Comment by ghaff | Hacker News Reader

Comment by ghaff | Hacker News Reader

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I agree with you but it can still be frustrating and there's a lot of entrenched interests involved.

My story is that I broke my foot about 10 years ago (in the Grand Canyon no less). Long story short, when I eventually got the doctor, she told me that this kind of fracture always took a long time to heal and the literature suggested that electromagnetic stimulation had some benefit. Of course, the insurance company wouldn't pay until it was deemed a "problem fracture" in a few months (as my doctor thought it would be) but I did eventually get my $1000 stimulator at about 50% off.

It had the most horrible interface one could imagine. If it slipped off the foot, it apparently simply shut down for that day's stimulation. In any case, my foot eventually healed.

A few years later, a friend had a similar injury. I gave her my stimulator. Apparently the allowable stimulations had expired by then. She took it into a medical supply place and they were horrified by the idea that they might simply reset the device.

I'm not a big pharma hater but this sort of story is why people get really mad.

Those ridiculous pricing policies are necessary to recover the cost of regulatory compliance which is seriously huge component of anything medical in USA.

As a side note, I know a company in India that manufactured a state of art blood test device. They tried to market it in USA and eventually gave up. Currently the company has tie up with Singapore hospitals which send blood to India for testing via flight and reports are mailed electronically automatically. There is a rig of blood testing machines in Powai-Mumbai which tests thousands of blood samples each day. This machine clearly can not be sold in USA (last time I checked was 6 years ago) because the cost of regulatory compliance is prohibitive.

If the medical device manufacturers indeed made windfall profits I would love to invest in their stock but they don't seem to be doing as well as the hatred directed towards them.

Wish there was something for medical manufacturing like pricepain.com - including a reduction in unecessary red tape. Sad, how it stifles innovation and actually harms more than it helps.

My portfolio is about 50% medical supply and machinery manufacturers, and they're incredibly steady investments which pay strong dividends even and especially when the stock price is down. Furthermore, they're often able to make biotech plays and their guaranteed revenue means they're strong candidates for acquisition: http://www.bloomberg.com/quote/HSP:US

Do you have any sources for your claim that regulatory compliance is hurting profits beyond a one-off anecdote? Because my experience has been that it's an industry rife with windfall profits.

Also, what's the name of this Indian company, and what's the brand name for the device? If it does what you say it does, you would be pretty foolish not to invest.

"More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report."[1]

I am not saying the companies aren't profitable. They aren't profitable the way people make them out to be.

And if there are indeed windfall profits to be made what is preventing smart-ass entrepreneurs from jumping in and making those profits ?

Tim Cook says that the Apple Watch won't become a regulated medical device, but Apple might make another product that is. Cook made the comments earlier today in an interview with The Telegraph, stating that putting the Apple Watch through Food and Drug Administration testing would slow its release cycle down too much and "hold [Apple] back from innovating."

[1] http://www.massdevice.com/study-fda-related-activities-cost-...

"And if there are indeed windfall profits to be made what is preventing smart-ass entrepreneurs from jumping in and making those profits?"

Incredibly high barriers to entry and very large established players who have already cornered the market? Following your logic, oil companies must not be very profitable since there aren't very many entrepreneurs buying their own offshore drilling platforms.

"They aren't profitable the way people make them out to be."

Who are these people? What is this way?

What concrete assertion are you refuting? How do you explain the P/E ratios of the biggest medical device companies?

If the cost of regulation is such a drag on profits and innovation, why are medical supply companies that primarily serve the US market so much more profitable in the long term than their counterparts in other countries?

Are you alleging that there's a bubble, or that they're cooking their books, or that they're not one of the most consistently profitable industries?

We could never have an 'open' or cheap medical device because of the extreme level of regulations and the tendency to pretend that the laws of economics shall not apply when it comes to human lives and medical devices.

i'm in the medical industry and love FOSS and I've contemplated this a lot. nearly every day.

I believe the way forward is with open, LGPL-style, reference designs, almost like the Red Hat enterprise model. individual companies must still be accountable and liable for their devices, but their real value-add is in the verifications and validations.

The auto industry doesn't share software, but the liability model is similar in that: how to build any car is mostly known, there are few important secrets. You choose your car based on features and quality and the companies provide those validated features and quality to customer expectations.

Reference designs in medical devices would especially help with the security crises we're undergoing.

So you could buy, say, an insulin pump based on a reference design from a dozen different manufacturers, but your feature set and quality of materials would be up to you and your insurance company. This is the best compromise I can find which allows competition to improve quality and spur development (competition is weak in med. devices) yet allows thousands/millions of eyeballs to improve software - and therefore life - quality.

The holy grail is a medical-grade embedded Linux. If any hardcore entrepreneurs want to talk with me about that, I have a lot to share on it.

That device practically screams, "hack me".

Are you just trolling? This is a device that isn't connected to any network. Indeed, it barely has a user interface.

I assume they meant hack in the friendly, Hacker News-type sense instead of the malicious, my-grandpa-thinks-someone-hacked-his-Google sense.

That word doesn't think what you think it means.

> That device practically screams, "hack me".

As in, "That device practically screams, 'please find a way to tweak me to overcome my restrictive and unreasonable limits (embedded in what is otherwise a functional device)'"

Or in other words, "hack me".

Fair enough although "hack" in the context of medical devices is most commonly used these days to mean something like "maliciously access."

Hack in most contexts these days means maliciously access. Yet, you are not currently browsing a community of malicious accessors, but hackers.

User also didn't get the jones joke. Lost cause.

fractured a metatarsal huh?

Jones fracture, specifically.

J-what? That's a whole other "leg" that doesn't even have metatarsals.

https://en.wikipedia.org/wiki/Jones_fracture

I also fractured my fifth metatarsal. It was a Pseudo-Jones fracture so I was up and walking in about 4 weeks(with lots of pain from the toe region and heel for some reason). I was just thankful it wasn't a full jones fracture.

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