Automated Manufacturing Fixture Development for Remote Health Monitoring Devices
Overview
Digital Health Solutions partnered with a Boston-based medical technology company to bring two generations of wearable vital sign monitors from concept to FDA clearance. While providing end-to-end support across engineering, regulatory, and validation, our key contribution was developing advanced manufacturing test fixtures. These tools automated calibration, wireless performance testing, orientation control, and End-of-Line reporting, ensuring scalable quality and compliance for global commercialization.
Project Highlights
Challenge
Complex testing requirements: Required automated calibration and verification of PPG, ECG/EKG, accelerometer, temperature, and Bluetooth/LTE-M wireless modules.
Strict compliance standards: Ensuring adherence to IEC 60601-2-47 and related international safety, performance, and interoperability standards.
Accelerated market timeline: Aggressive deadlines to align with market launch goals.
Advanced Test Fixture Requirements: Required orientation control, WhaleTeqsensor exposure, RF chamber simulation for LTE-M, touch sensor checks, automated EOL reporting, and IQ/OQ/PQ validation.
Our Approach
System engineering leadership: Drafted user needs, functional requirements, labeling documentation, and comprehensive trace matrices.
Software optimization and integration: Built secure cellular data transfer, improved interfaces, and added WhaleTeq-based PPG testing.
Custom hardware design – Designed control boards and test fixtures with orientation control, RF simulation, temperature, touch tests, and automated EOL reporting.
Rigorous validation – Executed IQ/OQ/PQ tool validation, benchtop testing, and compliance checks to international standards.
Impact
Comprehensive Test Suite: Final fixturing design verified compliance to established standards for general safety (IEC 60601-1), home healthcare (IEC 60601-1-11), electromagnetic compatibility for emissions and immunity (IEC 60601-1-2), wireless coexistence (ANSI C63.27), battery safety (IEC 62133-2), pulse oximetry (IEC 80601-2-61) and clinical thermometers (IEC 80601-2-56)
CM-Ready Fixturing: Performed design transfer with 2 contract manufacturers in Romania & Singapore.
Delivered scalable, secure solutions: Devices met clinical, safety, and usability requirements making it ready for broad deployment across US and key international markets
Takeaways
Regulatory expertise – Proven ability to navigate complex FDA approval processes and compliance standards.
Technical excellence – Advanced engineering and late-stage development that enhance product reliability and manufacturability.
Collaborative execution – Seamless partnership with client teams to align technical, regulatory, and manufacturing objectives.
Scalable solutions – From test fixture innovation to multi-site manufacturing transfer, our solutions enable rapid, compliant production.