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Cheap and simple medical devices have to overcome deeply rooted biases (newyorker.com)
217 points by 0xedb on Feb 11, 2019 | hide | past | favorite | 134 comments



Years ago, a friend of mine was in med school, and headed off for a semester in the rainforest of Ecuador, performing basic medicine and stuff for people who rarely got to the city to see a doctor. He called me up, on a Sunday afternoon, with this question:

"Our dentist in the group just realized she doesn't have a source of suction, you know, like the vacuum that slurps saliva out of the way during a procedure. We're in Houston and our flight leaves in 6 hours. Any solution needs to work off-grid for a month. Got any ideas?"

I thought for a moment, and said "Hit an auto parts store. Get a brake-bleeder kit. This has a hand-pump vacuum with a clear collection jar. Aim for one with a glass jar if possible, since it'll be easier to clean. Should set you back about thirty bucks."

And we didn't speak again for a few months. When he was stateside again, he said the brake bleeder kit had worked so well and was so simple to operate, they'd often just hand it to the patient. Not only did this free up a physician, it also gave the patient something to do during what's often a nervous and fidgety time, and may have thus decreased the need for sedation in some procedures.

Sometimes it really is that simple. He had numerous stories of doctors in hospitals picking the brains of janitors -- they called it a "facilities consult" -- to see if they could MacGuyver a solution to a problem that the medical industry hadn't packaged yet. PTFE plumber's tape apparently comes in a medical grade too, but sometimes you need to toss around ideas with some other hands-on maker-fixer sort of people before you figure out how to apply it.


One prominent example is superglue, which started being used by medics in the Vietnam War to control bleeding until a soldier could get to a hospital. Now you can buy special medical versions of the stuff at any drug store.


I think I've read that superglue was invented in WWI for exactly this purpose.

But beware that closing up a wound increases the chance of infection, so only do this if you're sure that you've been able to sterilize the wound first or if there is no other option for stopping the bleeding.

Otherwise it's best to leave the wound open and wrapped with bandages, and make sure to change the bandages at regular intervals.


If you need to control bleeding quickly you can also use hemostatic gauze which contains a clotting agent such as kaolin clay. The gauze can be used to pack arterial wounds where a tourniquet can't be used. I keep a pack of it in my backcountry first aid kit in case someone's bleeding from an artery and I can't get a tourniquet on it, which sometimes happens when the artery retracts into the body after a cut.

https://www.amazon.com/QuikClot-Advanced-Clotting-Kaolin-Str...

Be sure you know how to use it before you need to use it though.


Some versions of fast clotting agents have been reported to cause burns, so its not something you would want to use for little cuts.

A study related to that: https://www.ncbi.nlm.nih.gov/pubmed/18712606


Yeah. I am not a doctor, but I do have some limited first-aid training. I'm not advocating that everyone should use this type of gauze. But I was pointing out that in the case of severe bleeding this gauze would be better than simply closing the wound and hoping for the best. In fact, during my training I was told that you don't want to close an arterial bleed, because the artery will simply continue bleeding copious amounts of blood into the (now closed) cavity.

In my mind use of a medical device such as this type of gauze should be the subject of a risk/benefit analysis, where the risk is potential for burning in some cases versus the risk of bleeding out. If you've got a cut that isn't pumping arterial blood then you can probably rely on the body's own copious clotting agents to stop the bleeding. However if the patient is likely to bleed out, then it may be better to use quikclot gauze or similar, because the choice is "die from blood loss" versus "receive some burns."

A different calculus might apply in cases where you're not in the backcountry because the medical response speed is much faster. I wouldn't assume that search and rescue has a response time less than 6 or 8 hours, and if the conditions are especially shitty and you're far enough away from a trailhead it might be a day or two before you can expect rescue. From what I understand it can take an hour or two before the SAR people in my area are even headed toward their base. From there it could be another hour or two before they can mount a response, and then there's time spent in transit and time spent searching for you.

Under those conditions it shifts the mental calculus from solutions that will work for less than an hour toward solutions that will work for hours or days. So it's probably better to take a burn that won't get much worse instead of an arterial bleed that will kill you in less time than it takes for SAR to start driving to the chopper from wherever they're on-call at.


Those burning clot agents aren’t used anymore (at least in the US/Israel/Europe.) I just did a trauma refresher with the Stanford trauma center and that very question came up. That study you referenced is 10 years old. The new stuff doesn’t burn.


Those have been taken off the market as far as I recall. The ones on the market now should not have that problem.


Except that bandages fall off when you're working, especially if you're working on something dirty. Whereas super glue holds a cut shut even if you're covered in oil. Or, if the cut is on a finger, super glue allows you to keep working as if you aren't even cut.


Superglue / cyanoacrylate wasn't discovered until the 1940s. They were trying to create clear gun sights when they discovered the fact that it sticks to everything. My understanding is that it wasn't used in the field to close wounds until the Vietnam war.


Nowadays they have blood clot kits you just pour into the wound. It solidifies very quickly stopping most external blood loss but has to be surgically removed by the attending physicians.


If you need to clot a wound and have only common household products, ground black pepper and coffee grounds make for excellent temporary scab substrates.


That sounds incredibly painful.


There used to be a product (I believe from johnson and johnson) called liquid bandage.

It was a two-part formula, combining a treated applicator like a cotton swab and a bottle of adhesive.

You had a cut, you put a drop of liquid from the bottle onto the end of one of the swabs and touched it to the cut on your finger or wherever. The two parts together formed the adhesive.

It instantly secured the skin together.

It was the BEST. It would fix a paper cut immediately and securely. You would not accidentally dribble adhesive and stick your fingers together.

They pulled it from the market, for some reason shrouded in mystery.

Now all you can find is nexcare nu-skin which is not very good at all. (Basically it sort of covers your skin, but doesn't secure anything)

very sad.


TIL that that is not what neosporin is. Since hearing about that liquid bandage thing back in the 00s, I started hearing about people in the US putting "neosporin" on minor injuries; I had just assumed it was the liquid bandage stuff. I only just googled what neosporin was now.... it's a topical antibiotic.


Weird, can't find anything about it at all.

https://www.washingtonpost.com/archive/lifestyle/wellness/20...


The only references I can find is in the review comments for a short-lived (inferior) replacement product on amazon:

https://www.amzn.com/B00006IDL4

They basically all agreed the original worked very well.


they used to sell alum sticks around here for small cuts.

they're still available online, albeit rarish, but they're very convenient.


IIRC they use powdered mashed potatoes now.

I'm not sure if there's an official "medical powdered mashed potatoes" that doctors use.


I actually use this one all the time. I do a little wood working and if I slice open a finger, I just grab my Rockler CA glue, put some on, squeeze the slice shut and wait about a minute.

If you purchase liquid bandage in a drug store, it is just sterile CA glue.


I think I've read that medical cyanoacrylate based glues don't heat up as much when they cure, so they're less likely to cause burns.


Superglue is extremely effective at paper cuts, and sealing cuts in cold, dry weather that otherwise crack further. Any small "slice" type injury I use it over a bandage.


It is very effective and I've used it successfully at least a dozen times. However, you virtually guarantee a scar if you use super glue. Most of us dudes don't care (as long as it's not on the face), but it's something to think about when treating others.


You can get spray like bandages now. Which feels like a combination of glue and some sterilization stuff added in. Stings a little bit and then dries out and sticks like glue.


I recently looked at a couple places and couldn't find it.


Regular cyanoacrylate aka “superglue” is perfectly safe for wound closure (after cleaning and disinfecting of course).


The issue is not the compound itself, it's the impurities in the packaged substance. You don't know what possibly-toxic impurities or allergens might be present in a tube of hardware store adhesive, since they probably don't affect the glue's ability to do its intended job.


Also cyanoacrylate glue has a tendancy to react exothermically with cotton, which is a common bandage material. For the layman this means that it can get burning hot if you get some on a cotton bandage. The medical-grade superglue does not have this problem.


If you have the opportunity to use something better, then obviously use something better. But in practice these objections are not a huge deal for the vast majority of people closing their wounds with CA glue.

Pro-tip: you don't need to put the CA glue inside your wound. Squeeze your wound together, put the CA glue on either side of it on your intact skin, then place a piece of thread across the wound, fasted to the skin on both sides with the CA glue. The effect is a do-it-yourself suture without needing a needle.

And YES, it's exothermic with the thread. So obviously don't use a lot of it. Use the absolute bare minimum and don't attempt it with wounds severe enough that a lot would be required. If you slather on the glue than slap a patch of denim over the wound, you're going to get burned badly. Don't do that.


How do you hold the wound shut, hold the thread in place, and apply glue all at the same time without getting the glue everywhere, especially over the hand holding the thread?

I always just use a single-ply piece of paper tissue, and soak that in the glue. It's too thin to hold much glue, so it doesn't get that hot - if you need more strength, you can add more layers. And it can be applied one handed - place tissue over wound and apply glue. Done.


Cyanoacrylate rapidly hardens when it contacts moisture, so impurities are of little concern in my opinion, as they will be trapped in the polymerized glue (mixed with some clotted blood).

According to medical literature, people regularly ingest superglue without any issues (mostly children). They even put it in their eyes accidentally (it turns out that it's a bad idea to store your nail glue in the same drawer as your eyedrops, especially with impaired vision) without any damage aside from a few days of discomfort.


Being able to apply suction on my command seems like an added benefit. Sometimes I think I'm going to choke at the dentist waiting for him to start vacuuming. Could be comforting for people who aren't typically in the sort of situation and feel out of control of themselves.


Just set up a signal with your dentist before hand. "Hey doc, just to let you know I am sensitive to my own saliva, when I point to my mouth can you do the straw thingy?"

Works like a charm


Yup, or even ask if you can work the suction yourself. I've done this lots of times with my current dentist.

I hold the handpiece out of the way, and if I feel like I'm drowning, I kinda wiggle it in the direction of my mouth, they make room, and I go in and vacuum things up. If they see the need before I do, they just say "suction", just like they'd say it to any other assistant.

It's no different than holding my own jaw open. If the patient is awake, they're part of the procedure. Might as well make the most of that. And if it means less anxiety and discomfort, which means you're happier and more likely to return, that's a win for everyone.

During one visit, I noticed that the swing-arm lamp had a flat plastic cover on it that acted as a mediocre mirror, and I could see what they were doing in my mouth. As soon as I noticed that, the random shoving and scraping (which always made me nervous as hell) gained context of the work they were doing, and I calmed way down. I ask for the lamp every time now.


In a pinch, I've seen third world doctors use super glue to seal cuts.

American culture doesn't allow for anything better than the best outcome in medicine.


> "I've seen third world doctors use super glue to seal cuts."

Expanding on this a bit, commercial cyanoacrylate (such as Super Glue or Krazy Glue) was used during the Vietnam War by US personnel for wound closures, but was not approved by the FDA for medical purposes because its side affects hadn't been explored. Dermabond and other medical grade cyanocrylates have since been approved.

https://en.wikipedia.org/wiki/Cyanoacrylate#Medical_and_vete...


American culture allows for exactly two possible types of medical care:

1. The best

2. None at all

Often the choice between the two is financial.


That sounds good, but it's not true. There's a world of minute clinics out there with PAs and LPNs. There is mail order medicine and Walmart's pharmacy. There are bronze plans/borderline broken leg plans. There's a real problem with medical care access and finances, but it's not gold-plated or nothing.


Just as true of housing, transportation, education, etc.


This sounds really good to the ear, but it's just not true is it? Americans have a lot of choice when it comes to these things, at least compared to healthcare.


It's a byproduct of regulation. When you start telling people they can't consume this substance, or buy a car with fewer than this number of airbags, or without traction control, or you can't sell an apartment with a size smaller than this, you create consequences. Maybe people buy used cars instead of new cars. Maybe they live in illegal units that skirt the regulations not just on sizing, but on fire safety. And so on. You create black markets.

This is absolutely not to say that regulation is bad! It is just to point out that it creates unintended consequences you have to be aware of, and place the slider of regulation in the appropriate place.

After all, we all intuitively know that a minimum wage of $500/hr and a minimum allowable housing size of 7000sqft won't work! But we also know that telling a surgeon "just use whatever you find lying around" may not be the best approach either.


We have some level of choice with respect to healthcare as well. I'm just thinking of other nations I've traveled, in which lots of people chose to live in housing that wouldn't be allowed here, and drove vehicles that wouldn't be legal to sell here.

You might argue with the idea that they "chose" those things. That argument would apply just as much to health care. Yes, if someone had the choice between vast wealth and penury, one would choose vast wealth. Given the condition of penury, however, what's wrong with e.g. a tuk-tuk or a corrugated tin shack? Are those not better than living on the street in a cardboard box and walking everywhere you go?


Sure, American medicine does, for non-human animals. I suspect that at least part of the difference is that veterinary medicine is mostly uncorrupted by insurance.

And there is little reason to use hardware store cyanoacrylate glue on skin — you don’t know what’s in it, and there is evidence that hardware store formulations may cause issues on skin. Animals get to use a product such as Vetbond, which is designed for the purpose and is not much more expensive. (A whole bottle of Vetbond, which is reusable, seems to cost a little less than a single Dermabond applicator.)


> I suspect that at least part of the difference is that veterinary medicine is mostly uncorrupted by insurance.

It’s mostly uncorrupted by million+ dollar malpractice suits.


It's in use in America too. A couple years ago I dropped a knife and like an idiot tried to catch it, of course I didn't succeed it wound up stuck in the palm of my hand making a cut about .5" to .75" long and .25" to .5" deep (didn't measure quite how deep it was at the time you know other priorities) and the hospital cleaned, irrigated, disinfected and then glued it shut. Worked pretty well.


It's also simpler because you don't need to have the stitches taken out.


A relative of mine is a veterinarian, and does this whenever one of her kids gets a cut. First-world country.


Using superglue to keep paper cuts closed is a household remedy, at least in American midwest. But most paper cuts are hardly considered to require medical attention. I assume you're talking about surgical cuts that would otherwise require small sutures?


Anecdote: I had a surgical incision around six inches long glued shut after an operation in the UK. No stitches. I was surprised, but from talking to the nurses it sounded like that was standard procedure. Judging from other comments, the stuff they used (DermaBond) is a variant of superglue.


After a major knee surgery my incision was closed up with staples that looked suspiciously similar to ones I've seen in an office supply store. Well, except the price; I think the surgical ones cost several orders of magnitude more.


Surgical staples will be stainless steel, which office staples aren't.


When I worked in food service we had a brown medical looking bottle of "liquid bandage" that was basically just weak crazy glue. We had to use that if we cut ourselves to make sure not to contaminate the food. Once I found out what it was I started using normal crazy glue gel instead. Closed up the cut, kept it clean, totally waterproof. I keep a bottle of it in my medicine cabinet to this day.


Liquid bandage is not weak "crazy glue" (cyanoacrylate). It is a completely different formulation.

https://en.wikipedia.org/wiki/Liquid_bandage

For example, the popular brand New Skin consists of:

Active ingredient: Benzethonium Chloride 0.2% (antiseptic)

Inactive Ingredients: Amyl acetate, camphor, ethyl acetate, ethyl alcohol, n-butyl acetate, nitrocellulose.


That's not completely true. For instance the "LiquiBand" brand includes some products that are CA.

http://www.liquiband.com/region/uk/liquiband-product-range-w...


Interesting, thanks for the correction.

I noticed that the product you linked is intended for medical professionals. I wonder if there is a CA-based liquid bandage sold over the counter?


My mistake


I think you'll find it's done in America too. For cuts that aren't clean and straight, it's often more practical to just glue it together.


Superglue is standard operating procedure for sealing small wounds in Antarctica, since they like to crack open more.


Super glue for cuts has been a thing in the first world for a few decades too.


The first dialysis machine was made of auto parts.


I strongly believe that we should all be taught ~primitive engineering like this.


I spent the weekend dissassembling a hematology analyzer capable of measuring 17 parameters of the immune system from a large drop of blood. Nabbed it on ebay for cheap.

Was able to unclog a few of the lines and get it running, learning how it works by shooting cells past a laserbeam and looking at scatter. Overall, the complexity of the machine is far simpler than that of a simple laser printer, but its retail value is $10k as a veterinary instrument. Machines for human patients are way more expensive.

My dissappointment however was discovering that it refuses to run unless its barcode scanner can see manufacturer-validated reagent bottles. The chemicals needed to make it run are simple salt-waters that can be easily made for $10 of various powders, but the manufacturer sells reagent sets for $1000k each. Now its clear that getting any useful data out of it will require hacking the ARM embedded system onboard.

Why am I doing this? Certainly not for any kind of regulated medical treatment, but I personally want to know how my immune system changes on a day to day basis. Datasets like this dont exist on such a high frequency sampling rate. What I find however, is that the decades-old tech that powers this relatively simple machine is being held back by an overly restrictive regulatory environment and price gouging of chemical reagents.

Why the artificial construction of a $100 lab test, when the actual value to perform such a test is much much lower? Why can't we live in a world where such self-experimentation is allowed outside of the strict guidelines of diagnostics?


I happen to do some IT field support for my vet - she has one of these machines too, with the same problem of expensive reagents.

The problem space here is: of course anyone can mix the fluids together from powder... but under what conditions? Tested for impurities, contaminants or unevenly mixed/clumped powder? For a clean water source? Regular batch checks to ensure the stuff is up to spec? Mess up one of these things, the system doesn't work/produces false results, a pet or a human dies and the payout sums can be enormous.

The latter risk and the insurance premiums as well as mitigation risks are why medical stuff is so insanely expensive.

And another thing: at least when someone dies, it's over. Bit of a lump sum to relatives of the deceased, funeral cost, that's it. Now, when someone does not die, but gets stuck with brain damage, in an awake coma or bedridden for life, the costs of keeping that person alive can well run into double-digit millions of euros whereas 50 years ago that person would simply die sooner or later. Midwifes in Germany are retiring in droves because insurance premiums have skyrocketed - due to exploding costs for newborns requiring extensive care after e.g. being stuck in the vaginal canal during birth.


That's a pretty awesome project. Instead of hacking the ARM, could you just call up a vet to ask if you can have some of their empty reagent bottles, and fill those with your homemade reagents? (As a bonus, if you can get it to work, the vet would probably be interested in knowing the reagent recipe as well.)

There's a movement towards open-source designs for relatively simple biological instrumentation- perhaps this sort of machine will be in range of those efforts someday soon.


The one neat thing about hacking the ARM (its an at91 system if anyone knows details) is that I can get access to the raw data underneath. IE, the real-time cell counting events. I can envisage some neat deep learning on something like that, if only the dataset existed.


I don't know anything about this particular case, but systems like that based on controlling "consumables" are very common.

Sometimes it's simple price gouging, sure, or at least partly. Often, though, it was in response to capitol equipment budgeting and per-procedure pricing (& insurance). It can be easier for organizations to justify/budget the cost (and pass that on) amortized over N exams than all up front, so device manufacturers figured out ways to do this. These days some devices are entirely funded by contracted use (i.e. free razor, pay for the blades), much like office printers etc.

You are right that the industry as a whole has little interest and no incentive to allow experimentation and re-purposing. Part of this is liability, a lot is lack of any incentive. On the other hand, research lab equipment with similar functionality is often far more accessible (and more expensive)


Maybe you could get your hands on some spent reagent bottles, or even just photos of them. Reset the system's memory in between uses if it requires new bottles each time.

Hacking the controller could be challenging if it's been deliberately hardened.


You know its odd ... Ive gone looking for those photos online again and again .... and never could locate any...

But here I am at work, googling without my personal account connected, and alas they show up. Filter bubbles man! I know what Im doing tonight ...

https://scilvetshop.com/collections/hematrue/heska


Heads up: it looks like they have the expiration date embedded in the first barcode and one of the pictured reagents is expired. Have you been able to set the system clock?


I'm aware of the expiration date, but haven't been able to understand the embedding or how the pairs of codes may be "hash validated" in some way, which means that this is a one time use for me unless I can either generate them or access the nvram on the system.

Any insights? How did you find the embedding?


Generating a new barcode and sticking it on top of the old one shouldn't be a problem, though?


Those reagents are like printer ink and the manufacturer makes plenty of money off of them. Also, the whole thing is supposed to be run with sterilized lines and sterilized water.


Very cool. Love to chat at some point. I run a makerspace in Victoria, BC and we have done some medical device hacking. Derekja at makerspace dot ca


That is absolutely awesome, I've always wanted to do some kind of higher frequency analysis of my body's internal processes via blood sampling. It's cool to hear somebody doing that.


I should get my blog running, so I can document my adventures


Typo maybe? $1000k as in $100k or $1m?


My interpretation was $1000, or $1k


Bah, $10k - and yes, that was evidently the retail price for this guy :

Sorry for confusion .... Morning cough syrup hangover. Sometimes I wonder if the drug is worse than the fever! It would be nice if I could monitor my infection with this dang analyzer to see it's rise and fall :p


The answer to the headline is astoundingly obvious yet the article doesn't mention it once. The reason is regulation: you can't use a medical device that you've hacked together unless it has been cleared by the relevant authorities as being safe. Sometimes it's a matter of simply getting a cheaper alternative through regulatory approval, but other times its just not worth the cost to prove a cheaper alternative is as safe as the more expensive one. Very annoying article about an interesting subject.


The agonizing part is that having incredibly expensive medical tools isn't safe either - it leads patients to avoid medical treatment because of the cost.


It's not meant to improve patient outcomes, it's meant to avoid liability.


I wish people didn't phrase things this way. There's no single "meaning" to all of this. It's a bunch of different people with different priorities making different cost-benefit tradeoffs.

I mean, what would you do if a loved one died at least in part because someone was trying to save $1,000 on their treatment? How would you feel? What if you were permanently disabled or put in months of agonizing pain, and there were more expensive options that would have had a lower chance of doing that? Or just might have had a lower chance of doing that?

From the 10 miles up view, it's easy to say, "Holy shit, the US has such a high health care cost, we could get 97% of the same care at 50% of the cost," and that seems like a great idea. When you're personally looking at tragedy to save an amount of money that is not that significant for your specific medical case (the waste comes when it's applied to 50 more people who don't really benefit from it), the calculus looks very different.

It may still be the right decision. But can we be compassionate about the victims of that decision?

Then layer in that it is not in fact uncontroversially the case that this is what drives the costs of the US healthcare system. And layer in that there is unavoidable uncertainty about when a higher-cost procedure or device or medicine is really higher quality and when it's not, because we have well-founded limitations on how many experiments we can do on people.

I don't think it serves anyone to take such a moralizing tone. Liability exists for a reason. These cost-benefit decisions are tough ones. Information is not perfect.


> what would you do if a loved one died at least in part because someone was trying to save $1,000 on their treatment?

Accept that said loved one wasn't the type to spend $1,000 on something they didn't think was necessary, made the wrong decision, and lost. Same thing as if they were driving around in an old poor-crash-safety car and got T-boned.

But embedded in your comment is an assumption that this $1,000 wasn't being paid by the patient, rather by some ambient health insurance company looking out solely for their bottom line. This double principle agent problem is a large part of the train wreck! A market cannot function without pricing information. So either we need to vastly simplify how cost sharing works and change the culture so doctors supply prices alongside treatment options, or we need to stop clinging onto the fallacy of having a functioning market.

Here's an example of the principle agent problem at work. Right now I'm actually trying to price an expensive medication. The name-brand costs 50% more than the generic. Due to the way (privatized) Medicare copays work, the name brand is significantly less out of pocket for the first several months! After a whole year, the name-brand works out to be about the same. So to save money, I will be going with the name brand and driving up the general plan costs.


97% of the same care at 50% of the cost could be rolled into further R&D which improves outcome faster in the long run.


Maybe! I mean, that's definitely one way it could go.

Or maybe the extra money wouldn't get spent on medical R&D. Or maybe more money spent on medical R&D is reaching a cost/benefit asymptote where there's not much further gain. Or maybe a lot of things.

And it's still cold comfort to be told that your or a loved one's inferior care today may (or may not!) be of benefit to a stranger 10 years from now.

I want to be clear: I'm not arguing for the current status quo. I agree it has big downsides. I'm asking for people to acknowledge that there are hard problems here that aren't trivially fixed, and even to the extent that some problems are trivially fixed, they still produce some downsides.


Most of the time those are the same things.


The problem is ethical: How many hours of peoples lives must I improve for every person I kill?

If for example, you had a guaranteed treatment for obesity, but it killed 1 out of every 100 people it was used on, is it worth it? More than a few morbidly obese people would take those odds.

I was at CES many years ago, and a doctor had developed an asthma monitor for his daughter. This monitor would alert him and the school nurse immediately, and possibly 911 immediately if the episode was bad enough.

He couldn't get anybody to touch it because, at some point, it will miss an asthma event or the network will fail to deliver the event. And that child will die. And whoever sold the device will lose a multi-million dollar lawsuit.

As soon as some company with really deep pockets figures out that "indemnification" would allow them to generate scores of medical devices that nobody else can take on, we're going to witness an instant monopoly.


You mischaracterize the article. It mentions the FDA, and perhaps more importantly other disincentives.

Hospitals desire more expensive solutions because they get paid more for them. That is a second, enormous barrier.

The incentives are clear here. The costs are high, between regulations, marketing, out-maneuvering rent-seeking incumbents, and cultural issues. The reward is low. No one will become a billionaire for doing this work.


Yep.

And then you have to breach a very ugly topic most people don't like to discuss.

When does regulation kill more people by not having the $thing versus having the $thing? And how many people would suffer complication/dying with the $thing?

It's a very delicate balance, especially when you consider capitalist forces that encourage "move fast and break ~things~ people". The FDA is the chopping block for that... But also FDA overaction also kills people.


This can only be known after the fact.

To complain about "this obvious treatment that obviously works but regulations delayed for 10 years", is as valid as to complain about "this obviously flawed treatment that kills one person out of ten people and killed my husband, because obviously not enough testing was done".

The error in both complains is to assume that the answer was in anyway obvious. It was not. It almost never is.

I agree with you, totally. I just wanted to emphasize that point.


"Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace."

I have no personal doubt that the FDA has saved millions of lives in the US and internationally, and the balance of harm/good they have caused would would make the harm side look infinitesimally small.

Also... I be interested in what cases you know that the FDA caused the deaths of people by overaction. There are people out there with axes to grind who thought they were going to get rich with some drug or device, who couldn't subsequently prove the safety and/or efficacy of their product.


So, the food regulation side of the FDA's activities have certainly saved millions of lives and probably swamp what the FDA does in terms of drug regulations. But generally new drugs tend to be rolled out gradually, doctors hear about disasters, and I'd be surprised if the FDA saved more than a thousand lives a year at most. On the other hand a bad call in disallowing new medicines can have very bad consequences. The FDA only allowed the use of beta blockers in the US about a decade after they came into use in Europe which probably cost something on the order of 100,000 excess deaths. Those early beta blockers did have serious problems and the FDA's decision also probably saved 1,000 people from liver failure after taking those drugs but I don't think that justified withholding the category until a liver-safe version was made. These days the FDA is less strict than it was in the 1960s and has certainly improved. But we can still do better to move more in the direction of European style regulation where they have a dozen competing EpiPen equivalents.


You had to go back 60 years. You didn't even mention Fast Track. You are ignoring device, test, and implant categories.


I didn't mentioned Fast Track specifically but it was one of the things I was thinking of when I said the FDA had "certainly improved." A large part of the credit for that should go to AIDS activists but Reaganite Republicans also deserve a lot of credit.

I'm not sure the FDA of the 1960s/70s was a net positive in its drug regulating role on human health. I'm almost certain the FDA of the 2010s is a good thing on net but I'm pretty sure it's bad on the margin, compared to the EMA which I think gets things more or less right.

I'm not particularly conversant in how FDA regulatory behavior is different across product categories but it sure looks like it's the FDA's role as a device regulator that causes the differences in the market for epinephrine injectors in the US versus EU.


The FDA's drug approval criteria are extremely strict. Ask anyone who works in pharma and they can probably name at least a couple of drugs which showed great promise but got axed by the FDA on dubious grounds.

A classic example is Aspirin. We know from over a hundred years of experience that Aspirin is a widely useful and relatively safe drug, but if it were discovered today the FDA would never allow it to market, let alone approve it for OTC sales. Aspirin's mechanism of action is far too broad and the gastrointestinal side effects alone would be considered grounds for rejection.


Perhaps if you dropped a few more specific examples would could talk about their issues instead of in generalities, instead of Aspirin? I was going to reply in my own words, but will instead yield to this retired FDA compliance officer: https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-t...


What are your thoughts on this article? (which also cites a bunch of other articles on the first line)

https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d...


Right. The whole FDA system is set on the premise that inaction can cause no harm. This causes a lot of harm.


For every suction pump and super glue getting held up by regulation, there is also a witch doctor or snake oil. People love to talk about the clever hacks in some poor country, but not the high cost in QALY of superstitious or scam practices.

Since no one is clamoring to wholseale trade USA healthcare for India's, there are obviously done tradeoffs.


"Other time its just not worth the cost to prove a cheaper alternative is as safe as the more expensive one"

Sounds like a fatal flaw in the system which benefits manufacturers and insurance companies at the expense of consumers.


How do "more expensive" options benefit the insurance companies ?



What about large companies that underwrite their own health insurance?


Not if you manufacture the cheaper alternative.


Hmm, why would an industry based on profiting from high margin expensive medical technology not sufficiently promote low margin inexpensive technology? It's a mystery.


A related mystery: what's stopping greedy practitioners from using the cheap device but still charging the old price increasing their margins even more?


> But cpap machines, the standard device in a country like the U.S., are expensive and require uninterrupted electricity. In many countries, Burke says, doctors resort to using a makeshift solution: a Coke bottle filled with water and attached to some tubing

There's a limit to what you can charge for a coke bottle attached to some tubing that's much lower than for a machine that blinks and beeps and goes whirrr with lots of knobs and buttons. Sometimes the solution is to hide the bottle and tubing in a complicated looking box. Of course not _all_ of it is theater.


Um, please, finish the quote:

> "In many countries, Burke says, doctors resort to using a makeshift solution: a Coke bottle filled with water and attached to some tubing. The D.I.Y. approach can save an infant’s life but risks causing blindness."

That NOT a better solution, thanks.

The entire article is rife with this.

Ketamine isn't a better anesthetic--it's acceptable if you don't have enough anesthesiologists.

The condom with a catherer isn't better, but it is acceptable if you don't have a real UBT.

It's disappointing to see the fact that the ethics really aren't clear until the whole way at the end rather than acknowledging it in a much more important manner earlier in the article.

> "Kass, the bioethicist, is trying to puzzle out the ethics of what might be seen as lower-quality solutions."

Doctors are also more likely to use these solutions with lower-socioeconomic groups--that is the whole point of them being cheaper, after all. And that opens an even bigger issue in places like the US.


Because people don't keep track of all the buzzwords.

FTA: > “reverse innovation”: taking a technology or solution born of the resource constraints in developing countries and adopting it in wealthier ones.

Nothing "reverse" about it; the question is why rich countries don't import low-cost low-tech solutions from poor countries.

I presume the answer is profit motive.

The classic example that has been hiding in plain sight for decades is "so many expensive drugs that are about as good as cannabis, and cannabis still illegal."


Presumably because wealthier nations are cost insensitive. They don't feel the need to reduce wastes in their healthcare system when they can 'afford' it.


They may also feel that it's not actually lower-cost for them. For example: say your doctor uses a somewhat lower-tech, kitbashed uterine balloon on your wife during postpartum bleeding. And say she dies anyway (as someone surely will).

There is going to be a real temptation to sue the pants off the hospital and say, "Look, they used some jury-rigged contraption instead of the gold-plated device that would have cost 10x." And, I mean, that's a bad look for the hospital in front of a jury, "Yes, well, this might be a little worse, but it might not, and it cost less money!" Everyone wants healthcare to cost less until it starts to look like hospitals or doctors are prioritizing "profits" versus people's lives.


This is why we pay the most of any other country... we try for best outcomes.

If something cheap is used in the UK with a 97% good outcomes, we will spend 3 million to ensure we get closer to 98% outcome.


Depending on the amount of patients, even a 1 percent point increase for $3M could be a baragin. If, e.g., everyone undergoes such procedure once in their lifetime, 1% times the population of UK is 660K people that could be saved for $3M, roughly $4.5 per life saved, which is a no-brainer.


Yes, but we spend on better outcomes for things that aren't remotely critical.

Women in the US have a C-Section rate of 26% compared to the 10 to 15% average just because doctors want better outcomes.


I've long argued that we need a separate court system for medical & healthcare cases.

Our current civil courts aren't set up (conceptually) to consider best available science and standards of care at the time of treatment.

So we get pathological outcomes like overuse of cesarean delivery because one jury one time bought the argument that vaginal births caused cerebral palsy. And there's really no formal way to undo these bad legal precedents.


It seems like the real problem here is suing culture. I'm pretty sure the hospital would win that case here in the UK. As they should, because money saved in one person's treatment, means money that can be spent on someone else's (and the more cost-efficient the treatments, the better the overall level of care).


> Nothing "reverse" about it; the question is why rich countries don't import low-cost low-tech solutions from poor countries.

Simple: Because you will never make your money back running that device through FDA approval. Especially if there is already another device in that space.

If you want the cheaper versions available, just get some charity like the Gates foundation to shepherd them through the FDA approval process. After that, lots of manufacturers will be happy to build them.


I just want to say the title on yc is so much better than the original. Making something cheaper and simple is innovation. Reverse innovation is ambiguous and confusing.


Like Theranos'? Medical science is slow but steady for a reason.


"People are not necessarily comfortable with the price of medicine dropping?" Sorry, which planet are you from? Earth, you say? The US even? People in your country would do anything (and have) for affordable medicine.


No, they won't. As comments above pointed out, Americans will sue when something goes wrong and it's found that the medical provider didn't use the most expensive option available. And Americans do NOT do what they can to obtain affordable medicine: if they wanted this, they'd be demanding laws to rein in costs, to provide socialized medicine, etc., just like most other developed nations have already done. Instead, we got ObamaCare, and half our population wants it to be repealed.


A world where people don't have a good way to judge the quality of medical services and so they use price as a proxy for quality. Here is a 2-minute video where a very popular speaker explains the position, to the agreement of a large crowd: https://www.youtube.com/watch?v=kPsfo8-FhB0


Why would Americans physicians stand for this when they can make loads of profit off of backroom deals with device manufacturers and their expensive doctors?


Entrenched interests, innovator’s dilemma. Orgs and people get addicted to their revenue stream.


I've come across the ORT (ORS in other countries) problem in the US. They're often hard to find, and incredibly overpriced. In the past, many pharmacies simply did not carry them. I was sometimes told to buy Gatorade instead.


Buy them online and keep them on hand just in case?

https://www.amazon.com/Rehydration-Organization-Poisoning-El...


As per my understanding- sophisticated and expensive medical devices have sophisticated algorithms for processing raw data. I would love it if cheap devices just exposed raw data and I could use my own algorithms, arguably newer and better, to process them.

I don't know if cheap devices are much worse as far as raw data is concerned.


> "People in emergency medicine often joke “that you can figure out a solution with a couple of popsicle sticks."

But that wouldn't be covered by insurance without a going through a bunch of red tape. But the approved $1000 alternative is.


Just don't call it a medical device. Call it a "dietary supplement"


To be used inside a hospital an innovation needs official blessing. There are a lots of examples of everyday things like fish oil being rebranded and put through FDA trials so that they can be used by doctors.

https://slatestarcodex.com/2014/06/15/fish-now-by-prescripti...

Something called a dietary supplement just isn't going to be used. Both because they sound sketchy and because nobody is going to use expensive food to bribe doctors to sit through a 2 hour training course in some cheap dietary supplement.


>Something called a dietary supplement just isn't going to be used.

I have more faith in humanity


This reminds me of Victor Papanek's Design for the Real World.


Root cause analysis:

1. Developed world: Profit motive(i.e. greed).

2. Developing world: Profit motive(i.e. greed) and Bureaucracy(greed, but oft times incompetence).

Greed and incompetence are deeply rooted creations of concentrations of economic incentives in the hands of a few. Capitalism and Socialism are just two ways creating those things, just by slightly different routes. One needs true democratization of technology and its distribution to succeed. Its the only reason why the internet is so powerful and empowering.


What an awful headline.




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