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



