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.



