Research & Development
From concept to clinical deployment
Building a medical device requires rigorous science, disciplined engineering, and a clear regulatory strategy. Here is our roadmap from concept validation to FDA clearance and commercial deployment.
Development Roadmap
Four phases to market
Phase 1Active
Concept & Feasibility
2025–2026
- Technology feasibility assessment
- IP landscape analysis
- Clinical use case definition
- Regulatory pathway identification
- SBIR/STTR application preparation
Phase 2Planned
Prototype Development
Q4 2026–2027
- Hardware prototype v1.0
- EIT sensor array development
- AI model training on clinical datasets
- Signal processing algorithm development
- Bench testing and iteration
Phase 3Planned
Clinical Validation
2027–2028
- IRB-approved clinical studies
- Sensitivity/specificity validation
- Usability studies with medics and clinicians
- Adverse event monitoring
- Data for FDA submission
Phase 4Planned
Regulatory & Commercial
2028+
- FDA 510(k) submission
- CE marking (EU)
- DoD procurement pathway
- Commercial manufacturing scale-up
- Market launch
Patent Strategy
- EIT sensor array configuration
- AI trauma risk scoring algorithm
- Multi-modal sensor fusion methodology
- Ruggedized device form factor
- Provisional applications in preparation
Academic Partnerships
- Biomedical engineering collaborations
- Clinical data access agreements
- IRB protocol development
- Joint publication strategy
- Graduate research program integration
Regulatory Strategy
- FDA 510(k) predicate identification
- De Novo pathway assessment
- Software as Medical Device (SaMD) framework
- IEC 62304 software lifecycle compliance
- EU MDR CE marking pathway
Interested in a research collaboration?
We are seeking biomedical engineers, clinical researchers, and academic partners to accelerate BracyInsight™ development.