Leak Testing Misinformation Is Widespread in the Medical Device Industry
Here at Uson, we are obsessed with leak testing methods. One problem that we see often, particularly in the medical device industry, is the widespread belief that one type of leak test method is inherently better for nearly all applications. This is simply not true and the misinformation seems to have taken on a life of its own.
Here is a true story to show you what I’m talking about.
Recently, we received a call from a customer who wanted a leak tester with a particular type of sensor. He was very confident that was the best choice for his application because that was the only type of leak test he had done for the past half dozen years or so.
During our conversation, it became obvious to us that that he was at the absolute lower limit of where a mass flow leak test could be performed at the Gage R&R he needed. Using our experience and expertise in leak testing, we were able to demonstrate to the customer an alternate pressure decay tester producing the same Gage R&R while decreasing his test cycle time.
The result? A 12-fold decrease in test cycle time and a leak test instrument that could handle a design change with leak testing possible over a much wider range of test pressures.
Rapid innovation in the medical device industry is a given these days. Many new devices are developed each year and generations of devices designed decades ago continue to be tweaked as newer electronics, materials, software, etc. continue to drive product improvements.
Just as it was for this customer, it is highly likely that you will need to test your medical devices or their components at different test pressures or with subassemblies attached in different ways or with altered internal volumes or any number of other modifications that may make a leak test method used today a poor match tomorrow.
The test instrument “of choice” for rapid innovation, such as in the medical device industry, is one that can change seamlessly to meet new test requirements.
In the world of leak testing, these are multimodal leak test instruments that can do any number of the aforementioned tests in unlimited combinations and permutations.
Sure, the call that I have talked about here is not the norm, but we field enough of these calls to keep us on our toes. As a result, we have developed a no-cost quick turnaround leak detector selection service to help our customers select and spec a test mode within 48 hours, and, if requested, a complete spec of leak tester configurations as well.
Even though your in-house team may include NDT experts, my experience tells me you will benefit greatly by guidance from an expert—someone who thinks about leak testing every working hour on a daily basis. Better still, you will receive practical advice from leak testing experts who have “been there and done that” when it comes to all the medical devices being used today.
It is easy to see why so many years ago Uson focused on developing multimodal test instruments that can and should be applied to any and all test instrumentation and manufacturing equipment used widely in the medical device industry.