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Comment by PUSH_AX | Hacker News Reader

> the device will be priced through a subscription model at $199 monthly for five patients or $399 monthly for unlimited use.

Is this normal in the medical industry? It seems a little absurd to me but I know nothing about medical tech.

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In general med tech = so expensive your eyes bleed and your brain melts.

I'm assuming they've dropped in price a pretty good amount now, but digital x-ray machines with the require software were near hundred thousand price range and typically tied around some windows operating system. So if the controller came with XP, never expect to go to a new operating system. The companies general answers were, oh, you need a controller with a new OS, spend another $100k for the next gen, which unless you're pumping out huge numbers of xrays was just not going to happen.

>So if the controller came with XP, never expect to go to a new operating system.

That's not necessarily a bad thing!

In our industry, the idea of something using XP is ridiculous. Applying our experience to the medical field is a bad idea!

It's an appliance. It doesn't really matter what OS it runs as long as its stable and certified to do. It spits out imagery which you can then process and view on any compatible device - often a reasonably modern computer running some sort of health informatics platform.

For what it's worth, the "XP" OS is often licensed and supported for well longer than a consumer SKU. IIRC microsoft provided support and security updates for embedded/appliance applications until 2019!

These devices are often not openly networked, or if they are, they are through some sort of gateway that's appropriately locked down and updated.

It's an appliance with huge gaping security flaws that its very creator says you should use under approximately no circumstances.

> For what it's worth, the "XP" OS is often licensed and supported for well longer than a consumer SKU. IIRC microsoft provided support and security updates for embedded/appliance applications until 2019!

You're 100% right but that still means the thing has been sitting around for half a decade with no security updates whatsoever.

There is a fine line between stability and simply being a miser and refusing to update things within a reasonable period of time. Healthcare, especially corporate healthcare run by people other than physicians, is far to much on the miser end of the spectrum.

I recommend you all read the 2023 FDA cybersecurity expectations before commenting. https://www.fda.gov/media/119933/download

>These devices are often not openly networked, or if they are, they are through some sort of gateway that's appropriately locked down and updated.

Possibly in major hospitals with large large IT teams...

But I've worked in a lot of smaller clinics and the term 'often' changes to 'almost never'.

> In our industry, the idea of something using XP is ridiculous.

Only because of the lack of (security, drivers) updates though right? If I couldn't use Linux or macOS I'd rather use XP (if it were current) than anything that's come since.

(I also don't need accessibility features which I'm sure have come a long way.)

Being in the medtech/AI industry (our company, Eyenuk, created the 2nd autonomous AI approved by the FDA), nothing seems too strange here.

I've seen subscriptions supported, and the pricing doesn't seem alarming. If you look at any medical bill that includes lab work, or anything medical related, this is really cheap comparatively.

The cost of everything is required to lure companies into the space. The cost of research, running a clinical trial, the FDA approval, certifications (SOC2, etc.), insurance, etc. still push many companies away. In fact, in the EU, where the cost is lower, the approval process is getting harder (MDR) and many companies are leaving the market.

Why can't companies just charge X price, once, since it's already FDA approved (hence I assume models are validated), and in the future any upgrades cost Y?

It comes across as predatory that users be charged subscriptions for something that seems like it should be fixed.

Aren't other medical devices and drugs sold for a fixed price, regardless of all the FDA approval and marketing they had to go through?

Like, no one pays a subscription fee for an X-ray machine, or a subscription for a course of antibiotics.

Antibiotics are consumables - in a B2B context (it's a medical service provider who is paying the subscription fee), antibiotics are basically a subscription.

Many (most?) diagnostic devices have consumables which is where companies make the bulk of their revenue. Failing that, service contracts are usually in place to lock in some sort of sustained reoccuring revenue.

There is no fundamental reason why a company couldn't do your proposed model, but upgrades are definitely challenging - if you make your model better, or you improve your hardware, or basically do anything that isn't a bug fix or an ancillary upgrade (like I dunno, you made the thing boot up 25% faster), will likely require additional testing and approval from the FDA.

One of the genius medical marketing tactics was to create disposable condoms for thermometers, ear probes, etc., so that you can use one up for each patient and then purchase a whole big box of them on a subscription basis, rather than going through a simple bottle of sanitizer that could clean anything and everything that needs it. (And then of course, nobody cleans the probe underneath, as it just gets slightly grodier with each use.)

We didn't invent it. We in this industry refer to this as the "razor - razorblade model". Nothing is ever new.

That's not why disposables were adopted. A "simple bottle of sanitizer" is less likely to get rid of biofilm and spores, especially given the laziness and error of end-users.

Disposables are inherently safer. Lots of trash, and more expensive, but the best option for wealthy nations that can afford the best care.

I wouldn't pay for a 25% faster bootup unless it was an emergency life-saving device. You'd have to sell me something significantly better and worth my money, like any other seller in the world has to do with their product, from computers, to cars, to fast food.

I'm not sure that a software upgrade would require FDA approval, but product testing is a cost incurred by anyone in any industry. Even a new burger recipe would be tested at the restaurant's own expense. That doesn't seem to justify a subscription model (after paying the initial cost of the device, etc).

Software, it's never done.

An x ray machine does the same thing all the time, no Software maintenance needed. If you have a product that has a cloud component, any component to it where it needs to be maintenance from a security standpoint, that has cost, you need to cover that cost.

Modern X-ray machines use software to receive the image and view it.

If the models already work, why would it even require a cloud component? That's just risky, complex, and costly. Let the device do its thing, doc writes down the findings, data gets deleted, and device ready for next patient.

Yes, but they don't interpret it.

They aren't using AI or the cloud component to do what they can already do.

The whole promise that all these companies are pitching is to aggregate patient data over time, tie it to clinically measurable metrics so they can detect, prevent or treat things better. In your example the idea would be the model in the cloud is aggregating all the patient health record data, tying that to the xrays of those same patients, so that in the future the model can see things in x-rays that indicate disease or are predacessors to disease before we humans can even spot them.

All that takes money.

Not quite the example I was explaining. In my example the validated/FDA-approved model runs on local hardware, at the physician's energy bill. Need an A6000 GPU? Fine, I'll buy it.

If the vendor wants to improve the model, they can ask for anonymized data from physicians, if they're willing to provide it. That's their cost of developing a better product, just like anyone in any industry pays a price in some way to improve their product.

Your missing the details of why.

This stuff can't run locally, it's cloud connected by design. It's cloud connected by design because the company's value pitch is on the data, not the hardware. They loose money or break even on the capital hardware. This is always the case, intuitive makes their money on the instruments, others make it on the subscription fee.

If you want it this way, you'll end up paying a lot more for thr capital equipment.

There is no free lunch.

A bit late here, but I thought I'd mention something in addition - most hospitals and doctors don't want to take on the burden or supporting something new and specialized. They will focus on providing care and buy support. Some have small IT departments, but even IT support is regularly contracted out.

There are a lot of ongoing costs as well. Medical insurance is expensive, and there's a lot of process that is ongoing. A lot of effort goes into security, both monitoring and pushing updates. Medical device companies must also undergo regular audits of our quality systems, look up QMS/eQMS, where FDA reps will spend about 1 week a year reviewing everything we've done over the last year. Generating all the documents for those audits takes a lot of time (aka cost). That's not complete list, but this is in addition to regular SaSS costs.

Also, Eyenuk products looks great.

My wife will start PCP practice soon. I'm going to ask for a brochure ;)

$400 a month, in a reasonably busy dermatologists office, would probably come to about $20 "per use". A lot less if you have multiple patients use it a day.

Which will probably be billed at $200, if my long experience with dermatologists is any guide.

Primary use case would be PCPs who aren’t trained to diagnose skin cancer. There will be cost saving because the patient won’t have to visit a derm. Also it opens it up beyond dermatologists so it could be a PA or NP. That means in theory you could go to could go to a CVS minute clinic if you have suspicious mole.

I wonder what the liability will be if the machine misses a cancer and the PCP didn't refer them to a skin expert (eg, dermatologist).

> The FDA approval was based on results from a multicenter clinical trial led by the Mayo Clinic involving over 1,000 patients across 22 clinics.

Medical tech often requires clinical trials so there is some cost to that. And it can also limit how quickly competitors can create a competing device. But $399 monthly for unlimited use doesn't see so bad when a dermatology clinic might see hundreds of patients a month.

Dermatologists probably aren't going to use this. Primary care in rural areas is the best application for this.

It's normal in the US. Outside the US things are more competitive as companies chase fewer buyers/dollars and have to sell things cheaper. Sometimes this makes certain countries worthless in the eyes of a medical device manufacturer

In theory this lowers the barrier to entry. A small clinic can buy in at the limited use subscription and they can pay to remove the limit as they grow. Having one hardware SKU for everyone and selling feature unlock licenses simplifies manufacturing.

Price discrimination, intellectual "property" enforcement, and DRM are nothing new in the medical industry.

It’s B2B so I’d say it’s normal.

Yes, it's very common

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