Engineers at Norman Noble, Inc. (NNI) say that product design contributes significantly to the overall cost of the finished medical device. Therefore, medical device OEMs that have the foresight to consider manufacturing and design issues upfront, can shorten their product development time, minimize development cost and ensure a smooth transition into production for quick time-to-market.
“Design for Manufacturability” is the process of proactively designing products:
1. To use the most innovative and cost effective manufacturing methods,
2. To align the design specifications with the functional requirements and optimize the manufacturing functions, including: fabrication, finishing, testing, assembly and packaging, and
3. To use automation and validated processes to ensure the highest level of quality, regulatory compliance and speed-to-market.
Going hand-in-hand with Design for Manufacturability, NNI explains “Concurrent Engineering.” Concurrent Engineering is the practice of developing products and their manufacturing processes in simultaneous, parallel paths. If new processes are required for manufacturing, then the product and the process must be developed concurrently.
According to NNI, Design for Manufacturability and Concurrent Engineering are proven design methodologies that work for any size company. The process often cuts cost in half and time-to-market while adding significant improvements to quality and delivery. These services are most impactful when applied to projects that involve tight tolerances and exotic materials, such as NiTinol. NNI is a large laser machining contract manufacturer with the most NiTinol-based implants in the world; thus, its use of Design for Manufacturability has proven key to the company’s success.
Design for Manufacturability takes foresight now for benefits later. NNI’s Design for Manufacturability services have realized substantial benefits for clients of all sizes. Design for Manufacturability studies are selected based solely on market potential.
In broad terms, NNI assesses a Design for Manufacturability project’s viability by determining:
1. Can the current concept be taken to something that can be manufactured and compliant?
2. Can it be reviewed and revised to enable the company to use the newest and most efficient technology to reduce cost and maximize quality?
3. Can it be validated so the process can be repeated for a high yield?
From the beginning to the end of a product with a Design for Manufacturability process, NNI does two things: design for manufacturability and partner with the client; thus, this process evaluates:
· Material
· Manufacturing method
· Inspection method
· Validation
· Yield
· Functionality
· Characterization and testing
The team-based design partnership between the OEM’s and NNI’s engineering teams allowed the company to produce high quality products in high volume in accordance with all project milestone due dates. Together, the client and NNI achieved a significant cost reduction in manufacturing the final device. As a result of the project and a successful product launch, the customer has grown from a start-up, to a large medical OEM. NNI continues to successfully partner with this customer on new designs for next generation products using the Design for Manufacturability process.
Norman Noble, Inc. (NNI)
www.nnoble.com