A successful drug delivery system should be easy to use, intuitive and efficient. Human factors engineering is an integral component of a user-centered design process, and can help to ensure that the device or delivery system meets the cognitive, physical and emotional needs of the end user. Design experts must understand that the human condition, which should be carefully considered in the design, is not static but rather a series of evolutions defined by the changing disease state. By understanding the needs and desires of the patient at various times during treatment, drug and device manufacturers can mitigate user-based error and control or reduce any lapses in therapy associated with improper device use.

When creating a self-injection device, it is essential for pharmaceutical companies to understand the journey a patient goes through from new diagnosis to compliance. For the pharmaceutical industry, evaluating human capabilities and emotions at each stage along the journey are also key in designing an effective drug delivery device that can help patients adhere to their treatment regimens.

Stages of the Patient Journey
There are four main stages of chronic disease management:
1. Diagnosis. This stage typically begins unexpectedly, when a diagnosis is given that will impact the rest of the patient’s life. This news is often met with a period of denial, possibly culminating in depression once the truth starts to sink in. This commonly occurs in the days and weeks following initial diagnosis, but for those who refuse to accept their condition—often those lacking family/social support—it can last years.

2. Forced to Act. This stage begins when the patient is forced to take some action to manage their condition, however grudgingly, and proactively engage in a therapeutic regimen. There is acknowledgement of the need to better manage their health, but the patient doesn’t yet “know the game” with respect to variables and infl¬uencers, so they tend to experience frustration when their initial efforts yield little or no improvement.

3. Basic Competence. In this stage, the patient doesn’t feel fully in control of his condition, but has become more accustomed to its’ daily demands and presence. The patient has gained a basic working knowledge of the delivery device and uses it in a formulaic, automatic and often reactive manner. Throughout this stage, the patient generally exerts less effort to publicly hide the condition, but might still try to protect loved ones from seeing the full extent of the management process.

4. In Control. While relatively few patients reach this stage, those who do are truly “running the show” with their daily regimen, (eg. diabetes). These patients have had many years of experience living with the condition and, through time, attention, and interest, have gained a deep understanding of its management. They are expert users of their devices, and enjoy a heightened degree of control—predicting and planning appropriately for all circumstances. While they never wanted this “job,” their good job performance has become personally rewarding.

End User Environmental Research
Once pharmaceutical companies have a solid understanding of the patient journey, it can serve as a framework for a more personalized approach to understanding end user needs in various environments. Drug manufacturers have often relied upon patient focus groups for insight into end user considerations for self-injection systems. However, the narrow focus group setting doesn’t provide a full picture of how patients use self-injection devices in multiple environments: at home, work and other settings. Self-injection device design options must be considered in the context of how a patient interacts with the delivery system differently at each stage of their journey and in the various environments they encounter each day.

Human factors engineering and usability testing can provide a detailed understanding of a patient’s behaviors, motivations and needs. This process uses in-depth statistical analysis, data aggregation and synthesis techniques to produce actionable opportunities for innovations and enhancements to self-injection device technology. Environmental research is key to human factors engineering: observation and interviews provide the critical context needed to make a qualitative assessment of a patient’s abilities and challenges. Observing a patient as they go about their day— and considering all of the surrounding environmental factors such as temperature, noise and lighting—can help researchers better understand how the patient will use a device. In-person surveys, questionnaires, user-based performance testing and heuristic analysis also add to the base of human factors knowledge.

One-on-one usability testing/contextual inquiry is essential in effective human factors analysis. It helps better evaluate a patient’s physical abilities, cognitive abilities, state of being, knowledge of the disease state and experience with devices. This type of testing allows researchers to explore new product concepts while closely evaluating whether a delivery system is appropriate and effective for patients. The resulting data is extremely valuable in confirming patients’ needs, desires and preferences.

Once all of the environmental and usability data has been collected, human factors experts can perform detailed analysis of patient habits, human error triggers and risk scenarios. From there, designers are able to make objective recommendations on self-injection device design and develop a product adoption road map based on real-life experiences.

Working with human factors engineering and research professionals, pharmaceutical companies can learn more about how an evolving disease state can impact device use in self-administration situations. They then can help reduce user-based error, and control or reduce current and future risks associated with device use by employing a flexible set of design tools that will help refine and enhance the delivery device. Such refinements can help to create a system that not only aids in the effective delivery of a drug product, but that enhances the patient journey and potentially earns brand loyalty for the pharmaceutical manufacturer during the entire the course of treatment. By applying human factors principles and conducting extensive usability testing early in the device design process, drug manufacturers and their device partners can help ensure that a self-injection device is safe, effective and consistently delivers the intended treatment to patients.

Conclusion
Acknowledging the patient journey and understanding how environmental conditions impact end user needs are both important steps in developing products that can better help patients adhere to treatment regimens. When used effectively, good research techniques help manufacturers develop user-centered devices that improve adherence to long-term treatment regimens by satisfying the physical, cognitive and emotional needs of the patient at all points of their journey. Armed with this awareness, pharmaceutical companies are better enabled to select and develop safe, reliable and desirable drug delivery solutions.