“Ten years from now, we’ll all get on planes and fly somewhere to get treated”

Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.

The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.

“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump.

Full article on the slow and tough FDA approval process.

Comments (5)

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  1. Virginia says:

    Might this lead to the downfall of the United States as a paragon of medical innovation? If it’s cheaper to develop the product and easier to get it to market in India or Thailand, then why even bother with the U.S.? I’m predicting that more and more of these technologies will migrate overseas, as will the patients.

    Which reminds me, I think it’s time I pick up a foreign language.

  2. Devon Herrick says:

    There needs to be some type of cooperative agreement whereby if a device is approved in a certain percentage of the richer OECD countries, it is fast tracked by the FDA. It really doesn’t make sense for it to take years longer to approve a medical device in the U.S. that in European countries or Canada.

  3. Tom H. says:

    Not good news. I understand the FDA was on Capitol Hill yesterday trying to defend themselves. At least this is one good change that you can attribute to the change over in the House. Now these guys can be called on the carpet.

  4. Ken says:

    In the not too distant future, all we are going to have to do is cross the border. It will be as different as night and day.

  5. Greg says:

    Probably no need to learn a foreign language, Virginia. I suspect that lots of English speaking people will be expecting us.