Speaking of iPhone-ish diabetes devices (aren’t we always?), a number of readers asked us lately for an update on the new Tandem insulin pump, which could hardly look more Apple’esque if it tried:
The San Diego-based company has been developing this one for several years, and recently added some famous names to its Clinical Advisory Board: insulin pump experts Dr. Bruce Bode, CDEs Virginia Valentine and John Walsch, and Dr. Steven Edelman of TCOYD fame.
None of them could tell me anything, as Tandem is still pre-FDA approval, and under strict NDA. So I turned to the company directly, chatting briefly with CEO Kim Blickenstaff last week.
I say “briefly” with emphasis, because it seems Tandem is a classic case of stuck-in-FDA-purgatory.
“As you know, the FDA has swung towards heightened safety scrutiny… A major concern is that user interfaces on medical devices can be a source of error,” Blickenstaff says.
Yet the Tandem isn’t actually integrated with a phone or other consumer device; it simply offers “the entire interface experience via touch screen — so all profiles, settings, etc. are menu-driven to be more intuitive, more self-instructive,” he says.
So what’s the holdup, I wonder? Touchscreens can easily feature safety locks so that buttons don’t get pushed by accident. And this is a traditional, tubed pump that works with standard infusion sets. Are there other new and special features that might raise eyebrows at the FDA — and lure pumpers away from other models we’re using?
“For anybody that likes style and design … we think the ‘consumer design appeal’ is a major advantage,” Blickenstaff tells me. OK, I certainly get that. But is it really enough to make a success of an otherwise-standard insulin pump from a smaller player, that might not have the resources and reach of a company like Medtronic or Animas, nor the wireless appeal of the OmniPod?
“We’ve conducted focus groups across the country, talked to thousands of patients, and identified that there still are unmet needs. We’re working to meet those needs… But we’re very limited in what we can say publicly while we’re waiting on the FDA.”
Hmm, unmet needs? Ya think so? I bet folks here could name a few.
My thoughts are: the Tandem pump looks cool. I’d like to know what else it can actually do to improve life on insulin. And I sure hope it gets through FDA before the touchscreen interface becomes old news.