Kennedy Clark , Senior Director-Market Development , Innovation, & Technology , West Pharmaceutical Services, Inc.

In today's market, there is rising demand for integrated delivery systems, which combine an injectable drug, its container, and the system used to administer it. Part of the spike can be attributed to the popularity of self-administered therapies for rheumatoid arthritis, diabetes, and other chronic conditions. As companies shift to meet the demand, the patient's perspective and experience have become central to the design of any system. Because of this renewed focus on the patient, drug delivery system manufacturers are continually reevaluating the processes by which they improve the existing systems and how they develop new ones, making them an invaluable partner to pharmaceutical companies.

Putting Patient First

If patients are not comfortable with an injectable drug's delivery system, the natural result is a drop of adherence levels, which can have a negative impact on patient outcomes. As a result, manufacturers of integrated delivery systems have become proactive in seeking out patient feedback during design and development phases. Integrated drug delivery system development must be considered in the context of how a patient interacts with the system differently at each stage of their journey and in the various environments they encounter each day. Human factors analysis, usability testing, and engineering can provide a detailed understanding of patient behaviors, motivations, and needs. This process provides actionable opportunities for innovations and enhancements to self-injection system technology.

Designing for Patient Needs

Environmental research is a 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 can help researchers better understand how the patient will use a self-administration system. 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 enables contextual inquiry that 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 delivery systems. Human factors experts can perform detailed analyses of patient habits, which may lead to further understanding of potential human error triggers and risk scenarios. From there, designers are able to make objective recommendations on self-injection system design and develop a product adoption roadmap based on real-life experiences.

Working with human factors engineering and research professionals, drug delivery system companies can learn more about how an evolving disease state can impact system use in self-administration situations. Then, through smart design, they can help reduce user-based error, and control or reduce current and future risks associated with system use. 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 course of treatment.

Partnering for Positive Outcomes

Shifts in the healthcare industry toward biologics, self-administration, patient input, and the almost limitless possibilities of new technology have given rise to injectable drug delivery systems that are easier to use and can directly facilitate positive patient outcomes. An added benefit of this proactive approach is that packaging and delivery system manufacturers have become a more trusted partner to pharmaceutical companies, which are developing new drugs to meet changing demands. Together, packaging and delivery system and drug manufacturers can work seamlessly as partners to provide innovative solutions that help mitigate risk, encourage patient adherence, and enhance value through unique integrated delivery combinations.


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