Streamlining Your Supply Chain

How to Choose the Right Supplier as a Partner

Today’s business environment is as challenging as ever for a medical device OEM. To reduce costs and stay competitive, OEMs must continually evaluate different options. To meet their devices’ design requirements, supply chain managers must manage a fragmented, specialized supply base with varying capabilities. For OEMs requiring extrusions and secondary operations from different sources, juggling multiple suppliers and longer lead times is a challenge. For OEMs performing the secondary operations in-house, costs can also be high. Let’s consider a couple of actual case study problems — and their solutions.

Shortening the Supply Chain: Case Study #1

A medical OEM depended on two different suppliers for tubing with a ground feature. The extrusion from the first supplier was ordered, received and inspected. Next, it was repacked and shipped across the country to another supplier who performed the secondary operation. The second supplier then sent the ground tubing back across the country to the OEM who received, inspected, repacked and shipped it to an assembler in the Midwest.

The logistical complications of two suppliers were costing the OEM dearly, both in time and money. The solution was to choose an extruder who could supply the tubing with the ground feature. The OEM chose Vesta. Vesta worked closely with the OEM, eliminating the need to qualify and manage multiple suppliers, reducing the number of inspections and saving high cross-country freight costs. The result was a lower total cost for the finished piece.

An Alternative to the In-House Solution: Case Study #2

A medical OEM purchased a precision extrusion requiring a tipped end from a supplier who couldn’t perform the tipping operation. Instead, the OEM used internal engineering resources and lab equipment to perform the tipping operation.

The OEM soon realized that the cost of bringing the work in-house had been greatly underestimated. The solution was to source the tubing from a supplier who could perform both the tipping operation and the tube extrusion. They chose Vesta, and eliminated the direct and overhead costs of doing the tipping operation in house. The result freed up valuable engineering resources and capital for other projects.

When choosing a supplier, always make sure they’re fully equipped to deliver everything you need. In both case studies, the OEMs discovered the benefits of partnering with a manufacturer who had:

  • Extensive process expertise
  • A sophisticated quality control system
  • An experienced engineering team
  • Infrastructure capable of handling the process from start to finish

With the right partner, both OEMs were able to:

  • Produce a higher quality product
  • Reduce production costs
  • Shorten lead times
  • Simplify manufacturing processes

Ask an Engineer

Question:

What material requirements do I need to detail on my specifications or drawings to ensure regulatory compliance?

Answer:

In our last e-newsletter, we focused on the importance of properly defining materials and formulas to ensure proper traceability and change control.

In this e-newsletter, we focus on the importance of properly defining 1) critical features and 2) measurement methods to ensure consistent fit and function.

1) When designing a medical device, it’s important to determine which features are critical to its design and overall performance. Critical features are chosen subjectively based on the function and fit of your particular component. In contrast, non-critical dimensions may be areas of the part that are not close to mating assembly components, and do not affect the design intent or the overall performance of the device. Each critical feature needs to be properly detailed in your specifications. This includes nominal values and acceptable tolerances that define size, shape and sometimes physical properties.

2) Clearly defining how specified parameters of critical components are to be measured is as important as determining the critical dimensions themselves. Dimensions can be measured by contact methods such as mandrels and gauges, or by non-contact methods involving optical measuring devices. Results can vary depending on the method.

For example, when measuring the inner diameter of a tube with a pin gage or mandrel, you must consider that the inner diameter of the tube may not be perfectly round. The pin gauge or mandrel will measure the smallest diameter. When measuring that same tube with a non-contact system, the diameter of multiple axes are measured and then averaged. Which method is preferred? It depends on how your component is going to be used. It’s best to choose a measurement method that correlates to the function and fit of your component in use.

Precisely defining both critical dimensions and measurement methods will ensure proper process control, change control and document traceability in the manufacturing of your device.

If you have questions about best measurement methods for your device, please contact our engineers at 414.423.0550.

Look for more information about issues of regulatory compliance and medical devices in the next issue of this newsletter.

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