The MedTech Launch Ladder - A proven 5-stage process that gets devices to market faster:
Regulatory Route Planning
Design Control Architecture
Risk Management Integration
Verification/Validation Strategy
Submission Preparation
Fractional CTO Services
Strategic R&D leadership for medical device startups who need senior-level technical expertise without full-time executive overhead. We work with your team 10-15 hours per month to architect your regulatory pathway, establish design controls, and build scalable product development processes. Perfect for Series Seed to Series A companies preparing for FDA submission while managing burn rate.
Rate: $1.5-6K/month retainers
Technical Due Diligence
Independent technical assessment for PE/VC firms evaluating medical device investments. We provide comprehensive analysis of regulatory risk, development timelines, manufacturing feasibility, and IP positioning. The reports give investors clarity on technical viability and capital requirements before funding decisions. Typical engagements completed within 2-3 weeks.
Rate: Project-based for PE/VC
Regulatory Strategy Consulting
Targeted regulatory guidance for specific challenges in your FDA pathway. Whether you need design control architecture, 510(k) strategy development, or risk management frameworks, We provide actionable roadmaps that fit startup timelines and budgets. Ideal for companies facing specific regulatory hurdles or preparing for key milestones.