1. Business Case Development Key Components :
Company Analysis – Decision Process on Launching New Products or Product Expansion (J spend most time here…v key)
Business Case Development Key Components :
Product concept details – how this fits within a company overarching strategy
Total market potential
Development, testing, and regulatory approval costs
Manufacturing and supply chain costs – any capital investment needed? Ongoing cost of goods (COGs)?
Probability of success – approvals and general freedom to operate considerations
How to go to market – direct vs. distribution model; what infrastructure and resources are required?
Return on Investment (ROI) – How long will it take to break even, then start making a profit?
Net Present Value (NPV) – What is the potential total value of the product over an estimated lifecycle (e.g., 30 – 40 yrs)?
Company approvals – Go or No Go Decision

2. Maintenance of Business
Company Planning and Investment – Launching New Products or Product Expansion
Commercial Launch
R&D Expense
Development
Regulatory Approvals
Manufacturing Planning
Supply Chain Planning
Marketing, Portfolio, Sales, Go to Market Planning
Maintenance of Business
Approvals
Sales Force and other Headcount
Local Infrastructure
Distribution Agreements & Programs
Customer Claims
General Freedom to Operate