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New Medical Device Market Opportunity Assessment


Case Study


Scenario:
 
  • Start up medical device company developing new in-vitro diagnostic test needs market opportunity assessment and commercial overview for grant application
Background:
  • University tech-transfer spinout company was seeking to develop a cardiovascular in-vitro diagnostic test utilizing a novel biomarker. 
  • Company was seeking a grant to develop test device prototypes and needed a business plan overview and commercial justification overview to include in grant application.
Objectives:
  • Provide top level overview of Point of Care Testing (POCT) cardiovascular monitoring market
  • Hypothesize value proposition and opportunities for IVD test. 
  • Write commercial sections of grant application.
Approach:
  • Review of literature, secondary data and syndicated market reports
  • External resources used:
    • Multiple syndicated market reports:
    • Brief Literature search
    • Physician count databases
    • DHHS and AHA databases
  • Deliverables included commercial sections of grant application
Key Outcomes:
  • Provided top-level overview of target patient populations
  • Hypothesized size and structure of targeted office-based POCT and hospital markets
  • Identified key market drivers, adoption hurdles and reimbursement challenges that the company should anticipate and would need to overcome in order to attain commercial success
  • Made recommendations to overcome eventual barriers to use and generate product adoption if IVD test is successfully commercialized
Impact:
  • Commercialization grant received funding