Jan
3
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.
Comments
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My product review site:
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Congrats to JB and partners! And here’s hoping that SOON JB can free himself from the leviathan that is Microsquish and go forward with Vioguard. (P.S. owning your own business is great, but it usually means you work 2 times harder than “normal” people – but it IS something you love!).
Congrats to JB and his partners. Julie
Congrats!
Linda, that is great news. I used to work in marketing on the medical supply chain side. Tell JB to contact Novation and Broadlane, if he hasn’t already. These are two big hospital group purchasing organizations, and they contract with medical supply companies to negotiate pricing for hospitals. It’s tough to break into the market without them. I’ve worked at both companies. Drop me a line if you want more info.
Hi, long time reader here. My husband is an exec. at a medical device company and has worked in the industry for almost 20 years dealing with FDA approvals, patents, etc. The med device industry is small and relatively incestuous and my husband knows a few people here and there. I’ll show him your post, if you like I can give you his e-mail address and maybe JB could bounce some questions/ideas off of him.
Good luck, I know how nerve wracking this stuff can be but once you jump through the hoops, knowing the right industry folks can be huge.
Also … Novation offers this:
https://www.novationco.com/technology/products/product_submissions.asp
Glad to get this update as I have been curious about the Viogaurd product! Here’s hoping that 2012 is the year you get to write your “amazing ending” to this story. Cheers and congrats to JB and his partners for sticking it out through a very stressful year!
Here’s hoping! Maybe your other dream about moving can also come true this year, too! Congrats all around.
That’s awesome! I’ve been wondering how things were going. I work in a hospital too and can totally see the benefit of this product. Especially for the keyboards that are in patient rooms, where more and more people are in isolation because of various things.
Congrats to JB and his partners for sticking it out and doing it the “right” way.
Congratulations! He’ll be so glad in the long run he took the high road…. I wish him lots of continued success. Clearly, the best is yet to come!
That is great! CONGRATS to JB and his partner!
I was wondering about this a few months ago when I ended up in the hospital with possible msra (ended up being negative, yay!). Congrats to Vioguard. The FDA has been really backed up for the past 5 years or so. I had a recall due to patient injury and it was a YEAR after I closed the paperwork that the FDA finally followed up with me. The Class II is definitely worth the wait, it saves so much admin overhead in the long run.
Kudos to JB and his partners for doing things the right way, even though it sucked. And a HUGE congratulations to them for getting the appropriate clearance! I hope they’re still able to make it work.
Congrats to JB and the Vioguard team. It’s even making the local news…
http://www.komonews.com/news/consumer/Govt-approves-Kirkland-cos-self-cleaning-keyboard-136707863.html
HIGH FLIPPIN’ FIVE YOU GUYS! Seriously. High fives around. That’s big, even in it’s “smallness”.
I own a mobile food business and still supplement our self-earned income with part-time work. As a small business owner I can jive with things being way, way more difficult than they’re supposed to be and the often unforseen complications that self employment brings on — and I’m just a small bidnass without any FDA hooligans up in there to complicate the bejesus out of all of it. So congrats are seriously overdue for both his — and your!– patience and struggle with the whole thing. Props to both of you for making it work & awesome wishes for another great year. :)
Heard about Vioguard yesterday morning on Q13. Congratulations to JB and team! Hope it’s able to be sold to hospitals and what not soon!
Gah, It is so incredibly frustrating just hearing about this process. Like many others, I had been wondering whether JB had to abandon Vioguard all together. I’m so glad the answer is no. So, basically ditto to everything Scott said back at the beginning of the comments. Major congratulations to JB & co for doing the right thing and also persevering. You guys are a great team and I hope it all goes like gangbusters from here on out.
Saw Vioguard on the news (KOMO) this morning. Congrats to JB and his partners. It looks awesome!!!
Just saw Vioguard making the rounds on tech websites! Congrats JB !! http://www.ohgizmo.com/2012/01/06/vioguard-self-sanitizing-keyboard-gets-fda-nod/
Huge congrats!!