PMP Practice: Align scope with business objectives

Ocean Reyes is managing a medical device manufacturing project for Apex BioSystems. During requirements validation workshops, the clinical research director insists on adding real-time biosensor data streaming to meet emerging regulatory guidance that may become mandatory within 18 months. The manufacturing operations director strongly opposes this, arguing it will add 4 months to the timeline and $340,000 to the budget, jeopardizing the product launch window before competitors enter the market. Both directors report to different executive vice presidents. The project charter explicitly states the primary success criterion is capturing 30% market share within the first year of launch, and the sponsor has emphasized that missing the launch window would likely cut projected market share in half. The technical team confirms the biosensor streaming capability could be added in a future product generation with minimal retrofitting cost. What should Lila do?