10 MIN READ

Rethinking one-size-fits-all

As medical device designers, we care greatly about patient experience. Let’s face it, you don’t desire an inhaler or auto-injector. They are necessary products to manage your health or even save your life, yet they evoke a number of negative emotions, such as confusion, fear and anxiety.

The patient experience is affected by every touch point – by the device, the instructions, the packaging, even any supportive mobile apps offering reminders – and so it is important to think holistically when designing the device to ensure that themes and messages are communicated consistently.

However, we need to go one step further and ensure that devices are targeted as closely as possible to the physical and emotional needs of target users as by doing so we increase the chance that the device will be used and used correctly. This is not the silver bullet for improved compliance but is one positive step towards this noble ambition. It is certainly a departure from the current one-size-fits-all approach which is the norm, but which does not meet the expectations of patients used to living in a world of choice where they surround themselves with products – from cars to toothbrushes – that meet their unique emotional, physical and lifestyle needs.

Although the pharmaceutical industry will never copy consumer products, there is a middle ground to aim for where safety and efficacy are proven but where patients also have a number of options which, by meeting their ‘lifestyle’ needs, improve their compliance with the device they are given. After all, the device isn’t ‘just packaging’, it is the interface between the drug and the patient.
 

Compliance

For some time there has been a suspected link between user satisfaction with a device and compliance with treatment regime. This has been difficult to quantify because a range of consumer styled device variants isn’t commercially available.

In 2012, however, UK supermarket chain Asda started selling asthma inhalers over the counter without prescription, potentially starting the trend towards greater consumer choice. When a doctor prescribes a medication they make the decision for the patient. When the medication moves into the store, the patient makes the decision to buy based on aspects important to them, such as look and feel, brand name, features, functions, and on the opinion not only of prescribers but also of friends, peers and online communities.
 

More information

Information is no longer restricted to what the prescriber says. It is possible to share and form opinions online and what somebody’s peers say on Facebook can have considerably more impact on choice.

 
More competition

Competition between therapies, already evident, will only increase as more and more drugs and devices come off-patent. The generic players will look for opportunities for differentiation, and whilst they can’t change the core device, design does provide an opportunity to gain advantage.

One of the best examples from within the medical sector is the Novopen from Novo Nordisk, which for many years has exploited the power of design to create devices with strong appeal and emotional connections, such as the Novopen Echo for children which can be personalised. The device has the same core functionality and the same device architecture but minor modifications make it more appealing to different user groups.

Patients are diverse. They have different cognitive and physical capabilities, different lifestyles, attitudes, beliefs, aspirations and preferences. Their device requirements are affected by their age, location, who they live with, their job, leisure pursuits and, importantly, their attitude to their condition. A 12 year old girl in upstate New York is very different to a 70 year old woman living alone in a Paris suburb, yet their treatment regime may be very similar and – at the moment – the drug and device they are prescribed will be exactly the same. A further level of differentiation is added by the growing number of users in emerging economies, so the issues presented by diversity are not going to disappear.

Current drug delivery devices are a bit like Ford’s original Model T – available in any colour as long as it’s black. This one-size-fits-all model is not used in other successful markets and presents a commercial risk if your competitor’s product has greater appeal to a significant market segment. But we are not designing kettles or toasters. In the pharmaceutical industry we don’t have the luxury of making post-launch modifications and updating models every 12 months to keep up with trends. This focus on a single device exists for a good reason as the development and regulatory burden of marketing multiple variants is time-consuming and expensive. So as the industry is pushed towards greater consumer choice, what is a realistic target?

We can’t ignore the regulatory hurdles. Any change that impacts on performance and you are back in the clinic. Change the user interface – even change the instructions – and you’re back to human factors studies to prove that it doesn’t affect performance. It is important to acknowledge these hurdles, and that they aren’t simple to overcome, but there is a way of structuring the device architecture to give us maximum design freedom whilst limiting the effect on costs and timescales. Even if you are licensing-in a platform it is important to understand the potential for customisation whilst undertaking due diligence.
 

What do we mean by device architecture?

It is possible to break a product down – in this case a drug delivery device – into layers in order to isolate each component of the design, assess design choices, and look at the combined product – the device architecture.

Firstly, start with the device core – this could be the engine, the primary drug containment, the mouthpiece and airways (if it is an inhaler), or the delivery mechanism (if it is an injector). Consider the device core as sacred. Change it at your peril! So what other options do we have?

  1. Form factor – The shape and size of the device
  2. Features – Such as a dose counter, compliance monitor
  3. Aesthetics – The look and feel of the device
  4. IFU / IPL – The instructions or patient information leaflet
  5. Carton – The carton in which the product is supplied
  6. Accessories – Any accessories that the devices is supplied with
  7. Apps – Any mobile applications which the device or patient interfaces with

 
The device architecture

Each stage offers opportunities to modify the device or to personalise it. Any variation will cost time and money so we need to decide what design changes can be justified. But how do you make this decision? The answer is by introducing real users into the design process and carefully considering the impact of any change from a regulatory, commercial and technical perspective.

To demonstrate what is both possible and reasonable, let’s briefly look at three inhaler users with three different design briefs.

– User A

John, a 48 year old Marketing Director. He travels a lot on business and likes to travel light. He wants convenience, recognises quality products and can afford them, but is sensitive to the environmental impact of throwing away lots of plastic. The look of his inhaler matters but probably less than the size.

– User B

Tom, a 12 year old school boy with a very active lifestyle. He needs his inhaler when he is away from his parents but needs encouragement to take it correctly, and monitoring his use is a constant struggle for his parents. Tom cares what his inhaler looks like and what his friends think about it. He isn’t careful with it and throws it into his sports bag. Size isn’t a particular issue but robustness and personalisation are.

– User C

Mary, a 75 year old woman living in a warden controlled flat. Her inhaler is only one of a number of daily therapies. Mary gets quite confused and it is all about ease of use. Size isn’t important, if anything she’d like her inhaler to be bigger, and easier to handle. She finds technology confusing but like John, she doesn’t like throwing things away.

There are common requirements relevant to all these users but there are also some very specific requirements. Mary wants a larger inhaler, Tom and John both want a small and compact device, so we choose the small device as our base product. Tom needs something he can personalise, Mary and John don’t, but we should consider this when developing the base product. In this example, a common capsule inhaler is the device core.

Solution A

The base product would satisfy John. The inhaler features a secondary (factory fitted) component which allows customisation for different users and includes a mouthpiece cover (a non-critical part) that can also be customised. The overall aesthetics give a feeling of quality and efficiency, whilst the form factor is compact with smoothed edges to make it pocketable. The increased length of the mouthpiece cover protects the airways and piercing buttons whilst in a pocket, and a capsule storage compartment improves convenience.

Solution B

Aimed at Tom, the base component is manufactured in a rubberised material to improve robustness and integrates a compliance monitor, allowing parents to check usage. The same mouthpiece cover component is designed with a single curving surface to allow Tom to apply self-adhesive skins to personalise it.

Solution C

For Mary the small compact base now has a larger tapered base which allows her to hold the device firmly against a flat surface when loading. The device also has a larger tapered cap and added grip all over to improve ease of handling.

These devices are designed to meet the needs of three very different user profiles but are based closely on a ‘one-size-fits-most’ product with no changes to the device core.

This approach can also extend to device peripherals such as the packaging, instructions and supportive mobile apps. For Tom, for example, the packaging could use brighter colours, the box could feature a pack of self-adhesive stickers, and the instructions could be designed in a youth-orientated style and could contain other information about the device and asthma.

To date, choice has not been a concern in the pharmaceutical industry but the significant market drivers in the market around compliance, consumer choice, availability of information and increased competition mean that we need to start thinking this way. Yes, there are still regulatory burdens, and commercial barriers, but by adopting a user-centric design approach from the outset, structuring the device architecture to facilitate customisation, and considering how other product aspects can enhance the user experience, it is possible to create more appealing devices whilst working within necessary industry constraints.

This article was taken from issue 4 of Insight magazine. Get your free copy of the latest issue here.

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