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Regulation of IoT in Healthcare

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Regulation of IoT in Healthcare

A few years ago, I designed and prototyped an IoT device as a 'foot controller' for Virtual Reality gamers.  I ran a Kickstarter - but it didn't do well enough to fund final development.

But I soon found that this same device (with minor software tweaks)  would MASSIVELY help certain categories of diabetics — but as I look into selling such things I run into a horrible wall of paperwork and impossibly expensive hurdles put in place by the FDA because these are considered to be “medical devices”. They demand a similar level of testing and “human trials” as they would for a new drug.

Diabetics often lose the ability to feel pressure on their feet due to degeneration of their nerve endings.  When this happens, they may stand too long in one position and fail to shift weight around from one foot to the other and from the front of their feet to the back as normal people do instinctively.   This leads to ulceration and other damage that results in around 70,000 foot or toe amputations per year in the USA alone.  3.9% of all diabetics will ultimately need amputations because of this…with higher percentages higher for women, blacks and hispanics.

This is a device that slips inside a regular shoe — I could make them in bulk for $20 and sell at a decent profit for maybe $100.  It logs foot pressures and that could be saved for later examination by a doctor - or used to set of a gentle reminder on your phone.

However, I estimate that if I jumped through all of the regulatory hurdles, I’d have to sell these $100 gadgets for over $10,000 — and at that price, almost none of the people who could benefit could afford them.

Hence, this device will never see the light of day.

It’s ridiculous. This device can’t harm anyone — it’s only logging their data to be examined by their doctor — and (if the doctor decides it’s necessary), warning them with a gentle beep when they’re doing something wrong.

There needs to be some regulation to keep junk products off the market — but we need a VERY low cost way to get these kinds of non-invasive devices approved and on the market so that small entrepreneurs can bring good ideas to the market without having to get a gigantic healthcare company involved.   We know how that works - right?   Remember the ongoing $600 epi-pen scam - a device that contains 10 cents worth of drugs and should be available in every First Aid cabinet - costs about $15 to make sells for insane amounts of money).

Reader Forum: Regulation of IoT in Healthcare

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From: Steve Baker  Date: 2017-09-18 14:07:20  

Well, the trouble is with marketing. If you say "This will help cure XXX" then you're in trouble. The brain training people are merely seeking to enhance something that's not broken...so like weight training enhances your muscles.

The larger problem is that even at $100 people wouldn't buy this gizmo unless a doctor tells them that they need it...and, again, they aren't legally supposed to do that. More specifically, I really need for the HMO's to pay for it. If that happened then I'd get 10's of thousands of orders for this thing. The doctors would want it - the patients would want it - and the HMO's would be HAPPY to pay for it (if it works) because amputations and subsequent health care costs are HUGE. If it cut the number of amputations by just 1%, it would be cost-effective for the HMO's.

But getting it past the FDA is a nightmare.

Indeed, yes - I'm bemoaning the difficulties of getting DEVICES past the FDA. Drugs and things use surgically - obviously need heavy regulation. But a couple of pads that go into someone's shoes? I don't see the need to regulate them. Heck if homeopathists can sell quack cures that don't work without regulation...

From: Archon Shiva  Date: 2017-09-18 07:53:27  

Have you investigated going the way of "Brain Training" games? It's a device, for entertainment only, that measures your foot pressure. It has no more medical use than Lego or an Xbox controller - both of which have been used to help recovery of fine motor control and strength in stroke patients, but neither of which claims such usage.

Of course, the point of the article is that the US gravely needs to put new procedures in place, not to get one specific device to market...