Today is a happy day for fans of Insulet’s tubeless insulin pump system! The FDA has finally approved the next-generation OmniPod, which is 34% smaller, 25% lighter, and 16% slimmer — yet still holds same 200 units of insulin.

The new design will also feature a “pink slide insert,” that pushes a piece of pink plastic to be visible through a new, second window in the center of the Pod, to “help users verify that the cannula has deployed” (see photo below).

The PDM (Personal Diabetes Manager) controller is also being updated, with the following enhancements:

  • The status screen will now always show details about your current insulin on board (IOB). This will include info on BOTH corrections and meal boluses (yay!)
  • The communication distance between the PDM and Pod is increased up to 5 feet (although the two must be side by side at start-up)
  • There’s now a vibration option available for certain reminders and safety notifications (exactly which reminders are required to have an audible alarm will be published in the company’s new Quick Start Guide, which they’re working on now)

But the smaller Pod profile is the biggest change. “It’s just a significant difference in wearing it — a huge difference!,” says Hjalte Hojsgaard, Insulet’s Manager of Consumer Marketing, who does not have diabetes but has worn both systems.

It seems the diabetes community has been waiting on this FDA approval for a very long time (FDA submission happened in May 2011, but we saw conference demos long before that), and now it comes suddenly. “It was expected, but you never know until it’s all tied up — we just got a fax this morning with the green light,” Hojsgaard says.

“Now we’ve got to focus on training of healthcare professionals, training our own staff, and making sure we get volume on the manufacturing line. We’ll be converting about 40,000 patients; that’s a lot of pods, so there’s a lot of preparation that has to happen.”

Note that this is a whole new system: the old Pods won’t speak with the new PDM and vice-versa, Hojsgaard tells me. Costs will remain the same for users: around $35 per Pod, and a system setup cost of around $800 depending on your insurance. There will be no change to the Abbott FreeStyle test strips used in the PDM, btw.

The company expects to begin shipping the new system between late February and end of March 2013. But users like me will of course want the new Pod now, and want to know what they can do to get it asap. Here’s what the company tells me:

Transition Made Easy (i.e. Automated)

“For 18 months we’ve been working diligently to set up a detailed process for communicating the switch to current users and transitioning them in a safe, easy and efficient manger. It’s all going to be automated,” Insulet’s Senior Director of Marketing Sean Gallagher says.

Patients still under their four-year warranty will be automatically “switched out” to the new system, according to their regular reorder date. Anyone out of warranty would of course need to buy the new product. But Insulet is emphasizing that if you’re thinking of just starting with the OmniPod, there is no reason to wait!

“You’ll get transitioned easily as the new system becomes available,” Gallagher says.

Existing customers will receive an email notification about the transition according to their appropriate reorder date. They will be prompted (and given a unique link) to complete a short online training program — a brief introduction to the new system — that will be tracked by Insulet. Once this is complete, “we put you in line to get on scheduled reorder,” Gallagher says.

“If you don’t respond to the emails, we’ll call you. We’ll reach out… so people don’t need to worry about what they need to do to get the new system,” he says.

Some especially anxious customers (hello!!) may be wondering if they can do a trade-in of a box of older Pods for the new ones. That’s a no-go, sorry. “Keep in mind that millions of these are made and sent out every month. We have to do this transition in a way that is practical and convenient for everyone,” Gallagher says.

The biggies are training HCPs so they’re aware of the new system, and beefing up manufacturing capacity so that inventory doesn’t become a problem.

In case you’re wondering about CGM integration (as I was!), nothing new to report at this time. “We’re still working on the best possible integrated solution. We don’t have any firm timeline,” Gallagher says.

Business Notes

What are the implications of this next-gen Pod in the diabetes device market? Not surprisingly, prolific D-industry analyst David Kliff (a.k.a. Diabetic Investor) has a few thoughts on that:

“Although not mentioned in the press release, it is well known that this new Pod lowers Insulet’s cost of goods by approximately 20%+ which should help the company as it drives towards becoming truly profitable. The key now becomes insuring that the new Pod does not experience any manufacturing or quality issues. Diabetic Investor has been following how the new pod has been doing in Europe, where it is already on the market, and has yet to see any indications of any serious quality issues.

“This news also places even more pressure on Medtronic, who so far has only been able to sue Insulet and not come out with a patch pump of their own. As everyone knows, Medtronic has been doing lots of talking when it comes to the patch pump market, but this talk hasn’t led to any actual product going to the FDA. Just as the company is falling behind Dexcom in the continuous glucose monitoring market, they are now in even further behind in the patch pump market.“

Kliff says that if the OmniPod updgrade goes off without a hitch, this may put Insulet in an ideal position to reach their end goal — being acquired by a larger player.

As an OmniPod user, I’m just really excited about smaller for now.

{Look for updates on Insulet’s OmniPod website.}