Freescale Evolves Insulet's OmniPod

Insulet's OmniPod, the wireless insulin pump, has gotten lighter and better thanks to technology from Freescale. The second-generation Omnipod is 34% smaller than its predecessor, is more cost effective, and was cleared by FDA in December 2012, meaning it will be the first and only tubeless, wireless insulin pump on the market – a landmark for wireless medical devices.

The new OmniPod is tubeless and wireless. The wearable insulin delivery pod communicates wirelessly with the personal diabetes manager (PDM)
“We saw that Freescale had the right MCUs to control size and cost for the disposable pods, and RF connectivity for the PDM and pod to communicate wirelessly,”says Kevin Schmid, Insulet’s VP of business development. Freescale's began working with Insulet in 2002 to facilitate creating a disposable, wearable device that took the place of the handheld pump typically seen in these devices. David Niewolny, healthcare business development manager for Freescale, says the goal in working with Insulet was to open the pump market to a wider audience by making the product easier to use. “About five years ago the only pumps on the market were pumps like Medtronic MiniMed, but these are, basically, a fairly nondiscrete solution because the patient is always carrying something additional around.” Wireless technology, he says, has allowed for a much less obtrusive product. “It frees [patients] up to a normal life,” Niewolny says. “Parents love it for kids because it frees them to jump around and go swimming, for example.”
The new OmniPod system features two parts. The first is the pod, which integrates an insulin reservoir, tubing, infusion set, and inserter into a single device. The pod attaches to the body and is usable for three days of basal-bolus insulin therapy – delivering insulin in short bursts after meals and in steady amounts between meals and during periods of rest. It holds 200 units of rapid-acting insulin, which the Insulet says covers the requirements of 95% of Type 1 diabetes patients.
The second component is the personal diabetes manager (PDM), which features a built-in glucose monitor and can calculate calories and insulin doses based on a built-in food library. The new version of the PDM utilizes Freescale's i.MX21 processor which, combined with a wireless, 8-bit microcontroller (MCU), offers smaller size, more processing power, and more efficient and cost-effective power consumption. It also has a improved wireless range of 5 ft (up from 2ft in the previous model) allowing it to communicate with the pod via a proprietary sub-1 GHz wireless radiofrequency (RF) technology.
The new Omnipod relies primarily on proximity for its first level of security and patient protection. But
Niewolny says that future versions will take advantage of encryption blocks. The company is also looking into Bluetooth Low Energy technology for wireless communication for its energy-saving properties as well as its potential to link across a number of next-generation devices.
-Chris Wiltz is the Associate Editor of MD+DI
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