Project Brief

Respiratory Analytics approached our team, following a recommendation, to support a proof-of-concept for an Innovate UK project. Following this, we were entrusted with further developing aflo™ to be market ready and ensure regulatory compliance. Our primary focus was on the hardware and software aspects, including embedded systems software development, electronic engineering, and the necessary regulatory support. We collaborated closely with a digital product design consultancy to ensure seamless integration with mobile devices.

Design

Asthma inhalers often use a spacer to improve medication delivery efficiency. Even with a spacer, a proper inhalation technique is critical for symptom reduction. The aflo™ device is positioned between the inhaler and spacer. It utilises our advanced electronics to detect key aspects of inhaler use, such as shake duration, dispensing timing, inhalation strength and volume. The device delivers real-time feedback via LEDs on the device and messages through a connected app, guiding users towards a perfect technique.

Technical Details

We specced aflo™’s core electronics as a Nordic nRF52833 processor. This features Bluetooth LE (Low Energy) capabilities and an integrated antenna. The firmware was developed in C using Nordic’s nRF SDK, enabling communication between the device and a smartphone app, which captures the data and transmits it to a backend database. This real-time data processing and feedback system is crucial for guiding users through correct inhaler techniques.

“At the end of 2020, we approached i4PD with rough sketches, big ideas, and a modest budget. We aimed to create a tool to enhance inhaler technique. By 2023, after multiple development phases, we now have an elegant, highly functional device addressing a significant clinical need, thanks to superior electronics and user-centric design.”

— Susan Kelly, Founder and CEO.

Challenges and Solutions

We faced significant challenges due to the volatile electronics component market and unexpected obsolescence issues. Our team responded, sourcing and testing alternative components and developing adaptable software that could support hardware changes with minimal modifications. Mechanically, aflo™ was designed to fit multiple inhalers and spacers, ensuring it remained lightweight and user-friendly. The device includes a soft interface moulding for easy cleaning and a sliding guard for secure placement and protection during charging.

Outcome

At the time of this case study’s publication, aflo™ is in the final certification stages before CE marking. Our teams design work led the device to passing the rigorous testing required for meeting medical device standards. Additionally, the device is cost-effective and user-friendly, thanks to our holistic and collaborative approach. Respiratory Analytics’ studies show significant improvements in inhaler technique among users, highlighting aflo™’s (and electronics within medical devices) benefits for a broad patient population.