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.
Dec
29
It’s almost the New Year, which means it’s time for the annual year-end quizamathing. Just like in 2010, 2009, 2008, 2007, 2006, 2005, and 2004, here are my answers to a bunch of questions about how my year went.
As always, feel free to copy/paste for yourself! If you do post this on your own blog, please link to your entry in the comments here—I’d love to read them.
1. What did you do in 2011 that you’d never done before?
Spent a full year working from home, with all its ups and downs. Said goodbye to Dog. Took a family vacation to Missoula. Camped on the Rogue River with JB. Became the mother of a kindergartener. Went to the Humane Society and came home with a calico cat. Saw one of my children turn three, and the other turn six.
As I try to recap, it seems like 2011 was so uneventful compared to past years. Yet I look back on it as being filled with thousands of tiny happy moments, and a lot of overall contentment and peace.
2. Did you keep your new year’s resolutions, and will you make more for next year?
Here’s what I wrote for 2011:
• Take both the kids to swimming lessons, I mean it this time. Yes! The kids have been taking lessons for a while now, and they start up again on January 10. Hauling them to and from the pool is a giant expensive pain in the ass, but they’re getting much better.
• Continue going to CrossFit 3-4 times a week. Uhhhhhhh no.
• Start doing local race events again. Nope.
• Get a really good photo of the four of us. Pretty much a no on this one too.
• Grow out my hair. Yes! I have been doing this! It’s down to my shoulders and I can finally get it in a ponytail! Rocky theme!
• Do a better job of staying in touch with friends. Oh god. No. No, not at all.
• Peel off those extra five pounds I seem to be having so much trouble losing. Yes, if by “peel off” I meant “add 10 more.”
• Pay off our credit card. Not yet, but we have made major headway on this, and this feels like a huge accomplishment.
So here’s the thing—every year I sit down to do this little exercise, and I arbitrarily pick a handful of goals that seem vaguely important during the moment. Then I forget all about them until it’s time to revisit a year later, when I am inevitably confronted with the fact that my actual priorities ended up being in different places altogether. I mean, if I’d picked things like “Meet every writing deadline I’m given” or “Take on new professional challenges” or “Snap at least one crappy photo every single day,” I could have ticked those things off one by one.
This time around, instead of jotting down a half-assed list right this minute, I think I’ll give more thought to the idea of creating goals for the year. See if I can’t make it a bit more meaningful.
3. Did anyone close to you give birth?
Yes, JB’s brother and his wife have an adorable son who was born in August.
4. Did anyone close to you die?
Yes, I’m sorry to say. JB’s awesome uncle Jack.
5. What countries did you visit?
None.
6. What would you like to have in 2012 that you lacked in 2011?
A place to live in Oregon.
7. What dates from 2011 will remain etched upon your memory, and why?
Again, I’m thinking how 2011 was the year of quiet moments instead of big events. I can’t think of any particular dates that stand out, really.
8. What was your biggest achievement of the year?
I’m going to say adjusting to working from home, because it’s definitely been a challenging process. I feel much more happy and settled these days than I did during the first half of the year, and I think that’s due to figuring out a routine that works best for me and making that happen. I also feel like I did a good job with Riley’s homeschool activities before he headed into summer break and kindergarten.
9. What was your biggest failure?
I say this every single year: my biggest failures have to do with my sub-par parenting moments. No doubt about it.
10. Did you suffer illness or injury?
Not a damn thing. I’ve been remarkably healthy, the last time I even had a major cold was when I was pregnant with Dylan. *falls over, bleeds out in a horrifying manner from immediately contracting Hubris Ebola*
11. What was the best thing you bought?
My iPhone 4S, because it’s capable of taking such great pictures. Gas for road trips. Writing a check for my very last car payment. A GoPro camera for JB, because I think it’s going to be so much fun for him. A family gym membership.
12. Where did most of your money go?
The mortgage, paying off the debt we accrued in 2010, our savings account, kindergarten and preschool fees.
13. What did you get really excited about?
I’ll say BlogHer, because I was so geeked to see friends and meet new people and, you know, be around people whose butts I did not have to wipe for a couple days.
14. What song will always remind you of 2011?
Oh god. This ridiculous song, because Dylan has been singing it since July. JULY.
15. Compared to this time last year, are you:
– happier or sadder? Hmmm, probably about the same.
– thinner or fatter? Fatter, says the scale and my jeans and the mirror and shut up OMG.
– richer or poorer? Financially better off.
16. What do you wish you’d done more of?
More writing for fun, more exercise, more adventures, more activities outside of my comfort zone.
17. What do you wish you’d done less of?
Less time glued to my laptop, less dithering over adhering to one particular health/fitness approach, less downplaying the relevance of my job to people who ask what I do for a living.
18. How did you spend Christmas?
Like this.
19. What was your favorite TV program?
Same answer as 2010: Breaking Bad. We also got really into Sons of Anarchy, and I was religious about watching The Walking Dead (if not thoroughly devoted to its quality).
20. What were your favorite books of the year?
Crap, I can never think back on what all I read. A few that stand out: Coraline, The Gathering Dead, Blood Red Road, A Little More About Me, Divergent.
21. What was your favorite music from this year?
AWOLNATION, for sure.
22. What were your favorite films of the year?
Hanna (for the awesome first part, not so much the second half), Super 8, Bridesmaids, Crazy, Stupid, Love, Rise of the Planet of the Apes, Drive, Moneyball, Contagion.
23. What did you do on your birthday, and how old were you?
We celebrated at home. My cake had so many candles (37!) the icing melted.
24. What one thing would have made your year immeasurably more satisfying?
I don’t know that I have an answer for this one, really. It would certainly be satisfying to not have my work/home life/parenthood tasks colliding so often, but that’s the life I signed up for. Any one solution—not having to work, not having the kids around—would take away something that’s meaningful to me.
25. How would you describe your personal fashion concept in 2011?
This question is so abysmally stupid I hereby renounce it from all future questionnaires.
26. What kept you sane?
JB. The internet. My kids’ laughter. That magical moment around 8 PM when the boys are in bed for the night.
27. Tell us a valuable life lesson you learned in 2011.
It’s always worth it to do the hard work to figure out how to make things better. Don’t overpluck your eyebrows. Half and half is vastly superior to non-dairy creamer. Small children are happiest when you get down on the floor with them. The most painful things to write are usually the pieces you become most proud of. You’re only as sick as your secrets.
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