Working with the ideal contract manufacturer has a wide range of benefits. The right CM is capable of foreseeing a wide range of potential issues that could arise from the manufacturing process and the needs of the customer and can offer suitable solutions to enhance the process and projected results.
A full-service contract manufacturer allows for improved innovations, precision risk management, higher quality and, finally, a faster speed-to-market. Essentially, the right CM for your operations can increase the success of the program and benefit the bottom line.
Let’s take a closer look at the top ten tips to keep in mind when getting the very best results from your Contract Manufacturing partner.
Tip #1: Select a CM Partner Early in the Process
Partnering up with a suitable CM will allow your company’s program to benefit from increased innovations, improved manufacturing designs, cost management and supply chain management all of which will result in a faster speed-to-market. These benefits can be greatly enhanced by partnering up as early in the program as possible to ensure improved outcomes in quality and realistic timeframes by fine tuning target costs, examining budget quotes and solving all logistical issues. Your CM will review the entire process of the program and apply their lean manufacturing methods to design and plan the best repeatable process.
Tip #2: Define True Scope of Work
When working with your CM, it is helpful to step back and gain some perspective on the project at hand. This will give you and your CM the chance to examine the project in the light of following critical factors:
What expectations do all parties have?
Who will be responsible for key elements?
How deeply defined is the supply chain?
What is the timeline needed?
What are the key milestones in the timeline?
Both parties will need to have a clear answer to all these questions and be able to share them freely to avoid scope creep. By having these important factors addressed and planned from the early stages of the process, the project flow will also be greatly improved. Many times, the project manager will be eager to get the program off the ground before identifying these areas of concern clearly. The result can be a measure of confusion in all parties involved.
Tip #3: Prove-Out Process and Freeze Design Early
The process can be examined and the form, function and fit of your manufactured products can be proven with the production of pilot test lines or beta builds. Freezing the design early in the process will avoid time lags and the need to make adjustments later on. Parallel path lines can be applied to maximize time efficiency.
Tip #4: Define Sourcing Requirements
Your CM will also be able to work with you on addressing the details of sourcing requirements. Simplifying the supply chain is one of the most important ways of improving speed-to-market. Taking into consideration all the important factors from the beginning, like contingency plans, obsolescence risks and long lead component improves the purchasing strategy upon which your program relies.
Tip #5: Assume Unknown Design Iterations
Even after you have performed your due diligence, you should know that there will still be iterations needed in the future. You will need to set aside resources to address this eventuality and any other unexpected issues that will arise along the way. Equally important will be to include flextime in the program so that you can accommodate any other unknown situations that may arise and make changes as needed without interrupting the final projected deadline.
Tip #6: Do Not Minimize Ancillary Device Requirements
Ancillary device requirements, such as labeling, packaging and sterilization, are essential to larger projects with finished products and should not be overlooked.
Here are some important questions to ask:
What are the packaging requirements?
Will the product be packaged individually?
Will the packaging contain additional pieces?
Are there testing requirements?
There are also requirements for IFU/DRU/OIS that will have to be carefully planned with all the packaging label requirements. If the product requires sterilization, visual indicators will also have to be reviewed and verified.
Tip #7: Fully Explore Effects of Environmental Exposure
In addition to ensuring optimal packaging and labeling, the potential effects of environmental exposure should also be examined and considered.
Will sterilization affect the final components?
Will sterilization cause discoloring on the device?
Will bonding methods create any issues?
Where will the final product be shipped?
Will extreme temperature or high humidity affect the product or packaging?
8. Identify Inspection and Testing Requirements Early
Budget and timeline requirements can be more tightly controlled by identifying inspection and testing requirements as early as possible. This benefit is possible when you work with your CM early in the process. After this process validation can be implemented to ensure a repeatable process is being conducted.
9. Communicate Device Function to the CM
The function and application of medical devices must be understood clearly and the risks should be understood by all parties involved. High risk areas will be highlighted and addressed during the assessment of pFMEA. An experienced CM will have no problem assisting in the production and testing of such devices to ensure the highest possible quality.
10. Be Realistic About Total Overall Cost
One of the first obstacles that must be surmounted is determining what the final costs of manufacturing a device will have to cover. It is essential that a realistic projection of the total operating costs is created. Of course, not every project will stay on course precisely, but the better the planning and the more enlightened the perspective the less margin for error this financial projection will include. An experienced program manager will be able to define the costs and set a realistic budget. A talented CM with a keen understanding of the program will be able to help you determine the lowest overall costs.