Our Services

We are in the business of offering intelligent strategic solutions for the business of life sciences. Our comprehensive strategy consulting practice has been organized into the following key service areas:

• Strategic Evaluation of External Innovation Opportunities

• Assessment of Commercial Viability of New Products

• Technical and Market Due Diligence

• Comprehensive scientific review of key international clinical conferences

• Primary Research with Clinical and Market Thought Leaders

• Valuation Analysis

• Patent Portfolio Analysis

• Strategic Planning for US FDA and European Product Registration

• Development and Validation of FDA Strategy Through Input from FDA Insiders

• Preparations and Submissions of Filings (e.g., IDE, 510(k), PMA)

• Development of a defensive and offensive patent strategy for new and emerging technologies

• Directing finite IP filing and prosecution budgets to the most relevant and business-aligned invention disclosures

• Evaluation of the competitive patent landscape with a focus on key technology attributes and business objectives

• Narrowing large and crowded IP landscape to the most relevant competitive IP, to streamline patent counsel review and opinion

• Primary and Secondary Market Research to Evaluate Market Potential of New Product Opportunities

• Primary Research on Thought Leader Perspective on Critical Clinical and Market Issues

• Financial Forecasting on US and Global Market Potential

• 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

• 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

• 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

• 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

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.