Why Are So Many Medical Device Companies Being Left Out in the Cold by their Suppliers?

By Joe Pustka

The worldwide recession lingers, and although new nanomaterials and similar post-millennial innovations continue to drive new medical device development, all reports are that the industry is affected by these global financial trends too. Why then, we ask ourselves at Uson, are we getting more requests for proposals for leak detection equipment than ever before?

As someone who talks to most of the device manufacturers knocking on Uson’s door for assistance with leak testing solutions, I’m not seeing most of our queries coming from new innovations. Rather, most of the time I’m talking to one or another device manufacturer who paid for a leak detector, put it to work, and then when it did not work any longer they could not get the manufacturer of their leak tester to help them diagnose what was what and find a fix.

For example, at the MDM West show last February, a gentleman came up and asked questions about our equipment, telling us that he had purchased a leak detector from another company and then could not get a return phone call or email. That’s not even basic civility where I come from. Somewhere along the line, at some companies, the notion seems to have developed that it is acceptable to just leave your customers out in the cold. That’s just not the way it has always been nor how it should be. 

Is this just happening in the realm of leak testing? I doubt it. It appears that some, and perhaps many, suppliers to the medical device industry have responded to recessionary pressures by cutting back on technical personnel and the ongoing R&D it takes to be ready to provide answers when a challenging application requirement presents itself.

That’s short term thinking and it doesn’t work.

Valves provide a window on what I’m referring to. 

One of the first things you learn about any leak detection solution, it that the reliable performance of valves used in the application will make or break its success. That means that any reputable manufacturer of leak detectors doesn’t just rely on the spec sheets of the valve manufacturer. Extensive testing and validation to ensure valves perform as specified over the many cycles that that leak detector will need to handle is a prerequisite. This takes months to do, but if you plan to be in business you can’t sidestep that kind of investment to ensure your technology is up to the requirements at hand. 

But it doesn’t stop at the R&D level. Because leak testing often involves pressurizing or exhausting the system where the valves operate, they have the potential to be affected by debris. That means you sometimes can use filters to keep out such debris, but that comes with the trade-off of needing to test the filter with every test cycle, lowering production capabilities. Valves differ in terms of flow capacities, their internal volumes, and how they interact with the pneumatic components of leak testers. All of these combines to mean that there is no one single valve that is perfect for every application. Often, customization of valves is needed for optimum performance. 

Valves, like any mechanical device, will fail over time. You can use electronic validation and calibration systems—and we would always recommend that. But there is absolutely no way around the fact that every test solution gets down to a dependence on valves and which one you select for your application is key. From what I’m seeing in terms of the new customers Uson gets from the ranks of the dissatisfied manufacturers of devices that must be leak tested, they were often sold a leak tester with lower quality valves – perhaps as a way for the leak tester manufacturer to lower the cost of their tester. Then, because the valves were not up to the application requirements, they failed prematurely.  That means that the entire leak test solution loses its required Gage R&R.  

It doesn’t matter if you are a supplier or a device manufacturer. We are all in business and we know that you just can’t give your customer all warm and fuzzy feelings up front bundled in with a lower price tag, and then just leave them out in the cold when things go awry. At least we all used to know this.  

Worried about cheap competitors taking away your market share? My advice: don’t take short cuts on quality or customer service and you’ll be all right.

—Joe Pustka

Putska (pictured on the left) is a medical device leak testing technical support manager for Uson, which first developed high accuracy leak testing methods for NASA, and since 1963 has specialized in leak detection, leak testing, and non-destructive testing for the medical device and medical packaging industries, among others. Putska works with medical device companies throughout North and Central America and has worked with Uson in various technical capacities since 1980.

Image of snow from Flickr user johnivara.