Client: Global medical device manufacturer
Service: FDA 483 & quality remediation
Result: ~$10M one-time revenue recovered; $5–10M annual revenue enabled
The challenge
Regulatory inspection findings related to ethylene oxide sterilization led to held product and interrupted manufacturing across 82 SKUs representing about $35M in annual revenue. The technical work was complex, and many functions and outside partners had to move together.
The approach
Rather than wait for one complete solution, the program ran three pathways in parallel, built on shared prerequisites:
1
Recover held product
Release product already built.
→ ~$10M one-time revenue
2
Restore ongoing production
Get new product shipping again.
→ $5–10M annual revenue
3
Build long-term resilience
A more robust process to prevent recurrence.
→ Long-term resilience
The work included validation studies and external laboratory testing. I ran it through executive steering committees and daily management, with CEO-level reporting and coordination across Quality, Regulatory, microbiology, Commercial, external labs and sterilization partners.
The result
- Recovering held product returned approximately $10M in one-time revenue
- Restoring production enabled approximately $5–10M in annual revenue
- A longer-term resilient process was defined to prevent recurrence
