Study: FDA Driving Med-Tech Jobs, Investments Overseas
Many of Minnesota’s medical technology industry leaders will likely move jobs and investments overseas due to regulatory hurdles in the United States, according to a recent study.
The study was commissioned by local industry advocacy groups Medtech Resource Alliance and Minnesota Device Alliance and conducted by Hopkins-based Introworks. Fifty-nine med-tech CEOs and venture capitalists in the state responded to the survey.
Sixty-four percent of the respondents have an unfavorable impression of the industry “in large part because of the regulatory difficulty” that the U.S. Food and Drug Administration (FDA) poses, according to Medtech Resource Alliance and Minnesota Device Alliance.
Citing the study, the advocacy groups said that respondents indicated that the agency stifles med-tech companies’ ability to innovate and be competitive because of delays and uncertainty surrounding approval for new devices; the FDA takes 28 to 76 months to clear products for the U.S. market, according to the study.
Thirty-six percent of the respondents said they would not invest in the medical device industry. More than half said that in the future, they will focus on commercializing devices outside the United States.
Eighty-five percent of the respondents said the U.S. regulatory environment has negatively affected their ability to create jobs, and 35 percent said future job growth at their companies will occur overseas.
Meanwhile, the study found that some of the state’s med-tech leaders have high regard for the European regulatory system.
“Europe’s approval process is run by an independent third-party system that is well educated, trained, responsive, very experienced, applies common sense, and is not risk-averse,” a survey respondent wrote. “They know how to facilitate medical device innovation. FDA, flatly, does not.”
Respondents said that in order to regain its credibility, the FDA must simplify its approval procedures and regulations.
On the other hand, advocates for patients and those injured by medical devices criticize government regulators for not being tough enough, according to a Star Tribune report.
“It is important for us to find a balance between innovation and patient safety—and making sure it is not an unchecked carte blanche to try products out on American patients,” Genevieve Zimmerman, a local attorney who has represented people injured by medical devices, told the Minneapolis newspaper. Zimmerman said she doesn’t believe the FDA’s current procedures and regulations put U.S. device makers at a competitive disadvantage.
Meanwhile, an FDA spokeswoman told the newspaper that the survey “sheds no new light and is less informative than many prior surveys” of med-tech industry leaders.
Minnesota is home to more than 350 med-tech companies, which employ more than 35,000 people in the state, according to the study. Another 250,000 people in the state are reportedly employed by companies that serve the industry, including specialty manufacturers and clinical, regulatory, quality, and reimbursement consulting firms.