With populations becoming increasingly technically literate, there is currently great potential to rethink the way we can improve medical device instructional content through digital and web-based tools. These digital instructions, including informative web-based animations, videos and other virtual content, offer a wealth of opportunities to enhance the user experience through digital instructions for medical devices.
Traditional paper-based medical device Instructions for Use (IFUs) do not always support a positive onboarding experience for new users. It is widely known that, prior to first time use of a product, many users do not read the instructions thoroughly. Countless user studies and on market complaints data have shown that if an instruction can be misinterpreted, missed or ignored entirely, it will be.
Furthermore, the experience of interacting with a lengthy and sometimes cumbersome IFU prior to use can negatively impact your experience of the product as a whole. While improvements to format and layout, with a focus on reducing cognitive load, can go a long way to improving paper-based instructions, the potential of digital instructions opens a plethora of opportunities to improve the user experience.
Despite its potential benefits, the current lack of regulatory clarity around what can and cannot be included in digital instructional content has somewhat hindered its adoption. Finding a solution that works requires a balance of good design approaches, human factors and regulatory considerations.
Video and digital content is becoming an increasingly popular method of learning among different populations. Statistics show an average of 40% of internet users aged 16-64 watch online videos for learning on a weekly basis, while a report from Pfizer showed that 77% of almost 2,900 patients in England visited online sources to find more information about their medicines.
Indeed, many medical device manufacturers have recognised the need to include electronic instructions for use (eIFU) and other digital options for instructional content on their product websites. Alas more often than not for the user this means accessing the same written content as the paper-based IFU, only on screen. There are of course reasons for this. Regulatory bodies understandably want patients to see the approved and validated content when searching for the Instructions for Use online.
While having an eIFU available online does offer some benefits to users, such as the ability to view the information on screen, search for key terms or print additional copies out themselves, the potential limitations of the traditional IFU format remain. The challenge here is that paper-based IFUs for medical devices are written in a very specific way to meet regulatory requirements. Their evolution often starts from a task-driven process. The order of steps is driven by the task analysis and use-related risk assessment and the IFU must include all relevant warnings and cautions at each step. Though required by the regulatory bodies, paper-based IFUs are often ‘one size fits all’ and do not necessarily reflect how a device designer or a healthcare practitioner, would tell someone how to use their device in reality.
Beyond the simple eIFU, there are now a wealth of other digital approaches for instructional content, many of which have the potential to completely change the user experience. For example, videos and web-based tools can be used by device manufacturers to tell the story of device use in a more accessible way. Use steps can be displayed through animations, focusing on moving imagery to better visualise the process and guide the user through each step. By employing a variety of interactive and engaging features, users can experience tasks steps with a swipe of their screen or click of their mouse, enabling them to visualise correct use digitally, prior to interacting with the physical device for the first time.
Audio, video and animations offer a more dynamic approach compared to the traditional Instructions for Use as well, for example offering an easier way to include different languages and views. Information can be delivered at a set pace, with less potential for patients to skip ahead or miss key content, as they may do when reading an eIFU or paper-based instructions.
Exposure to digital health technologies has also increased in recent years, particularly during the pandemic when many populations were forced to adopt them. As a result, QR code scanning has become a more viable option for linking to online instructional content, with many device manufacturers now including it in their packaging and even on the device itself.
Digital instructions and approaches to training patients can be an effective way of addressing a variety of on market complaints for existing medical devices.
Take for example the issue of removing an autoinjector from the injection site before the injection is complete. Two-step autoinjectors have been designed to consistently deliver a specified volume (typically 1-2mL) of drug over a period of ~10-15 seconds into the subcutaneous tissue. Despite the device use being simplified to two steps – remove the cap and push down to activate the injection – in reality opportunities for use error still exist. Users of these devices continue to make foreseeable and preventable mistakes, which in turn lead to product complaints.
One particular challenge that all two-step autoinjectors face is user preconceptions. Often, prior to their first interaction with the device, a user will have existing beliefs of what an injection is and how long it takes to perform one. In human factors, this is known as the user’s ‘mental model’ of device use. Users often perceive that injections are quick or instantaneous. This is especially the case in recent years, where many people will have had recent injection experiences from a COVID-19 vaccination, an experience they recall being over in approximately 2-3 seconds.
This is compounded by the fact that most two-step autoinjectors share similarities with the design and appearance of an epinephrine autoinjector (e.g., EpiPen), which many people may have existing mental models of. Those experienced with injectables know that an intramuscular injection with EpiPen is very different to a subcutaneous injection with a two-step autoinjector. However, for untrained users and patients starting a new therapy, it is understandable and foreseeable that they may believe the injection will be delivered in 2-3 seconds.
While Instructions for Use can provide written content instructing a user to ‘press and hold for ~15 seconds’, this key information is likely to be buried in the detail of a leaflet or booklet that users are unfortunately often unlikely to read. A digital-assisted approach might convey this important instruction in one simple animation of correct use that a user could access via the manufacturer’s website or QR code.
Despite the benefits of these digital tools, careful thought must be given to how users (patients and healthcare professionals) can and are likely to access the digital content. This is as they inevitably require more work from the user compared to simply reading the paper-based instructions and using the device on its own.
This challenge can also be exacerbated when employing a drug delivery device companion app, which needs to be downloaded. It may need pairing with the device and require some sort of user sign-up to the system and the sharing of personal details. There can be a reluctance to do this among some people, meaning the manufacturer has to work harder to convince them of the benefits of the digital solution to get them to engage.
As a result, web-based content can be a more practical digital tool to implement, providing patients with access to support materials without the need to download an app or enter any details. QR code scanning has also become a viable option for linking to online content, with device manufacturers now including it in their packaging to guide users from physical labelling to digital content.
Whichever digital tool is used, it is important to consider a variety of prompts and behavioural design techniques to guide users towards it, utilising the various elements in the product ecosystem from the packaging through to the device itself.
The key to effective design is understanding the underlying behaviours, beliefs and unmet needs of your users. Conducting contextual research in patients’ homes is a valuable way to identify potential use challenges and obstacles to overcome through effective design. Once you have developed a contextual understanding of your user and their environment of use, a useful next step is to create a user journey map. The aim here is to map the different use steps and highlight pain points in a user’s journey – the areas of friction where improvements can be made. For example, there may be a point during the unboxing stage where you could guide the user towards your digital solution, such as a QR code on the device itself.
One of the key reasons digital approaches such as those described above have not been fully adopted to date is because the regulatory position on their use is still rather unclear.
Fundamentally, the health authorities will have the final say on what is acceptable or not. For device manufacturers, a key consideration is the consistency of digital instructions alongside the language and content included in the validated labelling. For example, does the introduction of a digital tool or instructional content introduce new use-related risk to users? Regulators are likely to ask this very question and it is therefore important to assess any digital tool with intended users and consider the implications from a risk perspective.
Further uncertainty remains around the feasibility of accessing digital content via the packaging and labelling for devices, for example via a QR code. One way to help ensure conformity here is by applying the exact same text as the IFU on any digital tools that are being used for instructional content, for example as subtitles to a video.
As noted, the potential to introduce new use-related risk by enabling users to view instructional content digitally needs careful consideration. For example, when employing a web-based approach, potential formatting issues might occur from viewing the page on different platforms, such as on a smartphone versus a laptop. The user interface (UI) design of these tools will need to be carefully considered to ensure that the device use steps and important safety information, derived from the use-related risk assessment, remain legible and visible across different formats.
From a use-related risk perspective, incorporating appropriate human factors engineering, analysis and assessments can help to build the necessary evidence to show that the right digital approach does not introduce new risks or contradict existing labelling.
Despite the regulatory uncertainty, there have been examples of digital instructional content being applied on the market. For example, Novo Nordisk offers web-based instructional content for their Norditropin FlexPro pen. Here, a QR code is used on both the product carton and Instructions for Use, leading to a webpage where the user is prompted to confirm the product they are using. A menu then enables the user to jump to specific sections or run through the process of using the pen on screen. Key information is highlighted at each stage, with wording drawn directly from the IFU, while scroll jacking allows the user to control the animation on screen to follow along with the use steps in time. The approach taken meets the expectations of regulators by including text from the IFU, however the focus is mainly on the digital content to show how the injection is performed. The key benefit of this approach is that users can pull up the page and follow it through live as they complete their steps.
Although this appears to be one of the first approved examples of digital instructions in Europe being used in this way, it offers some hope that more will begin to adopt similar approaches to providing digital instructional content.
It is natural for development teams to be nervous about adopting these approaches until there are more precedents out there, but the potential to improve the patient experience and differentiate from competitor devices is significant for those willing to explore such opportunities.
The IFU is a heavily regulated document and it is unlikely there will be any changes in validating the user interface. The industry is also a long way off from removing paper IFUs entirely. However, the use of digital tools, such as those described above, will continue to broaden how device manufacturers can tell the story of their device and improve the user experience for patients, helping to address on-market complaints and mitigate use errors. When applied effectively, these approaches will also become a way to differentiate products on the market and provide an important commercial edge.
This article was taken from Team Consulting’s Insight magazine. Sign up for your own copy here.
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