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HEALTHCARE, ACCESSIBILITY, REGULATIONS

Accessibility in Healthcare: Underestimated Pitfalls With Packaging & Labelling

Everything has been thought of in the new innovative therapeutic device for patients with rheumatoid arthritis: an ergonomic shape, clearly distinguishable controls for different modes, clear operating instructions for setting up and using the device. And what was the showstopper? The packaging. Due to the limitation in fine motor skills, it was extremely difficult for patients to open the packaging of the device. In addition, the patient information leaflet (PIL) and instructions for use (IFU) are sealed with adhesive tape that can only be removed by laboriously scratching it off. Does such a packaging design make sense for this disease with its accompanying symptoms?

6

MIN

May 7, 2024

This is not an unusual case. The packaging and often also the instructions for use or other accompanying material are often the first contact users have with the medical or drug device – and imagine you want to open the packaging of your drug delivery device, improving your well-being or that is even vital and you struggle opening the packaging or the instructions for use, possibly also combined with pain? In most cases study participants often told me in these cases, that they would ask their physician for an alternative drug, store the devices differently than intended or would always need to ask another person to prepare the devices for them. So, no matter how effective and good the product may be, if users fail right from the start due to poor packaging & labeling design, the experience with the product suffers and with it the perceived comfort.

From various usability studies the team and I observed that when it comes to packaging & labeling materials, such as the instructions for use, user-centricity incl. accessibility aspects, such as focusing on the intended user group(s) and their specific characteristics, are not very well considered. Who is going to use my product? What cognitive, physical, sensory or environmental limitations do my users have? What do I need to consider in the design of the packaging and labelling?


Assume the worst case scenario

In the IT industry, the design of a website, for example, is always based on the worst-case scenario of a user. In IT, this is a person who has no prior knowledge of computers. Ideally, the aim of the design is for the user to be able to navigate the website intuitively and without any obstacles. Well, we do not usually talk about websites in the medical device and healthcare industry, but we should also take this approach into account here.  The "worst case" here can be the degree of limitations a user has due to e.g. their disease and (lack of) prior knowledge.

Is your product designed in such a way that the "worst case", i.e. a severely impaired user with no prior knowledge, can use it without any problems? What could go wrong when using it? What happens if the packaging is roughly torn open, perhaps because the user has a tremor? Is there a risk of the product to be damaged, e.g. by dropping onto the ground? All these questions need to be considered – making accessibility aspects part of risk analysis.


Small remedies can have a big impact

Things like a clearly visible perforation can work wonders. A medical product manufacturer has also taken perforations into account for its adhesive sealing tapes for the packaging of a drug delivery device, but the tape was laboriously scratched off by the users. The perforation was just not noticed. Small color highlighting can already help here to ensure quick recognition.

In principle, color coding is always a good tool for highlighting elements. But which colors would you use to make important elements easily recognizable?  Red or green, the classic signal colors? What about people who have a red-green color vision deficiency? For them, the bright green could just be a dull grey, which may not be perceived as a highlight due to the rest of the packaging or labeling design.  And elements in the color grey are often interpreted as "inactive" or "unimportant" - and this is where problems can arise. I'm not saying you should never use red or green - it's just a simple example to illustrate what difference a color choice can make for users with impairments. Well, as it is often the case: it's the little things that can cause big problems.

Let's stick to the topic of vision: Is your product intended for an older user group? Studies show that more than half of all Germans need a visual aid (https://www.aerzteblatt.de/nachrichten/109584/Mehr-Brillentraeger-durch-mehr-Bildschirmnutzung), and the trend is rising with age. How large is the text on your Packaging & Labeling? Have you considered a larger font in the instructions for use? Do you only work with text or also visuals and commonly known symbols?

And even more should be considered: What situation are users in when they use the product? Are they in a calm environment or perhaps in an emergency situation where quick action is required?  Do they have the time to read a huge amount of text in small font size or would rather need a quick reference guide using clear visuals?

Such "little things" as a colored perforation or large text, easy language and visuals which have an enormous effect on the intended users experience, can set a product apart from the competition – and yes, starting with the “unboxing” experience.  


Low-threshold is the keyword

Imagine one of your intended users wants to setup their new therapeutic device. The person gets stuck at one step in the instructions for use. What options do you have here to help the user as simple and fast as possible?  The "standard" support would be to print a customer service number somewhere in the instructions for use.  This is not particularly low-threshold. Normally, this is also small or hidden and the hurdle of actually calling a support number, being stuck in the waiting queue is often high – and depending on the intended user group not the fastest and most comfortable way.  Low-threshold and simple approaches could be to offer the option of an electronic IFU (eIFU) via a QR code or the code leads to a website with FAQs or a help chat portal. This also has a practical side effect: if you provide the customer with "help for self-help", this also reduces customer support costs. Plus, it is always beneficial to provide multiple options for help, to address different preferences and situational circumstances.


Keep it clear and simple

Have you ever noticed that instructions for defibrillators only use pictures? In theory, even a child can understand how this device works. A picture is worth a thousand words. Use clear visuals in the instructions for use or even create video tutorials to provide users with further, simple assistance. Again, think about the issue of accessibility and possible limitations of your intended user group when providing further assistance materials. For example, for type 1 diabetes patients, visual impairments can be a symptom. Therefore packaging & labeling materials should work with high contrasts. Symptoms such as fatigue, sleep problems, or decreased mental sharpness, e.g. within patients with chronic kidney disease, can have an influence on the cognitive capabilities of a person. Therefore, instructions should avoid lengthy and complex descriptions, use easy language and visuals to decrease the mental load for these users, supporting them to easily understand the instructions for their medication.    


Medical technology: user experience on your own body

In the field of medical technology, safe use and a positive user experience are extremely important - especially when the products are used by the patient themselves or by relatives who have no medical training. However, anyone who has had a bad experience with a device on (their own) body will probably never use it again and will advise everyone around them against it. Because if something goes wrong, it can be accompanied by pain or other negative effects. This is why it is particularly important to eliminate all stumbling points for the intended users, starting with packaging & labeling, before product launch with the help of user-centered development, to ensure accessibility and comfort for all users.


Avoids costs, risks and dissatisfied customers: Establish user experience as a repetitive process

Poorly designed packaging and labelling materials can pose the risk of users not being able to use the product properly. If a syringe for example falls out of the packaging when it is opened incorrectly, and breaks, this can mean that patients are unable to receive their prescribed dose. The well-being of the patient can depend on good packaging and labelling design.

When designing products and associated materials, many parties need to find a compromise: Management, human factors, design engineering, regulatory, quality, sales, marketing and everyone else involved. It therefore makes sense to integrate a user-centered mindset into the development team right from the start. If a test shows that participants intuitively open the packaging from the top instead of from the side (as intended), the design team can use this finding to guide the improvements in box or labeling design, reducing the risk of the syringe to fall to the ground. Integrating such concepts into existing products at a later stage is significantly more complex and expensive than integrating them directly into the development process. In addition, a negative association with the brand and the product is prevented.

 

Our thoughts summarized: What should be considered for packaging & labeling design?

 

  • The central question: Who is my intended user group?

  • In which situations will my product be used (environmental restrictions)?

  • What (physical, cognitive, or sensory) limitations do my users have?

  • What hurdles do my users may have to overcome?

  • How can we keep these hurdles as low-threshold as possible?

 

A good user experience looks beyond the product itself and focusses on the overall (application) experience. This also includes the experience with the accompanying material, such as packaging and instructions for use. The design must adapt to the user, not the other way round. There are a lot of hidden pitfalls here that need to be discovered first. The good news: You don't have to tackle this alone. There are user experience experts who will support you with their knowledge and passion.

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AUTHOR

Tabea Daunus

Tabea is one of our UX researchers in Hamburg who has been conducting user research studies since 2015. As a certified medical device usability expert (TÜV), she is primarily interested in the area of medical device usability / human factors research. Standards and guidelines do not scare her, and she likes to work with attention to details. Next to research she is responsible for the quality (ISO 9001) and information security management (TISAX) at uintent.



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