By Joe Pustka

Staying one step ahead of the market by coming out with new design iterations consumers want proves to be a winning strategy for most.

Change the color to one that market research shows has more appeal? Why not!

Use a newer composite material that will significantly lower the device weight? Why not!

However, based on my experience developing leak detection systems for medical devices, considerable fat can be trimmed from new product development if more upfront consideration of every detail of full-scale production is made even at the earliest stages of prototype development. This could be that added lean manufacturing boost that so many seek in these economic times.

When product design considerations of newer models have had a large aesthetic component as a driver, there sometimes seems to be a lack of forethought that impacts testing. Whenever there is a change in the materials the device is made of or even the color of the device you have to think through modifications in the manufacturing process in far greater detail. 

Even the slightest change of shade of a device will have an impact on how it dissipates heat. That means that a leak detector will not “see” a device of one color the way it sees another. Usually, this means knowing that you are going to need to change settings in the leak detection equipment to account for that color’s intrinsic characteristics for heat absorption, reflection, or dissipation. Creating a new signature for the new color device is readily doable, but those designing assembly lines need to know that these alterations will need to be done if more than one color device is being manufactured on one line.

Does the new material being used for the device have different flexibility and stretch? Even mild modifications in those characteristics may require entirely new test fixture designs.

Best practices for prototype development mean calling in medical device test experts like Uson at the earliest stages of device development for no-cost consultations---even if it is considered a minor design change such as altering the hue a shade or two. Lower production costs, faster time to market, faster production lines---it’s a win, win, win. 

—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.