Healthcare Product Testing

Used by a Leading Healthcare Product Company

Company: Essity

Category: Production Testing

Industry: Medical

In the medical industry, ensuring the quality of products is essential. When moving production from abroad to Sweden, Essity wanted an existing test system to be redesigned to be more reliable.

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The Problem

One of our customers wanted to update an existing test system for more reliable testing. They wanted test results to be stored online and accessible anywhere. Products needed to be laser engraved and given labels to meet medical regulations. To meet production deadlines, the project needed to be completed quickly.

The Solution

QESTIT used the QATS platform and modular hardware to design a robust but flexible test system. It tests the product as a PCB and in its final casing after assembly.

Product Test Rig

Test Rig Front Panel

Product Test Rig

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This test system was an interesting task for us, as it incorporated production steps such as laser engraving, PCB testing, result management and 3rd party elements over 3G communication. This combined with the high requirements for medical products and the need to meet a production deadline, made the project a challenging but rewarding experience.

As this was an upgrade of an existing system, the original system's capabilities were analysed and the critical components were highlighted. We also highlighted the project's top priorities which in this case was high quality and low time to release. We started by moving the existing code to the QESTIT QATS platform. QATS is a test platform developed by the Systems team which is used for production testing. It uses modular code snippets to allow us to quickly build code and make changes throughout the development process. This reduces development time, maintenance time and therefore overall system cost.

Simultaneously we began designing/ordering the system's hardware. At the center of this system is an NI compactDAQ unit. This modular designed piece of hardware, has card slots for different kinds of measurement recording cards and can be used to capture digital and analogue signals of all different types. In the future, cards can be replaced as new models are released and when the system reaches the end of its life cycle, the hardware can be repurposed.

The rig's mechanics were designed and constructed by our partner Columbia. This simple open/close design allows for fast and safe PCB testing. This is ideal for batch or small scale production in medical or other high quality industries. Needles connect test points on the underside of the PCB while poles press the PCB from above. From the front of the rig several cables connect to the product during final stage testing.

The test system was delivered to the manufacturers site with the system architect assisting installation. The product was evaluated and adjusted on the manufacturing floor. The direct feedback from production staff significantly improved the system performance and sped up system integration.

Christopher Hyde was the project architect for this system and worked closely with the customer to meet the production deadline.

"I think this project is a testament to the versatility of our test software and the QATS platform as a whole," says Chris. "Many platforms would struggle to incorporate production control steps in that way that QATS does. Being able to make custom code and then easily use/distribute it definitely reduced the project's development time. The customer was very satisfied with the speed at which changes were able to be made."

Throughout the development process several large changes had to be made. "It's a reality of engineering I think. You can start a project with the most detailed plan ever made but something will always need to be changed as new information becomes available. The only thing we can do is expect the unexpected and try to prepare for that. That's one of the reasons QESTIT made QATS in the first place."

Another key aspect to this project was engraving plastic cases as part of the production process. "The laser engraver was a bit of a 'curve-ball' for us. It was completely new. I quickly learned a new coding language and made some automated scripts for the engraver".

Another difficulty was discovering there were no fixtures for holding parts being placed into the engraver. This led to some rapid development, "We learned there we no fixtures available quite late in the project. To fix this we custom designed and 3D printed two new test fixtures that fit into the engraver. We've now purchased our own high end 3D printer for any future projects. That will be useful for sure!"

The complete test system, including the test rig, engraver, label printers and QRM licence was installed on site before the production deadline. With a support agreement, customers are able to call QESTIT for support or requests for changes to the system. Support is handled by the engineer which designed the system or if they are not available, another member of the team. We understand that getting good support is essential, so why get it from anyone other than the designer of the system itself?

Summary

Overall the project was a success and achieved the production deadline required. The customer recieved a system which was capable testing units as a PCB and when assembled. It successfully tracked product serials, generated labels and laser engravings. Test results were stored online and are accessible anywhere thanks to the power of QRM.