MedTech Investment Advisory for VCs and Founders
MedTech Due Diligence, Regulatory Strategy & Fractional Executive Services
Comprehensive advisory for medical device investors and companies—from technical due diligence and FDA/IVDR strategy to execution support and commercial launch.
Fractional CTO / Executive R&D Leadership
Strategic technical and R&D leadership for early to growth-stage medical device companies. Drive product development from concept through FDA/IVDR approval to commercial launch.
- SaMD development & IEC 62304 compliance
- Design controls & DHF management
- R&D team building & mentorship
- Technical platform architecture
- Regulatory-aligned development strategy
Technical Due Diligence for VCs & Investors
Comprehensive technical and regulatory due diligence for MedTech investments. Identify risks, validate claims, and provide post-investment execution support to protect and grow portfolio value.
- Deep-dive technical assessment
- Regulatory pathway validation (FDA/IVDR/CE)
- Platform feasibility & IP review
- Team capability assessment
- Risk mitigation roadmap
Early-Stage Concept & Risk Validation
Help pre-seed and seed-stage founders validate technical feasibility, identify regulatory and commercial risks early, and build a fundable foundation with clear paths to FDA/IVDR approval.
- Technical feasibility analysis
- Regulatory pathway planning (510k/PMA/IVDR)
- Early risk identification & mitigation
- Fundable technical roadmap creation
AI/ML & Digital Health Transformation
FDA-compliant AI/ML development and validation for SaMD and digital health products. Navigate complex regulatory requirements while accelerating R&D productivity through digital transformation.
- FDA-aligned AI/ML validation (SaMD)
- Algorithm development & V&V
- Digital R&D infrastructure
- Knowledge management systems
FDA, IVDR & Global Regulatory Strategy
End-to-end regulatory strategy and submission support for medical devices. Proven success navigating FDA 510(k), PMA, De Novo, EU MDR/IVDR, and international pathways with efficient timelines.
- FDA 510(k), PMA & De Novo pathway
- EU MDR/IVDR compliance strategy
- IEC 62304 & ISO 13485 QMS implementation
- Design History File (DHF) development
- Pre-submission strategy & submissions
Commercial Strategy & Market Entry
Market entry and commercialization strategy for medical devices. Navigate reimbursement, payer engagement, partnership development, and international expansion for emerging and established markets.
- Market assessment & sizing
- Reimbursement & payer strategy (CPT, DRG)
- Commercial partnership development
- International market entry (US, EU, India, LATAM)
Need help selecting the right engagement?
Schedule a Confidential Consultation20+ Years Driving MedTech Innovation, Funding & Exits
Serial medical device entrepreneur and CTO with 3 successful exits, 10+ FDA submissions, and $30M+ raised. Deep expertise in regulated R&D, SaMD development, FDA/IVDR compliance, and scaling high-performing international teams.
AI-Powered Insights for Faster, More Cost-Effective Results
We leverage advanced AI technologies and proprietary tools to accelerate analysis, identify risks earlier, and deliver deeper insights—reducing consulting costs by up to 40% while maintaining the highest quality standards.
- Automated regulatory pathway analysis and risk scoring
- AI-driven technical due diligence with pattern recognition
- Real-time market intelligence and competitive analysis
- Faster document review and compliance gap identification
Select Engagements
Technical & Regulatory De-Risking for VC-Backed MedTech
Supported investors and founders with in-depth technical, regulatory, and execution assessments across medical device, IVD, and SaMD programs. Evaluated FDA and IVDR pathways, design control maturity, and development risks, enabling investment decisions supported by clear risk-mitigation plans and realistic value-creation roadmaps.
De-Risking Large-Scale IVD Programs Under FDA & IVDR
Led multi-million-dollar molecular diagnostics programs from concept to market within a global organization. Structured regulatory and development execution under FDA, CE, and IVDR constraints, aligning cross-functional R&D, quality, and commercial teams to reduce execution risk, control timelines, and protect portfolio investments.
Building a MedTech Company from Concept to Acquisition
Founded and scaled a medical device company from concept through successful acquisition. Defined product, regulatory, and go-to-market strategy, raised $30M+, managed full P&L, and led FDA and CE approvals, delivering investor value through disciplined execution and exit in a highly regulated market.
MedTech Invest Advisory provides independent, senior-level advisory services to MedTech startups and investors across the US, EU, and international markets. Engagements are delivered remotely and invoiced under standard professional consulting terms, ensuring clarity, compliance, and ease of collaboration across borders.
Test Drive Our Capabilities
Explore interactive demos and tools that showcase how we solve complex medtech challenges. Get a hands-on preview of our approach.
Need a Custom Solution?
We can develop custom tools and simulations tailored to your specific investment thesis, market focus, or due diligence requirements.
Discuss Custom ToolsReady to De-Risk Your MedTech Investment?
Whether you need technical due diligence for an investment decision, regulatory strategy for FDA/IVDR approval, or fractional CTO support—schedule a confidential consultation to discuss how we can help you succeed.
Response Time
Within 24 hours