In a bold move, Medtronic Diabetes is buying its way into the smart insulin pen market and will for the first time reach people who aren’t interested in using an insulin pump as their delivery method.

Medtronic announced on Aug. 11 that it’s acquiring San Diego-based Companion Medical and its Bluetooth-enabled InPen, the only FDA-cleared insulin pen that connects with an app to track data and gives users personalized dosing recommendations.

This allows Medtronic, the largest insulin pump manufacturer, to reach a huge swath of insulin users who may never be interested in wearing a pump. And for the many people with diabetes still doing injections, research shows that at least 2 out of 3 need help calculating their insulin amounts when dosing for food or correcting higher blood sugars.

Insulin users on multiple daily injections (MDI) have been an untapped market for Medtronic until now — as the pharma giant gobbles up the startup that was the first to bring a connected smart pen to the market.

This also puts Medtronic in a position to compete with others developing smart insulin pens: Eli Lilly and Novo Nordisk, along with the Northern California startup Bigfoot Biomedical that’s filed with the FDA its Bigfoot Unity pen system for use in an automated insulin delivery (AID) system.

As part of the acquisition announcement, Medtronic shared a blog post with a YouTube video, in which Executive VP and President Sean Salmon (who took over in October 2019) spoke about their new vision aimed at serving people “where they are in their diabetes journey” regardless of the insulin delivery method — versus Medtronic’s traditional approach of only selling insulin pumps.

“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI),” Salmon said in a news release. “We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual.”

First cleared by the FDA in 2016 and launched a year later, InPen has a lot to offer:

  • It’s a reusable pen that works with short-acting insulin cartridges (Humalog, Novolog, and Fiasp), which are easily inserted into the pen device.
  • It can be dosed in half units (compared to most insulin pens, that only offer full unit dosing).
  • It collects insulin dosing data and transmits it to the Companion app that includes a dose calculator to recommend your dosages (like a pump’s built-in bolus calculator) and also calculates and displays real-time active insulin on board (IOB).
  • Like a pump, the Companion app also allows you to set up reminders for specific dosing times like breakfast, lunch, dinner, and bedtime snack, and if you haven’t dosed by the end of the set time window, the app will alarm.
  • While it doesn’t work with long-acting basal insulins, users can track those doses and set reminders via the mobile app.
  • It holds up to a year’s worth of insulin dosing data.
  • It comes in three colors — blue, gray, pink.
  • It includes a temperature sensor built into the pen that sets off an app alarm if the pen’s temp dips below freezing or above body temperature, ensuring that your insulin stays intact.
  • It allows remote monitoring — users can set the app to automatically text message their dosing info to up to 5 people. This can include not only every insulin dose, but also blood glucose and carb values (if entered manually) — all compiled into a single text message.
  • You can share reports with healthcare providers.
  • The free Companion app works with both iOS and Android, though compatibility may depend on the particular smartphone version.
  • It’s FDA-approved for use in all ages as of June 2020.

Once the acquisition is finalized by Fall 2020, those InPen features will be a part of the ever-evolving Medtronic lineup along with the Minimed insulin pumps and closed loop technology.

This includes the Sugar.IQ mobile app software to its prior acquisitions of two nutrition-focused startups: Nutrino, which uses algorithms to predict glycemic responses to food, and Klue, which uses hand gestures to measure food consumption.

Importantly, Companion has already reached agreements with both Dexcom and Senseonics for both of those CGMs to share data directly with the InPen app.

Medtronic tells DiabetesMine that it does not plan to discontinue the ability of the InPen to communicate with the Dexcom CGM, even though Medtronic makes a competing product. Down the road, the company also plans to integrate its Guardian CGM sensor and future sensor data into the InPen, and vice-versa.

This is a huge factor for those like Dr. Aaron Neinstein, an endocrinologist at University of California, San Francisco, who says he believes Companion’s push for device interoperability from the get-go is key. He appreciates how insulin dosing data can be shared with platforms like Apple Health, Dexcom’s open-source APIs, Glooko, and others.

“I hope MDT leverages acquisition to improve mobile UX, very important in #diabetes care,” he shared in a Tweet. “Widespread, nat’l prescribing & onboarding for InPen are challenges. MDT can help here to get InPen into far more users’ hands. MDT’s distribution network is mostly endo clinics. InPen should have a huge primary care opportunity. Can MDT get it there?”

We asked Medtronic if there would be anything different as to the product branding, such as the InPen name possibly taking on a Minimed moniker. It’s too early to tell, Medtronic says, as those details won’t be known until after the acquisition’s finalized.

When that time comes, Companion’s roughly 100 employees will be absorbed into Medtronic’s diabetes group, we’re told.

Going global: Medtronic points out that it will expand the InPen to other parts of the world beyond just the United States, where it’s available now.

Pricing: Companion likes to tout how it’s covered by most insurance plans, and that with coverage or financial assistance programs, the InPen doesn’t cost more than $35 per year. But notably, it does have a steep pricetag of nearly $800 for the device itself, not including the insulin cartridges. Nothing is changing on that front, according to Medtronic.

For existing InPen customers: Nothing changes right now and they should continue to call Companion Medical directly for their support needs. As the companies integrate after the deal closes, Medtronic will communicate any changes that customers need to know.

Future customers: During the pre-close and transition periods, new InPen customers can start on the product as they would otherwise. Logically, once Companion Medical is absorbed into Medtronic, customers will be dealing directly with them.

In many ways, this is history repeating itself in the diabetes space. Remember, Medtronic has been around for decades, but didn’t step into the insulin pump universe until it acquired the small insulin pump manufacturer Minimed in 2001.

That was a historic moment for the Minnesota behemoth, one that brought a couple decades of insulin pump leadership under its belt and gave it a footing to become a force in diabetes technology.

Now, Medtronic enters the smart insulin pen arena in much the same way.

Sean Saint

Companion founder Sean Saint, a fellow type 1 who founded the San Diego startup in December 2013, is over the moon about this deal. And in many ways, it brings him back full circle to the early days of his career.

A veteran in the diabetes and health technology space, Saint began with Medtronic as a senior engineer in the vascular division, and later worked in engineering at Dexcom and Tandem Diabetes Care. In fact, his own T1D diagnosis came about a decade ago, while he was working as director of engineering at Tandem.

Assuming the acquisition closes, Saint will once again be at Medtronic — which seems almost ironic after his years as a struggling independent innovator.

“I am so proud of the whole team’s efforts,” he said. “Creating a company is fundamentally hard. It requires zigging when everyone else is zagging… requires thinking differently, which also means you will be told you are wrong. My team stuck with the vision and believed in it when that was a very hard thing to do. Today, we have proven that smart pens matter and will be a real category in their own right going forward. I couldn’t be happier.”

In some ways, Saint said this has been the goal from the start — knowing that a connected insulin pen was needed but wouldn’t be able to get into everyone’s hands who wants it, without a larger company stepping in.

Without delving into specifics, Saint said the two companies had been “aware of and interested in each other” for years. He first approached Medtronic more than 5 years ago, when Companion was in its infancy before even launching the InPen. But recently, everything fell into place.

“I think it was critical to attain a certain level of commercial success with InPen and now that we have, the time was right,” he said.