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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Eric's Mommy
10 years ago

That is awesome. I work for a pharmaceutical company so I know all about dealing with the FDA.
Congratulations to JB!

Pete
Pete
10 years ago

Congrats on the hard work.

Christine
Christine
10 years ago

Congratulations to JB and his partner! What a supreme pain in the ass the FDA is. Really really toothless on top of it all. May Vioguard be wildly successful.

JennB
10 years ago

Congratulations to you and Vioguard’s partners… I have a ton of ideas and inventions, but I don’t have the time or financial resources to chase them down, as we are currently a single-income family as well (and unsure of our next steps, as we’re out of $$ to keep these shenanigans up).

Here’s to a brighter 2012 for JB and his partners!

erica
erica
10 years ago

Congrats! And wonderful innovative thinking… great minds working ahead of the curve for our benefit!

divrchk
divrchk
10 years ago

Thank you for posting this! I have been wondering what had happened to his product. This is wonderful news. I hope that he and his partners can get a bit more funding to see it through to market.

Sarah
Sarah
10 years ago

Start-ups are so hard WITHOUT having to deal with the FDA (I work in clinical trials…I KNOW). Congratulations to JB for sticking with it, keeping his integrity, FINALLY getting that elusive approval AND doing what needed to be done to take care of his family in the meantime. Good luck with the next steps!!

Carrie (in MN)
Carrie (in MN)
10 years ago

Big congratulations to JB and his partners.

Melody
10 years ago

Congratulations to JB and his team! I have wondered what was happening with that, because when you first wrote about Vioguard, it seemed like such a great idea, I couldn’t believe it didn’t already exist. I wish them lots of success!

Scott
Scott
10 years ago

Congratulations! I wholeheartedly support their decision to do the right thing, as tough as it was.

Over the last year I’ve come to realize that there are lots of people who make the wrong decision in those cases, so it’s easy to torture yourself by looking at what other people do: “Look, they did the other thing, and they’re doing fine!”

But at the end of the day, we are defined by the decisions we make. So the question is, what kind of person do you want to be? Would you be happy to be successful while doing the wrong thing?

JB and his partners decided that they want to be successful only if they can do it the right way, which is incredibly admirable. The world would be a better place if more people were like them. It sucks that they have to risk their financial future to do that. (And in my opinion it’s dangerous. The FDA should be doing everything they can to make it easy for companies to be safe.)

At the same time, I think they’ve already been successful. Regardless of what happens with Vioguard, JB and his partners will *always* be an example to Riley and Dylan of how to do business and make tough decisions. That’s not the kind of success you dream of when you start a company, but I’ve come to believe that it’s the most important.

So congratulations to them for making the tough call, and congratulations on the approval. I hope they’ll get all of the rewards that they deserve. Good luck, JB!

Sara
Sara
10 years ago

Congrats JB, this is AWESOME…so sorry it came at such a price though.

Mariya
Mariya
10 years ago

Wow, that was exhausting to read about…I cannot imagine actually having to go through it. Congratulations are definitely in order!

Danita
Danita
10 years ago

I work in a hospital and let me tell you I would KILL for one of those keyboards. We all pass germs around – regardless of glove use etc… Ick.

spacegeek
spacegeek
10 years ago

Wow, what a great idea! I work in spacecraft operations, and we share keyboards. It grosses me out continuously. When I have to be in the ops area, I always carry sanitizing gel and use it like crazy! I could see that this would be an extremely useful tool! Sorry for the troubles you’ve had!!

Courtney
Courtney
10 years ago

Thanks for updating on this front, I’d been wondering…

And a very sincere congrats to JB and his partners, both for their (eventual) success and decision to take the high road. Congrats to your family for having the guts to at least *try* something!

Amy
Amy
10 years ago

Wow.. two years? That’s…..super efficient? But really, it has to be nice to be finished with the waiting – good luck with whatever comes next!

Erika
Erika
10 years ago

Congrats to finally getting clearance! Here’s hoping that he can move forward with his product(s) soon.

Steph T.
Steph T.
10 years ago

Don’t know if you knew this…but I have worked in the medical device industry for about 13 years, so I know exactly what he was going through. I had to leave the small company in order to survive. I’m now with a larger (but still privately owned) company, so if it takes a while to get clearance, we don’t have to struggle. Way to go Vioguard! I’m so excited for JB and his partners.

Redbecca
Redbecca
10 years ago

I echo everyone else when I say congrats to JB and his partners and fooey on the FDA for all the red tape. I get why they think they need it, but still!

bj
bj
10 years ago

I also thought the keyboard is a great idea and I hope, for selfish reasons (I’d love to see keyboards in public areas be safer) that it comes on the market soon (and, I do hope, you’all benefit from the success of a product that seems like a good idea).

NancyJ
NancyJ
10 years ago

Congratulations to JB and his partners!
I hope they are now able to go forward and the waiting game they had to endure will be a blip when they look back at where they started.

bj
bj
10 years ago

PS: This saga is one of the reasons why I am in favor of health insurance not tied to employment. I know too many people who have to stick with Microsoft because their health insurance needs are incompatible with a start up or other small employer. One can save a couple of year’s salary to follow a dream, but not usually if you also have to buy insurance independently (and have high health care costs).

Washington State does have a strong clause allowing you to buy insurance, with no pre-existing condition clause if you have been previously covered (but, I don’t know how the costs get determined). Group Health Cooperative offers individual policies, but I do not know how their rates depend on known health care needs (for example, if you have a child with autism, as one MS employee I know does).

Lori
Lori
10 years ago

I agree with Christine @ 9:25 am – shame the FDA is toothless after all the red tape. They can stick it to the “little guys” but with enough money and friends you can get anything approved.

AnEmily
AnEmily
10 years ago

That’s great news!

Sarah in Huntsville
10 years ago

That’s awesome news! Congratulations to JB! It sounds like an incredibly useful and needed product, so I hope things really take off now that the FDA is on board.

Jesabes
10 years ago

I’m so glad you updated! When you took the kids trick-or-treating (I think? or something else?) at Microsoft, I wondered if/why JB was working there again. Congratulations to him and Vioguard!

Amanda
10 years ago

I can’t believe it’s been that long. I often wondered how the company was doing but assumed you’d update us with any big news. Again, I can’t believe how long it took. I remember when you first mentioned it.

T
T
10 years ago

So amazing that this is finally happening…congrats to everyone, Linda! Hopefully this means that sometime later this year we’ll be reading that your dreams of moving to Oregon are coming true as well! ;-)

Life of a Doctor's Wife

Oh I’m SO GLAD this had a happy ending!! Congratulations to JB and his partners! I hope that they rock the world with this new product and make bundles and bundles of cash. (And, obviously, help some people!)

Brad
Brad
10 years ago

Money paid to expedite the approval process goes directly to congress, not to the FDA. Hmm, maybe that’s patents, I can’t remember.

Brad
Brad
10 years ago

Also, thought I’d mention I found this on Reddit first, then came here.
http://www.reddit.com/r/technology/comments/o1952/selfsanitizing_keyboard_wins_fda_nod_for/

el-e-e
10 years ago

So glad to hear of this long-awaited success! I HAVE been wondering about it! Hope the rest falls into place for JB and all involved.

Kris
Kris
10 years ago

Congrats to JB & his Vioguardians!!

Wow, our government pisses me off. If their published website says a 60-day review period, they should be fined for every day which they’re late. Imagine what the world would be like if all the rest of us blew off our deadlines.

bouncy
10 years ago

Great news for a new year! Congratulations!

Carmen
10 years ago

Congratulations to JB! Wow, that’s infuriating to have to wait so long especially when then stated wait times are so much shorter. Thanks for updating us on the situation, I’ve often wondered where Vioguard was with their FDA approvals. Here’s hoping for lots of sales in 2012!

Francesca
10 years ago

Congrats to you and your family! I was wondering what was up — it’s a really great idea! Good luck. :)

sooboo
sooboo
10 years ago

That is (finally) great news. Sad he and his partner were dinged for having integrity. Also, I second bj on the whole health care tied to a job sitch. It really makes entrepreneurialism difficult/impossible, which seems opposed to the great American spirit of invention.

marilyn
10 years ago

I hadn’t realized that JB returned to MS! I really hope Vioguard can now find the enormous success it deserves.

Gigi
10 years ago

My company is now dealing with the FDA and it’s a real pain in the ass. I know we need government regulation on some things to keep us safe – but dealing with them is insanity.

Nancy
Nancy
10 years ago

I’m a medical device QA/RA professional and can sympathize with the frustration JB and his colleagues have experienced. Good for them for sticking with it and doing it the right (hard) way. Now, to get that baby to market — sending you good wishes for continued success!

MotherGooseAmy
MotherGooseAmy
10 years ago

Congratulations! Let me know when Vioguard is ready to hire sales reps!

Nancy
Nancy
10 years ago

PS It’s not entirely fair to fault FDA for not meeting their published review periods. While I think government is likely a worst offender with minimal punishment for not meeting stated goals, like everyone else these days they are underfunded and understaffed. FDA is forced to take a risk-based approach to approvals and monitoring. When a new device doesn’t fit nicely into an existing classification, unfortunately the best option is typically de novo, which doesn’t move quickly. That’s an unfortunate symptom of an over-burdened, CYA-focused, highly litigious process, industry and government agency.

D'Ann
D'Ann
10 years ago

Congratulations to your hubby and his partners! I just saw a short piece about it on the local channel 2 news here in Portland. I’d like to get a very large machine like that to surround my house sometimes!

Serror
Serror
10 years ago

Awesome! Great news! Congrats!

Taryn
Taryn
10 years ago

Truly awesome! Great idea and glad they stuck to it and saw it through!!! Hope all the waiting pays off big!

Angella
10 years ago

I’ve been wondering how it was going. I saw your tweet about it today, but it’s great to hear the whole story. Go, JB and team! And you! :)

LizScott
LizScott
10 years ago

I’m so happy for you, I’m so bitter for you, all at he same time.

My dad was IBM and then leapt to start his own company. And then his next. And so on. My brother left AOL to do the same. When they – and others – get on my case about how there are too few females in startups, because “women fear risk” I LOSE MY SHIT BECAUSE OH MY GOD, IT COULDN’T POSSIBLY BE BECAUSE OF MATERNITY LEAVE AND HEALTHCARE ETC ETC

Sorry. My stuff. But I hear you (both) when you speak of the barrier to entry of this particular part of the American dream

Kathleen
Kathleen
10 years ago

YAY! I’ve worked with so many of those companies that make claims that mean nothing. Hallelujah for doing it right, and I hope this makes it into reality – as a microbiologist who has worked with hospitals, yes please!

Aimee
10 years ago

Congrats to them all! (And to you, because I know how hard it is to have a spouse under that much pressure.)

Victoria
10 years ago

I’m really happy to hear this! Well done JB and all :)