Preventing Compliance Issues by Understanding the Users’ Context
Especially since existing solutions had issues with patient compliance, we needed to ensure our design met the users where they were. We started by researching their current experience in-depth: understanding their living arrangements, where they typically store shoes, their daily routines, and whether the product needed to function while they were on vacation or in nursing facilities. We also explored factors like how frequently they wore shoes indoors versus outdoors and their ability to manage simple tasks like charging a device or following setup instructions. This detailed understanding allowed us to ensure the product would integrate seamlessly into their lives.
The research led us toward a plug-and-play system that avoided mobile apps and Wi-Fi setups. The system needed to function seamlessly across living environments, from private homes to nursing facilities, ensuring ease of use and reliability.
Validating our Approach through Rapid Prototyping
The Ovyl team began by testing the feasibility of placing temperature sensors in an insole capable of detecting precise measurements at multiple locations on the foot. Using a proof-of-concept prototype, the team created a silicone foot model with heating elements at seven distinct spots to simulate temperature changes. The team then dressed the foot in a sock and validated the temperature detection accuracy.
These tests validated the solution's technical feasibility, allowing us to move forward confidently with detailed engineering and design.
Tacking Specific Technical Challenges
Sensor Integration: Ovyl designed small, coin-cell-powered sensor boards embedded within the insoles to monitor specific foot regions.
Data Transmission: The team developed a gateway device featuring a Nordic NRF52832 central unit paired with a cellular modem. This gateway collected data from the insoles via Bluetooth and transmitted it to the cloud using the MQTT protocol.
Battery Life: Ovyl optimized the sensors and communication systems to ensure a six-month battery life, ensuring minimal interaction and maintenance for patients and clinics.
HIPAA Compliance: Ovyl ensured all data transmission adhered to strict HIPAA regulations, safeguarding patient information.