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

70 Responses to “Update on Vioguard”

  1. Eric's Mommy on January 3rd, 2012 9:21 am

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

  2. Pete on January 3rd, 2012 9:24 am

    Congrats on the hard work.

  3. Christine on January 3rd, 2012 9:25 am

    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.

  4. JennB on January 3rd, 2012 9:27 am

    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!

  5. erica on January 3rd, 2012 9:34 am

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

  6. divrchk on January 3rd, 2012 9:41 am

    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.

  7. Sarah on January 3rd, 2012 9:56 am

    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!!

  8. Carrie (in MN) on January 3rd, 2012 9:59 am

    Big congratulations to JB and his partners.

  9. Melody on January 3rd, 2012 10:01 am

    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!

  10. Scott on January 3rd, 2012 10:03 am

    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!

  11. Sara on January 3rd, 2012 10:04 am

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

  12. Mariya on January 3rd, 2012 10:07 am

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

  13. Danita on January 3rd, 2012 10:10 am

    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.

  14. spacegeek on January 3rd, 2012 10:23 am

    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!!

  15. Courtney on January 3rd, 2012 10:24 am

    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!

  16. Amy on January 3rd, 2012 10:28 am

    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!

  17. Erika on January 3rd, 2012 10:35 am

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

  18. Steph T. on January 3rd, 2012 10:37 am

    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.

  19. Redbecca on January 3rd, 2012 10:40 am

    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!

  20. bj on January 3rd, 2012 10:45 am

    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).

  21. NancyJ on January 3rd, 2012 10:52 am

    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.

  22. bj on January 3rd, 2012 10:52 am

    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).

  23. Lori on January 3rd, 2012 11:26 am

    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.

  24. AnEmily on January 3rd, 2012 11:26 am

    That’s great news!

  25. Sarah in Huntsville on January 3rd, 2012 11:28 am

    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.

  26. Jesabes on January 3rd, 2012 11:28 am

    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!

  27. Amanda on January 3rd, 2012 11:47 am

    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.

  28. T on January 3rd, 2012 12:05 pm

    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! ;-)

  29. Life of a Doctor's Wife on January 3rd, 2012 12:14 pm

    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!)

  30. Brad on January 3rd, 2012 12:27 pm

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

  31. Brad on January 3rd, 2012 12:34 pm

    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/

  32. el-e-e on January 3rd, 2012 12:48 pm

    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.

  33. Kris on January 3rd, 2012 12:50 pm

    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.

  34. bouncy on January 3rd, 2012 1:07 pm

    Great news for a new year! Congratulations!

  35. Carmen on January 3rd, 2012 1:34 pm

    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!

  36. Francesca on January 3rd, 2012 2:39 pm

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

  37. sooboo on January 3rd, 2012 4:12 pm

    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.

  38. marilyn on January 3rd, 2012 4:12 pm

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

  39. Gigi on January 3rd, 2012 4:49 pm

    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.

  40. Nancy on January 3rd, 2012 5:07 pm

    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!

  41. MotherGooseAmy on January 3rd, 2012 5:10 pm

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

  42. Nancy on January 3rd, 2012 5:12 pm

    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.

  43. D'Ann on January 3rd, 2012 6:01 pm

    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!

  44. Serror on January 3rd, 2012 6:07 pm

    Awesome! Great news! Congrats!

  45. Taryn on January 3rd, 2012 6:58 pm

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

  46. Angella on January 3rd, 2012 7:18 pm

    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! :)

  47. LizScott on January 3rd, 2012 8:07 pm

    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

  48. Kathleen on January 3rd, 2012 8:16 pm

    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!

  49. Aimee on January 3rd, 2012 9:23 pm

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

  50. Victoria on January 3rd, 2012 9:43 pm

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

  51. alyn on January 4th, 2012 12:00 am

    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!).

  52. Julia on January 4th, 2012 8:41 am

    Congrats to JB and his partners. Julie

  53. Edith on January 4th, 2012 9:31 am

    Congrats!

  54. kristylynne on January 4th, 2012 9:37 am

    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.

  55. Tammie on January 4th, 2012 9:43 am

    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.

  56. kristylynne on January 4th, 2012 9:45 am
  57. adequatemom on January 4th, 2012 10:11 am

    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!

  58. June on January 4th, 2012 11:08 am

    Here’s hoping! Maybe your other dream about moving can also come true this year, too! Congrats all around.

  59. Kate on January 4th, 2012 11:32 am

    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.

  60. willikat on January 4th, 2012 1:54 pm

    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!

  61. Wanda on January 4th, 2012 8:00 pm

    That is great! CONGRATS to JB and his partner!

  62. angela on January 5th, 2012 1:37 am

    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.

  63. Dawn on January 5th, 2012 9:47 am

    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.

  64. Jay on January 5th, 2012 3:28 pm

    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

  65. cara on January 5th, 2012 4:23 pm

    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. :)

  66. Dianna on January 5th, 2012 5:37 pm

    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!

  67. Laura on January 5th, 2012 10:02 pm

    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.

  68. Trina on January 7th, 2012 9:44 am

    Saw Vioguard on the news (KOMO) this morning. Congrats to JB and his partners. It looks awesome!!!

  69. travelmonkey on January 7th, 2012 6:30 pm

    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/

  70. Kelly on January 13th, 2012 5:09 pm

    Huge congrats!!

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