Transport-Ready Medical Mounting Platform for Emergency and Critical Care
Overview
Digital Health Solutions collaborated with a global medical device leader to design and deliver a mounting platform for securing life-sustaining therapy equipment during ambulance transport and interfacility transfer. This custom system ensured safe attachment of critical care devices to ambulance stretchers, expanding their use beyond hospital environments. We provided full-scope mechanical design, prototyping, validation, regulatory documentation, and manufacturing readiness to enable product deployment in dynamic emergency care settings.
Project Highlights
Challenge
Environmental Requirements:Designed a stretcher-compatible mounting system to secure the therapy console during high-movement transport conditions.
Regulatory Demands:Validated structural performance under simulated emergency scenarios to meet safety standards like IEC 60601-1-12.
Human Factors Compliance:Required usability validation to ensure ease of use, reduce use-related risks, and meet IEC 62366-1 standards.
Our Approach
Mechanical Design Engineering: Developed a robust, human-centered platform with durable, EMS-friendly features and compatibility across stretcher models.
Prototyping & Validation: Built and tested multiple prototype generations under fit, impact, vibration, and loading conditions to confirm stability and usability.
Compliance & Manufacturing: Authored a complete Design History File (DHF), supported standard compliance, and implemented scalable manufacturing workflows.
Impact
Prototype Delivery:Provided multiple fully functional prototype units for internal evaluation, field testing, and stakeholder demonstration.
Validated Performance:Platform passed rigorous mechanical and usability testing for emergency and hospital use.
Regulatory Readiness:Delivered comprehensive design and test documentation to support future FDA submissions
Manufacturing Launch:Transitioned to production with finalized BOMs, inspection protocols, and in-house assembly for early deployment.
Takeaways
Production-ready design: Delivered a validated, stretcher-compatible platform built for emergency and hospital use.
Regulatory-ready documentation: Created complete design and test files to support future FDA submissions.
Early deployment enabled: Transitioned from prototype to production with scalable assembly and quality processes.