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 activitiesincluding distribution, user training, marketing, advertising, sales, clinical studies, and reimbursementare equally regulated. And of course a wide range of business regulations also apply to medical device companiesespecially 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 issuesand 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.
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