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Medical Device Design: Will It Be Used in a Harsh Environment?

How environment can determine a product’s success or failure

Roger Bohannan November 22, 2019

This is an excerpt from the medical white paper Designing the Ultimate Operator Experience. For the full white paper, download here.

 

The environment a medical device operates in matters.  Whether it’s a wearables device used for remote monitoring that needs to function in the world in which its user travels, to surgical devices that need to function in the sterile environment of the operating theatre – each has its own unique set of requirements and challenges.

For the switch component, this is an important consideration, since the environment will determine the level of protection that needs to be built into the switch.

Questions about how it will be sealed and whether it needs to protect against invasive fluids and contaminants all need to be answered to ensure the right switch is selected for the environment it will operate in.

In urban outdoor locations such as swimming pools, sports arenas or shopping centres these devices are exposed to extremes of weather and are vulnerable to tampering. Contrast that to the more controlled and sterile conditions of medical facilities where they are exposed to damaging fluids and harsh sterilising technologies.

More than any other industry, medical and critical care equipment needs to perform in a diverse spectrum of conditions. From exposure to blood and body fluids or harsh sterilization chemicals, to getting bumped around in the hectic atmosphere of a hospital emergency room – this equipment needs to be corrosion-resistant and durable. Components that can handle a serious impact or an operator pressing too hard on a button, for example, help the medical device to work reliably for years – even in challenging situations.

There are different applications, different configurations and different capabilities required for switches in these environments. A switch can be sealed to either IP67 or IP68. IP67 means the unit can be dropped into a body of fluid up to a meter deep for half an hour, while IP68 guarantees protection in liquid up to 1.5m deep for the same period.

Roger Bohannan
Roger Bohannan

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