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U.S. regulatory barriers burdensome, device makers say
European patients gain access to new technologies before patients in the United States because medical device companies find it easier to get their products to market in Europe, a survey of device companies found.
Members of the Advanced Medical Technology Association view problems with Medicare reimbursement, the costs of clinical trials and U.S. regulatory requirements as the most significant challenges to bringing new treatments and tests to patients, according to the survey.
Other concerns of companies surveyed included the staffing and expertise levels of Food and Drug Administration personnel to adequately perform their jobs and the increase in overall development time for breakthrough medical technologies. Almost three-quarters of the companies with technologies requiring a premarket approval from the FDA said the average elapsed time for new technology development had increased, in some cases to more than 5 years.