Thursday, January 20, 2011

Look out - change ahead!

First - mental note to self - it may look like water on the road but it could be ice, which is slippery and will cause you to fall on your butt and cause bruises later on.

We have change ahead and of course there are protests - even though the changes should prove good in the long term. The FDA wants to change the way medical devices are approved. The current system was started in 1976. Times have changed since then. Any system based on information that is 35 years old probably does need a tune/upgrade/replacement. Think of it this way, if your kitchen was 35 years old with no upgrades in the meantime, you might need some new appliances and a coat of paint to say.

But of course the big drug companies are protesting the change. Their lobbying group said: 'they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.'

Of course they say that because they have to change and spend money to adapt their business policies. But one of the bigger problems with the 1976 system is there is a loophole that allows the approval of some items that slip through the process.

'The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing. Hip replacements and drug pumps are among the devices cleared under the system.'

So if a new device is slipped through because it is similar to products already on the market, but if device A went through the approval process and 25 years later and 25 new models later, how similar is the 25th generation product to the original device A? Your IBM selectric typewriter was approved in 1976 and now you are typing on your iPhone. What's the difference?

I see nothing wrong with change. Change is inevitable. We cannot stay the same and expect the word to stay the same. Technology has changed everything as well.

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