From Concept to Manufacturing: Engineering a Secure, and Compliant Remote Monitoring Platform
Overview
Digital Health Solutions partnered with a Boston-based MedTech company to develop a wearable sensor system that monitors scoliosis brace wear-time. The project encompassed end-to-end development of hardware, firmware, mobile and cloud software, cybersecurity, verification & validation (V&V), and ISO 13485-certified manufacturing. The sensor automatically syncs data via Bluetooth to a mobile app and uploads to a web portal, allowing clinicians, patients, and users to monitor compliance in real time.
Project Highlights
Challenge
Outdated Hardware Architecture:The legacy sensor featured a large PCB footprint and insufficient power optimization, limiting wearability and battery life
No Integrated Data Ecosystem:The client lacked infrastructure for BLE-based data transmission, mobile interfacing, or secure cloud connectivity
Manufacturing Scalability Gaps:No validated processes or tooling existed to support ISO 13485-compliant production at a 5,000-unit annual scale
Regulatory and Standards Gaps:The internal team had no prior experience with FDA Class I medical device submission, IEC 60601/IEC 62304/ISO 14971 compliance, or Bluetooth-enabled software development for medical applications
Our Approach
Integrated Engineering & Compliance:Delivered system design, traceability matrices, and final Device Master Record
Robust Software Development: Built Bluetooth-enabled firmware, mobile app, and cloud platform to IEC 62304 standards
Advanced Cybersecurity: Implemented end-to-end encryption, penetration testing, and a full post-market cybersecurity strategy
End-to-End Risk & Quality Management: Conducted dFMEA, risk traceability, process validations, and device history tracking for full traceability
Impact
On-Time Market Readiness: Completed pilot batch of 300 sensors within the 1-year timeline
Seamless, Gamified User Experience: Delivered intuitive mobile app for children and parents
Manufacturing Readiness and Production: Validated processes for scalable production under ISO 13485 – Product currently being manufactured by DHS
Regulatory Compliance: Supported client’s first-ever FCC ID and FDA Class I listing with complete documentation
Takeaways
Cross-Disciplinary Expertise: Our team delivers end-to-end product development with regulatory confidence
Accelerated Timelines: We drive rapid development without compromising quality or safety
Regulatory Know-How: Deep knowledge of FDA and international standards
True Partnership: We empower clients with clear communication, transparency, and collaboration every step of the way