Comment by sethc2 | Hacker News Reader

Comment by sethc2 | Hacker News Reader

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I worked in R&D at Philips making ultrasounds. From my experience this is definitely what it is.

The amount of people that were employed to simply test, do documentation, and verify safety alone was staggering, let alone all the smart people it took to develop custom ASICs, FPGAs, mechanical housings, image processing etc. There are physicists who do research, there are sonographers who help achieve the best possible images for clinical scenarios.

The amount of effort it takes to make a high quality, safe, ultrasound is immense. When you add in the fact that you also need to follow a myriad of FDA regulations, even small code changes often require a huge amount of overhead in documentation and review before they get checked in, and then there will be whole teams of people to manage source control.

Ultrasound companies do an immense amount of R&D, but also put out a safe, well-regulated product, and the prices reflect that. I'm surprised the the author in the article found even a low quality ultrasound as cheap as he did.

Sometimes that's just a hangover from "the way it was always done.' Telephone switches used to be insanely expensive, and developed with fleets of coders, QA, documentation people etc. in projects costing hundreds of millions. Now any shady outfit with an Asterisk server is a phone company. Five nines? Is that a burger chain?

Not saying that's how FDA approved devices should be developed, but don't be surprised if "prosumer" grade equipment starts penetrating the medical field especially if anyone gets the cost incentives right.

I wouldn't be surprised if we see a number of modernized devices in spaces where there are established consensus standards.

Having taken courses in biomedical engineering, and done some research for a company looking to do what you describe, I can say with some certainty that it is very difficult to start a medical hardware company. You need to outsource production to an expensive certified CM with large expensive MOQs, unless you want to go through time consuming and expensive manufacturing approvals yourself (before being allowed to make or sell anything). You must also develop (easy) and have your device approved (hard), as well as not being allowed to change anything without additional time consuming and expensive approvals. Add in the fact that most diagnostic electronics require the highest level of scrutiny, paperwork, bureaucracy, and delays, and you quickly figure out that you're better off doing something else.

For what it is worth: It can be done though, completely in house, in a couple of years by a smallish group of people who know what they are doing.

Are the regulations very different in different countries? I can think of a few places where getting live-saving machines an order of magnitude cheaper with a small percentage increase in risk of causing harm might be an acceptable trade-off in some cases.

I've been to hospital in one of the places you're thinking of, and I noticed that phrases like "approved for use in the EU" were used as code for "this is not a scam".

I fear the market niche between "scam" and "not a scam" might be very narrow.

I mean, I was thinking less private-clinic of dubious standards in a city, and more "what can the national health services of developing countries reasonably deploy to most rural communities?".

For example, I am from Mexico, and cysticercosis (a brain parasite infection) is not uncommon in rural areas in Mexico. MRI scanners, which can be used to detect it, on the other hand, are quite uncommon outside of major cities. This might or might not be a good example, since I don't know the cost/safety trade-offs for MRI or all the alternative solutions, but if one could get, say, $20,000 USD MRI scanners that are close to in practice to $1 million ones, it might be worth a small safety delta. Public health in Mexico at the national level also tends to fall under "generally trustworthy enough, but critically under-resourced".

Edit: Again, not sure how realistic this particular scenario is, but I think in general getting cheaper equipment for national health services might be worth it in cases where having a lower-standard device can save an order of magnitude more lives than it harms.

This is not my area of expertise, but in speaking to Regulatory Affairs people when I was working in the field, most of the EU and some of Asia base their regulations on the US FDA, or at least have very similar regulations. In addition to FDA audits, we were also periodically audited by the regulatory bodies of other countries.

However, in many countries, enforcement is lax, so you get lots of devices that don't come close to meeting whatever regulation is in place.

They appear to take some very specialized training to operate them well also. There is all the overhead of training the operators and attempting to build something that is reasonable for them to use

I can understand the need for quality testing, but what's the medical threat they're trying to guard against from ultrasounds?

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