Advancing a Smart Implant System for Pediatric Scoliosis Treatment
Overview
A pediatric MedTech company partnered with Digital Health Solutions (DHS) to transform a smart implant and external controller system for Early Onset Scoliosis (EOS) from a promising but incomplete prototype into a fully engineered, regulatory-ready product. Originally developed by another organization, the system required significant technical, software, and compliance enhancements. DHS provided full-lifecycle support including firmware and FPGA remediation, SDLC implementation, cybersecurity documentation, UI design, and quality system integration.
Project Highlights
Incomplete Design History:Inherited system lacked documentation, traceability, and compliance with regulatory standards.
Unstable Software & Firmware: Bugs in firmware and FPGA impacted device reliability and communication.
No Formal SDLC or Cybersecurity: Missing foundational processes needed for FDA alignment and future scalability.
UI and Usability Gaps:Controller interface was not optimized for clinical workflows or pediatric use.
Challenge
Electronics & FPGA Overhaul:Updated implant hardware and refined FPGA logic for safe, accurate operation.
Robust SDLC Implementation:Delivered full documentation, validated development tools, and automated unit testing.
Cybersecurity Integration:Conducted risk assessments, static/dynamic code analysis, and built FDA-ready security documentation.
UI Redesign:Developed a clinician-friendly, touchscreen interface tailored for pediatric use cases.
Our Approach
Incomplete Design History:Inherited system lacked documentation, traceability, and compliance with regulatory standards.
Unstable Software & Firmware: Bugs in firmware and FPGA impacted device reliability and communication.
No Formal SDLC or Cybersecurity: Missing foundational processes needed for FDA alignment and future scalability.
UI and Usability Gaps:Controller interface was not optimized for clinical workflows or pediatric use.
Impact
Breakthrough designation earned: Helped secure FDA Breakthrough status for a novel pediatric scoliosis therapy system.
System stabilized and secured: Transformed a buggy prototype into a reliable, cyber-secure, and clinically usable device.
Regulatory path enabled: Delivered full SDLC, V&V, and cybersecurity documentation to support premarket submission.