by Amy Jeary
A critical component of medical device manufacturing has always been speed to market. Every day, medical device organizations are making the decision to outsource manufacturing to be more efficient and effective by choosing a strategic partner with the right in-house capabilities. When it comes down to making the decision to either make internally or partner with an outside manufacturer; the most common reasons to outsource are:
1. Scale production without major investment.
2. Increase time to market with dedicated resources and manufacturing expertise.
3. Free up money and resources to work on different projects or initiatives.
CM vs CDMO
CM is short for Contract Manufacturer. CDMO is short for Contract Development and Manufacturing Organization. The main difference is the development part.
Full-services CDMOs handle all innovation and development work that occurs prior to manufacturing; considered a strategic partner with specific expertise that aligns with their customer. They guide customers from concept, design, and development to regulatory, prototyping, testing, and manufacturing. Their ability to design for manufacturing (DFM) puts an emphasis on process optimization and lean manufacturing initiatives early in the planning process to reduce waste, mitigate risks, and realize opportunities.
The most important thing is finding a strategic partner that is best aligned for your needs. The dedicated expertise, knowledge, and specialization of your CDMO partner can provide you with the skilled and experienced professionals you need to accelerate your time to market and avoid unnecessary costs.
All too often, unforeseen issues surface well after a product launch or during the manufacturing transfer. In the beginning of a new partnership, it’s an open line of communication. Choosing the right partner that aligns with your organization’s vision and values will help mitigate future risks and set you up for success.
Ideal CDMO Partner
- Aligned Goals
- Cost Management Strategies
- Timeline - Achievable and Realistic
- Process Optimization
- Design & Processes Optimization Expertise
- Lifecycle Management
Most Common Pitfalls
Trust in “Legacy Knowledge”
Assessing all processes for nuances in undocumented procedures is key in the early stages of a new partnership. Vital to fully understand the current production line and processes in place before optimizing.
Testing & Validation Criteria
A full upfront understanding of testing and validation criteria prior to moving a production line is vital. The right expertise is needed to avoid costly delays or problems down the road.
Outdated Processes
Grandfathered-in processes and equipment may not be ideal for the modern age or suitable for the location your manufacturing is moving to. Its necessary to evaluate the products, processes, and related risks to see if they meet the new standards. Governing bodies are constantly changing their requirements and a CDMO can ensure they are understood and met.
Supply Chain Management
Supply chain is a key component to any successful manufacturing. Ensure your CDMO partner has the right team and process in place and that they’re looking ahead and making changes as needed to meet your needs.
Choosing the Right Partner Begins a Long, Two-Way Relationship
Nissha Medical Technologies has evolved over the past 30 years in business to a full service CDMO so that we can be the best partner we can be to our customers, offering a full range of manufacturing needs and vertically integrated capabilities to scale to any project status or size. With locations across the globe, NMT combines large company resources with small company personalization to fit your needs.