Due Dilligence

Strategic Intelligence

Deep Dive Diligence on Actionable Targets with a Focus on Risk Assessment

Defensive & Offensive IP Positioning

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– Understanding of the competitive IP landscape
– Evaluating both freedom-to-operate issues and strength of IP to block competition
– Reviewing prior art IP (typically over 100 relevant patents) to identify the top 2-3 patents of most significance for review by IP counsel
– Process informed by professional experience of principals within litigation departments of major law firms

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Technical Diligence

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– Primary focus on assessing key areas of strength and weakness, technical viability, manufacturability and technical differentiation from competing technology platforms
– Clinical data, if available, is also used to ascertain validity of claims made
– Final deliverable: overall risk assessment on relevant development challenges

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Overall Market Receptivity

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– Driven largely by Key Opinion Leader interviews
– Nationally / internationally renowned clinical experts are interviewed to ascertain key validation points or explore receptivity of KOLs to the proposed value proposition, and assessing the applicable market segmentation
– Particularly focused on Payors’ perspectives on cost/benefit value proposition of the proposed technology
– Final deliverable: summary of each interview conducted; consolidated account of key findings and recommendations

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Regulatory Risk Assessment

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– Vetting adequacy of proposed product risk classification and regulatory clearance strategy
– Assess accuracy and completeness of U.S. and EU regulatory submissions
– Assess adequacy of GMP compliance or remediation programs
– Assess adequacy of Risk Management policy, procedures, and practices
– Assess adequacy of product testing and validation methods and documentation
– Assess conformance with regulatory and industry testing and performance standards
– Final deliverable: summary of status for compliance with health authority premarket clearance requirements

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Market Modeling, Valuation Analysis

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We take and objective and research-based approach to meet the following key diligence needs:
Valuation analysis of pre-launch medical device technologies, based on a variety of factors ranging from projected development costs, to technology adoption rate, post commercialization resource needs, and projected revenue growth based on benchmarks to comparable medical device platforms.
– For early stage technologies, we have developed an array of scenario-based revenue and cost models, in support of business and strategic planning exercises.
– Such valuation analyses have also been used in assessing the value of damages associated with failure to execute appropriate strategies or meet critical development timelines.

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