Dive Brief:

• Bigfoot Biomedical has formed a commercial supply agreement with pen needle provider Owen Mumford ahead of the planned introduction of its diabetes subscription service.

• The medtech startup is best known for its experimental automated insulin delivery systems that have attracted close to $100 million in venture funding and deals with Abbott and Eli Lilly, but it also plans to wrap these devices in a subscription service offering.

• As a result of the commercial supply agreement, subscribers will receive periodic shipments of Owen Mumford's Unifine pen needles alongside the swabs, test strips and other products they need to manage their conditions.

Dive Insight:

Bigfoot's internal development is centered on automated insulin pumps and injectors, called Bigfoot Loop and Bigfoot Inject, respectively. The West Coast startup is developing these delivery devices in combination with Abbott's FreeStyle Libre with the goal of creating a closed loop system that uses data from the continuous glucose monitor (CGM) to inform insulin dosing.

As Bigfoot has advanced the devices using investment from Abbott, Quadrant Capital Advisors and others, its leadership team has consistently expressed a desire to package them as part of a subscription service.

In the case of Bigfoot Inject, the service will include pen needles alongside the smart pen caps Bigfoot is developing to determine dosing. Subscribers will receive periodic resupplies of these pen needles, in addition to the test strips, alcohol swabs and CGM sensors that are used and disposed of by diabetics.

Bigfoot has chosen Owen Mumford to provide these pen needles. Having evaluated other potential suppliers, Bigfoot selected Owen Mumford because its pen needles work will all disposable insulin pens and are available in the most widely used lengths and gauges. The needles work with insulin pen products sold by companies including Lilly, Novo Nordisk and Sanofi.

Striking the supply agreement furthers Bigfoot's efforts to create a one-stop supply service for people with diabetes.

"We know that one of the largest, non-therapy related burdens people face is the acquisition and management of diabetes supplies." Bigfoot CEO Jeffrey Brewer said in a statement. "Our inclusion of Owen Mumford's Pentips in our supply bundles will ensure our customers always have access to a high quality, comfortable pen needle."

Bigfoot envisages its subscription model encouraging uptake of its devices by eliminating the need to make a large upfront payment and enabling patients to access supplies through a single co-pay. To realize that vision, Bigfoot needs to clinically validate its devices and get them past FDA.

At one time, Bigfoot expected to be on the U.S. market by now but its timeline has slipped in recent years, in part due its decision to switch from Dexcom to Abbott CGMs. Now, Bigfoot expects to bring its products to market in 2020.