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New Medical Device Opportunity Exploration and Strategy Development


Case Study


Scenario:
  • Investment group needs technology opportunity assessment to evaluate investment potential of medical device company with blood banking in-vitro diagnostic test in development.
Background:
  • Medical device company was seeking funding for development and commercialization of a blood banking IVD test to monitor red blood cell degradation levels in stored blood units to ensure that only viable units are transfused.
  • Economic development based investment fund needed due diligence on the technology and strategic recommendations to guide funding decision.
Objectives:
  • Conduct market opportunity assessment
  • Evaluate commercial potential of diagnostic test and proposed business model
  • Provide market insights, business planning and commercial development recommendations to company founders
Approach:
  • Review literature and secondary data
  • Conduct hematologist, pharmacist and blood bank director interviews to evaluate unmet needs, awareness of problem, product potential, and strategic opportunities
  • Evaluate proposed business model and estimate peak sales potential based on interview results and assumption of successful product launch
  • Identify opportunities to overcome any barriers to use and to capitalize on any evolving market trends
Key Outcomes:
  • Determined that the value proposition for the IVD test was supported in the literature, but was not a recognized unmet need within the medical and blood banking communities.
  • Identified key barriers to adoption that the company would face.
  • Uncovered strong need to work with and develop a key opinion leader within the medical community to publish and speak on the clinical ramifications of red blood cell degradation and need for solution to problem
  • Made recommendations on how company should develop a commercial development plan in concert with product development plan
Impact:
  • Company founders revised business plan and strategy
  • Company was able to identify trauma surgeon interested in pursuing solution to blood supply integrity issue. Surgeon provided support for initiating and conducting clinical trial to generate outcomes data.