Monday, May 18, 2009

The difference between slow and cautious.


There is a large difference between slow and cautious. Slow is a speed; cautious is a tempo. Caution implies a slow process for most people, but I think they are missing the point of caution. There are many projects that are designed to save people, not to make life more convenient. Caution for such projects should be a speeding up of the process. Why do we stunt the growth of lifesaving medical processes? Improvements and innovations for already existing technology can wait, they are just increasing convenience; I’m not talking about such technology. I’m particularly aimed at technologies that will save lives.

The FDA has a particular problem today. In a lecture at Fischell day at UMD I heard one lecturer refer to the FDA’s problem as having only one gear. The issue is that the FDA is too cautious when reviewing some new technologies. For one of the projects the lecturer explained the process to get the new innovation into America. It was a nightmare. The new process will have been used in Brazil hospitals and European hospitals for at least 2 years before it makes it into the United States. That’s a long time. Why would the FDA require so much work for the company get it approved for use in the United States? The FDA needs a turbo charger. We need to be nurturing ideas that save lives.

To speed up processes is dangerous, but why not do what the Supreme Court does. Sort through all the cases, and place the ones of extreme humanitarian value on a fast track to approval. If the process takes more than 2 or 3 speeds, then I fear that it would become too bureaucratic and complex. Simplicity is needed. We have a design that is too simple right now. Oversimplification forces all cases to be treated the same. Why? We recognize that differences exist between a drug that allows someone to not sneeze because of allergies, and one that prevents someone from dying due to cancer. Too much caution and no work will ever get done.

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