A medical device company approached Sunrise to develop the next generation of its home-use, Class II treatment device. Our client wanted to evolve their earlier generation, standalone device to include full connectivity across device, mobile app, and the web. The goal was to increase patient engagement and let both clinicians and caregivers monitor compliance and usage.
Key functionality required for the new product included:
- Connection of the device to a mobile app
- Storage of device data and metadata securely in the Cloud
- Patient activity including real-time use of the device, viewing of historic usage data, messaging with their private user community
- A clinician portal to view patient progress and track achievement
- Risk analysis and cybersecurity mitigations
This next generation device will ultimately 'set the stage' for further revenue opportunities for our client. Sunrise's charter was to develop, and verify the next generation system.
Sunrise Labs Solution
The client chose Sunrise based on our experience in developing medical device software and electronics, including miniaturized electronics with complete connectivity. The Sunrise team designed, engineered, and verified a new a solution, transforming the previous standalone device into a full system with the following features:
- Bluetooth LE capabilities for device-to-mobile connectivity, including assigning a device to a specific patient, tracking usage locally and in the cloud and over-the-air firmware updates
- Android and iOS mobile apps and web browser applications for three types of users -- patient, caregiver, and medical provider - to view device usage data, monitor compliance, message other users, and configure user settings
- A customer service application for our client to provide efficient and timely end-user support.
- Amazon Web Services (AWS) infrastructure, which fulfilled all the mitigations prescribed by the cybersecurity risk analysis Sunrise performed. Additionally, the System met HIPPA privacy requirements
Sunrise delivered a completely redesigned system, which fulfills our client's multi-host connectivity requirements, cybersecurity standards, HIPPA privacy requirements, and provided extensible architecture to support future connectivity to electronic patient management systems. Our client's solution has received FDA approval.