Thursday, December 30, 2010

Byproduct of Regulation

CT Curmudgeon has close ties to Research and Development departments in domestic and international companies. One of my peers works very hard and has become a venture capitalist. Good for him, he deserves it. He has put lots of people to work in the past two decades. He funds medical products. They are in several categories, ones that need a 510(k) approval, and ones requiring clinical studies (IDEs). The cost of bringing medical products to market must include the approval process. He won't go near IDE projects because of the 10-20 million dollars needed for the study, amid the uncertainty of the attitude of the FDA. Anything new and improved needs to go over this hurdle. Devices that would improve patients lives are not brought to market because the cost of regulation. This is going to slow the advance of medical treatment. The government sometimes shows an anti business attitude. CTC know patent reviewers with this same attitude. It is almost like we spend most of our time figuring how to deal with the bureaucrats.

This is just one facet of Big Govt. How much business doesn't happen due to Sarbanes Oxley. 

Much of the regulation is coming from Europe, they love to write laws. CTC is working to get a CE mark on a product. It the interest of "better products" ensure by the CE mark, we need to spend a fortune and hire do nothing consultants who's only asset is they understand the system.

Congress listen up. Citizens, listen up. Stop making so many laws. They are like weeds that are getting out of control, sort of like Kudzu. A Japanese vine introduced in the American south, it takes over and chokes out the natural plants.

Happy New Year.

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