Jan

3

Update on Vioguard

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Many months ago, I told you that JB had left Microsoft to start his own company. I’ve talked a little about how we started thinking pretty seriously about what it would take to move to Oregon, and how it then became necessary to relocate that dream to the back burner, but I haven’t been able to give an update on JB’s job situation for a while.

I’d like to do so now, for those of you who might be interested.

In the last part of 2008, JB left Microsoft in order to launch Vioguard along with his business partners. In September of 2009, Vioguard notified the FDA of their intent to market their UV sanitizing keyboard as a medical device, as part of the 510(k) clearance process required by the U.S. Food and Drug Administration. The 510(k) process, by which the FDA determines what category the device falls into, is supposed to take 90 days. Vioguard had no reason to believe their keyboard wouldn’t be cleared, and they moved ahead with their sales and manufacturing plans.

Fast forward an increasingly stressful year, and Vioguard still didn’t have the clearance. The FDA had decided there wasn’t a predicate product the keyboard could be compared to, so the company had two options: they could apply for premarket approval as a Class III device—putting their keyboard in the same category as, say, a pacemaker or a breast implant—and face the incredibly rigorous and expensive application process that entailed, or they could submit a de novo petition.

The FDA’s de novo reclassification process is what’s involved when the government has to create a new category for a medical device. It was the only way Vioguard could get the Class II clearance they needed, so that’s what they did. It was supposed to take 60 days.

It didn’t, of course. Months went by, and Vioguard couldn’t sell their product. Now, one course of action would have been to go ahead and market the keyboard anyway, regardless of their FDA status. It’s clear that plenty of companies do this, merrily making all sorts of scientific claims and ignoring any warning letters the FDA might send their way.

JB and his partners didn’t go into business to be sleazy or get fined, though, so they waited. And waited.

In January of 2011, JB went back to Microsoft. He still had great hopes for Vioguard, but we couldn’t keep getting by on one salary. The company had used up their funding, and the stalled FDA process kept them from making any sales. At that point, everyone believed the FDA clearance would come through any day.

On December 20th, after JB had been back at Microsoft for nearly a year, Vioguard finally received a letter from the Food and Drug Administration stating that their keyboard had been cleared and approved as a Class II medical device.

There’s no exciting ending to this whole saga, at least not yet. Maybe there never will be, although I’m certainly hopeful something good eventually comes of all this effort by Vioguard to do the right—and legal—thing. Between the FDA clearance, their published clinical trials, and their granted patent claims, Vioguard has created some extremely valuable assets over the years.

Still, it’s a frustrating example of how hard it can be to chase down that elusive American dream. Between the piles of government red tape (one study showed that FDA de novo applications average 482 days of review time from start to finish—much longer than the 60 days the review process is supposed to take) and the impossibility of getting by even for a short period of time without health insurance, there was no way for JB to stick this out. I find it crazymaking that so much blood, sweat and tears went into creating such a fantastic product, and yet they were prevented from bringing it to market for two years . . . for the sole reason that no one else had thought of it before.

At any rate, here’s a long-awaited congratulations to JB and his partners for crossing that seemingly impossible FDA hurdle. I’m so proud of everything he’s done.

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