Tandem Diabetes Care Inc. has developed a tool for the remote deployment of its insulin pump software. The device updater will allow diabetes patients with the t:slim insulin delivery system to have access to new features, without having to wait on reimbursement to buy a new pump.

Provisions of a patient's insurance plan typically limit eligibility for a new pump. Patients are often unable to receive the benefits of any new innovations or features that come out after they've received pumps. But the San Diego-based company's remote deployment tool allows patients to receive updates throughout the life cycle of the pump.

"Tandem has always taken a market research and consumer-focused approach toward the development of its products," Susan Morrison, chief administrative officer, told Medical Device Daily. "As we see with any mobile phones that are out there today, all you need to do is plug it in and all of a sudden you have access to all the new software and features."

Tandem first received the FDA nod for its t:slim insulin delivery system back in 2011. (See Medical Device Daily, Nov. 21, 2011.) The devices were launched in August 2012.

"Included in those pumps [that were launched in 2012] was technology that would allow the devices to be [upgradable]," Morrison said. "But we needed to wait until the company was a little bit more mature and had created new and innovative software, to be able to roll something like this out."

The software update launch provides new features to in-warranty t:slim pumps purchased before April 2015. The features included in this software release include a variety of product enhancements for convenience and flexibility.

In-warranty customers who purchased their t:slim pump before April 2015 will receive an email in the next three weeks with their update ID number and instructions on how to update their pump.

In the future, Tandem will have the ability to launch FDA-approved automated insulin delivery algorithms on the pump's software update platform. The company is also working on an update that would allow for its pump's integration with San Diego-based Dexcom Inc.'s G5 Mobile continuous monitoring system.

AS THE DIABETES MARKET TURNS

The dynamics of the diabetes space are changing. Players such as Google's Verily Lifesciences Inc. and Tandem's longtime partner Dexcom Inc. have gained ground. Older players in the space have stepped back a bit.

In January, Johnson & Johnson Corp. executives revealed they were mulling over a possible sale of the firm's diabetes businesses. The New Brunswick, N.J.-based company's businesses brought in about $1.8 billion in 2016, down about 7.2 percent from 2015.

Last month, Abbott Laboratories Inc. gained a bit of ground in the space when it released data from a study showing patients who scan more frequently with its Freestyle Libre system spend less time in hypoglycemia or hyperglycemia. (See Medical Device Daily, Feb. 21, 2017.) The data could help the company get FDA approval for general use of Freestyle Libre. The device has the CE mark.

One of the biggest developments in the diabetes treatment and monitoring space occurred last year with FDA's approval of Medtronic plc's 670g hybrid closed loop system, dubbed the artificial pancreas. (See Medical Device Daily, Sept. 29, 2016.) The device stands to have the greatest impact in the diabetes space.

Tandem's strategy in the market is simple, Morrison said. The company is looking to more align with consumer technology to gain traction for its technology in the diabetes space.

"I think it's really easy for medical device companies to get stuck in past eras, because there isn't anything to force them to accelerate," Morrison said. "I think Tandem is able to change the industry because we're saying there's no reason why there should be antiquated technology that's difficult to use."

Morrison pointed to relying on more modern features for its technology like a universal serial bus port or a rechargeable battery.

Cowen and Co. analyst Doug Schenkel said in a relatively short period of time, Tandem has captured meaningful market share in its initial target market, the U.S. type 1 diabetes patient population, which remains significantly underpenetrated.

"We believe Tandem is well positioned to continue gaining market share over the long term," he said. "But the launch of Medtronic's 670g could make the near to medium term setup for the stock challenging."