A medical device OEM was bringing a new Class II diagnostic product to market but faced significant risk across supplier qualification, design transfer, and manufacturing readiness. The internal team lacked a dedicated program manager to coordinate across engineering, supply chain, regulatory, and contract manufacturing partners.
Back to Case Studies
Device Manufacturing
Professional Services
Regional Medical Device OEM
NPI Program Launch: Class II Medical Device Manufacturer
Led a full new product introduction (NPI) program for a Class II medical device, navigating supply chain complexity and design transfers to deliver on time.
Duration
14 months
Team Size
2 PMs, 1 Business Analyst
Investment
$1M - $5M
Methodologies
Waterfall
Embedded a senior PM to own the NPI program plan across all functional workstreams. Implemented a stage-gate governance model with executive dashboards, managed supplier qualification timelines, and coordinated design transfer milestones with the contract manufacturer. Ran weekly cross-functional standups and monthly steering reviews.
Product launched to market within original 14-month window. Supply chain qualified on schedule with four suppliers. Design transfer to contract manufacturer completed with zero rework loops. First commercial units shipped within 3 weeks of manufacturing readiness sign-off.
Key Results
Yes
On-Time Launch
4
Suppliers Qualified
Zero
Rework Loops
3 Weeks
First Ship Post-MR
Methodologies Applied
Waterfall
Stage-Gate
Tags
Device Manufacturing
NPI
Medical Device
Stage-Gate
Supply Chain