Madison, Wisconsin-based Propeller Health has secured two new FDA clearances for new sensors that are designed to work with two particular inhalers on the market: the Diskus inhaler from GlaxoSmithKline and the Respimat inhaler from Boehringer Ingelheim. Unlike previous FDA clearances for Propeller, the new clearances actually allow Propeller to market its new devices as improving — not just tracking — medication adherence.
“From a business standpoint, these are really important medications because they’re widely used and they’re so important in the daily management of COPD,” Propeller CEO David Van Sickle told MobiHealthNews. “So bringing them on to our platform and the people who are using them to manage their condition has been an important goal with us for a while.”
Propeller’s previous sensor worked with a standard metered-dose inhaler (MDI) and it was able to deduce when the inhaler was being activated through mechanical means. For these more tightly designed inhalers, there’s “a lot more electronics involved” Van Sickle said.
“What we’ve done is put a lot of work into engineering a solution that doesn’t require the person to do anything, but then uses a lot of electronic means to understand when those medications are delivered,” he said. “A lot of different sensors are used to measure the actuation when there isn’t a simple linear path of force that we can monitor like we could with the MDI.”
The data submitted to the FDA for the clearance included not only studies comparing sensor users and non-sensor users, but also data that compared use of just the sensor with use of the sensor plus different kinds of feedback Propeller uses to promote adherence. That’s how the system was able to secure the indication for improving adherence.
“In general in adherence, we’re putting to work a multi-dimensional approach to improving it,” he said. “So you’ll see in these clearances things like audio-visual reminders on the devices themselves to encourage the person to take their medication when the time has come. And we’re using other things like in-app notifications, SMS, and even follow-up form clinical support team to help support ongoing adherence to these regimens.”
Propeller has been working with Boehringer Ingelheim for about a year. Last fall they announced the partnership at Health 2.0, including a pilot of the Respimat sensor that just received clearance. Boehringer and Propeller are working together on COPD. With GlaxoSmithKline, on the other hand, Propeller has no working relationship, it just built the device on its own as an add-on to GSK’s inhalers. It has plans to make sensors available for a wide range of inhalers on the market.
Medication-adherence companies that have been in the space a long time are now turning to the FDA to back-up their claims. Earlier this month, Proteus Digital Health received what it believed was the first FDA clearance indicated for measuring medication adherence. Now, Propeller says it can go one step further and improve adherence, and can market it’s offering to providers as such.
“For us it goes back to our core strategy, which is working with health plans to bring their populations of members and patients who have sub-optimally managed asthma and COPD into a digital program,” Van Sickle said. “And you can’t really do that if you don’t have the facility to monitor the use of the most important medication that they could be on, to prevent symptoms from recurring and to help them gain control. This is really just rounding out our ability to enroll broad populations into the Propeller program. And then being able to monitor and encourage and support appropriate adherence to their medications, so they get the full benefit of the therapy.”