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An MD&DI December 1996 Column

EDITOR'S PAGE

A Prognosticator's Confession:
I'm Not Sure What's Going to Happen

One week last spring, when the upcoming presidential elections were but a slightly gloomy cloud on the horizon, I received two pieces of junk mail. Now, I actually get quite a lot more junk mail than this, but I remember these two pieces because they were so diametrically opposed. Both were from financial gurus promoting their exceedingly expensive newsletters.

The tactic they had both chosen was to make bold predictions about the results of the election and how investments would be affected. One of these gurus said Clinton would win, hands down. The other, that he would lose in a landslide.

I remembered these predictions after the election, but I'm willing to bet that at least one of the gurus didn't. Indeed, few prognosticators like to review their records.

As it happens, December is the month in which editors like to predict the future. But I'm fresh out of insight—and I don't seem to be alone. Will we have legislative FDA reform this year? Will Kessler leave office? Will application review times continue to go down? No one seems sure, least of all me.

So in lieu of making risky predictions this month, I'll review my past record, beginning with December 1992, just after the previous presidential polls. Entitled "The Third-Party Solution," this column noted that "with the coming of a new Democratic administration," many observers were predicting a renewal of regulatory vigor and hard times for the industry at FDA. In other words, the Democrats were going to be up to their old tricks.

I countered that "there is plenty of evidence that the old paradigms may no longer apply." I went on to predict—cautiously—that FDA would explore the use of nongovernmental third parties for GMP inspections. Although FDA has yet to try such inspections domestically, it has at least begun a pilot program for third-party application reviews. And third-party inspections make so much sense that they surely can't be far behind.

My December 1993 column addressed healthcare reform, then the burning issue of the day. Drawing on the results of a recent MD&DI survey, I noted that "for all the fervid speculation and fear mongering that surrounds the issue of health-care reform, it appears that the device industry is prepared to deal effectively with the challenges that will result."

This came true, in part because legislative healthcare reform never happened. But it has also continued to come true—so far, anyway—because the industry has continued to adapt to the free-market reform and consolidation that even then was already under way.

In December 1994 I avoided predictions altogether, but a year later I returned to the future as a theme. Portentously entitled "A Coming Transformation," this column brushed aside the ultimate significance of FDA reform to focus on "the much more intractable problems posed by the restructuring of the healthcare-provider marketplace." My conclusion was that "within five years the device industry will be transformed by the profound changes taking place in the healthcare market."

This sounds somewhat overstated to me now, but there's no denying the trends I highlighted in the column:

• Increasing consolidation of larger medical device companies.
• Widespread partnering of small companies with larger manufacturers or distributors.
• The rising importance of information systems such as electronic data interchange.
• A greater focus on cost-effectiveness in R&D.

Whatever happens in the coming year, I'm convinced that ultimately nothing will shake the resilience of the medical device industry. After more than five years of observing it from behind this desk, I know just how innovative and adaptable it is and will continue to be.

John Bethune
john.bethune@cancom.com.