[Case 01]
End-to-End Launch of Regulated Medical Device
Medical Device Manufacturing
Launching FDA-Approved Glucose Meter
Delivering a regulated product line through complex stakeholder alignment
[Problem Statement]
This first-time collaboration between a Fortune 10 U.S. client and a oversea development team faced major coordination challenges—unclear roles, cultural and language barriers, and no established workflow. As the newly assigned Product Manager, I was tasked with aligning teams, defining process, and driving execution under tight timelines and budget.
Client name withheld due to confidentiality
[Industry]
Medical Device Manufacturing
[My Role]
Product Manager
[Scope]
Concept-to-Launch
[Timeline]
Q4 2024 - Q4 2025 (Ongoing)
[Key Challenges]
This project involved cross-border collaboration between a Fortune 10 client, our overseas parent company (in charge of development), and our internal team.
While the parent company had strong technical capabilities, it was their first time working with this client, who has exceptionally high standards for branding, quality, and compliance. My role was to manage both sides—aligning timelines, resolving uncertainty, and driving decisions to keep the project moving forward.
[Goal]
Clarify team ownership and communication flow
Establish a repeatable workflow for samples and decisions
Deliver on time within cost and quality constraints
[Frustrations]
Unclear roles caused delays and misalignment
No process made tracking and coordination difficult
Shifting client needs added pressure and rework
[Process]
[Outcome]
Cut 75% approval lead time by streamlining internal feedback cycles (4 weeks → 1 week)
17% reduction in project timeline by introducing an artwork framework and standardizing collaboration tools
Drove execution of product launch, ensuring packaging, artwork outputs met strict brand and FDA requirements on a tight timeline
[Key Learnings]