Reducing Medical Device Inspection Costs

As an OEM, your goals include:

• Getting in market quickly
• Constant quality
• Reasonable cost and value
• No surprises

Without an industry standard, OEMs often depend heavily on the guidance of their manufacturing partner. With a wide range of approaches, customers may feel that they have to choose between cost and effectively managing risk.

With a less comprehensive inspection process, are you creating an inherent risk of variation or failure?

A more involved process such as complete 100 percent inspection adds time which can impact the bottom line.

How Can You Find the Right Approach?
At Lowell, we can apply many different systems to find the best level of certainty while delivering value through deep experience with a variety of approaches and leveraging statistical methodology.

There are three statistical models that can be utilized together to minimize inspection costs.

Statistical Process Control (SPC): This demonstrates the manufacturer uses statistics to control processes on the manufacturing floor. When a manufacturing process is in a validated state, SPC on the manufacturing floor can give OEMs confidence that the process is stable and in control.

Inspection Correlation: This process uses statistical techniques to correlate the way a contract manufacturer measures a device with the way an OEM measures it. Measurement data from the contract manufacturer and the OEM are statistically analyzed to show if they correlate to each other. If the two inspection systems are found to be correlated and matched, the OEM can potentially use the contract manufacturer’s data as its own.

Process Capability (Cpk): This number is used to indicate how capable a process is and can be used to reference the AQL sampling charts for how many parts to inspect in a batch. Contract manufacturers determine Cpk by running statistical tests on inspection data. It’s common to complete 100 percent inspection on the first several runs of a part to establish Cpk and have a good record of historical data.

To reduce your costs, a combination of the three methods above can create a system that creates a consistent process in manufacturing, reduces complexity, and streamlines final inspection.

Interested in going deeper into strategies for reducing inspection time? Check out our whitepaper on how precision GD&T can help. Or view more on seven tips to reduce lead time through project management. For a personalized discussion, contact phil.allen@lowellinc.com to learn more about your options.