Have you ever, when using a cooker hob, pressed the button and the wrong ring has lit up?
Have you grabbed a door handle, pulled it and then seen the word PUSH?
Have you ever gone to the supermarket and used the self check-out for speed, then had to call for assistance?
If, like us, you’ve experienced any of these things you’ll understand why its important to get design right, after all, it could be a matter of life and death.
Usability Testing & Medical Device Design
We have been asked on occasion “Why bother with usability testing, isn’t it blindingly obvious how to use the device.”
Now take a moment and think about the everyday gadgets you own, how many of them were blindingly obvious to use: TV, Microwave, Cooker, Washing Machine, Phone, Shower, toilet flush, door locks.
Now consider the less common items, such as a medical device; diabetic pen, asthma inhaler, blood glucose monitor, digital thermometer, pregnancy test kit. What may be blindingly obvious to some is often completely missed by others, especially when they are part of the product development team – it’s a recognised phenomenon known as “group think“.
Human Factors and User testing provide you with feedback on your design (User Interface) from; Human Factors and Usability experts, Healthcare Professionals and importantly your Users. Using that information to inform your design’s development enables you to mitigate any potential design risks and use errors, improve the product by improving usability and uptake.
Human Factors – why it’s important for medical device development
In the last few years the FDA has adopted human factors engineering as an important tool in improving the safety of medical devices, including drug delivery devices. Similarly, the EU’s Medical Device Directives now include requirements for device manufacturers to establish and follow a Usability Engineering Process (ISO 62366).
This impetus to incorporate human factors knowledge and techniques into the device development process isn’t stopping any time soon. Since the FDA moved it’s Human Factors Team into the Office of Device Evaluations, 510(k) submissions for devices and combination products have been rejected because of weak, incomplete, or missing human factors data.
Imagine the cost to the companies concerned!
Could you afford not to address Human Factors as part of your development process?
Find out how we can help you, read more about our Human Factors services.