Due Diligence

What Investors Want to See

Investors need comprehensive technical and commercial validation before committing capital to innovative medical device and materials technologies.

• Clinical Evidence & Regulatory Pathway: Clear FDA/CE approval strategy, clinical trial data, and regulatory milestones
• Market Opportunity: Total addressable market size, competitive landscape, and reimbursement strategy
• Technology & IP: Patent protection, technical differentiation, and freedom to operate
• Team & Expertise: Management experience in medical devices, regulatory affairs, and commercialization
• Business Model: Revenue projections, cost structure, and path to profitability
• Manufacturing & Quality: Manufacturing plan, quality systems, and scalability
• Risk Assessment: Technical, regulatory, and commercial risks with mitigation strategies

Technology Assessment

Our due diligence process specializes in evaluating early-to-mid-stage ventures, mostly on the medtech, biotech or deep tech space. For example:

• Technical Viability Analysis: Evaluate the scientific foundation, technological readiness level (TRL), and feasibility of scaling from laboratory to commercial production.
• IP Landscape Review: Assess patent portfolios, freedom-to-operate, and potential IP vulnerabilities or opportunities in the competitive landscape.
• Regulatory Pathway Mapping: Identify applicable regulatory frameworks, certification requirements, and timeline/cost projections for market entry.
• Risk Identification & Mitigation: Conduct systematic analysis of technical, regulatory, and commercial risks with actionable mitigation strategies.
• Design controls: Is clinical data requirements in sync with human factor requirements

For advanced materials-based technologies, such as medical devices and advanced materials technologies, with deep expertise in biomaterials, implantable devices, and novel therapeutic delivery systems, we provide specialized evaluation including:

• Material characterization and performance validation against claims
• Manufacturing scalability assessment
• Biocompatibility and safety profile evaluation for biomaterials
• Supply chain and raw material sourcing analysis

Deliverables

Our deliverables provide a comprehensive, evidence-based assessment that combines technical depth with strategic clarity, enabling informed investment decisions and identifying key value drivers and risk factors specific to each technology.

• Executive summary with investment recommendation
• Detailed technical assessment with data-driven insights
• Tentative risk matrix with probability and impact analysis
• Development roadmap with milestone-based funding recommendations
• Competitive positioning analysis