Medical Devices: Last Week Tonight with John Oliver (HBO)


Medical Devices: Last Week Tonight with John Oliver (HBO) 22

Medical Devices: Last Week Tonight with John Oliver (HBO)

Source


16 Comments

Comments:

  1. [The Bleeding Edge on Netflix was a crazy watch.](https://www.netflix.com/search?q=under%20the%20knife&jbv=80170862&jbp=1&jbr=1)

    EDIT: ECT Devices have also never been FDA approved…so frustrating.

  2. The commercial lady in the beginning reminds me of Jane Krakowski, [](#s “and then it surprised me that she parodied that commercial”).

  3. Man thankfully my insurance doesn’t cover these and that I’m too poor to afford them. Really dodged a bullet on that one.

  4. I gotta say this was without a doubt one of the most interesting and informative episode LWT has had in a while to me personally. Concise , informative, actually staying on point not getting off track for a joke.

    While I find myself the often target audience for most of LWT this was a topic I had never though off and the information was in some ways terrifying, but important and hopefully we get some creation of a new regulatory agency or a change up at FDA to make sure the equipment we put in People to save their life isn’t killing them

  5. I think the short haired lady in that Momz in da Hood segment is [this one.](https://www.youtube.com/watch?v=IS2KQ46Kf84) Bob’s Burgers had an episode where they based a character [on her.](https://www.youtube.com/watch?v=nHNdes00Bco)

  6. As someone who works in the medical device industry, this segment makes a lot of errors and grossly misrepresents the industry. Firstly in that “number of deaths” reported that is from all possible device related adverse events resulting in deaths and those are reported from all trials that go into a PMA submission so it includes overseas deaths as well as deaths that might not necessarily be caused be the device itself. An example of this could be an IVC filter failing and allowing a thrombosis to become a pulmonary embolism. Had the device not been there the patient would be dead anyway, the device failed to prevent the patient’s death but it did not cause it. That’s the issue of assessing the effectiveness of livesaving medical devices in general because the alternative to using the device is often death.

    He also says that some medical devices do not go through clinical trials. While it is true that low risk devices like tongue depressors or hospital beds or devices that are substantially equivalent to other devices (e.g. a manufacturer making a new version of a device that has been tested) all devices that are life sustaining or especially risky (Type III devices) have to go through clinical (i.e. human) trials.

    Calling the 510(k) pathway a “loophole” is a huge misnomer and ignores what is included in that process. Devices that go through 510(k) clearance that have prolonged contact with patients still have to be go through bench testing, biocompatability testing and, in cases of implanted devices, animal testing. It isn’t a rubber stamp process. Even for big companies with buckets of money to throw to regulatory, it takes a significant amount of time and effort to go through a 510(k) submission. For example I know IBM spent years working on the submissions for their Waston software for healthcare and that doesn’t even come into contact with the human body at all.

    Bringing up the J&J hip implant scandal, the vaginal mesh scandal and essure like they were everyday occurrences in the industry is a massive misrepresentation. These were a huge industry scandals that everyone knows about. It’s like bringing up the Hindenburg or the Titanic as everyday representations of airship or cruiseship travel. Every industry has issues, its just that the issues with the medical device industry can cause medical problems.

    What this clip fails to capture is that the process that devices go through in the US is actually the most rigorous in the world. Most medical devices manufacturers will go through approval in Europe or Asia first so they can start making money to fund the studies that the FDA requires. What it also fails to capture is that margins in the medical device industry are actually razor thin compared to pharmaceuticals or many other fields. Part of the reason healthcare costs in the US are so high is because of how costly it is to get a device through PMA (the other process he doesn’t talk about).

    The PMA process costs companies an average of one hundred million dollars for an initial submission. GLP trials and multi-phase clinical trials are hugely expensive. Making every device go through this process would either kill the industry or make these devices so expensive that there is no way that the average person could afford them.

    It’s fun for shows like this to preach from their ivory tower of what the world should be like but once you get into the weeds of what it actually takes to bring a device to market you’d realize the solutions are not simple. I took multiple college and graduate level classes on medical device regulations; I know people who spend their entire careers working with and analyzing the path to market of devices from both sides; trying to sum up the state of an industry and a process that takes years to understand in a 20 minute clip is misguided at best and more likely a journalistic ethics violation (if this wasn’t billed as a comedy show).

  7. I’m in my thirties and have degenerative hips. I had surgery on one and was told eventually I’d need both replaced since most doctors think it’s easier to just do a replacement than fix things. And that video has kinda freaked me out.

    Someone downvoted me for this. Never change, Reddit.

  8. Do you ever notice that John Oliver pretty much gets 1/10 the attention if he doesn’t talk about Trump or the GOP? Dude knows what he is doing lol

%d bloggers like this: