Pros of Using a CDMO
Faster Access to Expertise
Immediate access to specialized skills and experience without recruitment delays
Expertise across multiple regulatory environments and product categories
Established quality management systems that meet ISO 13485 and FDA requirements
Established SOPs to guide the documentation process and ensure compliance.
Infrastructure & Equipment
Avoid capital expenditure on specialized manufacturing equipment and facilities
Access to cleanrooms, testing equipment, and production lines
Existing validated processes and equipment qualification
Scalability
Flexible capacity that can scale with product demand
Ability to manage multiple projects simultaneously
Reduced overhead during product development cycles
Cost Structure
Convert fixed costs (salaries, benefits, facilities) to variable costs
Potential for lower overall development costs for specific projects
Reduced training and onboarding expenses
Cons of Using a CDMO
Loss of Control
Less direct oversight of critical processes and decisions
Potential communication barriers and delays
Dependence on third-party priorities and schedules
IP and Knowledge Protection
Risk of intellectual property exposure
Critical knowledge remains with the CDMO rather than in-house
Potential future dependence on the CDMO for product knowledge
Long-term Costs
CDMO margins make them potentially more expensive for sustained production
Contract renegotiations can increase costs over time
Hidden costs in transfer of manufacturing or technology
Organizational Learning
Reduced internal knowledge development
Limited opportunity to build institutional expertise
Potential challenges in product iterations and improvements
When Each Approach Works Best
CDMO Approach Works Best When:
Speed to market is the primary concern
Capital is limited for infrastructure investment
Specialized expertise is needed for a limited time
Project scope is well-defined and unlikely to change frequently
Internal Employee Approach Works Best When:
Core technology requires tight integration and control
Long-term production is planned
Intellectual property protection is paramount
Organizational knowledge building is strategically important
Frequent iterations and development cycles are expected
CDMO Ambassador can help you maximize the Pros and minimize the Cons.
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