Madison, Wisconsin-based Propeller Health, maker of several smart inhaler sensors and companion apps, has received FDA 510(k) clearance for its latest offering – a sensor that works with GlaxoSmithKline’s Ellipta inhaler.
This marks the company’s eighth FDA clearance, and was born out of a partnership the company struck up with GSK last December. Given Propeller's growing familiarity with the process, the company said the development-to-clearance timeline was relatively swift.
“We’ve gotten pretty good at this,” David Hubanks, Propeller’s head of operations, told MobiHealthNews in an interview. “Each time we do it, we are able to shave off a couple of months. Beyond the fact that getting FDA is the law, it’s more important to us, in a sense, to have this nice partnership with the FDA. We have good dialogue and have found working with the FDA to be really collaborative. They ask really good questions.”
Propeller’s products work to help patients and their physicians better manage and understand asthma and COPD with sensor-enabled inhalers and connected apps. The company’s digitally-guided therapy platform pulls information from various sources, like connected medications, then leverages machine intelligence to personalize recommendations for individuals.
While some digital health companies may choose to develop products in a way that avoids the need for FDA clearance, such as apps or sensors that simply give information rather than diagnostic insight, Hubanks said it would behoove companies in the space to go through the regulatory process.
“Digital health is this really big space that everyone is grappling with understanding, especially with regards to how much products really benefit the patient,” Hubanks said. “The role the FDA is playing is to make sure we deliver on that promise.”
Propeller’s familiarity with the FDA, Hubanks said, allows them to “up their game” and really understand what kinds of questions they need to address every time they introduce a new product. The company received clearance for their connected platform in 2014, and last year the company received two clearances that pushed them past simple tracking of medication adherence to actually improving it.
With the numerous inhalers on the market, Propeller must come up with different ones to work with varying form factors and delivery methods, making it impossible to create a generic one that could go with multiple pharmaceutical companies’ offerings.
Propeller has developed other sensors and partnered with several pharmaceutical companies, including Boehringer Ingelheim, Vecture and GSK.
“The most difficult part is the usability – making sure patients know how to install and use it,” said Hubanks. “That’s really tricky to have something ready to take out of the box and easy to use. We have devices cleared for use in people age 2 to way up on the age spectrum, and one of the most difficult parts is getting the obviousness of the usability design right.”Nike HyperRev 2017