Medical Device Daily: Insulet Takes Insulin Delivery to Another Level with OmniPod

December 17, 2012 - Medical Device Daily

If a person is looking to purchase a new television – they’re probably going to be hard pressed to find the huge floor model set pieces that dominated the market prior to the ‘90s. Now sleeker more compact flatscreen models have replaced those heavy bulky furniture piece throwbacks to the past. One med-tech company is hoping to have the same effect in the insulin pump market and change the way patients view conventional pumps.

Insulet (Bedford, Massachusetts) reported that it has received 510(k) clearance from the FDA to market the next generation OmniPod Insulin management system.

“This is the equivalent of your newest generation iPod compared to your old eight track cassette player or your record player,” Brian Roberts CFO of OmniPod told Medical Device Daily. “What’s exciting about the next generation of insulin pumps is that when you think of conventional insulin pumps, they haven’t appealed to a lot of people in the past, and what’s nice about our product is that three quarters of our new patients have never been on an insulin pump before. So as I always say to folks as we’re increasing our numerator of customers we’re also increasing the denominator of patients who’re enjoying pump therapy, which is overall a good thing. I really believe that we’re taking share and adding share in the market.”

The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features. In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager (PDM) that also features a series of enhancements.

“We wanted to come up with a product that maintained all the benefits of our current product,” Roberts said. “It’s tubeless; it’s waterproof; and it holds 200 units of insulin...effectively you wear it for three days at a time. All of those benefits are in the current product today but this next generation device is in a smaller and lighter package. Ultimately this package is about 38% smaller in overall size and volume than our current device and it weights about 25% less.”

The first generation of the device was introduced back in 2005, the company said.

“Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production,” said Duane DeSisto, president/CEO of Insulet “We expect that these initiatives will take approximately two to three months to complete and anticipate our fi rst shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition.”

The OmniPod offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with freedom and ease. The tubing-free OmniPod insulin pump has just two easy-to-use parts: the discreet, waterproof Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin; and the Personal Diabetes Manager (PDM), a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood glucose meter.

The company said that around 1.5 million people in the U.S. have Type 1 diabetes and noted that probably somewhere between 25% and 30% of these patients are on insulin pumps.

“It’s always been striking to the company that if Insulet continuous insulin infusion therapy is looked at pretty commonly as a better treatment over time than multiple daily injections, then why isn’t the take rate higher,” Roberts told MDD.

He pointed out that the limitations of conventional insulin pumps were the driver behind this. He noted that those impacts led to the creation of “pump holidays”, when patients left their pumps behind because of the impact the devices would have on their lifestyle.

“You literally couldn’t take your conventional pump to the beach because it couldn’t do well in water,” he said. Roberts noted that the OmniPod was designed to specifically overcome these limitations and could be used not only in the water, but could be used discreetly as to not hinder activity from the user.

Some of Insulet’s competition in the insulin-delivery space includes Valeritas (Bridgewater, New Jersey), a small startup that was formed in 2006. Valerias developed V-Go Disposable Insulin Delivery Device, which provides basal-bolus insulin for adult patients with diabetes.