[agumonkey]

People's work shouldn't be reduced, but drugs and devices should be to an extent. Firefighters told the portable EKG costed thousands of dollars (5 or 10 don't recall). That thing had bad 2G connectivity so the graph coudn't be sent to a cardiologist. The sensor/dsp part is worth money, the rest would cost 100$ from any smartphone maker today with better performance and portability.

I'm sure the price is rigged for margins. This shouldn't be a market, it should be an open duty to make these cost efficient.

[ams6110]

The real cost is not so much in the hardware but in the certification requirements. Medical devices need to be built to and work at a higher standard than consumer electronics, for obvious reasons.

[epicureanideal]

But if the cost becomes so high that people simply go without the devices, is that really a good tradeoff? Maybe a device with 1 in 10,000 failures is better than no device at all, for some subset of illnesses?

Also, I suspect this is FUD by some entrenched medical devices companies who know how to play the game of complying with standards. Anyone here ever gone through compliance testing with software? I've seen systems pass that are worse than what I would have just thought up in 30 minutes and coded up for fun. It's just a warm fuzzy feeling.

[candiodari]

That's one thing. But there's other problems:

1) certification that takes 10 years (more like 3, but ...) means you, at the very best, have 10 year old technology

2) Certified at a higher level. That can for various reasons be very different from reliable at a different level. For instance, circumstances change or knowledge advances.

For instance certification tends to take "proof" that something works. Yet the most reliable robots are pretty bad hardware, with the ability for multiple components to do the same job "most" of the time. Such a device, despite being much more reliable, is disqualified a priori in nearly all certification processes I've seen.

(needless to say, every time the things they take as proof tend to be ... less than proof)

Plus we've all been in a company having this discussion. "For the price of this one 'reliable' server we could have 20 normal ones, and they would be a hell of a lot more reliable together. Hell, just give me 3 of the cheap ones and I'll make it more reliable". And we all know what the boss's answer and the resulting reliability was.

3) You assume no regulatory capture (or outright dishonesty on the part of government employees and/or lawmakers)

[agumonkey]

Of course, but the interface and connectivity part of that EKG machine wasn't even up to 2005 cellphones standard. On that point, it's a scam.

[gmueckl]

So you would trust a random baseband chip to never ever in a thousand years lie to you about the success or failure of its operation or its internal status? Or to behave in an unexpected way that interferes with the core function of the device? E.g. by suddenly sending random junk to the main CPU?

How do you verify that the display controller is not acting up and not blanking out a region of the display that contains essential data?

If you cannot prove things like that for your medical device, you won't be allowed to sell it.

[monocasa]

If only. I work in the same town as a big medical device manufacturer, and several co workers over the years had worked there and immediately nope-ed out on moral grounds. Stuff like panics on anything out of the order in a morphine pump that defaults to full on while resetting. Apparently those killed a few people.

Meeting the FDA guidelines is more about finding the cheapest way to technically meet the spec rather than trying to build something safe.

[gmueckl]

I do get that such a device panics on the smallest error. But then it is supposed to go into a safe mode. "Full on" does not seem safe to me. Full off and emitting an acoustic alarm until it is actively acknowledged would be the right thing to do. Whoever designed this thing to do what it did was frankly a morron.

But gaming the certification process is unfortunately also a thing. In the EU the certification is performed by private companies who are themselves certified by the government for this job. The kicker is that they are competing against each other on a free market. Potentially shopping around for the most lenient certification process could be a thing. I haven't witnessed it yet but it certainly is possible in that system. The thought alone scares me.

[agumonkey]

Oh yeah EU certifications are sadly super weak. Now to your original point, I think it's quite possible to have an open review system. Linux and the likes have shown great capabilities in finding and fixing issues fast. With a national effort to ensure paid engineers it's not science fiction.

[agumonkey]

You know this mindset is becoming the norm. Everything is about doing the minimum to be legal and avoid lawsuit.