Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to secure the bike and the plastic strap was broken. The strap is not removable or replaceable, so for now I’ll have to stick to running. Luckily, I have my receipt and the manual that came with the bike rack – and it says there is a lifetime warranty. I wrote a short note to the company explaining my situation and am hoping to get a positive response.
This situation got me thinking a lot about product reliability. To me, the broken bike rack is a mere inconvenience. But what if you had a medical device that didn’t live up to your expectations? Even worse, what if that medical device was an implant?
We’ve seen it happen time and time again, recalls of hip implants, vaginal mesh, pacemakers… and it makes me understand even better how important the roles of quality and reliability are. Reliability folks have a really important job in the medical device field - they need to be able to design tests to stress a product to its limits, and show that it can still be safe and effective. Tests such as HALT (Highly Accelerated Lifecycle Testing), Environmental Chamber Testing and Use Case testing can reveal vulnerabilities with the product far before it hits the field.
Even if the device you are making is not an implant, quality and reliability are still very important. Just like the bike rack manufacturer, many medical device companies offer warranties for the product. If quality and reliability are low, you will likely see a lot of returns within your warranty period, and your costs will be high.
Reliability is important to every business – everything from a Class 3 medical device, to an ordinary bike rack.
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