The Continental Device Divide

It is true that a lot of highly innovative, modern European orAsian made medical devices and instrumentation are not and cannot be used here in the U.S. One key reason is due to a very restrictive, aside from being bureaucratic and highly political atmosphere existing within the realm of the FDA.

This artificially induced hurdles result in the lack and availability for such highly technological / advance medical equipment. Resulting into a shortchange of needed medical care for the majority of the patient population who would have otherwise be benefiting to such innovations. Only those few affluent ones who can easily travel abroad can avail themselves and therefore take advantage of such developments.

...paraphrasing what the great American humorist said, "...we have the BEST government that money can BUY--not the quickest..."

This is a double edged scalpel. I have a friend that is a sales manager for a large US medical device company.

The good part is, that medical devices are all manufactured on US soil, which provides jobs and keeps people working.

The downside, (not for him), is that they are very expensive, and importing them would surely lower, at least that aspect, of medical care. But it would also kill more US jobs.

I suppose one way to create jobs in the US, would be to regulate all imports to the point that nobody finds it worth it. Then we would all have to make and buy our own heavily regulated, overly expensive stuff.

'....Many U.S. device manufacturers are going abroad for regulatory approval....'

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Hmm, sharing innovative medical devices with the world, while increasing and diversifying sales of US based device makers....the situation doesn't seem that dire.

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...until the second shoe drops....

'....while an increasing number of European medical companies are avoiding the American market altogether....'

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Sounds scary. Wanting to see more specifics, I followed the link. How large is the increase? How rapid? What types of devices do the companies make?

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But I can find nothing. Can you please link to some specifics on the 'increasing number of European medical companies avoiding the American market altogether'?

Thank you.

You can download the final study here.

Thank you for the link.

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I find nothing in the 'final study' supporting the claim of an increase in the number of medical companies avoiding the US markets altogether.

In fact, reviewing the 'study' triggered alarm bells ringing in my head at the stench of an alarmist/sensationalist call to action masquerading as a scientific 'study'.

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The 'final study' is more of an attempt at gaining support for grievances medical device makers have with the FDA, than a sound scientific study. The backbone of the 'study' is a questionaire given to US medical device makers. Additionally, the opinions of medical device venture capitalists are widely sited, seemingly presented as if it were the analysis of an impartial expert (though there is no specific claim to that effect).

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Of course medical device makers and venture capitalists want cheaper quicker and easier pathways to the lucrative US medical market. That isn't science. That isn't even news.

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Still, the medical device industry might have some legitimate grievances. The FDA might also have some areas that could be significantly improved resulting in benefits of improved healthcare at a lower cost....Unfortunately this 'study' didn't bring us closer to knowing.

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Shame on the medical device makers and venture capitalists for masquerading their attempt at persuasion as a scientific study. The ends do not justify the means, but they certainly illustrate a severe ethical dissonance.