PMP Guide — Empowering Project Managers
Business EnvironmentHybridHardECO: Business Environment Task 1.3

PMP Practice Question: Business Environment — Hybrid, Hard

A pharmaceutical company is developing a new drug delivery device using a hybrid approach: the drug formulation follows a stage-gate predictive process due to FDA requirements, while the device hardware uses iterative development for user-centered design. The predictive stream has just completed toxicology studies (Gate 3 of 5) when new research emerges suggesting a competing delivery mechanism may be significantly more effective. The agile hardware team could pivot to this mechanism within two sprints, but the predictive drug formulation team would need to restart from Gate 1, losing 18 months of work and $12M in sunk costs. Market forecasts show the competing mechanism could increase market share by 35% but also involves higher technical risk. Patent analysis shows the company could secure IP protection for either approach. What should the project manager recommend?

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