The Founder’s Challenge
When Don came to Go Vertical ICM, his mission was personal, and urgent. He envisioned a safe, therapeutic vaporizer tent that could help children with chronic respiratory issues breathe easier at home. But transforming that vision into a Class I-ready medical product presented real complexity.
This wasn’t just about a product, it was about peace of mind for families. To make it happen, we needed to solve critical design, regulatory, and user-experience challenges:
- What materials are both vapor-compatible and medically safe?
- How can we ensure child safety, ease of use, and comfort?
- Can we design around a Class I regulatory pathway to avoid heavy clinical burdens?
Our Strategy at Go Vertical ICM
We approached Granny’s Vapor Tent as more than a device. It was a mission-driven care system, designed from the ground up to be safe, intuitive, and regulatory-aligned.
Key Strategic Actions:
- Material Selection & Risk Research: Identified heat- and moisture-tolerant, non-toxic polymers suitable for warm vapor exposure.
- Pediatric Safety Engineering: Applied EN 71 & ASTM F963 standards to avoid choking, overheating, or skin irritation risks.
- Design for Comfort & Calm: Developed non-restrictive, low-noise form factors that encourage child relaxation and parental ease-of-use.
- Regulatory Positioning: Structured for FDA Class I listing—minimizing burdens while ensuring compliance through QMS-ready design.
🔗 Learn more about how we approach Regulatory Pathways for Class I Devices
What We Delivered
In just 6 months, Don had everything he needed to move from concept to readiness:
✅ A fully mapped Concept Brief outlining risks, functions, and design parameters
✅ A modular CAD design optimized for DFM (Design for Manufacturing)
✅ A draft QMS roadmap for FDA listing with clear documentation templates
✅ A brand foundation focused on trust, care, and family-centered design
📎 Explore how we help clients prepare for Design for Manufacturing
Results & Readiness
- Complies with pediatric safety benchmarks
- Functional prototype concept ready for testing
- Positioned for future pilot studies with family wellness providers
Final Thought
Granny’s Vapor Tent isn’t just another wellness product. It’s a story of inventing with heart, from one parent to millions of others. With Don’s vision and Go Vertical ICM’s strategic structure, we proved that hardware can be both meaningful and manufacturable, especially when it’s built for home, health, and hope.
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