Navigating the CDMO Change in Medical Device Manufacturing: What You Need to Know
- gtzhang100
- Feb 20, 2025
- 1 min read
🚨 Med Device Leaders, questioning your CDMO change might be more than finding a new one?
✓ How will design transfer impact your product's regulatory status across current and planned global markets?
✓ What changes to design or manufacturing processes might be necessary, and how will they affect your timelines and budget?
✓ Have you mapped out region-specific regulatory requirements and approval timeframes?
✓ Is your technical documentation package complete and transfer-ready?
✓ What specialized equipment will you need, and what are your procurement options?
✓ Would the current CDMO support the knowledge transfer?
✓ Should the new CDMO adopt your current suppliers?
✓Do you have raw materials, WIP, and finished goods in the inventory to transfer?
✓ How will you maintain inventory levels during the transition period?
✓ How do you ensure this move will not negatively impact the COGS?
✓ How to select a new CDMO?
What are some of the questions you have asked?
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