Testing and validating medical devices are the final steps before delivery to a customer. Therefore, it’s critical to uphold the highest quality at this point in production. Companies that have automated some testing may still rely on manual processes because they don’t leverage all of automation’s benefits. To ensure a full understanding of the benefits of automation, ask the right questions and evaluate each type of system to determine which will be most suitable. The right system will let you test consistently, get feedback on possible failures, improve return on investment (ROI), and enhance device quality.
Determine a need
Deciding when to automate is driven by individual needs. Before implementing any type of automated test solution, determine the overall goal. Consider:
- What will the overall cost be?
- How much automation is necessary?
- How much benefit will there be?
- How much will it improve quality and production speed?
“The challenge is trying to figure out how much automation makes financial sense,” explains Jim Campbell, president of Viewpoint Systems, a member of the Control System Integrators Association. “Occasionally, there are some hurdles to overcome, such as people not believing that automation is worth it because they might have tried it in the past and the system didn’t operate as well as it should have. Subsequently, they just ditched it as a waste of effort.”
Campbell adds that, “Having good processes and good understanding about what needs to be done to verify the test’s design will give companies a system that’s functional and reliable.”
Automation will lead to more consistency and accuracy, without relying on manual labor for repetitive tasks.
Available testing systems
Several automation tools allow companies to achieve consistency and repeatability. Viewpoint Systems offers various measurement and control equipment to test parts. For example, a robot arm with a camera or a high-speed voltage measurement evaluates a part being tested by using hardware and software to analyze different locations and performance, allowing customers to connect to the test equipment and run their product through its functions to verify that they work properly.
“We create custom systems for companies that are highly dependent on what their product does. And every product is different and requires its own standards,” Campbell explains.
Users can also reduce errors by using electronic documentation to capture data during a test, beneficial for products that must be tested during manual or semi-automated assembly, as well as full automated test. Electronic documentation improves consistency, speeds production rates, lowers assembly errors, and increases visibility into the production process.
“You save time and minimize or eliminate transcription errors common with manual processes,” Campbell says. He addes that electronic records track where “parts have been, if they have been reworked, were shipped to a customer and sent back for warranty. They have a much better understanding of the history of that part.”
When designing a new product, manufacturers also need to know how it will perform under a wide variety of conditions, and potentially throughout a long duration. During prototype development, they can test certain features and use LabView to collect data and measure the performance of each parameter. The software can automate control, measurement, test sequencing, and test report generation. By creating a user interface for display of data and status, it also allows the operator to check on performance and status in real time.
About the author: Michelle Jacobson is the assistant editor of TMD. She can be reached at 216.393.0323 or firstname.lastname@example.org