Key Impact
- 30% cost reduction through design optimization
- FDA & CDSCO regulatory compliance achieved
Client Overview
- Geography: Global
- Market Segment: Remote Patient Monitoring
- Engagement Model: End-to-End Design & Development
Business Objective
A global digital health company aimed to develop a wearable ECG monitoring device for continuous cardiac tracking. The goal was to create a patient-friendly, clinically reliable system with real-time data capabilities, while ensuring scalable design, cost-efficiency, and regulatory readiness for global commercialization.
Our Approach
Design & Development
- Led industrial design and engineering development focused on usability and clinical performance
- Built a system enabling real-time cardiac data reporting and communication
- Integrated hardware and system architecture for reliable continuous monitoring
Product Engineering & Optimization
- Engineered a 14-day battery life on a single charge, enhancing uninterrupted usage
- Designed for long-term wearability with ergonomic and patient-centric considerations
- Focused on form factor optimization to ensure comfort and ease of use
Regulatory & Compliance
- Achieved US FDA and CDSCO regulatory compliance
- Ensured adherence to relevant standards and documentation frameworks
Results & Business Impact
- Achieved extended continuous monitoring with optimized cost structure
- Completed pilot production within accelerated timelines
- Established a scalable product architecture for future growth
- Secured FDA and CDSCO compliance
