Client Overview
- Geography: India
- Market Segment: Remote Patient Monitoring
- Engagement Model: End-to-End Design & Development
Business Objective
A medical technology startup focused on improving patient care and clinical outcomes, aimed to develop a wearable lung fluid detection device designed for continuous monitoring and early intervention. The objective was to create a reliable, patient-friendly system capable of detecting lung fluid. This required a strategic partner to deliver a scalable, cost-effective, and regulatory-compliant device-from concept and prototyping to pilot production-ensuring readiness for commercialization.
Our Approach
System Architecture & Device Functionality
- Designed a wearable diagnostic system using near-field and far-field spectroscopic techniques
- Integrated Bluetooth connectivity for seamless data transfer to hospital systems and mobile applications
Electronics & Product Engineering
- Optimized electronic design for reliability, performance, and cost efficiency
- Integrated Battery Management System (BMS) with wireless charging capability
- Enabled robust system architecture for continuous monitoring and data accuracy
Mechanical & Industrial Design
- Developed a durable, ergonomic, and wearable device enclosure
- Ensured compatibility with standard ECG electrodes
- Focused on user comfort, aesthetics, and ease of use while maintaining manufacturability
Design for Manufacturability (DFM) & Prototyping
- Applied DFM principles to optimize manufacturability and assembly processes
- Designed test fixtures and validation setups for production readiness
- Built and tested functional prototypes to validate performance, reliability, and usability
Manufacturing Readiness & Pilot Production
- Conducted pilot production runs to validate product design and manufacturing workflows
- Established quality assurance processes to ensure consistency and zero-defect goals
- Enabled scalable production framework for commercialization
Regulatory & Compliance
- Ensured alignment with CDSCO and US FDA 510(k) regulatory pathways
- Delivered complete documentation, testing, and validation reports
Results & Business Impact
- Established a manufacturing-ready design with validated workflows
- Achieved cost-effective and reusable device architecture
- Prepared device for CDSCO and US FDA 510(k) submission readiness
- Positioned the client for entry into remote patient monitoring and digital health markets
