change doesn't effect the function of the product, and in which case internal testing and documentation is all that is required, or it does 'effect the function' of the product, and you have to redo the entire 510k process - which is a crap load of money and time and effort. The result is that sometimes you end up releasing a suboptimal product, and NOW YOU CAN'T IMPROVE IT. Having some sort of intermediate level of testing/approval seems like it would be incredibly beneficial. That said, I'm obviously biased given all the frustrations I've been running into at work. Another thing that's super annoying is that the guidance document for weather or not a change requires a new 510k is woefully out of date and hilariously vague. It's from 1994 I think (so it doesn't deal with the concept of software very well), and the last time they tried to update it, they made it so specific that it got shouted down while in draft form. The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose. I honestly think that this is a net lose for everyone, both in terms of health outcomes, and total cost.

seehafer 11y ago
So much of what the House is trying to do here could be accomplished by making the FDA actually make some real guidelines and stick to them. Like you say, deciding whether not change X is a memo to file, a special, abbreviated, or full 510(k) is pretty much black magic because of how vague FDA is, so it basically comes down what your Regulatory VP is willing to live with, politically, inside the company. "The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose." I think the latter part of your larger players argument is most valid: it's not so much that the big guys have people in FDA who can give them informal reads, though that's true. It's that the big guys can take the hit of another year of delay when something doesn't go their way.

transfire 11y ago

Pure bunk. The oversight of the FDA on medical devices is one of the worst parts of the medical system. It is drowning in outdated equipment and limited supplies of over priced new equipment. The FDA exists to protect profits, not patients.

bwilliams18 11y ago

It seems to me like the biggest problem is implantable devices vs external devices. Anything that would require surgery to recall should have much more strenuous testing than something you could simply remove and replace without seeing a doctor. Especially because so many of these implantable devices end up in older people where the risks of complications from surgery go up so much.

seehafer 11y ago
But they do, and for the authors of this op-ed to try and insinuate otherwise is massively dishonest. Most implantable devices are what is known as Class III: the highest risk that FDA assigns. Accordingly, they go through the most stringent approval process, and they most definitely require multiple clinical trials.

seehafer 11y ago

I'm willing to accept to a large amount of honest disagreement of how much regulation is appropriate for medical technology. But articles like this, which twist the truth and drop so much context make my blood boil. Some examples: "Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials)" This is only true if the medical device in question is an update to an existing medical device that has extensive clinical data and use in the field. Sometimes that minor update is as minor as a software modification. "And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence" This is true because it's unethical to conduct major surgery on someone to give them a placebo, so we can't really blind the studies. They are definitely randomized and controlled though. "In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay." This is laughably untrue. I've in fact worked for two companies that received penalties for not being timely in postmarket surveillance. It might be true that FDA has never given a warning letter (which is their version of 'you've been a bad boy, no new products for you until you get your shit together) solely for postmarket reporting failures, but that's a much different claim. "When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses)." Wingspan was left on the market because for certain classes of patients it was a good treatment. FDA's action was appropriate. "But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices." This is the mechanism that Europe uses to approve all medical devices, not just changes, and it is not the nightmare scenario the authors make it out to be. The reason is that the regulatory middlemen have balanced incentives: they can't be too lax because when they get audited by the European Commission they can lose their license (and in effect go out of business). They can't be too strict because a manufacturer has 5 other companies they can do business with.

WalterBright 11y ago

I've proposed that legally consenting adults be allowed to take any treatment they want, provided that they sign an affidavit stating they understand that the treatment is not FDA approved. The flip side is that FDA approval would grant the drug maker immunity from lawsuits over deleterious consequences of the drug. Of course, the drug maker would not be allowed to make fraudulent claims in either case.