Analyzing failure data to reduce test times, risk and liability for highly regulated medical products
"One specific example that I have is on the side rails on a new product that we had recently released. It’s the use of test-to-failure as opposed to test-to-pass. So our traditional method would have required 45 samples, because side rails are a safety feature that requires a higher sample size. So we would have to test 45 units to zero failure. There’s a lot of risk tied up into that, and a lot of time and a lot of samples."
"We were able to boil that down to one month of testing on 12 samples, so significant savings, both in samples and in time. Definitely knocking time off of schedules is a huge way. Also taking the question marks out of risk. The risk associated with testing the path is you don’t know when it’s going to fail. You just know that it passed. When we do test-to-failure and apply ReliaSoft Weibull++ as a tool to analyze that failure data, we know exactly where that requirement is."
"I would highly recommend Weibull++ software because of its user friendliness, the fact that it handle a lot of data, and it has a lot of feature. Weibull++ as a tool is absolutely key in the safety of our products. We as a company have purchased over a hundred seats, having seen the value of it to our company."
Hill-Rom, Inc. is a medical technology company that operates worldwide. It designs, manufactures and distributes of medical products for hospitals and health facilities. They include surgical beds, intensive care beds, lifts and other devices, plus communications technologies and software solutions.
Being in the medical industry, we are an FDA-regulated company. And one of the things the FDA requires is statistical justification for all requirements. And so as part of that statistical justification, we have come up with a demonstrated quality limit and confidence.
This will bring together HBM, Brüel & Kjær, nCode, ReliaSoft, and Discom brands, helping you innovate faster for a cleaner, healthier, and more productive world.
This will bring together HBM, Brüel & Kjær, nCode, ReliaSoft, and Discom brands, helping you innovate faster for a cleaner, healthier, and more productive world.
This will bring together HBM, Brüel & Kjær, nCode, ReliaSoft, and Discom brands, helping you innovate faster for a cleaner, healthier, and more productive world.
This will bring together HBM, Brüel & Kjær, nCode, ReliaSoft, and Discom brands, helping you innovate faster for a cleaner, healthier, and more productive world.
This will bring together HBM, Brüel & Kjær, nCode, ReliaSoft, and Discom brands, helping you innovate faster for a cleaner, healthier, and more productive world.
