For many years, industry attention in clinical trials was heavily focused upon the data. As the industry has evolved, so has the realisation that the quality of the data is contingent upon patient engagement with the investigational drug product. If the medication is not taken properly, the success of the product is compromised, resulting in false or unusable trial data.

In response to this, there has been increasing discussion of patient centricity over the past several years. This has resulted in a reconsideration of the traditional methods of drug development and commercialisation, including how the concept can be applied within clinical trials. The approach offers benefits for all stakeholders, including patients, pharmaceutical companies and healthcare providers.

However, unlike the consumer sector, the industry has not readily embraced patient centricity with regard to packaging, but this looks set to change. Craig Scott has experience of working in both fields and is keen to incorporate end-user engagement into product development. Having worked for Kimberly Clark, Johnson & Johnson and Pfizer, he is not short of credentials and has a clear passion for incorporating the patient perspective into standard working practices.

The industry can learn a lot from consumer companies, which have a long history of putting the customer at the centre. “I did a bit of work recently for a recipe box company,” says Scott. “All they wanted to do was watch people open the box, over and over again. That is true person centricity. They wanted to know what the unboxing experience was like.”

This approach has not historically been adopted within the pharmaceutical industry. “The traditional pharmaceutical model used to be ‘create a new medication, stick it in a pack and launch it’,” says Scott. “Really, the gatekeeper was the prescribing physician.”

Doctor, doctor, I know exactly what’s wrong with me

The model is starting to change, however, with patients becoming increasingly involved in their treatment, including the medications that they want to receive. “There is now a new model in healthcare where patients are walking into their doctor’s office saying ‘I’ve been on Google’,” Scott says. “Patients are far more informed; they are actually requesting specific medications by name, which never used to happen, and they are influencing the healthcare provider.”

This means that patients are starting to become the gatekeepers, and their needs and preferences are thus becoming of greater importance for drug manufacturers. But what does patient centricity actually mean in practice? “It is not rocket science; it is simply spending more time with your patients to understand their needs better,” says Scott. “That applies to packaging, medications, medical devices – anything really.”

When integrating patient centricity into packaging there are some key considerations. The first, unsurprisingly, is regulation. “You have to do human factors research, which is driven primarily by safety,” says Scott. “If you’re working, for example, with an auto-injector for diabetic patients, if they press the button, does the syringe fire as it should? That kind of research is done for due diligence and safety, and it is very necessary.”

Of course, this kind of thinking also applies to packaging, which must be safe for patients to use, as well as being child-resistant.

Although safety is clearly imperative, patientcentric packaging means thinking more broadly. “What we look at is emotional needs as well as practical or functional needs,” says Scott. “Is the packaging easy to understand? Is it easy to open? Does it do everything it needs to?”

This means engaging patients from the start of packaging development. “A classic example is if you have a medication that is targeted more at elderly people, hand dexterity is often an issue, and so if you’re going to launch your medication in a pack that is fiddly as hell, it’s not going to work,” says Scott. “How do you know whether they will find it fiddly or not? Well, you go and research it, and you observe them and ask what is was like and if it was easy or not.”

It is not just the practicalities that are important in patient centricity. “Emotional needs are also important to consider,” says Scott. “A lot of the medication packaging seems to be white, for some reason – I don’t understand why.”

Although such packaging might be the most convenient way to get the drug to a patient in a clinical trial, it is not necessarily the most effective. Adherence, which can be as low as 30–40% for certain conditions, can easily be improved with some small tweaks. This requires a different way of thinking about packaging.

“I think you have to go right through to the end-user experience of using a pack,” says Scott. “Depending on how frequently you take a medication – every day or multiple times a day – it is still an opportunity for you to develop something that is patient-centric, easy to use and demonstrates your brand’s values.”

Interactive packaging

This might involve, for example, providing medications in a unit-dose format demonstrating exactly how it needs to be taken and when. Compliance-prompting packaging can also be used so that participants can monitor their progress and keep to the regimen. There is also scope for incorporating interactivity into the packaging, such as providing a prompt to take the medication, an ability to provide feedback on the experiences or connecting patients with communication tools as part of the trial.

These capabilities not only boost patient adherence and engagement but also provide realtime information for researchers. This can be particularly valuable in adaptive trials, for example, where the data can be drawn upon during the course of the study. For Scott, failing to include these elements is a missed opportunity. “I just don’t think patient centricity in packaging is valued,” says Scott. “Companies assume there’s no return on their efforts, but that just isn’t the case.”

This work does have a considerable cost, in terms of time and money. If looking from a purely shortterm perspective, little benefit is to be obtained from incorporating patient centricity into packaging. However, if adopting a longer-term and more holistic approach, this work has a clear economic benefit, as it increases the chance of success once the product is on the market.

Embracing patient centricity in packaging means standing out. While companies are keen to do this from a product perspective – with the continual quest for innovative therapies – they are typically much more reluctant when it comes to packaging.

“My experience of working in the industry is that they are very wedded to the techniques they use, they are very comfortable with them and they’re conservative, which they have to be to some degree because of the regulations,” says Scott. “When pushing them to do something differently, their instinct is to push back because it’s not familiar.”

For companies willing to take the first steps in this arena, there are substantial gains to be made. “If you did some research on a particular medication and you found that there was something you could improve, there is a point of competitive advantage,” explains Scott. “It’s something you can talk to healthcare professionals about, saying to them ‘this is something our packaging does that another doesn’t’.”

This means being willing to ask questions. “Really, the only way you can find out is to go and explore, spend some money, do some research,” says Scott. “There are not many companies willing to have a punt to see if there is some competitive advantage that could be used.”

So what does the future look like for healthcare packaging? “I think healthcare companies will become more patient-centric,” says Scott. “But at the moment, they are talking the talk but they are not following through.”

This certainly isn’t going to happen overnight. “I think it is a matter of time; I think it will take a lot longer than we expect,” says Scott. “Probably more than a couple of decades.”

The rise of digital technology, however, might fasttrack this process. “What’s interesting is that mobile health tech will have a major impact,” says Scott. “If you look at these providers, who are delivering health metrics, such as tracking exercise or heart rate, they are straying into the healthcare industry; and they bring fantastic consumer-obsession skills with them.”

This could serve as a major wake-up call for the industry. “That would be a trigger for pharma to think, ‘we’ve got some new entrants into our market who are doing some interesting things and we need to up our game’,” says Scott. “Existing companies could be blown out of the water overnight.”

Drivers of pharmaceutical packaging innovation – a case study

Proposition 1

Technology development drives pharmaceutical packaging innovation.

Proposition 2

Legislation drives pharmaceutical packaging innovation.

Proposition 3

There is a lack of logistics, marketing and sustainability drivers of innovative pharmaceutical packaging solutions. Innovation is most successful if there is a broad spectrum of drivers, so the lack of drivers is a barrier to pharmaceutical packaging innovation.

Proposition 4

Introducing new driving forces creates opportunities not only for meeting society’s demands on pharmaceutical packaging but also for new business.

Proposition 5

To move from product-centred to patient-centred packaging innovation, external driving forces need to pull innovation towards the patient rather than having innovation pushed by suppliers and manufacturers.

Proposition 6

Innovation managers who carefully consider the pharmaceutical packaging needs of multiple stakeholders can realise unexplored business potential.

Proposition 7

For innovation managers, not only is the drug product and the way it interacts with packaging relevant, but the way the packaging affects stakeholders and the environment is also of interest.

Source: Drivers of pharmaceutical packaging innovation: a customer-supplier relationship case study,
Journal of Business Research