Scenario: In all four problem-prompts described below, you have graduated from NAU and landed a very competitive job as an Operations Manager in a small startup company. The firm is a medical device manufacturer; it develops and manufactures trans catheter aortic valve replacement systems.

Problem 1

The firm is planning on receiving a regulatory permission to sell its product in different regulated markets. The details are presented in Table 1. The marketing department conducted research and summarized the cost and duration of processing the application, the odds of a positive outcome, and the sales opportunities. Deciding what market the firm should enter is based on the potential profit generated over a 24-month period.

You need to decide which market the firm should start the regulatory approval process.

Carefully read the grading criteria on the LP5.2/Problem 1 Assignment Rubric to ensure you understand how this problem will be graded.

Table 1: Summary of Marker Research

Agency Name Processing Fee Average Processing time (months) Approval Chance Annual Sales per market

USA FDA 248 K 5 0.8 $1,000,000 per month

EU MDD 300 K 1 0.85 $700,000 per month

China CFDA 82K 3 0.9 $660,000 per month

Japan PMDA 320K 12 0.9 $250,000 per month

India CDSCO 47K 5 0.95 $470,00 per month