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The Pioneer of Modern Leak Testing

Are You a Medical Device Industry 2 Percenter?

Medical Device TaxAs I was reading the news headlines on a popular medical device industry (Is there a more volatile industry?) web site, I could not help but notice how many companies were reporting lower than forecasted Q1 sales, financial losses and plant closures.

Buried among all the gloom and doom and the usual M&A news, there was an item about the 2.3% medical device tax. It was an unremarkable piece of journalism but it included some links to other articles on the tax subject.

Behind one of the links was one piece of news that caught my eye. I had to read it several times to make sure I was not mistaken. It said that in a survey done by the Silicon Valley Bank of start-up medical device company executives, only 2% of those surveyed had never heard of the medical device tax. Only 2%?

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Speed Leak Testing Throughput With Customized RFID Tags

Most manufacturers I know like to follow the best practices of lean manufacturing. If you are a company that manufactures products with leak rate specifications, you will benefit greatly from using Uson’s customized Radio-frequency identification (RFID) tags.

Customized RFID tags from UsonThese customized RFID tags have two components to them – standard and custom components that are both designed for specific applications. The custom part of these tags streamlines parts processing and helps manage test data while cutting your overall production cost.

I was a member of the technical team at Uson that pioneered and developed the custom RFID tags that are used by our customers today. I saw a huge potential to help our manufacturing customers get more out of their leak detection equipment.

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Multiple Leak Tests in a Single Test Station

One of our medical device customers called us recently with a challenging leak test application.

He had a medical device that is part of a system designed to monitor gas flow and concentration. The device housed a pair of filters with a number of monitor lines and he wanted to perform 5 separate leak tests in a single test station.

The five leak tests to be performed were:

  1. Test for blocked sensor ports
  2. Leak integrity test
  3. Check that the sensor lines have been connected in the right order
  4. Check the pressure drop across one of the filters
  5. Internal port leakage

The medical device was designed to allow monitoring of the gas flows and restriction of two filters mounted in series in the flow path with a connection to monitor the patient’s breathing.

Do you want to guess how many leak testers would be needed in this single station? You would be wrong even if you guessed three or even four separate testers.

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How Math-Powered Leak Test Optimization Streamlines Production Processes

Design engineers who need to leak test their industrial products or components are looking for ways to add continuous quality improvements to their processes. One of the challenges they face is achieving faster leak test cycle times while maintaining a specific Gage R&R.

We have developed a solution for this problem. We call it our online video consultation for using Uson’s Optima vT’s built-in mathematical tools to improve yields and quality. This is a no cost solution from Uson.

Don’t be fooled into thinking it is just a throw away freebie! This is NOT a standard run-of-the-mill online video demonstration. It is a one-on-one consultation customized for your specific leak test application.

Here’s how it works:

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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 a 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 considerable 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.

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.

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How to Make Better Capital Investments in Leak Testing Technology

Faster innovation on a global scale is forcing many product manufacturers to rethink their capital equipment investments. Manufacturing facilities equipped with instrumentation for needed quality controls and other plant designs either anticipate new products not yet imagined or they do not. Obviously, companies that are forward thinking in capital equipment investment along these lines are building in long-term advantages to grab market share through innovation.

In the medical device industry, basic scientific research worldwide in nanotechnology, computational fluid dynamics, etc. is driving innovation. We see it in the form of new materials for prosthetics and implantable devices and new designs for surgical instruments. Catheters and drug-eluting stents, insulin pumps, sterile surgical tables and instrument packaging, and new laparoscopic surgical techniques are now possible because of improved instrument design.

Engineering teams – design, process, manufacturing, quality, etc. need to be thinking about the elasticity of every capital investment and its real economic-life if and when product designs change.

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Reliable Leak Testing of Medical Devices Demands Versatile Testers

The medical device industry faces some of the toughest challenges when it comes to leak testing as compared to other manufacturing and industrial applications. Product safety and consumer protection place a very high priority on the reliability of leak tests for medical devices. This in turn requires the medical device manufacturer to consider several factors to ensure successful leak testing.

There are many types of leak testers and leak testing techniques available today. Shouldn’t that make it easy to pick the right leak tester? While it may be true in many applications, it certainly isn’t when it comes to leak testing of medical devices.

Choosing the right leak tester for medical devices

Here is a quick checklist for you to use when selecting a leak tester for medical devices.

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Gage Pressure Decay Calculator from Uson

Are you a manufacturing engineer who has to deal with stringent leak rate specifications on a daily basis?

If so, I have some very good news for you. We have released a new Gage Pressure Decay Calculator. This fully automated test calculator will help you get almost instant answers to “What If” modeling of pressure decay leak testing variables. That’s not all; it will also provide you exact returns-on-investment (ROI) calculations from our new 8-sensor concurrent leak testing technology.

What can you do with the Gage Pressure Decay Calculator?

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Leak Testing for Sealed Components

How can you test for leaks if the component is completely sealed, and has no ports or openings?

Leak tests are performed using a process known as the sealed component method. It is based on the ASTM Standard F 2338-09 for Non-destructive Detection of leaks in packages by Vacuum Decay Method.

This ASTM standard provides detailed information on the test process and shows that holes as small as 5 microns can be detected.

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