A Wake-Up Call to Device Entrepreneurs

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published February 1996

Jeffrey J. Kimbell

Executive Director, Medical Device Manufacturers Association (MDMA),

Washington, DC

Over the past year the medical device industry has witnessed a constructive effort by the 104th Congress to remove the regulatory hurdles that have stifled small business entrepreneurs in many sectors of the economy. From the vantage point of frustrated device manufacturers, no regulatory or enforcement agency has been more unpredictable than FDA. If leaders in Congress and industry accomplish their goal, however, the rules may soon change for the benefit of all.

It is common knowledge that the United States is rapidly, and unquestionably, losing its dominant edge in the high-technology medical sector of the world economy. Changing this perilous situation calls for action on the part of the thousands of device companies scattered throughout congressional districts nationwide. The FDA reform debate--filling the pages of MD&DI for a year now--must not occur solely in Washington, DC. If it does, the industry may soon find itself settling for toothless reforms that will aid few and continue the loss of U.S. technology to other countries.

During the past year I have spoken with many state device organizations, including the Michigan Medical Device and Suppliers Association and the Colorado Medical Device Association, and specialty groups such as the Orthopedic Surgical Manufacturers Association. These encounters have underlined for me the vital role such groups can play in drafting national policy. The former Utah Biomedical Industry Council--now the Utah Life Science Industry Association--and the Indiana Medical Device Manufacturers Council are two examples of groups that have used their elected leaders to take FDA reform from a local level to a national level. One reason for their effectiveness is their recognition that elected representatives are sensitive to the needs of employers based in their states or districts.

MDMA will continue to press the Clinton administration and the U.S. Congress from Washington, but the entrepreneurial companies that are the backbone of the medical device industry must join in the call for reforms from MDMA and like-minded state groups. To accomplish meaningful FDA reform, it is essential that every representative of the device industry express a position to those seeking election or reelection. The democratic system certainly has flaws, but failure to participate is one flaw that can be prevented.

BEYOND WASHINGTON

What must occur in the first four months of 1996 is for device industry CEOs and employees, health-care practitioners, and consumers who use devices to get involved through letters and phone calls to Washington and follow-up meetings with the members of Congress in their districts. If there is one undebatable outcome of the 1994 elections, it is that no congressional district is safe anymore. It is also clear that FDA responsiveness has been demonstrably altered by the activities of Congress and a continued interest in FDA by Vice President Gore. The result is an opportunity to get legislative cures for the illnesses at FDA.

The only companies that traditionally have had a voice in drafting device industry policy are those that have been able to maintain Washington offices and be active in larger trade associations. Although I encourage these companies to continue to be active in the democratic process, I ask the companies on the perimeter of the battle to come in and lend support. If you cannot participate with resources, then lend staff for CEO fly-ins and meetings with lawmakers at the local level.

Industry representation in Washington must have been asleep to allow the Safe Medical Devices Act of 1990 to pass. Eliminating the 90-day statutory requirement for 510(k) clearance has had the most damaging effect on entrepreneurial companies that cannot afford to wait 175 days or longer. Some large multinational, multibillion-dollar companies believe that paying FDA user fees to the tune of $52,000 per premarket approval or $3200 to $7200 per 510(k) may be an appropriate way of eliminating the bureaucratic sloth at the Center for Devices and Radiological Health. The vast majority of medical device companies--77% of which have fewer than 50 employees--do not.

MDMA speaks for those entrepreneurs who believe in market-based answers to government-imposed bureaucratic entanglements in business. As part of the National Medical Device Coalition, MDMA, along with nine smaller associations, successfully defeated the user-fee initiative on a very limited budget. The coalition succeeded because its message was clear and simple: taxing small business and giving more money to an agency with a documented management problem will not solve anything. The entire system is deficient at the core, both in the approval process and in the enforcement arena, and requires a fundamental revision, not an incremental fix.

STRENGTH IN NUMBERS

If more companies do not get involved in initiatives to elicit change at FDA in 1996, it is likely that only a small portion of what needs to be accomplished will be signed into law by President Clinton. A relaxation by the device industry in the next 12 months could result in a tremendous opportunity missed. The industry simply cannot afford the status quo to continue.

There is no question that we have witnessed a sudden mood change and shift at FDA, exemplified by its effort to embrace the industry by increased involvement with trade associations, like MDMA, and dialogue with grassroots partnership meetings around the country. Although these efforts are significant, the regulatory pendulum swings with the political tide on Capitol Hill and could easily swing back to 1993 approval and enforcement levels unless the industry maintains constant vigilance.

The public health is not a subject that can be explained in 10-second sound bites or 30-second commercials. It is going to take a push from industry trade associations speaking with a common voice, physicians demanding access to the best available devices for their patients, and the patients them-selves detailing horror stories of being forced to travel outside the United States to get the most state-of-the-art devices and therapies.

To the device industry, FDA reform is not about partisan views, but rather about survival. This is a critical time for the industry. I urge every U.S. medical device company to participate in local, state, national, or specialty organizations. Through such cooperation, we can achieve industry's goal of fundamental reform of FDA.