Case StudyConnected Devices - Smoking Cessation
About This Project
Development of a visionary approach to disease management by pairing a programmable passive transdermal drug delivery wearable with mobile applications to provide behavioral coaching, with initial focus on smoking cessation
- Challenges
- Approach & Solution
- Outcomes
• Time to market pressure led to goal of parallelizing development of mobile app and wearable device resulting in verification challenges
• To reduce the overall regulatory burden, planned to segregate the mobile app medical device software from the non-medical device components
• Elegant user experience (UX) was essential to ensure patient engagement
• Designed and developed architecture and library encapsulating the medical device software as a distinct component from the non-medical device software
• Developed interface definition for BLE communication from wearable device to mobile app, allowing parallel development at low risk
• Developed validated simulator of wearable device, accelerating development/verification of mobile app
• Produced all artifacts to support IEC-62304 for the medical device software
• Regulatory compliance through segregation of medical device and non-medical device software components and thorough IEC-62304 artifacts
• Optimized time to completion through smooth integration of the mobile software with the completed wearable device
• Fully integrated mobile software and enterprise backend for reporting wearable and mobile operations, and for receipt of clinical patient-coaching content