Researchers said the U.S. approval process is onerous for small firms. An agency official said their methodology may be flawed.
Companies developing some of the most-innovative medical devices are launching them abroad first, well before they reach U.S. shores, according to a new study by researchers at Northwestern University.
The culprit behind this perceived technology drain? The researchers point to the Food and Drug Administration (FDA).
Their survey of more than 350 professionals found that two-thirds of small medical device companies engaged in developing new products are obtaining approvals in Europe first. This suggests, they said, a "delayed market entry" in the United States.
Released Tuesday, the survey was funded by the Institute for Health Technology Studies, or InHealth, a nonprofit foundation that "supports research and analysis into the role of medical technology in advancing health care and patient quality of life."
While large companies expressed similar complaints about an allegedly clunky FDA approval processes, researchers said the issue is especially acute with smaller companies, which tend to develop the most-innovative new products. These cash-strapped companies are more vulnerable than their behemoth counterparts.
"What's at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace," John Linehan, a biomedical engineering professor at the school in Evanston, Ill., said in a statement.
The perceived unpredictability of the 510(k) approval process, which is the way most medical devices are cleared for launch in the United States, attracts the most criticism from those who took the survey. Only 8 percent felt the U.S. approval pathway was the most-predictable in the world.
A frequent criticism of the agency involves the uncertainty many companies say they face while trying to gain clearance through the 510(k) process, which generally does not require tests on humans before a device gets clearance.
Seventy-six percent found it was "uncertain or unclear" what would be required in a particular 510(k) submission. About 72 percent found that information requested by FDA reviewers went beyond necessary requirements. And 14 percent said that in the past three years they experienced changes in the lead reviewer for their application.
In short, the lack of predictability with the process has hampered device innovation, the researchers concluded.
Dr. Jeffrey Shuren, who heads the FDA's device division, said at a news conference Tuesday that he appreciated the efforts by the researchers "on challenges we all face keeping the 510(k) process robust and maintaining the United States' edge in medical innovation while assuring patients receive devices that are safe and effective."
However, Shuren pointed out a number of "limitations" with the survey. While there are more than 5,000 medical device companies in the United States, the survey included responses from 350 individuals, less than 10 percent of the industry, he said. And some questions elicited even fewer, and particularly subjective, responses.
Still, he said he shares a number of concerns highlighted in the survey, including the need for the FDA to enhance predictability and transparency when dealing with companies seeking clearance for a new product.
A number of these concerns were tackled in changes announced by the agency earlier this year, including the need to stem high turnover of FDA reviewers, a need for enhanced training for both FDA staff and companies trying to negotiate the approval process, an increased focus on decisionmaking based on scientific evidence, and earlier notification if a company's application is not going to be cleared.
In the meantime, the Institute of Medicine is reviewing the 510(k) process at the FDA's behest. A report from the independent advisory group is due this summer.
Janet Moore • 612-673-7752