# The Karow Advisory Group

## About
The Karow Advisory Group is a strategic advisory firm for MedTech, wearables, and digital therapeutics companies. Founded by Blythe Karow, the firm brings 20+ years of experience helping medical device and digital health companies navigate from concept to commercialization.

## Services
- **Product Definition & Market Positioning**: Market analysis, competitive positioning, value proposition development
- **Commercialization Strategy**: Go-to-market planning, regulatory navigation, reimbursement strategy, clinical evidence planning
- **Strategic Advisory & Fractional Leadership**: Ongoing strategic counsel, fractional C-suite support, board advisory

## Specialty Capabilities
- **Regulatory**: FDA interaction strategy, Pre-Submissions, 510(k), De Novo, PMA support, Breakthrough Device programs
- **Market Access**: Reimbursement pathway and payer strategy, market access planning, health economics and outcomes strategy
- **Clinical & Evidence**: Evidence strategy and study planning, clinical workflow and adoption analysis, patient journey and use-case validation

## D.E.V.I.C.E.™ Framework
A proprietary commercialization readiness assessment covering six dimensions:
- Development (Design History & Development Discipline)
- Engagement & Economics (FDA Engagement & Reimbursement Strategy)
- Verification & Validation
- Intelligence & Information Governance
- Claims & Category Boundaries
- Evidence Strategy

## Contact
Website: https://thekarowgroup.com
Assessment: https://thekarowgroup.com/assessment

## Key People
- Blythe Karow - Founder & CEO