White Paper
Design Optimization Collaboration Provides Lowest Total Cost for Medical Implants.
Product design contributes significantly to the overall cost of the finished medical device. As a result, medical device OEM’s that have the foresight to consider manufacturing and design issues upfront 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:
- To use the most innovative and cost effective manufacturing methods.
- To align the design specifications with the functional requirements and optimize the manufacturing functions, including: fabrication, finishing, testing, assembly and packaging.
- To use automation and validated processes to ensure the highest level of quality, regulatory compliance and speed-to-market.
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.
Design For Manufacturability and Concurrent Engineering are proven design methodologies that work for any size company. The process often can cut in half costs and time-to-market while adding significant improvements to quality and delivery. We have found these services to be most impactful when applied to projects that involve tight tolerances and exotic materials, including NiTinol. Norman Noble, Inc. is the largest laser machining contract manufacturer, and we manufacture the most NiTinol based implants in the world.
Benefits of partnering with Norman Noble on Design For Manufacturability include:
- Access to Norman Noble, Inc.’s innovative machining and finishing technologies for implants and devices.
- Product design support, which establishes the feature set, how well the features work, and, accordingly, the marketability of the product.
- Prototype manufactured in dedicated Process Development Centers (PDCs).
DESIGN FOR MANUFACTURABILITY IN PRACTICE: Design for Manufacturability takes foresight now for benefits later. Norman Noble, Inc.’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, Norman Noble assesses a Design for Manufacturability project’s viability by determining:
- Can we take the current concept to something that can be manufactured and compliant?
- Can it be reviewed and revised to enable Norman Noble to use the newest and most efficient technology to reduce cost and maximize quality?
- Can it be validated so the process can be repeated for a high yield?
CASE STUDY: A medical start-up OEM was developing a vascular implant design. The company needed quick-turn prototypes to verify the design and also required a manufacturing process that could achieve target production pricing. The OEM provided a draft drawing with a few basic dimensions, and submitted a request for quote to Norman Noble that noted a specific interest in cost-effective manufacturability.
Norman Noble was chosen as a partner for the project based on proprietary machining technologies it could apply to produce the product quickly in a process development center (PDC) using productionequivalent equipment that provided the best quality and yield. From the very start of the project, Norman Noble and the OEM conducted design for manufacturability discussions to evaluate:
- Material selection
- Manufacturing and finishing specifications
- Inspection method
- Validation strategy
- Yield percentage
- Functionality
- Characterization and testing
As one outcome of this process, the testing was streamlined to eliminate months of now-unneeded prototype iterations. The prototype design was also modified to enable the use of a single operation machining technology, which drastically improved the manufacturing process flow. Additionally, by developing some of the functional specifications, the team minimized the amount of traditional inspection required and implemented automation for dimensional and visual criteria. With a robust design and manufacturing process in place, Norman Noble’s validation team was able to easily demonstrate the process capability required to support the transition to full-scale production.
The team-based design partnership between the OEM’s and Norman Noble’s engineering teams allowed Norman Noble to produce high quality products in high volume in accordance with all project milestone due dates. Together, we 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 very large medical OEM. Today, Norman Noble continues to successfully partner with this customer on new designs for next-generation vascular products.