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“The facts sort of are the facts,” he said. “Is it getting worse? The holistic answer is: ‘Yes, it is.’ ”
But Mandle said there are “so many pieces” at play in what is hurting the device industry that it’s too simplistic to lay the blame at the feet of a cautious FDA. A new medical device tax, which saps millions a month from med-tech companies, “is relevant,” he said. So, too, are overall poor economic conditions and aggressive competition from Europe, Japan and China to woo jobs overseas.
But the uncertainty of the approval process plays a major role in chasing away investment, he said. An industry that has always been a risky investment now faces reduced return on investment, making it too risky for some, Mandle said.
The industry was lamenting much the same thing a couple of years ago. What has changed is that politicians are talking about ways to improve it. Minnesota Sens. Al Franken and Amy Klobuchar and Rep. Erik Paulsen have called for new efforts to speed the approval process without jeopardizing patient safety. “A lot of the rhetoric has changed,” Mandle said. “So far, on the ground, I would say very little has changed.”
A tough spot
Not everyone in Minnesota med-tech, of course, has a beef with the FDA.
Tim Cook, founder and president of Uromedica, said the FDA has been “demanding with respect to clinical data and safety data from us. But they’ve been pretty open.”
Uromedica, which is going through a longer process called pre-market approval, has developed devices to treat urinary incontinence. Cook said the key with regulators has been open communication and feedback.
“I don’t have a lot of complaints,” he said. “They have been clear with me.”
Ralph Hall, a University of Minnesota law professor who studies the FDA, said the agency is trying to address industry concerns, noting an entrepreneur-in-residence program to give regulators a better industry perspective.
The FDA also is trying to improve efficiency by giving companies faster feedback on whether their application needs to fill in some gaps, Hall said. Given that the agency receives thousands of applications each year, he said it’s likely a few could stand improvement.
And, at a time when regulators come under fire for every faulty artificial hip or defibrillator wire that made it to market, some believe the FDA needs to ask tougher questions. In the end, he said, the question of whether regulators are appropriately asking tough questions or needlessly bogging down the process “needs to be a matter of public debate,” Hall said.
None of which makes CoAxia’s limbo any easier for Weiss and his investors to bear. After a hearing in which members of an advisory panel said they needed more data in order to make a recommendation, Weiss said the company’s days appeared numbered.
In the past couple of weeks, however, CoAxia’s plans to sell off its assets and permanently shut its doors have been put on hold. Weiss is talking to an FDA administrator who still could recommend the device be ruled safe and effective for stroke patients.
CoAxia is getting him more information.
James Walsh • 612-673-7428