“We’re not here to bash the FDA,” Mark DuVal, president of Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon.
Too late.
The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and Drug Administration’s 510(k) approval program, the “lifeblood” of Minnesota’s medical device community.
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But the nearly two-hour session felt more like group therapy, with entrepreneurs, doctors and venture capitalists unloading years of bottled-up anger and frustration over FDA staff delaying or even killing promising medical technologies.
“This could change the medical device industry in the state in a big [not good] way,” said David Stassen, managing director of Split Rock Partners in Eden Prairie, Minn. “Let’s not fool ourselves. We could be regulated away.”
As it turns out, a little venting is a good thing and I’m not just talking about the cathartic release you feel after dumping your problems to a friend.
For years, the state’s medical device industry has whispered (loudly) about what it sees as the alarming demise of the 510(k): unflattering media coverage, stinging Congressional reports and endless delays by FDA regulators now determined to hold device companies to a tougher standard than what the agency traditionally used in evaluating an application.
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But executives and investors have largely held their tongues publicly, in large part to avoid pissing off the very people who could make or break their companies and wallets.
Not anymore. With growing calls in Washington D.C. to alter or even scrap the 510(k), guys like DuVal and Stassen feel the time has come to move the debate from vague, pie-in-the-sky warnings to flesh-and-blood examples of real-world consequences.
And there has been a lot of flesh and blood. Take Disc Dynamics Inc. The 10-year-old start-up (and I use that term lightly), based in Eden Prairie, shut down earlier this month because it could not win approval in the United States for devices to treat lower back pain, Stassen said.
Despite selling in Europe for three years, the company could not convince the FDA to let it start a clinical trial in America. Investors like Split Rock and Medtronic Inc. of Fridley, Minn. had invested $60 million in Disc Dynamics, but the company ran out of time and money. A group of doctors who supported the technology even tried to buy the company, a first for Stassen.
In fact, winning European approval means virtually nothing in the United States, entrepreneurs say. Founded in 1997, Uromedica Inc., a Plymouth, Minn.-based company developing balloon technology to treat urinary incontinence, won a European CE Mark in 2001. Nine years and 8,000 European implanted patients later, the company is still waiting for Pre-Market Approval (PMA) in America.
CEO Tim Cook said he submitted 13 years worth 0f clinical data to the FDA in August 2008. After the six-month review period, the FDA asked 37 additional questions. Cook complied, but a FDA panel last year ultimately rejected the application, citing clinical bias and problems with the control study. Cook said he will appeal the decision to more senior FDA officials.
PlaCor Inc. in Plymouth has been selling in Europe for three years. The company has already conducted two clinical trials in the United States. Since April 2009, PlaCor has been negotiating with the FDA for a third clinical study. What does PlaCor make? A device that tests platelets in blood taken from a finger prick.
“We’ve been sitting here three years later with no idea of what our path is,” said CEO John Reinke.
Celleration Inc. of Eden Prairie won 510(k) approval for its wound care device in 2004, but not without great headache. Founded in 1999, the company sparred with the FDA several times despite treating thousands of patients. Kris Johnson, general partner with Affinity Capital Management in Minneapolis, which invested in Celleration, said the company would have died if just started in the last few years.
I’m not a scientist or regulator so I won’t even guess what goes on behind the scenes at the FDA. I’m sure the FDA staff reviewing 51o(k) submissions have their reasons, but three clinical studies for a point-of-care diagnostic device does seem a little excessive.
You could chalk up each individual complaint as sour grapes, the usual butting of heads between company and regulator. But taken together, these anecdotes say something is going on in Washington.
Remember, companies submitting 51o(k)s must prove their products are safe and effective compared to other technologies already in the market. High-risk, break-through-the-mold technologies must seek the gold standard PMA.
Logically, it’s hard to understand why a 510(k) device already approved and sold in Europe must go through several years of clinical trials in the United States. Three years for a blood test? Really?
What does the FDA know that regulators in Great Britain, Germany and France don’t? Remember, this is the same group of people who hate genetically modified foods, something that’s widely available in America.
I think everyone can agree, however, that abolishing or radically reworking the 510(k) would not be good for Minnesota’s medical device community. Aside from companies shutting down or stuck in FDA purgatory, investors will not pump money into a device that has no endgame.
“VCs are frozen in their decision-making,” Johnson of Affinity said. “There are no clear standards on how to measure risk versus reward.”
