Originally Published MDDI August 2004

Reflections

DSMA has acted as an important liaison between government and industry during the past quarter century, and both have prospered because of it.

Neal Dunning

George Santayana, a poet and philosopher, first said, “those who cannot remember the past are condemned to repeat it!” But I, too, said it in my first medical device address, launching a new outreach effort of the Division of Small Manufacturers Assistance (DSMA—then OSMA). Many who remember the last 25 years of medical device development would not mind having to repeat it—but they would most likely add a few improvements.
 
Many of my memories of the developments in the medical device industry have been chronicled by MD&DI. In addition, several interesting things happened to me personally in 1979, including undergoing a 4-way CABG from the famed Denton Cooley. It supplied part of my credentials for going to work for the Bureau of Medical Devices, also in 1979. 

A little later that year, I recall a visit from two journalists—Van Shears and Clay Camburn. I remember we met in my office at DSMA in the Silver Springs Plaza. Van and Clay were traveling about the industry inquiring about support and interest in a monthly magazine focused on the medical device industry. I assured them it was a good idea, and very timely as well. The Medical Device Amendments of 1976 had just been implemented as regulations, and Dave Link and Larry Pilot had gotten the Medical Device Bureau up and running. Many of us in the field thought we could see a glowing future for this newly organized industry.

Government Getting Involved

Neal Dunning

Industrialists often rail against “those bureaucrats that keep interfering with the progress of industry.” Sometimes they are correct. But I believe that the Medical Device Amendments, brilliantly envisioned by Peter B. Hutt and carefully implemented by the early members of the Bureau, helped form the foundation of this booming industry. Notably, it is now one of the few commercial sectors in which the United States has a strong positive balance of trade.

But back then, one major hope of DSMA officials was that we could help maintain the strong entrepreneurial characteristics of the infant industry. Some felt this could best be accomplished by maintaining an atmosphere that protected the small firms that made up much of the industry. Certain studies at the time, in fact, showed about 80% of the firms having fewer than 50 employees. 

The regulation of medical devices seemed almost impossible. How do you write regulations that cover devices ranging from tongue depressors and crutches to defibrillator pacemakers and MRI machines? This is especially difficult if you believe it is necessary to have some kind of premarket notification to protect patients from dangerous devices. It was apparent that drug mentality regulation, one that mimicked the pharmaceutical industry's premarket processes, had a high probability of smothering these thriving entrepreneurs. Plus, the one-sizefits-all concept would certainly have been disastrous. After much deliberation, regulation proportional to risk appeared to be the only workable approach. Over time, officials at CDRH have varied in their approach to this principle, but together they have made it work. 

DSMA's Role 

The early job of DSMA was to convince industry that the division actually wanted to help them comply with the Medical Device Amendments requirements while consuming the fewest possible assets. One of my articles, “We Are From the Government and We Are Here to Help You!” tried to express this idea [MD&DI, December 1979, p. 8]. It has often been quoted—though sometimes tongue in cheek—by many in the industry. To that end, we established what may have been the first toll-free number in FDA (or possibly the government). Admittedly, it did take a bit of persuasion to get government accountants to accept that idea. But 800/638-2041 was a winner and, although it took some time, people in industry learned to trust the DSMA staff. It eventually took about a dozen experts to answer industry's many phone calls. 

Those early days were sometimes trying but always rewarding. I recall wandering one day into the office of the acting director of the Bureau of Medical Devices, Vic Zafra. I found him writing an admonishing letter to Denton Cooley about the implantation of an early ventricular assist device under questionable circumstances. I, being fresh out of Cooley's bypass assembly line, said, “Vic, you can't do that—only God can do that, and then not often.” But Vic sent the letter, and St. Luke's administration wisely explained it had all been a misunderstanding that wouldn't happen again.

Government and Industry, Hand in Hand

DSMA would have accomplished little without the understanding and support of FDA officials. We had the enviable, though sometimes impossible, position of trying to represent industry interests to FDA and trying to explain FDA actions to industry. To do so, we used many methods new to government but not to industry. We hired Lou Harris Associates to conduct a survey to establish trends relating to sales, capital investment, employment, and the effect of the Medical Device Amendments. This study emphasized the amazingly high proportion of small but highly technical entrepreneurial firms in this industry.

Encouraged by these results, DSMA bought Dun & Bradstreet data to help describe and understand this young industry better. The data clearly showed the small, entrepreneurial nature of the industry. However, some of the data also revealed that many small manufacturers were not in compliance with one or more regulations. Since DSMA was supposed to help industry, we decided not to turn these data over to the Office of Compliance. I reported this decision in one briefing to FDA Commissioner Arthur Hull Hayes. Somewhat to my surprise, he concurred. This kind of support set the stage for the high level of mutual trust that developed between industry and DSMA.

We also would have accomplished far less with the resources available had we not had the strong support and cooperation of MD&DI in a series of national workshops and in its publications. A search for my name in the magazine's article index shows 15 articles in these 25 years, all related to industry concerns or trying to explain FDA actions. Interestingly, the second of these articles repeated my earlier claim: “We Are From NCDRH and We Still Are Here to Help You!” [MD&DI, December 1983, p. 10]. The article 

reports on the amalgamation of the Bureaus of Medical Devices and Radiological Health into the National Center for Devices and Radiological Health—the name favored by its long-term director, John Villforth. Fortunately, John had much better staying power than did the term national, which was dropped after less than a year. 

I have been enjoying the fields of industry since 1990, but DSMA—now DSMICA (having added International and Consumer Affairs)—is still here to help you under the solid guidance of John Stigi. And MD&DI is also still here, together with the MD&M conferences, helping the industry to grow and prosper.  

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