I knew it before I left California. The OmniPod crew had determined they couldn't give me a unit yet, since I'm way outside their covered region (spanning the run of the East Coast, as of this month). But we talked about some writing opportunities, and they were gracious enough to invite me for a Grand Tour of their burgeoning manufacturing facility in Bedford, MA (just 40 min. out of Boston, but apparently another country to your average Boston cabby.)
Soon we were donning the shower caps, robes, and booties necessary to protect Clean Room production, and walking around the surprisingly intimate manufacturing floor. Not more than 50 people, obviously chummy and on first-name bases, sat clicking and patting and punching highly specialized equipment designed exclusively to create the Insulet insulin pods. They were clearly proud to exhibit their work. The head engineer explained in great detail the placement and function of each tiny part -- so many of which were made specifically to prevent insulin leakage or contamination of the pod unit. And off in another area, where sterilization is not required, they assemble the PDMs (Personal Diabetes Managers -- the controller units), considerably fewer per week than the pods, as required.
But look! Over there -- that shiny spanking new floor surrounded by what appears to be giant sheets of Reynolds Wrap. "Next week, the automated equipment will be here, and we can step up production!"
* Light Bulb! * No wonder, the gradual roll-out. No wonder, the seemingly slow response to the torrent of patient demand. They're Still Makin 'Em By Hand!! I've seen many the Software Startup fumble with "vaporware," and slightly suspected the same sort of case here. But insulin delivery systems are fundamentally different: they're intricate hardware (requiring expensive customized manufacturing machinery), and they're life-sustaining medical devices. No option to blast out a Version 1.0 and just see if it flies.
The latest round of VC funding will enable Insulet to turbo-charge production at last. They hope to reach full capacity by Q1 2007, they tell me.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
Meanwhile, the customer queue grows. And the Marketing team is caught in no-man's land between fantastic demand and strictly limited supply: a love-fest for a product they can't churn out fast enough. I hope to help them tell the stories of some of the lucky ones who're already loving the new "tubeless insulin management system" (don't call it a pump). And I'm crossing my proverbial fingers for a fast expansion to the West Coast.