Medical Device & Diagnostic Industry
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An MD&DI June 1999 Column
Organizing for Compliance: Reflections Twenty Years Later
Richard D. Manthei
It has been 20 years since I authored an article for the very first issue of Medical Device & Diagnostic Industry titled "Organizing for Compliance." Surprisingly, a number of suggestions I made then remain viable today. The original article was written three years after passage of the Medical Device Amendments of 1976, and many of the concerns medical device companies were facing at that time are similar to those they face today. The significant difference is that, in 1979, many companies were facing regulation that was focused specifically on their industry for the first time. For those companies, a major issue was how to organize to comply with the new legislation and the regulations that were soon to follow.
When the article was written, our regulatory affairs and quality assurance function at American Hospital Supply Corp. was approximately seven years old. I believe it was the first combined regulatory affairs and quality assurance department in the industry, and we may have been the second healthcare corporation to establish a discrete regulatory affairs function. Many pharmaceutical companies had employees who worked on regulatory submissions, but they generally reported to other disciplines, such as research and development. A regulatory affairs department was certainly a new concept for the medical device industry.
Our regulatory affairs function was at first part of a department called Regulatory and Consumer Affairs. It was later renamed Regulatory Affairs and Quality Assurance. At that time, only a handful of individuals were considered to be regulatory specialists—a striking contrast with the current membership of the Regulatory Affairs Professionals Society (RAPS), which numbers in the thousands worldwide. The number of regulatory consultants alone must now number in the hundreds; hardly a day goes by in which most medical device companies don't receive a promotional brochure from a regulatory consulting firm. In the late 1970s, however, we soon discovered that you could not hire regulatory specialists. You had to find people who were interested and train them. We believed then—as I do now—that most regulatory decisions require both scientific and regulatory knowledge. People possessing both skills were a very rare commodity.
RESPONSIBILITIES OF REGULATORY AFFAIRS PROFESSIONALS
I had not read my original article in many years, but I was pleased that it seems to have passed the test of time. One hopes to have learned something over two decades, but I believe I would give substantially the same recommendations as I did then.
My original article outlined a number of specific areas that could be handled by a regulatory affairs function. They included:
- The development of company-wide policies regarding compliance with regulatory requirements.
- The review of labels, labeling, and advertising.
- The preparation and coordination of product submissions.
- The dissemination of pertinent regulatory data to all interested parties.
- The assumption of the role of principal spokesperson to regulatory agencies.
- The coordination of product recalls.
- The education of company personnel on regulatory issues.
- The responsibility for internal audits.
All of these responsibilities remain important and are now routinely part of most companies' regulatory affairs departments.
There are several concepts set forth in the original article that I believe are still absolutely essential to a successful regulatory function.
I stated 20 years ago that "to ensure compliance ...Regulatory Affairs would have to be involved from the conceptual stages of product development all the way to ultimate deletion from the product line." Twenty years of experience has only strengthened my view that regulatory input is critical at every stage of a product's life. Research and development, animal studies, clinical studies, labeling, marketing and distribution, and deletion from the product line all require distinct and specific regulatory input. This input is especially critical in the early stages of product development. With the emphasis on time-to-market, it only makes sense to plan a regulatory strategy early and follow the product development process closely.
Having observed many regulatory affairs departments and professionals over the past 20 years, I am even more firmly convinced that "the successful regulatory affairs function is sold to, not forced on, company personnel." Clearly, top management must be fully supportive to have a successful program. It is also crucial that people believe in the program. While the terms "corporate cop" or "corporate conscience" are still used occasionally to describe a company's regulatory function, company personnel must believe in the basic merits of a regulatory program and not just respond because they are required to. If the program is perceived as anything other than essential to the company's overall success, there will always be a temptation to ignore it, to take shortcuts, or to downplay regulatory affairs during critical decisions.
REGULATORY PERSONNEL
As mentioned previously, the available pool of regulatory affairs talent is much larger than it was 20 years ago. It is still essential, however, that a company's regulatory affairs function be staffed with competent personnel. A competent staff can contribute significantly to the bottom line, with well-prepared product submissions resulting in faster FDA review times and approvals. Adopting the right regulatory strategy at the right time can also eliminate costly recalls.
Almost all regulatory decisions require a combination of scientific expertise and knowledge of the relevant laws and regulations. Both of these competencies can generally be learned. What is difficult to learn, however, is what I call street sense—the ability to determine what is important and when it is important. Twenty years ago, I referred to this as "exceptional judgment." The former members of our department who have gone on to top-level positions in other companies and become leaders in the industry invariably possessed a large measure of this quality.
Just as was the case in 1979, many regulatory matters are not clear-cut but rather fall into an ambiguous area. The correct decision can often be difficult to make and painful to implement, but may be essential to the survival of the company.
GLOBAL REGULATION
There is one other major consideration that was not emphasized in my original recommendations. Today, we have to think globally. Whereas many companies have international regulatory representatives, a truly coordinated international program still seems to be the exception. All potential markets and their regulatory requirements should be considered early in the development process, thereby helping to minimize unnecessary duplication. The regulatory strategy for each product should be designed to satisfy as many international requirements as possible.
CONCLUSION
The summary of my 1979 article read as follows: "A manufacturer's overall objective must be to ensure maximal business growth within the parameters of regulatory and corporate standards.... There seems to be a growing awareness that an effective internal regulatory program can ensure long-term economic gain by enabling a company to adjust to regulatory matters before these matters become regulatory problems." I don't think I can say it much better 20 years later.
Richard D. Manthei is vice president of scientific affairs at C.R. Bard Inc. (Murray Hill, NJ). He was formerly a partner and chairman of the food and drug department at McKenna & Cuneo LLP, and corporate secretary and deputy general counsel at American Hospital Supply Corp., where he managed the development of the regulatory affairs and quality assurance functions. He served as a member of MD&DI's first editorial advisory board in 1979.
