The importance of medical devices is indisputable. But designing a successful product is a complex process taking into account not only the final function of the device but a range of additional factors too, including its interaction with human beings.
We wouldn’t buy a product and accept the fact it we couldn’t get it out of the box, hold it properly or find it awkward to store. If we invest in an upgraded vacuum cleaner for example, we assume we will be able unwrap it alone, that we can use the product easily and that it actually does what we bought it for – vacuum.
Given the crucial, often life-saving role that medical devices play, it’s not surprising guidance exists on product usability to ensure safe and effective products reach the market. Of course we would expect a medical device to perform the function it has been designed for but other factors also come into play – the testing or manufacture of the product or how easy it is for a healthcare professional to remove the packaging when needed? How easy is the device to transport and does it lend itself to scale-up?
