Regulated Industry

Steve Halasey

November 1, 2008

2 Min Read
Regulated Industry


No matter what far-flung, cutting-edge specialty a company may be exploring, it's not a bad idea for company leaders to remind themselves, every once in a while, of the fundamental principles that underlie their efforts.

For medtech companies, the most fundamental principle of all is simply this: the medical device industry is regulated.

In almost every nation, governments have developed or adopted regulatory schemes to control the commercial availability of medical products used by healthcare professionals and lay users. Moreover, medtech regulation doesn't end with product development and manufacturing. Many other activities—including distribution, user training, marketing, advertising, sales, clinical studies, and reimbursement—are equally regulated. And of course a wide range of business regulations also apply to medical device companies—especially publicly held companies. Taken together, such regulations help to prevent company errors and excesses from becoming commonplace, and preserve public confidence in the medical device industry.

It's worth remembering all of this when confronted by public statements implying that the medical device industry is inadequately regulated. New and different regulations may be necessary to address emerging issues—and industry leaders should be at the forefront in helping to devise appropriate changes. But those who would propose new regulatory schemes must also demonstrate an understanding of how medical products are already being regulated, and why.

Over the years, the staff of MX has enjoyed bringing to print an executive-level perspective on issues involving the global medical technology community. With this issue, however, MX will cease print operations and will begin a transition into online-only availability. We invite our loyal readers—and new ones—to follow us into this brave new digital world by signing on at Doing so will enable readers to receive our monthly e-newsletter, MX: Issues Update, as well as announcements about forthcoming installments in the MX Executive Webcast Series.

Copyright ©2008 MX

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