As someone who is taking a product from working prototype
to commercial medical market, I can tell you that it's easier to
be a charlatan and make wild claims for 'non medical
used than to be the 'real deal'. (Aberciser, Dr. Ho's stim gym, etc.).
The regulatory jungle is easily TRIPLING the cost of our device.

And the FDA regulations are sometimes absurd.
About the only way to get something speedily approved is to claim that
it is based on an approved 'predicate device'.
This means that battery powered stimulators are force fit
under line powered stimulator regulations because no manufacturer wants
to spend the 4 million plus it takes to get a new regulation
written that would make it easier for a competitor (since the competition
wouldn't have to bear the regulatory ground breaking cost).

The result is that our battery powered device must have 4KV of
isolation between patient leads and anything the patient can
touch, even though the unit only produces a maximum of 100V pulsed DC.
It makes sense to have 4KV if the unit were line powered, but
it isn't, but there are NO battery powered stimulator regs that
we could be approved under, so we have to put a LOT of effort into
meeting rigid regulations for line power isolation.

In a parallel vein,
Melatonin has a lot of anecdotal and research support for it's
efficacy in treating sleep problems, but no drug maker will
spend the millions on clinical trials to prove that it is safe
and effective (getting a DIN number) because everybody and his
dog could then produce if for less since the competition wouldn't
have to amortize the cost of the drug trial.

Why are American's so eager to buy Canadian Drugs (cross
border shopping)? Because the patent regulations up here
don't allow a 20 year monopoly so the price is lower.
Ironic that your government claims that our drugs 'are not safe'
even though they are the VERY SAME DRUGS made in the
VERY SAME PLANTS as what you get from your health care system.
But your president wants to make the importation of cheaper
Canadian distributed drugs illegal. Drug money talks...

Unfortunately, your marketplace is big enough that we jump
through your hoops, but YOU end up paying the higher costs incurred.

Lawrence Lile wrote:
>>One thing that I'm most afraid of is that it seems to be a rule now:
>>they are always trying to find a treatment, not the cure!
>>
>>Francisco
>
>
> A similar case is Asthma.  Drug companies make gigantic profits on
> asthma drugs, since the sufferers have to take them every day.  There is
> huge funding for more research into drugs.
>
> But a cure?  Nobody is working on a cure, there is too much money to be
> made in addressing the symptoms.  Innovation loses, and patients lose,
> once again.
>
> How does this phenomenon play in medical devices?  (Which brings the
> discussion back to PICs and electronics of course)  It seems that there
> is more latitude in a device, versus a drug, and the bar is lower for
> entry into the market.  This might foster more innovation in a device

No, it's only slightly lower since it only takes millions, instead
of 10's of millions to get a 'medical device' approved.

> versus a drug.  Is this actually true?

I know of several devices that never made it to market because
of regulatory impediments or economic ones. "Once everyone has one,
and with no consumables to be purchased, we cease to be profitable".

Mr. Gillette gave away the razor, but sold blades. The same marketing
approach is taken with drugs and medical devices.

> For example, I saw some news about a migraine zapper that used special
> magnetic fields on the patient's head.  The device looked like a toy
> gun. Since there is an incentive to patent and sell the device, might we
> expect to see one of the market soon?

Of course not. Might be used by terrorists for mind control.

Robert

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