Collaborating with the right contract manufacturer (CM) can have many benefits. The right CM provides program management, which anticipates the needs of the program and the customer, and offers services to resolve unknowns that may arise. Full-service contract manufacturers provide risk mitigation, innovation, quality, and ultimately, faster speed-to-market. An experienced CM partner can help the success of a company’s program.
 
Following are ten tips to consider in planning a program with a contract manufacturing partner.
 
Tip #1: Select a CM Partner Early in the Process
Partnering with a CM can lead to increased design for manufacturing, innovation, and cost management, as well as better supply chain management, resulting in speed-to-market. Working together early on sharing target costs, receiving budget quotes, and considering logistics will favorably affect quality outcomes and create realistic timelines. A CM can also review the program and utilize lean manufacturing methods to help produce the best possible repeatable process.
 
Tip #2: Define True Scope of Work
When working with a CM, it can be beneficial to step back and review the true scope of a project. Both parties should seek to examine a variety of critical factors, such as:
 

• What is the timeline needed?
• Who will be responsible for key elements?
• What expectations do all parties have?
• How deeply defined is the supply chain?
• What are the key milestones in the timeline?

 
Ultimately, both parties need to define a document to help avoid scope creep. Addressing these factors at the initial stages of the project can benefit the overall project flow as well as overall timeline. Oftentimes, the team is eager to start a project and run with it without taking time to identify the key areas that will provide a clear scope to all parties.
 
Tip #3: Prove-Out Process and Freeze Design Early
Utilizing pilot test lines (beta builds) to confirm form, fit, and function will help prove out the process. Freezing the design early can help avoid time lags due to continual changes later. Parallel path options should be utilized when possible to reduce downtime. Adding additional time in the up-front stages can help save time in the later stages of the project.
 
Tip #4: Define Sourcing Requirements
By working with the CM to define sourcing requirements, you can simplify the supply chain while increasing speed-to-market. Taking into consideration factors such as identifying the obsolescence risks, creating contingency plans, and identifying long lead components can significantly impact the purchasing strategy of the program.
 
Tip #5: Assume Unknown Design Iterations
Even after due diligence in the planning stages, assume that post alpha and beta iterations are likely. Additional capital should be budgeted to address any unknown capital requirements. Including flextime in the program schedule to accommodate any unknowns that may arise can help to expedite changes without interruption to the program’s final deadline.
 
Tip #6: Do Not Minimize Ancillary Device Requirements and Potential Impact on Cost and Timeline
With larger programs and finished devices, don’t overlook ancillary device requirements such as packaging, sterilization, and labeling.
 

• What are the necessary packaging requirements of the device?
• Will it be packaged individually?
• Is it packaged with additional pieces?
• What are the testing requirements?

 
The IFU/DRU/OIS requirements need to be planned as well as all final packaging labeling requirements. Will the product require sterilization? If so, the necessary “visual indicators” in labeling should be reviewed and verified depending upon how the final product will be handled.
 
Tip #7: Fully Explore Potential Effects Environmental Exposure Will Have on the Device
In addition to packaging and labeling, effects of environmental exposure on the final devices should be considered early in the development stages.
 

• What effect will sterilization have on the final components?
• Will sterilization discolor the device?
• Will any bonding methods create issues?
• Where is the final product shipped?
• Will high humidity or extreme temperature affect the product and packaging?

 
Answering these questions early in the process can help the CM provide options that will ensure a smooth process.
 
Tip #8: Identify Inspection and Testing Requirements Early
As your device program scales up from pilot to production, identifying inspection and testing requirements early will help control budget and timeline requirements.
 

• Do test stations need manual fixtures?
• Are completely automated, 100 percent verification stations needed?

 
Working with your CM early in the process will identify and provide the needed verification. Process validation requirements can then be implemented to ensure a repeatable process is in place.
 
Tip #9: Communicate Device Function to the CM
For manufacturing of innovative medical devices, a clear understanding of the function and application for the final device is necessary. Overall risk should be clearly understood by all parties. High-risk areas should be identified and addressed during the risk assessment of pFMEA. A well-versed CM will be able to assist with manufacturing, design, assembly, and testing requirements to provide the highest quality devices.
 
Tip #10: Be Realistic About Total Overall Cost
One of the first challenges with any project is to determine the costs associated with manufacturing the device. Being realistic about total overall costs is key. While few programs stay exactly on target price and schedule, well-planned programs will have taken into account the possibility of launch delays, or any market changes that might arise affecting time and cost. Experienced program managers have the knowledge to help define costs and work with a customer on a realistic budget. The lowest overall cost can be achieved from partnering with a CM whose capabilities are the best match for the program’s requirements.
 

---

Barbara Tischart is vice president of marketing and communications at SMC Ltd. She has over 25 years of experience in sales and marketing, and additional years of experience as general manager of a custom manufacturing organization. Tischart holds a Bachelor of Science degree in Mechanical Engineering from the University of North Dakota and a Master’s of Organizational Leadership from the College of St. Catherine.