Incorporating human factors into pharmaceutical packaging can help ensure people receive better treatment and are able to live more productive lives. Dr Laura Bix, associate professor at the School of Packaging at Michigan State University, explains what this means for the industry and how it will impact market trends
Humans are complicated; we need a lot of different things to make our lives easier. Everyday factors like how we stand and walk can seriously affect on our well-being: repetitive tasks like sitting at a desk to use a keyboard can be detrimental to our health, depending simply on the angle at which we hold our wrists, for example.
Problems such as these, and the ways in which they are evaluated and solved, are known as ‘human factors’, which should be considered in all areas of consumer goods production. Dr Laura Bix, associate professor at the School of Packaging at Michigan State University, describes this transparency in the marketing level of production as "design that should empower people to meet and exceed their level of ability".
Human factors encompass various aspects of life that influence people and their behaviour. Most often, human factors are thought of in terms of how they affect people in the workplace. But in terms of pharma, it often comes under the remit of packaging design. Essentially, it asks the question: how can pharma companies deliver the best, safest and easiest-to-use packaging to patients?
Being human
Considering human factors means that when designing products, systems or processes, packagers must take into account how people will use them. A product should have positive psychological and physiological effects on the user, and must meet certain aesthetic properties to ensure that the user finds it pleasant to interact with.
Bix is an expert on human factors. She has sat on governmental committees on consumer, pharmaceutical and medical packaging; and she was a member of Committee F-02, the flexible-barrier-material committee. With a hand in many areas of the industry, she has a lot of insight to offer.
Bix sees a bright future in human factors, particularly in a user-centred environment where personal choice is paramount. "Packaging is an interdisciplinary field; generally, we focus on understanding the science between product and package in the interest of protecting it from physical damage, extending its shelf life or preventing dangerous interactions such as the migration of certain substances from the materials," she says, but there is much more to packaging than simply being well made – particularly for pharma.
"An aspect of good design incorporates interaction between people and packaging," Bix says. "My team’s mission is to try to apply the scientific method in meaningful ways to garner insights regarding these interactions, perceptively, cognitively and physically, with an emphasis on improving health outcomes."
Visual displays, packaging design and general design principles are governed by regulations. The US Food and Drug Administration (FDA) has suggested in its guiding document that medical-device manufacturers show which types of devices need to have human-factor data included in pre-market submissions.
FDA’s document states that its purpose is "intended to support manufacturers in improving the design of devices to minimise potential use errors and resulting harm". The document gives descriptions of the human factors and usability-engineering processes that can be employed by manufacturers during the development of the device.
FDA advises manufacturers to focus specifically on user interface, which includes elements such as displays, controls, packaging, product labels and instructions for use. The document states: "Addressing use-related hazards by modifying the device design is usually more effective than revising the labelling or training."
The reasonings are that the user’s memory may be unreliable, labelling may be unavailable during use and knowledge gained through training can wane over time.
R&D processes
Human factors are firmly embedded in the research and development process of any product, which Bix explains is down to the most fundamental level of the design.
"Take something as simple as labelling: in recent history we have relied on things like asking people which label they prefer or which one they think would be better," she says. "This is fine for research purposes, but insufficient to directly measure behaviour. Instead, we use things like force/choice tests, where we take two labels of a medical device, one containing latex and the other not, and ask healthcare providers or patients to choose the one that does not contain latex as quickly as they can."
This means the researchers can access a much deeper level of knowledge. "We start to get a direct measure of behaviour and ability, because we can compare trials with differing design strategies to objectively evaluate how different label designs impact performance," Bix says. It means they can start to measure the impact of things such as colour, boxing and data use on the ability of consumers to pick the correct product – and the amount of time it takes someone to choose it.
Human factors concern more than just ease-of-use and ergonomics: they also take safety into account, playing an important role in regulatory compliance. In 2010, Matthew Weinger, director of human factors at Vanderbilt University’s Center for Research and Innovation in Systems Safety, wrote in his Handbook of Human Factors in Medical Device Design: "Packaging is left as the very last step in the product-design process. This is unfortunate, since critical packaging issues are much easier to address when they are considered at the earliest stage."
Bix agrees that human factors need to be applied to packaging in the early stages of design, particularly for healthcare products. Despite these insights, a variety of products and services have been identified in marketing studies as inhibiting older people’s abilities to maintain their independence in some situations, such as when using public transport, working in certain kitchens and accessing internet banking. Few factors, however, are highlighted as often as elderly people’s difficulties opening and closing packaging.
"I think the world is changing. As cost pressures change, the way healthcare is delivered puts the onus on the frail or suffering person themselves," Bix says. "We’re seeing a shift: people used to be held in acute-care hospitals under the close supervision of trained professionals for an extended period of time. Now, we’re seeing people being treated at ambulatory-care centres or day surgeries, and released at the end of the day on their own or to the care of a frail and ageing family member."
Bix sees this as a sign that the environment for consumers is changing, and that healthcare is moving rapidly. "The same shifts are happening in hospices and with end-of-life care: cost pressures are putting people into these environments, and many would rather recuperate – or even die – in their own home."
She believes that this is one situation in which considering human factors can help the general population. "As we start to embrace more of a home-healthcare model, having packaging designs that work, regardless of our ability, is very important."
Tricky packaging that has not considered the end user means that older people risk suffering from embarrassment, anger and frustration at not being able to access their medication. This could even worsen their illnesses.
Bix says that human-factor research for pharma is being guided by the ageing population. "It’s one of the mega trends," she explains. "I think it’s also a natural evolution of design. You have to take care of the needs of the product and the ability to efficiently produce it to begin with; and now that we’re at this point in the industrialised age, it’s time for us to evolve."
It is also time for the pharma community to think beyond the needs of the product, and move into thinking about how packaging design can help users to ensure the use of products results in the appropriate health outcomes. "I think extending efficacy to include packaging design factors is necessary, as it leads us to the appropriate and proper dosage schedules and amounts."
This change will take time to materialise, but Bix has faith that the tide has started to turn. "When you get to the point where you’re objectively measuring behaviour and the ability it takes to make a correct choice, it’s much more powerful than prompting the user with questions of what they think of a design and speculating whether they would choose one product over another."
Bix says: "I think we have done a fantastic job, partly driven by the regulatory department, applying science to better understand products, and the interaction between products and packaging."
However, she does have some qualms about pharma companies’ commitment to the change: "I don’t think we have brought the right level of firepower and care to understanding the human environment or the challenges that humans, particularly the ageing and frail population, face. With some creative thinking and by leveraging different techniques from multiple fields, we can garner powerful insights that will benefit the health outcomes for many."
Bix believes that many pharma companies will implement human factors in their design processes, but she is concerned that adherence to the new FDA guidelines remains optional. Manufacturers will not need to submit general human-factors data that can improve packaging. All that is required of them is to notify FDA about something that could cause serious harm to a user.
Using human factors will improve the design of products, and Bix is certain that when this becomes widespread, ageing populations will have better control over their healthcare and a greater sense of independence.