Originally Published EMDM May/June 2005
15th Year Anniversary
Remembering the Past, Building the Future
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In 1990, Europe’s medical device industry braced for change as the first “new-approach” medical device directive was introduced. That same year, Canon Communications launched International Medical Device & Diagnostic Industry, the chrysalis from which European Medical Device Manufacturer would emerge in 1994. The change in name did more than recognize the unstoppable momentum of the single market; it also placed an emphasis on med-tech manufacturing. Although we have continued to introduce new features and refine the editorial content since then, EMDM has not wavered from its core mission: covering the various technologies that companies rely on to design and produce next-generation medical devices.
In this 15th anniversary section, we take the opportunity to reflect on where the device industry has been, and to speculate on where it might be going.
The journey begins with the signing of directive 90/385/EEC on Active Implantable Medical Devices in 1990. EUCOMED’s regulatory affairs director Dario Pirovano, who participated in the document’s drafting, recalls the context in which the new-approach directive took shape in a feature article in this section. He also cautions against some current trends that misguidedly make perfect the enemy of good. It may not be a perfect system, writes Pirovano, but then, what system is? The important thing to remember is that it works.
Since much of EMDM is devoted to the many technologies used by medical device OEMs in the design and manufacture of their product lines, we thought it would be interesting to ask suppliers how their relationship with the med-tech industry has evolved over the past 15 years. Michael Scholla, senior consultant for DuPont (Wilmington, DE, USA), spoke for many when he noted the transformational effect of globalization. “Fifteen years ago, many of the converters were family-owned and -operated businesses,” says Scholla. “Today, many leading converters are part of multinational corporations. Bringing corporate resources into many of these companies has enabled them to develop [innovative] technology.” Turn to page 61 for more industry perspectives.
Finally, we have included a timeline in this section highlighting some of the industry, regulatory, and societal milestones from 1990 to the present . . . a reminder of how much ground has been covered over the past 15 years.
Of the many remarkable medical achievements, one that truly enthralled me was French surgeon Jacques Marescaux, located in Strasbourg, France, using a remotely controlled robotic surgical device to remove the gall bladder of a patient in New York City. The implications of this technology for the vast number of people who are underserved by medical science because of geography, socio-economic conditions, or other reasons could be astounding. To my mind, it puts a whole new spin on doctors without borders.
The next 15 years undoubtedly will produce even more amazing technological feats. It will be EMDM’s privilege, and mine, to report them.
Copyright ©2005 European Medical Device Manufacturer
