Medical Device Makers Shun United States -- New York Times Article Featuring a Spine Patient Society Member

[Justin]

A Spine Patient Society Member, Marti Conger, is featured in a New York Times article entitled "Medical Device Makers Shun United States."

Marti traveled to England for a two-level cervical artificial disc replacement (Spinal Kinetics M6) with Nick Boeree. Since her operation on October 14, 2009, she has become an advocate for faster device approvals in the United States.


Medical Device Makers Shun United States

New York Times
By ANDREW POLLACK
Published: February 9, 2011

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, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”

Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.



Marti Conger, a business consultant in Benicia, Calif., went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif., a short distance from her home.

To read the full article featuring Marti, click here --> Medical Device Makers Shun United States

[KBear]

Very interesting article. I can definitely see both sides of the issue.

[Cindylou]

Yes, I enjoyed this article too. And kudos to Marti for her time, energy, and involvement in advocating on behalf of the device makers. I can't help but believe that the FDA could speed up their process. It's the government for pete sake, with all their red tape, probably have to call a meeting before someone can blow their nose or take a dump. Sorry. But honestly, it sickens me to see US executives pull out of American markets and move overseas, but I can totally see why. $65 million down the tube. It's sickening. Personally, and of course I'm just me, I'm nobody, but I think just possibly the FDA could step it up a little bit, maybe a lot, to help our economy. Something isn't necessarily wrong, or weak, or harmful just because it could move more expeditiously through a process. There is something to be said for efficiency, that's all.
I'll get off my now. Cindylou

[JK2234]

Good Read!

[JK2234]

Ny times is big...

[Marti in Benicia]

Hello, all. One responder praised me for advocating for device manufacturers. Actually I'm advocating for spine PATIENTS patients and other people Waiting for MEDICAL DEVICES that are slogging through the FDA and/or are readily available and successfully in use in other trusted nations.

I also testified on July 20th before the House Committee on Engery & Commerce's subcommittee on Investigations and Oversight with the same message. The good news is that we have supporters on both committees, which have direct impact on how the FDA's CDRH does business.

Am also working on legistlations that will require insurers to paid for FDA-approved devices and procedures, as well as reveal contracted rates on request so patients can "shop" for the best price -- for services when the provider doesn't make much difference.

I'll keep you posted.