IFU’s are not required for medium to low-risk devices if they can be proved to be used safely in trials without the user having access to an IFU. However, this is often difficult to prove so IFU’s are generally found with most devices, and so the MDR stipulates that IFU’s should be provided with the device. IFU’s can come in the form of paper based booklets as seen with the NHS Covid-19 self-test, packaged with an inhaler, or on the exterior of devices such as EpiPens.
What an IFU should include and harmonised standards for iconography and text, layout etc is heavily detailed in MDR so all IFU’s with devices sold in the EU follow this regulation. It does make provision for the use of electronic based IFU’s for both ease of understanding and environmental reasons, however, these are less familiar than those detailed above.
The purpose of an IFU is mainly to both protect the customer and the manufacturer as it removes equivocality from the intended use of the device. Although IFU’s are included with every device, there are still regimes for training devices which suggests that in some situations the IFU is a protective document rather than a functional one. So, with this in mind what might be in store in the future of IFU’s?
Our approach at HD places our primary focus on designing devices so that the user can pick it up, and unequivocally discover the intended steps and use of the device. A nice storyboard on a piece of paper should be seen as supplementary not a primary means of discovery. Why is this important? It means that the user is likely to remember the steps in a pressured situation, aren’t reliant on always keeping the paper with them, and it means that the likelihood of misuse in all situations comes down, lowering the risk level of the device. Maybe we can also save some paper! Interaction design methods such as visual/auditory prompts and good mapping can help build an IFU into the device itself.
With this being said, every person discovers things in their own unique way, and there may be circumstances where the device is perfectly understandable and the steps are clear for 80% of the population, but that 20% need something extra. There are also engineering and practical constraints that may hinder what methods of discovery can be designed into a device.
So, there are a few things to bear in mind when we look at where the future of IFU’s might lead, they definitely aren’t going anywhere!
The market has recently seen regulation on when/where eIFU’s can be used, these will slowly become more common place, but the key caveat for many of these is with assessing the risk that the user will not have access to technology. eIFU’s already offer a good alternative to cater for multiple languages; MDR dictates that IFU’s must be provided in the native language of the region the device is sold, with a large number of languages an eIFU is much more streamlined.
As new technology integrations continue to develop in medical devices, HD expects to see the way in which IFU’s are considered with a device to become more complementary to it. Some examples of how this might manifest are listed below:
The IFU’s purpose will not change over time and the format it is provided in will move with the times. As new tech allows for better digestion of instructions and training, innovation will slowly happen. Our goal is to make the user understand how to use the device as elegantly and seamlessly as possible, which in turn will result in better patient outcomes. How IFU’s are presented will only follow the trend of this, ultimately tech will be utilized to make information easier to digest.
Overall, the future of medical device instructions for use is likely to be shaped by a combination of technological advances, regulatory requirements, and evolving user needs.
We hope you enjoyed our insight.
Design Development Engineer
Rob graduated from the Dyson School of Design Engineering at Imperial College London in 2021 with a Master’s in Design Engineering. Prior to joining HD, he worked in the automotive sector using state of the art 3D scanning and 3D printing techniques. He has a keen interest in human centred, interaction and experience design and has expertise in additive manufacturing, CAD, IoT, UI and mechatronics.
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