Originally Published MDDI
May 2004
25th anniversary
Plus Ça ChangeIn 1979, MD&DI launched its first issue. A look at what industry said in the magazine’s first few issues is very revealing.
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| We must guard against a “zero-risk” mentality, as it could result in restrictive interpretations of the law that are contrary to congressional intent. —John Jennings, vice president, Medical Devices and Diagnostic Products, Pharmaceutical Manufacturers Association, July 1979 |
Plus ça change plus c’est la même chose. In a perusal of the early issues of MD&DI, we found that this adage is eerily appropriate for the medical device industry. In a just a few select quotes, we noted that, in fact, the more things change, the more they remain the same.
• The medical device world is a dynamic one, requiring an imaginative and enlightened regulatory policy.
—Donald Kennedy, Commissioner of Food and Drugs, June 1979
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| Unless a hotter fire is kindled under the various standards organizations, comprehensive [biocompatibility] standards will not be published for another three to five years or more. —Richard Schlesinger, CEO, Bio-Technics Laboratories, September 1979 |
• The Bureau of Medical Devices exhibits far fewer of the symptoms of distrust that regulators in other parts of government frequently manifest. This may be mainly attributable to the bureau’s youth and therefore its relative innocence. Perhaps it is a bloom that will one day fade as the bureau’s regulatory work progresses and as more and more crooks engage in shoot-outs with officers.
—Larry Oster, July 1979
• I would like to see the small firms stay in the innovative arena and not get pushed into becoming part of larger firms.
—Carl Bruch, deputy associate director for device evaluation, Bureau of Medical Devices, FDA, August 1979
• Three years after the passage of the Medical Device Amendments of 1976, there is little evidence to show that the prophets of doom were accurate in their predictions. Conventional wisdom held that small manufacturers would disappear, introduction of new products would grind to a halt, and medical prices would be excessively increased.
—David Link, director, Bureau of Medical Devices, FDA, September 1979
• Evidently the assumption that everyone knows what a 501(k) is, is erroneous.
—Ellen Guba, manager of regulatory affairs, Cooper Laboratories, September 1979
• [Health, Education, and Welfare] policy staff members do not yet fully understand how their reimbursement policies will limit the availability of new and more efficient technologies.
—Drew Upton, staff director, Medical Devices and Diagnostics Section, Scientific Apparatus Makers Association, December 1979
Copyright ©2004 Medical Device & Diagnostic Industry
