Cardessa Health
Class II medical device manufacturer, two regulated plants
- Engagement
- 22 weeks
- Office
- Singapore
- Lead partner
- Priya Natarajan
The challenge
Cardessa's design transfers took 34 weeks on average, and the last regulatory audit had surfaced seven major findings, four of them traceable to supplier controls.
What we did
Priya Natarajan's team rebuilt design transfer as a gated program with named criteria, ran supplier qualification in parallel rather than after, and rewrote the supplier control plan around the processes that actually carried risk.
Quality agreements were renegotiated with the twelve critical suppliers; documentation was redesigned with the line crew until it survived a busy shift.
The outcome
The next design transfer completed in 18 weeks. The follow-up audit closed with zero major findings, and the documentation system held through a volume ramp without a single late batch record.
Design transfer cycle −16 weeks
Major audit findings −7 count
Critical suppliers under new agreements +12 count
Bars are scaled per metric against its own maximum. Direction of improvement: Design transfer cycle, Major audit findings, Critical suppliers under new agreements — see each metric.
| Metric | Before | After | Change | Improvement |
|---|---|---|---|---|
| Design transfer cycle | 34 weeks | 18 weeks | −16 weeks | Lower is better |
| Major audit findings | 7 count | 0 count | −7 count | Lower is better |
| Critical suppliers under new agreements | 0 count | 12 count | +12 count | Higher is better |
Expertise behind this program
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