INSIGHT REPORT
Vol 3  #10 
December 2000

INSIGHT REPORT

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Well, here we are. It’s December 3, 2000, and we are still without a confirmed President of the USA. Seemingly, it may not really matter too much except if you are invested in the stock market and were long on tech stocks.

So what really is the point here? What did the Presidential Election mean to the Medical Device industry going into the year 2001 and 2002? What, with the US Senate at a stalemate of 50/50 (50 seats Republican and 50 seats Democratic), it appears, on the surface, that the next two years will be one big boring session of no change. That may not be too bad for this industry.

It is my considered opinion that we will be lucky to see any major changes on top of all the changes that have taken place in the last 4 years, with no new directions in regulatory issues or policies being pushed from neither political party.

But, be assured that the one thing that our government knows how to do - is ride the wave. Looking at the layers of this election it should be apparent that whether we end up with the likely Republican or Democratic candidate, there was no real consensus from the people to change the legislature’s structure and put one party in control of each House of Congress.

This all goes to my belief that this lack of mandate by the populace points to the probability that the FDA will not be a hot topic in the next few years… unless there is a catastrophe that would affect the American public and the blame for that catastrophe falls on the FDA’s lack of staff, money or enforcement.

During the last few years, with a Republican Congress, the FDA has been leaning more to the industry, which in turn has given the agency a somewhat a friendly appearance to the public. However, all indications point to the fact that if the Democrats had taken control of the House of Representatives, that would have changed. But with the splitting of power in Congress, there will most likely be minimal change, if any, in how the FDA will continue to do business.

As we have learned of the years, the reality of politics being as it is, I see the governments concern with the hot issues of saving Social Security and Medicare becoming the prominent focus which makes me think that the FDA will become an orphan child during this administration.

And what does that mean? Well, if the industry keeps it’s cool, does not let the rope that the agency is throwing at them become a noose, then the next two years should be good years for regulatory issues.

On the other hand, if industry pushes the agency to far, industry will shoot themselves in the proverbial foot - as has happened previously in the not distant past.

Which means that for the coming year, we will have to keep a close eye on new developments. If I see anything on the horizon, you will be the first to know.

Next Insight – The New Improved ISO9000. What is it and why it may finally become a worthwhile tool to implement?

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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