WASHINGTON In tones that exactly fit his message, Chris Chavez said that he'd "rather have one person around me with passion than 100 people around me with just some interest." Punctuating the point, Chavez said that the Medical Device Manufacturers Association (MDMA; Washington) "has passion and will not go away."

This was the feisty and "we'll try harder" style of the message delivered by Chavez, president and chief executive officer of Advanced Neuromodulation Systems (Plano, Texas) and in his second year as chairman of MDMA, in delivering the keynote presentation opening the association's annual meeting at the Phoenix Park Hotel last month. In looking at the history of MDMA, Chavez seemed to reference earlier times in both the country's history and the history of medical device regulation, referring to the MDMA as a group which took a clear stand and was formed by "a handful of rebels representing the small, entrepreneurial, innovative sector" of medical technology and a healthcare industry on the verge of major growth. This rebellious stance was the group's key objection to user fee legislation first proposed for the industry in the early 1990s.

While user fee legislation did not reach fruition until recent years, MDMA has not stilled its voice on the subject, with much of the conversation, in both the conference meeting rooms and hallways, referencing it. Much of that talk focused on the need to make changes in the user fee terms so that they do not stifle the innovative activity of small firms the type of companies which Chavez cited as making up the bulk of MDMA's membership. He made references to the larger association which pushed for the user fees: the Advanced Medical Technology Association (AdvaMed; Washington), which MDMA sees as representing the larger players in the sector.

Thus, he said that the small entrepreneurial companies must make sure their voices are heard. If not, "others will do it for you in ways you don't want it done for you." He cited the key device industry fact that "the majority of innovation firms are small companies with less than 50 employees" and that such companies both become bigger firms citing his own company's growth from "less than 50 employees" to now around 500 and that they are the main engines for development of new healthcare technologies. "It's critical that the small, innovative entrepreneurial companies be in an environment to survive and succeed," Chavez said. "Millions, billions of people are depending on us to improve the quality of their lives and save lives . . . We're in the business of helping people and we must keep that in the center in our minds."

He said the association had given its input on the proposed user fee legislation with "passion" and, that even after fee changes were made for small companies, it continued to have "serious reservations" that have proven to be true. While the med-tech sector has fulfilled its obligations in making user fee payments, Congress has not played its part, he said. While promising to contribute $60 million to the fee fund, the legislative branch has "to date contributed less than 10%," or around $5.5 million. "We must unite to make sure we don't perpetuate this," he said.

While Chavez warned that the large companies too often "have dominated this dialogue," he also held out an olive branch to AdvaMed: "We're not adversaries. We can do a lot of common good for the future of this industry."

Don Long, Managing Editor

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