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Pharmaceutical Manufacturing and Packing Sourcer

The Perfect Fit

Virtually any consumer item, from cars to smartphones to toothbrushes, can respond to our desire for choice, or can offer personalisation of some kind. Take the example of cars: the Fiat 500 is a remarkable success story, and Fiat make a big thing of personalising ‘your’ 500. If you walk into a Fiat showroom you will be told that the range of engines, trim levels, colours and optional extras is so extensive that the 500 is available in about 500,000 different permutations.

Why should this not apply to drug delivery devices and other pharma products? No one asks to suffer from asthma, diabetes or any other condition. But if you are told that, from now on, life must include the means to deliver your medication, why should this be devoid of choice or personalisation? After all, people are vastly different, even if they suffer from the same condition.

Personalisation Challenges

Users can have a range of different cognitive and physical abilities. Some may need devices or tablet packs that are simpler and easier to handle. This could be due to the condition being treated, or in some cases it may be other, unrelated conditions which limit dexterity or strength. Others may have problems reading or understanding instructions for use.

Equally, patient and user lifestyles will differ widely. The patient or user’s attitudes and beliefs can play a significant part in their attitude to the drug delivery device they have to use. For instance, some may regard environmental impact as the most serious consideration in device choice and thus they don’t like the idea of throwing items away.

The aspirations and preferences of users are particularly significant where younger patients are concerned. For a small child, he or she may like a device that includes an image of their favourite cartoon character. For teenage users, this can morph into a requirement that the device is cool.

There are some examples where manufacturers have tried to approach serious pharmaceutical products with personalisation in mind. Self administration of insulin is over 60 years old, and Novo Nordisk was the first company to offer a ‘pen’ type injector device back in 1985. Its most recent pen attempts something different by including a choice of stickers, which allow the product to be altered or personalised.

This may sound ‘superficial’ but it actually has a significant impact on patient appeal and, in turn, on the entire user experience. If we are talking about a device which effectively has to become a part of the user’s life, is it really so superficial after all? Just think about the emotional relationship which increasing numbers of normal, rational people have established with their smartphones.

So what freedom do we have and what opportunities are there for innovation to enhance the user experience in relation to a drug delivery device, bearing in mind the tightly regulated field in which such devices exist?

Innovation Potential

Actually, there is quite a lot of opportunity for innovation as we move away from the ‘device functional core’ and into the areas closer to the ‘patient interface’ (see Figure 1 on page 12). This includes the aesthetics of the device, accessories (such as a cover – once again, think about the smartphone market), the outer packaging (carton, literature), and not forgetting the possibility of peripherals such as smartphone apps.

As an example of what is possible, look at the capsule inhaler. Just like the insulin pen, this has been around for a long time and has proven its functional effectiveness. Importantly though, both are supplied to a very wide spectrum of patients, all with a similar condition but very different requirements and aspirations.

User Profiles

To illustrate this point further, let’s explore the creation of targeted products for three quite different inhaler user profiles, while making minimal changes to the base product.

Firstly we have John, a 48-year-old marketing manager. He is away a lot on business and likes to travel light – it’s all about convenience, having everything together and accessible when required. He recognises a quality product but is also sensitive to the environmental impact of throwing away masses of plastic every month. Device size is more important than appearance or style. Hence the brief is to provide a small, discreet, self-contained device that minimises waste.

Next is Tom, an active 12-year-old schoolboy. He needs his device when he is away from his parents, but requires encouragement to take it correctly. Monitoring his compliance is a constant struggle for his mum and dad. Regarding usability, Tom can work out how to use most things in a matter of seconds. He cares what his inhaler looks like and what his friends think about him. He is probably not quite as careful with it as he should be – it gets thrown into his sports bag and kicked around the changing room after rugby. Size is not a particular issue as he has plenty of other stuff to carry around and his bag has more than enough space to fit things in. So for Tom, the brief is to create a robust device that can be personalised and allows his parents to monitor compliance.

Finally we have Mary, who is 75 and lives alone in a warden-controlled flat. Her inhaler is only one of a number of daily therapies she takes, including drugs to control her arthritis. For Mary it’s all about ease of use. She gets quite confused about what to take when. She would like her inhaler to be on the larger side, and easy to grip and handle. Mary finds technology confusing and likes things to be simple and uncomplicated. Like John, she is uncomfortable throwing things away and would much rather have something she could clean and reuse. The brief for Mary is a simple product, low tech and familiar, easy to utilise, with a minimum of waste.

Meeting the Briefs

The starting point for this approach has to be the device core, which actually delivers the medication. In the case of the capsule inhaler, this comprises: a capsule chamber; a piercing mechanism to provide access to the drug within the capsule; and an air path which goes from the inlet ports on the device, via the capsule and its chamber, and exits at the mouthpiece. The device core – the engine – determines the aerodynamic performance of the device and hence its pharmaceutical performance in conjunction with the powder formulation of the drug (see Figure 2). It therefore cannot be altered and stays the same for all users.

However, as we move away from the functional core of the device we can explore the other features and aesthetics. These deliver the user experience, including the impressions of quality, efficiency, style and overall lifestyle ‘fit’.

To address the brief for John, the length of the mouthpiece cover is increased, which protects the airways and covers the piercing buttons while in a pocket. The form is kept compact with smooth, rounded edges – again making it more pocket-friendly. A clipon capsule storage compartment has been added to improve convenience – a key aspect for John, who wants ‘everything in one place’ with no fuss.

In Tom’s case, the same cover is used as John’s, as the protection of airways and piercing buttons is equally useful to any user. However, because the cover has been designed with single curvature surfaces, stick-on ‘skins’ can easily be applied for personalisation. The clipon storage compartment that John required is replaced with a rubberised base (Tom can be careless so the added robustness will be useful). This base also includes a simple compliance monitor, which allows Tom’s parents to monitor his compliance.

Finally we come to Mary, for whom it is all about ease of use. She needs something that is easier to handle so the small compact base is replaced with a larger, flared base; this allows Mary to hold the device firmly against a table top when loading. A larger, flared cap is added alongside a ribbed, rubberised surface to both cap and base, improving ease of handling. All three configurations for John, Tom and Mary are shown in Figure 3.

What About Manufacturability?

For any volume-produced drug delivery device, success ultimately depends on maintaining a balance between three fundamental attributes:
  • Functionality – does the device perform reliably in accordance with specification/label claim?
  • Usability – can the patient/user use the device effectively and safely?
  • Manufacturability – can we produce devices which meet the usability and functionality criteria at a commercially acceptable cost?
The approach suggested here has to adhere to the same principles. Clearly, the technical performance (such as emitted dose, or fine particle fraction) remains a function of the core device and must be satisfactory. The characterisation to suit user personas is intended to improve the relationship between user and device, and as such can actually improve usability (for instance in Mary’s case) and hopefully enhance compliance (in Tom’s case).

The major components (the device core) are unchanged across all variants, so the considerations of design robustness, capability and design for assembly remain exactly as they should for a high-volume, high-integrity medical product. Some differentiating features – the three alternative bases (capsule container, compliance monitor and flared base) and the flared cap (for Mary) – will require additional mould tooling and some flexibility in the assembly process. However, the suggested approach avoids changes which affect the tightly regulated core device features.

Other Factors

As with any product, the first contact the user has is with the outer packaging. Anyone who has a smartphone will appreciate the thought and care which has gone into the carton and packaging, all of which contribute to the overall user experience. Again, why should it be any different for medical devices? Figure 4 illustrates three different ‘unboxing’ experiences to fit with the three different device configurations.

For John and Tom, the shape and dimensions of the inhaler are the same, so the carton is the same footprint. On opening his carton, John finds a quick start guide (QSG) telling him how to use the inhaler, then the inhaler itself and finally the patient instruction leaflet (PIL).

For Tom, the carton is much the same, though it may have a ‘younger’ outer graphic (which could be a printed sleeve to allow a common carton). Inside, the QSG is a booklet designed in a youth-oriented style, containing both instructional and education information about the device and managing his condition. The inhaler is next, beneath which is a selection of stick-on skins to allow Tom to personalise his inhaler. A slip-over pouch in a waterproof neoprene material to protect the inhaler could also be included, followed finally by the PIL.

A slightly different approach is shown for Mary. The carton is larger to allow large, clear text. The device is accessed after several flaps which, when lifted, provide a step-by-step guide to correct use. The PIL has to be included but is below the device (and is unlikely to be read by Mary). There is nothing especially challenging in terms of cartoning and inserting requirements, although some flexibility in setup is clearly a key requirement.

Benefits from Producer to User

The approach suggested does require that some regulatory issues are dealt with (though these are certainly manageable). Inevitably, there are also commercial implications to introducing some diversity to what was formerly a ‘one-size-fits-all’ product.

However, the potential opportunity that this approach offers needs careful consideration. A number of studies in recent years have indicated that, across the board, average compliance levels are seldom much better than 50 per cent. If we can provide patients with devices which are not only effective, not just usable, but which actually relate to the patient and his or her lifestyle and circumstances, it is reasonable to expect that compliance will be better. In other words, John, Tom or Mary will feel good about owning and using their inhaler, or insulin pen, or any other device, and they will be more likely to comply with the use regimen. After all, this is exactly what we see with other products outside the pharma and medical field, so why not within it?

If we accept this proposition, then we should also expect the clinical outcomes to improve – the condition (such as asthma or diabetes) will be better managed, which is great for the patient, the healthcare system and those paying for it. As for the company which markets the personalised device, it is entirely reasonable to expect that they would see an increase in market share and customer retention – ‘doing well by doing good’ if you like.

Does a more holistic, patient-centric approach to design, which can provide benefits right through the chain from producer to user, sound too good to be true? We can become too cynical sometimes; if this does work for the patient, then why shouldn’t the benefits ripple through the system? There is an opportunity here to be grasped. 


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Andy Fry is a founder of Team Consulting. He has played a leading role in developing the company’s drug delivery business, both in development of client and partner relationships and in technology solutions. Andy is a mechanical engineer by profession, with over 25 years’ experience in medical device development. With a background in materials processing and manufacturing automation, he has been instrumental in transferring best practices from manufacturing industry to the pharma and medical sector.

Paul Greenhalgh, Director of Design, heads up Team Consulting’s Industrial Design group, working closely with clients and colleagues on projects and driving innovative approaches to designing medical devices. He is a passionate advocate of the importance of ‘good design’ and is involved in all stages of development and project management, from product strategy to seeing devices through manufacturing.
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Paul Greenhalgh
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