Most of the commercial devices used to measure VO2 Max aren't regulated medical devices.

I think this would really be great. The extra regulations of the FDA are showing to be more and more of a burden as years go on (let's not get into their corruption). Something like a chip and a device sold separately but trivially put together. I myself ran into this problem when trying to buy a blood lactate meter as an American, which can be trivially purchased all across Europe and Asia.

It’s ironic that a lot of their approval process amounts to filling out paperwork without any verification or testing on their part.

Source: I know people.

What are the insane aspects of the regulations?

One of the common complaints is the lack of accounting for the harm done by delaying a device/therapy/drug.

If $DISEASE kills 10k people/year, and $DEVICE can save 90% of them but 5% suffer $DEVICE related deaths, delaying the release 10 years trying to get to 0% related deaths doesn’t sound like the best strategy.

However, this isn't just the FDA.

If $DISEASE kills 10k people/year, the company manufacturing the device doesn't have to pay anything for them.

If $DEVICE kills one child, the company manufacturing the device is on the hook for several million dollars.

So your $DEVICE needs to clear (roughly) 10K*5%*$2 million per person killed or roughly $1 billion in profit to be economically feasible.

That means that those 10k people need to spend, $100K+ each for that device to make it feasible.

It's not just the FDA that makes companies want to drive that 5% down to damn near zero.

Most of them are written in blood.

You are assuming that the existence of regulations means that there’s testing required.

You’d be surprised at how much is just about filling the proper paperwork, paying some fees and knowing the right people. The amount of independent testing is negligible.

I'm sorry, but this is just patently false. The FDA requires extensive V&V testing, especially for medical devices that have a significant chance to kill the people that it's used on. That, and you need to have a very sophisticated quality management system (QMS) in place that tracks all the changes you make during your design and test process, links up source requirements to passing test reports in an auditable way, tracks all of your manufacturing information (including which batches were tested using what procedures, and the results), all of which can be randomly audited at any time, no matter where the facility is located on the world.

You may be referring to the 510k (pre-existing predicate device) pathway, which has been abused by companies to leapfrog and skip _some_ of the more stringent test requirements, but they still need to prove similarities, and that requires real data. However, in the vast majority of cases, these devices are things like masks, IV tubing sets, etc, not complex life saving equipment, which gets an enormous amount of scrutiny. If anything, it's the medical device companies that are at fault for lobbying Congress to allow abuse of 510k pathways, and Congress for allowing these things to happen.

> I'm sorry, but this is just patently false. [..] The FDA requires extensive V&V testing [..] and you need to have a very sophisticated quality management system (QMS)

Paperwork, they require paperwork.

It’s the same issues that plague FCC and CE, the amount of tricks and handwaving you can get approval for makes a lot of this (self performed/self directed) testing completely useless.

There’s a whole market of “expert consultants” whose job is gaming the tests and finding loopholes, and as long as tests are conducted in this manner, they will exist.

That's a little reductive. Companies get shut down all the time when their quality management is not up to snuff (for a high profile example of this, look at CMS' shutdown of the Theranos labs in 2015). The system generates the paperwork, and the data enclosed is generated by the processes you have to put in place to get approval in the first place.

Like I said, the world of predicate devices is a different ball game, but you're not going to get by with hand waving on a device that can kill people.

> Companies get shut down all the time when their quality management is not up to snuff.

That’s not a good measure for the performance of the regulation. In fact I’d like to see the numbers on the exact reasons for those shut downs, because I’m willing to bet they’re related to bad classification and other technicalities.

If the FDA were to be a test, you’d want it to have good discrimination at a low cost.

Anyone who has been involved in the process knows the cost is enormous, and scandals like Theranos (and good but extremely late good cases) show that discrimination is not that good to begin with.

I have been involved in the process, my company has a de-novo device (with an issued IDE), and I can agree that it is expensive and time consuming, but what their requirements result in is ultimately a better product, better processes, and dramatically reduced risk.

These regulations are written in blood. They're difficult to comply with because if you invite poor engineering you will get poor engineering and dangerous devices.

I don't think I can accept that, especially with regard to items like hearing aids. There's a fundamental difference between things like implants and surgical tools and relatively simple devices like CPAP machines and hearing aids; things where the harm of a failure scenario is extremely limited.

This is a government at the end of the day. It would be imprudent to not consider the effects of regulatory capture, cronyism, and so forth.

do you have experience in the discipline? It doesn’t sound like you do.

I have some experience, and i can think of about a half dozen ways cpap machines and hearing aids could cause serious harm as a result of design flaws or lack of QA that would be de rigeur if not for regulatory pressure.

So can headphones and earbuds, and society seems to do just fine with the normal level of consumer electronics regulation. Is there really value in the medical device regulations for hearing aids beyond that?

Kids listening to music too loud has been a problem since the invention of the speaker.

What are some of those ways that are not addressed by regular old (non-medical-specific) electronics/safety regulation?

Most of the ways I can think of a CPAP failing would be extremely obvious with equally obvious and relatively low-impact effects (I get a crappy night's sleep or wake up in the middle of the night).

Recent case involving very popular Philips Respironics machines: the foam used for internal insulation was degrading and getting into the stream of air, landing those particles in patients lungs. Huge recall, etc. The kind of problem that testing imposed by regulators can detect.

Incorrect use of CPAP can lead to development of central apnea. (Even APAP machines can be programmed to keep the pressure too high which is long term unhealthy).

With that, I am all for liberalization of the laws. My GP did not prescribe me a CPAP machine despite obvious signs of apnea. "Lose some weight instead" (that despite me having apnea even when I had a BMI of 21).

I never felt as much of a positive difference on my life as when I started using the machine and had my first good night of sleep in decades.

I wish my govt would let me buy an insulin measurement device, but nope, those too are regulated and not available for the general public.

there's an ongoing CPAP recall, so there's at least one way they can be dangerous

https://www.fda.gov/medical-devices/safety-communications/ce...

What are the devices you have in mind? It doesn't seem like the intersection between "people with biomedical engineering skills" and "people who need treatment limited by the expense of the equipment" would be that large. I suppose I can imagine a sort of shadow economy of cheap medical treatment on home-built equipment, but surely the providers would be uninsurable and sued into oblivion at the first mistake.

Ones that immediately comes to my mind are ultrasound,and hearing aids. If they were unregulated there would be cheap OTC devices available.

I work on a handheld ultrasound device that attached to a phone or a tablet. It is much easier to use than traditional ultrasound machines, because of the attention paid to the UX off the app, and the familiar smartphone UI.

That being said I will haven't learned how to use it in a meaningful way myself. Getting a good image, and then interpreting the 2d video stream requires training!

Making ultrasound easy enough for non specialists to use will require an AI that guides the user and interprets the images. I'm not convinced skipping FDA approval would be a good idea in this case.

At least in the US, there's a fair amount of immigrant medical professionals who have the training, often the experience, but not the licensing.

What’s getting in the way of their american licensing ?

If they didn't finish their school their studies are often regulatorily worthless in the US, if they did there's still massive hurdles to jump without existing relationships/wealth to aid the transition.

The AMA.

Why can't ultrasounds produce 3D?

They can, but since the data is very noisy the 3D reconstruction is usually not very good.

If you actually need to measure something, analysing the 2D images is much more precise.

EDIT: Also, it's really hard to visualise density in a 3D view.

I just don't see what harm there is in making unregulated devices even if they're hard to interpret and less acurate.

The problem with 3D reconstruction being difficult has nothing to do with wether devices are regulated ornot.

Also,noone is stopping you from making a DIY ultrasound and selling it to enthusiasts.

OTC hearing aids may actually be happening:

https://www.fda.gov/news-events/press-announcements/fda-issu...

We need a currently "missing" network effect that cheap 3d printer supporting everything from more flexible plastics to metal will eventually provide.

Wake me up when we can 3D print pills and I can craft the perfect Tylenol or 5 hour energy from some React app. Now that'll be a medical revolution!

You don't need a 3D printer. Just order bulk acetaminophen and caffeine powder, then put as much as you want into capsules. (Don't poison yourself.)

Once this is done, printing chemicals might be achievable too (thanks to the network effect of lots of people already having 3d printer to produce the required hardware), but maybe not immediately :)