Achieving Integration: Best Practices for Human Factors Testing in Combination Drug Products

In order for a drug product to be truly effective, it must be administered properly and the appropriate treatment regimen must be followed. Yet adherence to long-term therapy for chronic conditions is a painful and stressful daily routine for many patients. According to the World Health Organization, adherence to long-term treatment recommendations hovers at just 50 percent in developed countries. 

As the trend toward self-care continues and patients take an even greater role in decisions regarding their treatment, easy-to-use, integrated delivery systems will be essential. An integrated system combines the drug, its primary containment system and its delivery system (i.e., the device component). While many products do this with reasonable success, a truly successful combination product also must consider the needs of the end-user. By focusing on the relationship between the delivery system design and the patient interface, manufacturers stand a better chance at satisfying the emotional and physical needs of the intended user/patient. 

By applying best-practice user-research methodology, manufacturers can gain insight into a user’s preferences and emotional requirements, and those findings can translate into feature sets and design elements of the combination product. By gaining detailed information on the emotional and physical needs at different points in the patient journey, pharmaceutical manufacturers can design a product that not only suits a patient’s need for medication, but also one that is aesthetically, functionally and emotionally relevant. Such a shift from a product-centric focus to a patient-centric focus may help manufacturers design a combination product that encourages adherence and brand loyalty in crowded market segments.

Best Practices Begin with Patient Insight
Recent U.S. Food and Drug Administration guidance on human factors and the mitigation of user-based risk in the development of medical devices has spurred companies toward understanding the scope, depth and nuance of human factors engineering and design for usability. Human factors experts, those experienced in both the science and art of understanding human capabilities and limitations, have developed a deep understanding of design options and how they affect human interaction.

Patients suffering from a chronic condition move through a variety of stages on their therapeutic journey. A successful delivery system will be designed with these stages in mind since a new patient is likely to have different needs and emotional connections with the delivery system than a more seasoned user. At any given point on the patient journey, a delivery device can become as important as the drug product itself when it comes to effective adherence.

With an initial diagnosis, a patient may feel relief or shock—attitudes that can improve or impair the likelihood of adherence. With early treatment, the patient is acclimating to the prescribed therapy and instructions must be clear and a delivery device simple to use. As the patient becomes more comfortable, needs change. Aspects of device use that may have been heavily appreciated during earlier stages, such as ease of learning and demonstrability, likely will have waned in importance when users become more experienced with operating the device. Now, patients are likely to make new demands of their device around convenience of use, and the impact that the prescription therapies have on lifestyle and quality of life. Devices that are quick and efficient to use, especially regarding the time required to prepare and actuate delivery, stand a better chance of encouraging adherent behavior because impact to daily routines becomes negligible. Discreetness of the device also becomes more important. A discrete device provides its user with a greater range of options for how to integrate the dosing regimen into daily life. It also enables use without calling undue attention to the device, creating distractions to others or feelings of stigmatization. Delivery systems deemed inconvenient or overly conspicuous can negatively affect a patient’s emotional attitude and motivation to sustain adherent behavior. Later, as the patient ages or degrades, lapses in therapy may occur due to the physical and emotional burden of the condition.

Use of well-designed discovery research to help define product requirements and inputs can better guide a design team through important areas such as form-factor, user interface, device feedback to the patient and emotional elements, such as the ability to conceal the device. When used effectively, good research techniques help manufacturers produce integrated solutions that improve adherence to long-term treatment regimens by satisfying the physical, cognitive and emotional needs of the patient at any point on the patient journey.

Human factors guidance and best practices provide a robust framework for categorizing four major components of usability. All are inextricably linked in the context of understanding what usability means. They are:

• Physical abilities, including anthropometry (the measure of bodies, such as heights or the size of hands), biomechanics (what can be accomplished physically, e.g. how much weight can be lifted, how firmly something can be grasped), and sensory abilities (vision, hearing, tactile sense, etc.).
• Cognitive abilities, including how brains process information, the capabilities of memory, the manner in which humans learn new things, and how habits are developed.
• State of being, including the general health of the expected user, disease states and co-morbidities the patients are likely to be challenged with, mental and emotional states, and motivation for learning new things.
• Experiences, including educational background, knowledge of a particular disease state, and lifelong experiences with objects that will guide behavioral interactions with any delivery system.

• Contextual inquiry;
• Interviews and focus groups;
• Function and task analysis;
• Heuristic analysis; and
• Expert review.