FREO2 Six Critical Capabilities - Scaling Framework

FREO2 Six Critical Capabilities Framework

Mission-Critical Infrastructure for Scaling from 138 Systems to Global Impact
"Transition to Scale - Building the Foundation for Systematic Health System Integration"

October-February Assessment Timeline

Sept-Oct 2025
Document & Define
Nov-Jan 2026
Assess & Quantify
Feb 2026+
Execute with Investment
138
Systems Operational
27.5K+
Children Treated Since 2018
4
Government MoUs (2 signed, 2 pending)
96%
System Uptime
111
Health Facilities
24
Months to Scale
1
Regulatory & Quality Systems
Gateway to Global Health System Integration
Mission Critical
Transform: Local validation → Global market access
Unlocks: UNICEF/WHO catalogues, government tenders
Timeline: 24-month certification pathway
Why Critical: No scale without procurement eligibility
2
Partnership & Financial Architecture
From Grant Dependency to Sustainable Revenue
Active Development
Transform: Grant recipient → Health system partner
Current: 50% untied grants, 50% project funding validating scaled model
Focus: Testing co-investment frameworks with government partners
Why Critical: Sustainability requires diversified revenue beyond grants
3
Impact, Evidence and Learning
From Project Validation to Systematic Infrastructure
Active Development
Transform: Project evidence → Scale-ready validation
Asset: 27.5K+ children treated, peer-reviewed validation (Subhi et al.)
Focus: Building evidence frameworks for WHO/multilateral requirements
Why Critical: Evidence unlocks procurement eligibility and policy influence
4
Operations Excellence
From Proven Pilots to Industrial Scale
Planning Required
Transform: 138 systems → Industrial-scale production
Current: 96% uptime, ISO13485 partner in Uganda, Tanzania advancing
Challenge: Manual coordination limiting scale potential
Why Critical: Quality at scale determines impact reach
5
Digital & Data Infrastructure
Building the Nervous System for Scale
Planning Required
Transform: Fragmented data → Intelligence-driven operations
Current: Valuable data streams exist but disconnected
Vision: Every data point optimises impact delivery
Why Critical: Data-driven decisions enable sustainable scale
6
Organisational Capabilities
Structure That Scales with Mission
Planning Required
Transform: 30 pioneers → Optimised structure (being determined)
Focus: Adaptive development for scaling scenarios
Approach: Build capabilities as requirements clarify
Why Critical: People deliver the mission

Investment & Implementation Timeline

2026
Foundation Building
2027
Scale Execution
2028+
Systematic Scaling

Six Capability Investment Requirements

Investment requirements are being assessed during the October-February period. These preliminary indicators will be refined and fully costed for February 26 submission.

1. Regulatory & Quality Systems
RMU equipment testing, Prioritiser CE marking, WHO prequalification, ISO 13485
~$1.0M over 24 months*
*Preliminary estimate based on consultant assessment
2. Partnership & Financial Architecture
Revenue diversification and partnership leverage models
To be determined
Requirements emerging from business model validation
3. Impact, Evidence and Learning
Evidence requirements for procurement eligibility
To be determined
Frameworks aligned with multilateral standards
4. Operations Excellence
Production capacity and support infrastructure
To be determined
Scale requirements based on validated projections
5. Digital & Data Infrastructure
Learning organisation systems and data architecture
To be determined
Integration needs across capability areas
6. Organisational Capabilities
Team structure and capability development
To be determined
Optimised structure for mission delivery

October-February Assessment Focus

The October-February period focuses on defining specific requirements and quantifying investments needed across all six capability areas. This assessment phase will culminate in a comprehensive scaling framework with detailed costings for the February 26, 2026 submission.

Immediate Actions (Oct-Nov 2025)
• Regulatory consultant engagement
• Partnership framework development
• Manufacturing partner assessment
• Digital architecture planning
Assessment & Costing (Dec-Jan 2026)
• Detailed cost modelling per capability
• Risk assessment and mitigation planning
• Dependency mapping and sequencing
• ROI projections and scenarios
Framework Delivery (Feb 2026)
• Comprehensive investment requirements
• Detailed implementation roadmaps
• Phased scaling approach
• Success metrics and milestones