FDA and the Meaning of Life
Salt Lake City, 15 March 2013 – I’ve written this post three times. I started it on Sunday as I was mentally preparing for an FDA site audit of the company that employs me to manage its device event reporting department. That post was prefaced by the fact that my Garmin decided it was not very happy with the change to Day Light Saving time and shredded my ride data. Things were not looking so good and I didn’t have the wherewithal to push the post button.
On Wednesday, after the auditor finished with what felt like a relatively smooth review of my department’s processes and reporting I went for a self congratulatory ride, had some dinner and went to bed. All of the emotion by then was drained from my head and only exhaustion remained. I had nothing to say. You learn after being a part of such audits that sitting quietly while the auditor is reading and reviewing information that you should not speak. That’s a difficult thing for many people when they are under such pressure. The trait, though difficult to master, is important; it keeps you from sticking your foot in your mouth and giving the auditor some idea of what he should be looking for.
I observed the audit on Thursday, leaving the office thinking we had just been handed our first observation. For those who have never been through such an audit, an observation is not a good thing. It means you’ve got something to clean up that becomes part of the public history of your company’s quality health. After the audit, I biked and promptly repeated my Wednesday night’s activities. Exhaustion overwhelmed me; I went to bed lacking any energy to share my thoughts.
Today is Friday. And although most auditors will tell you that they will be reviewing your practices for at least a week, the government is subject to sequester as much as we mere mortals. The last day is often a wrap-up session filled with requests for documentation, procedures and test reports. As we approached 2:00 the tension in the room was as thick as the processed office air. We sat waiting for the shot to our egos and the findings of the audit. Strangely, after a deep breath we all heard him say there would be no observations, that he had comments but not formal findings. By 2:30 he was gone and there was an emptiness in the building. All that effort to prove our systems were working, when we know we have some spider webs to clear, was effective. Did we win? Or did we lose because most people will go back to their daily grind thinking they’ve accomplished something and that nothing needs to be improved.
If I tried to compare this to riding a bicycle I think it would be comparable to coming in second at a crit and never bothering to try to get to first place. You would just give up, and go home content with mediocrity. Mediocre is just that: meh as they say these days. I don’t see the validation for your effort in that thought process though. Conquer the race, the hill or just your daily loop. Do it because it will help you find the meaning to life.
Castelli Style
Salt Lake City, 5 March 2013 – Greg sporting Castelli with his best Rapha face, once again proving if your bicycle isn’t fly your kit should be.
Incidentally
True, the bike is incidental but it is the means to the end–the mode to the summit.
English Cycles Great Divide Race 29er
Denver, CO, 23 February 2013 – English Cycles 29er modified for the Great Divide Race getting beauty shots at the 2013 NAHBS. The wheels are interchangeable front to back if the rear drive hub goes t!ts up, as the British say.
Gates Carbon Drive
NAHBS 2013, Denver, Colorado, 23 February 2013 – The Gates Corporation has been building drive belts for automobile engines for over 100 years. They’ve been doing the same for bicycles since 2007. At the 2013 NAHBS, Gates sponsored a contest in an effort motivate custom bike builders to adopt the Gates Carbon Drive system into their bike designs. Many industry innovators did just that and almost every builder booth had at least one bike fitted with the Gates belt system.
The Gates Carbon Drive website says their internal testing found the belt had a life expectancy double that of a traditional chain drive. And according to the Gates rep we spoke with at the show the belt would most likely last three times that of a chain. The reasons are simple. The original technology for Gates belts used in autos has to be durable enough to spin at 2,000 RPMs for many years. How many times have you changed the belts in your car? Take that technology and add carbon fiber threads to the belt and you get a drive system that will not stretch giving the belt a life expectancy of many thousands of miles. On top of the long life, there’s no oil required and minimal maintenance making the system versatile enough for many applications. These qualities are certain to help the Gates Carbon Drive system move quickly into the mainstream bicycle market after such a grand introduction on some stunningly beautiful custom bicycles.
Enter The Deuce, Part III
NICU Somewhere, 5 March 2013 – I know where his fears originate. I was there watching two tiny beings taken from their mother’s womb smaller than my hands, smaller than expected and so vulnerable. Today, they are two month’s from 16 years old. One will get her driver license and her brother will most likely never drive-the consequences of a minute of oxygen deprivation and luck. They are both beautiful and amazing in their own rights. Just like your son will be in whatever form his future becomes.
Sano Magic Bicycle
Denver, Colorado, NAHBS 2013, 23 February 2013 – This is a Sano Magic T3 mahogany bicycle built in Japan by Sueshiro Sano, a ship builder whose family has been building ships for over 100 years. The mahogany used in the bike is laminated to create tubes of wood, with hollow interiors like any steel bike. You can have a Sano Magic bicycle for ¥2,000,000. I’ll let you do the conversion but you could buy a Toyota for that much money. The best part about a Sano Magic is that it will appreciate in value, so your investment will most likely double in a few years. Greg spoke to Sueshiro who told him that it takes three months to build one bicycle. The wait list is very long but you’ll be one of the very few to own this beautiful piece of bicycle art. Sueshiro told Greg he could ride it at the NAHBS show, but Greg was afraid to have to give him our Rav4 if it broke. We needed the car to get home after the show.
All photos copyright OneOffTwoWheels.com
Rhubarb Bud
Salt Lake City, UT, 3 March 2013 – This tiny fire-red bud will soon be an explosion of rhubarb foliage. Soon after the stems will become rhubarb custard pie – a sure sign that spring has arrived.
Photo copyright oneofftwosheels.com 2013
Spring Thaw
Salt Lake City, UT, 3 March 2013 – Snow melts after a day of rain that would have been inches of snow had the air been colder; a glacier recedes exposing the moss and hardpack gravel of our arbor walk. Spring is fast approaching.
OneOffTwoWheels 
Recent Comments