Twenty Candles for the Past, Some Thoughts for the Future

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI June 1999 Column

This column is normally dedicated to profiling an author or otherwise expanding upon information presented in the current issue. In putting together the 20^th anniversary issue of the magazine, we sought out contributors who had a long history with the publication. Two of our authors, in fact, were included in the inaugural June 1979 issue, while one, columnist James G. Dickinson, has contributed to every issue (see Washington Wrap-up for some of his reminiscences about the early days of MD&DI).

Given the unusual circumstances of this very special occasion, I thought we might depart from the standard format of Inside MD&DI and talk about a few things that don't appear elsewhere in the issue. For example, during the preparation of the 20^th anniversary timeline that begins on page 108, we were acutely aware that space and layout constraints meant we would necessarily leave out important events. Deciding between synthetic human insulin and cyclosporine, between toxic-shock syndrome and Voyager I, or between interferon and the big-bang theory are by definition judgment calls, subject to disagreement. Our readers will undoubtedly suggest alternative events and hierarchies of importance.

Additional information that didn't make it into the 20^th anniversary section but nevertheless influenced our thinking about the issue came in the form of survey responses from MD&DI's editorial advisory and reader boards. We posed two questions related to the magazine's milestone: "What do you consider to be the most important developments in the medical device industry over the past 20 years?" and "What do you think the most important developments in the medical device industry will be over the next 20 years?"

The answers to the first question tended to fall into the areas of advances in technology, regulatory initiatives, and general business trends. Technological developments cited include new forms of imaging, minimally invasive surgical procedures, noninvasive diagnostic techniques, biodegradable implant materials and other novel polymers, implantable defibrillators and transplant-assist devices, medical lasers, device miniaturization, and embedded microprocessors.

In the regulatory arena, one respondent named "the Kessler FDA"; others listed design controls, the movement toward ISO standards and internationally harmonized regulations, GMPs and the QSR revision, FDAMA, and "the change in climate from open to restrictive to open once again." The most frequently cited general business factor was the globalization of the industry and the development of a world market.

Turning to the future, MD&DI board members predict breakthroughs in tissue engineering and organ-replacement techniques, gene-modification therapies, artificial blood, drug delivery modalities, custom-designed implants, and "smart" microdevices, among others. The picture is not entirely rosy: one respondent anticipates a host of "new diseases—for example, viruses, prions, and mutant micro-organisms resistant to conventional sterilization methods such as irradiation."

Regarding regulatory and industry concerns, along with expected benefits from continued global harmonization there are worries about increased federal oversight, the disappearance of small companies in a merger-dominated climate, and "the subversion of medical decisions by financial decisions."

Will the device industry in 2019 be anything like we imagine? Prophecy is a notoriously tough business, and not all birthday wishes come true. Whatever happens, as MD&DI blows out the candles on its first 20 years, we want to thank all those—authors, reviewers, board members, readers—who brought so much hard work, insight, and liveliness to the ongoing party.

Copyright ©1999 Medical Device & Diagnostic Industry