Hackathon to Pilot (Q1 2026)
Prototype development and initial validation
🏆 Catalyst Hackathon
Present working prototype at MAMC SCISOC Catalyst Hackathon. Demonstrate Smart Pad functionality and AI triage engine with live scenarios.
📋 Design Refinement
Incorporate hackathon feedback. Finalize PCB design and enclosure for manufacturing. Complete firmware optimization.
🏥 Clinical Partnership
Establish formal partnership with MAMC for clinical oversight. Begin IRB application for pilot study.
📜 Regulatory Pathway
Initiate CDSCO (Central Drugs Standard Control Organisation) registration process for Class B medical device.
Phase 1 Deliverables
Delhi Pilot (Q2-Q4 2026)
Real-world validation with Delhi ambulance services
🚑 Partner Organizations
- CATS Delhi (Centralized Accident & Trauma Services)
- AIIMS Trauma Centre
- Safdarjung Hospital Emergency
- Delhi State Health Mission
📊 Study Endpoints
- Primary: Triage accuracy vs. ER assessment
- Secondary: Time to intervention metrics
- Exploratory: 30-day mortality outcomes
- Usability: Responder satisfaction scores
📋 Success Criteria
- ≥90% triage concordance with ER
- ≥85% responder usability score
- ≥95% device reliability
- <1% critical alert false negative rate
National Expansion (2027+)
Scaling from pilot success to national infrastructure
| Year | Cities | Kits Deployed | Lives Saved (Est.) | Investment |
|---|---|---|---|---|
| 2027 Q1-Q2 | 10 Metro Cities | 10,000 | 3,110 | ₹3 Cr |
| 2027 Q3-Q4 | 25 Cities | 25,000 | 7,775 | ₹6.25 Cr |
| 2028 | 50 Cities | 50,000 | 15,550 | ₹12.5 Cr |
| 2029+ | National | 500,000 | 155,500 | ₹125 Cr |
Target Metro Cities (Phase 3a)
Risk Mitigation Matrix
| Risk Category | Risk | Impact | Mitigation Strategy |
|---|---|---|---|
| Regulatory | CDSCO approval delays | High | Early engagement, phased submission, regulatory consultant |
| Technical | Device reliability in field | High | Extensive beta testing, ruggedized design, OTA updates |
| Clinical | Training compliance | Medium | Simplified UI, video tutorials, recertification program |
| Financial | Funding gap | High | Diversified funding (govt, CSR, grants), milestone-based releases |
| Operational | Supply chain disruption | Medium | Local manufacturing partnerships, buffer inventory |
| Market | Competitor entry | Low | IP protection, first-mover advantage, government partnerships |
Regulatory Pathway
Regulatory Timeline
Documentation Preparation
Technical file, risk management file, clinical evidence dossier
CDSCO Submission
Submit application for Class B registration with NABL-accredited test reports
Review & Response
Address any queries from CDSCO review team
Approval & Commercial Launch
Receive registration certificate and begin commercial deployment
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