Cheap and simple medical devices have to overcome deeply rooted biases
newyorker.com
newyorker.com
"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.
American culture doesn't allow for anything better than the best outcome in medicine.
1. The best
2. None at all
Often the choice between the two is financial.
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?
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.
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...
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.
http://www.liquiband.com/region/uk/liquiband-product-range-w...
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?
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.)
It’s mostly uncorrupted by million+ dollar malpractice suits.
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.
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.
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.
I'm not sure if there's an official "medical powdered mashed potatoes" that doctors use.
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.
https://www.amazon.com/QuikClot-Advanced-Clotting-Kaolin-Str...
Be sure you know how to use it before you need to use it though.
A study related to that: https://www.ncbi.nlm.nih.gov/pubmed/18712606
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.
If you purchase liquid bandage in a drug store, it is just sterile CA glue.
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.
https://www.washingtonpost.com/archive/lifestyle/wellness/20...
https://www.amzn.com/B00006IDL4
They basically all agreed the original worked very well.
they're still available online, albeit rarish, but they're very convenient.
Works like a charm
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.
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?
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.
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
Hacking the controller could be challenging if it's been deliberately hardened.
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 ...
Any insights? How did you find the embedding?
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.
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)
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.
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.
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.
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.
Since no one is clamoring to wholseale trade USA healthcare for India's, there are obviously done tradeoffs.
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.
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.
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.
https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d...
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.
Sounds like a fatal flaw in the system which benefits manufacturers and insurance companies at the expense of consumers.
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.
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.
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.
> "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.
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."
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.
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.
Women in the US have a C-Section rate of 26% compared to the 10 to 15% average just because doctors want better outcomes.
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.
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.
https://www.amazon.com/Rehydration-Organization-Poisoning-El...
I don't know if cheap devices are much worse as far as raw data is concerned.
But that wouldn't be covered by insurance without a going through a bunch of red tape. But the approved $1000 alternative is.
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.
I have more faith in humanity
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.