ARLINGTON, Virginia – Helping to assure the success of Medical Device Manufacturers Association (MDMA; Washington) members is Stephen Northrup, who has served as executive director of the trade association for the last two and one-half years. During this period, the organization's membership has grown from about 70 companies to 130. Following the association's annual meeting, Northrup talked with BBI about MDMA and the state of the medical device industry.

"As an association, we've made great progress. We have broadened the range of services that we provide to our members and have made a lot of headway in the issues we have tackled." However, he added, "we've still got some work to do." He said he is especially concerned with the fate of the small- to mid-size companies that primarily make up the association's membership. "I hope we can remain competitive with the larger conglomerate companies. I don't want to see new companies get turned into R&D affiliates for these large companies." He added, "I really have concerns that the days of the 'mom and pop,' small start-up companies that [go on to] make it big are numbered."

Organizations such as MDMA, Northrup said, "must make hospitals aware that the contracts and short-term profits associated with these large companies will translate into long-term higher prices with the elimination of smaller-company competition, not to mention the degree of innovation, since the conglomerates will not assume any risks at the expense of their bottom line."

According to Northrup, MDMA has only recently attempted to wrestle with the Health Care Financing Administration (HCFA; Baltimore, Maryland) issue. "We think they're coming around," he said. And in regard to the FDA and regulatory issues, Northrup termed the current policy environment "pretty good."

The culture of such government bodies as HCFA and FDA, he said, "must be changed so that it reflects more of a partnership between business and government than the authoritarian role it presently assumes. These groups must focus on what their most critical missions are and take advantage of outsourcing opportunities." He said outsourcing would provide government and the industry "an impartial third-party arbitration process and allow the government to focus its limited resources on regulating new unproven technology."

'No company is an island'

"This industry will always need a watchdog group like MDMA," Northrup said. "I don't think many companies realize the importance of associations like ours. No company is an island today, especially at our level." He noted that "government is more inclined to talk to a group like ours than thousands of individual companies. We are the collective voice of the industry."

Overall, Northrup expressed optimism that these smaller companies can weather the storm, noting especially the impact of aging in the U.S. This shift in national demographics "will have nothing but a positive effect on this industry," he said. But he stressed the need for the independent companies to stick together: "We must be ever vigilant, band together and continuously maintain a dialogue with government in order to accomplish our goals."

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