How patient input has impacted integrated drug delivery system development

Largely because of the popularity of self-administered therapies for rheumatoid arthritis, diabetes and other chronic conditions, the market demand for integrated delivery systems — which combine an injectable drug, its container and the system used to administer it — continues to grow

West’s SmartDose electronic wearable injector


The increase in self-administered drugs is part of an even larger shift towards a more patient-centric approach to the production of integrated delivery systems.

Because of this renewed focus on the patient, drug delivery system manufacturers are continually re-evaluating the processes by which they improve existing systems and how they develop new ones.

As a result, delivery system manufacturers have become an invaluable partner to pharmaceutical companies.

The rise of patient input

If patients are not comfortable with an injectable drug’s delivery system, the natural result is a decrease in 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 to ensure that the final product is something that patients are comfortable using.

Because of the demand for self-administered medication, patient feedback regarding how they interact with delivery systems is more important than ever. Drug manufacturers have often relied on patient focus groups for insight into end user input regarding self-injection systems.

However, the narrow focus group setting doesn’t provide a full picture regarding how patients use injection systems in multiple environments: at home, work and other settings, for example. 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 factor analysis, usability testing and engineering can provide a detailed understanding of patient behaviours, 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 system technology.

Understanding patient needs

Environmental research is key to human factor 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 the immediate environmental factors such as temperature, noise and lighting — can help researchers to 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 factor knowledge. One-on-one usability testing enables the contextual enquiry that is essential for effective human factor analysis. It helps to better evaluate a patient’s physical abilities, cognitive abilities, state of being, knowledge of the disease state and experience with delivery systems. This type of testing also 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 when it comes to confirming patient needs, desires and preferences.

Once all of the environmental and usability data has been collected, human factor experts can perform a detailed analysis of patient habits, 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 factor 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. They then can help to reduce user-based error and control or reduce the current and future risks associated with system use by employing a flexible set of design tools that help to refine and enhance the delivery system. Such refinements can help to create a system that not only aids in the effective delivery of a drug product, but also enhances the patient journey and potentially earns brand loyalty for the pharmaceutical manufacturer during the entire course of treatment.

By applying human factor principles and conducting extensive usability testing early in the design process, drug manufacturers and their delivery system partners can maximise the likelihood that the self-injection system user interface is safe and effective for use by the intended users, uses and environments.

Most often, patients seek the following attributes in a drug delivery system:

  • Ease of use: Perhaps the most essential consideration is how the patient uses the drug delivery system. Even the most innovative drug can only provide the appropriate therapeutic benefit if it can be delivered effectively and the patient adheres to the necessary treatment regimen. Most patients are not trained medical practitioners; therefore, they need delivery systems to be intuitive. Ensuring a self-injection system is easy to hold and deploy, as well as limiting the number of administration steps that a patient has to manage, will greatly increase their satisfaction with the injection system and can help to promote greater adherence.
  • Affinity-based design: Simply designing a delivery system that patients “can” use is no longer sufficient. Delivery systems should be designed for affinity, and encourage patients to “want” to use them. This starts with a thorough understanding of patient needs, including the fact that these needs may change during their treatment journey. These same inputs also ensure that risks from user-based errors are identified early in the design and development process and provide critical user information to the development team for risk mitigation measures. The full development process should consider the effectiveness of the integrated delivery system constantly, and adjust as needed.
  • Lifestyle integration: Patients who self-administer drugs — especially those who do so on a daily basis — want the process to be a part of their routine as opposed to interrupting it. For example, manufacturers have responded with partnerships that connect delivery systems with smartphone apps. Some apps record the data gathered from the injection event. A physician could access this data to monitor a patient’s self-care, serving as a proxy for office visits. The data would also offer a view of compliance with time. There has also been an increase in easily concealable wearable injection systems that automatically deliver accurate dosages and don’t require a patient to stop what they’re doing.

From reactive to proactive development

For many years, a presiding belief in the pharmaceutical industry was that if a drug was good, the delivery system was less important. However, the introduction of biologics has elevated the importance of the delivery system for two reasons, and has ushered in an era of proactive — rather than reactive — innovation and technology.

The first reason is that biologics are very often administered in injectable forms — frequently as a self-injected dose — which has put their delivery directly into the hands of patients instead of trained medical practitioners. This shift has prompted delivery system manufacturers to prioritise patient needs more so than in the past.

The second and most important factor has to do with patient safety and regulatory compliance. Several recalls of injectable drugs because of particulate contamination have pushed manufacturers to explore alternatives to glass as a primary packaging material, such as novel polymer containers that are less prone to breakage or chemically react with the drugs themselves.

Today, because delivery systems must more critically address patient safety and usability needs, drug and delivery system manufacturers are more vigorously exploring innovation and technology to stay ahead of the technological curve and market demand.

An added benefit of this proactive approach is that packaging and delivery system manufacturers have formed more reliable partnerships with pharmaceutical companies who are developing new drugs to meet changing demands.

More than ever, drug companies are seeking out partners who are focused on providing innovative, high-quality solutions and have the knowledge and expertise to ensure that the drug, the primary container, the delivery system and the end user are understood and effectively managed. Together, packaging and delivery system and drug manufacturers can work seamlessly as partners to provide innovative solutions that help to mitigate risk, encourage patient adherence and enhance value through unique integrated delivery combinations.

Conclusion

West’s SmartDose electronic wearable injector utilises a Daikyo Crystal Zenith drug container

The key consideration for any new drug has always been the patient, but the delivery system has not been as patient-facing until recently. The combination of increased self-administration, patient input and the almost limitless possibilities of new technology has given rise to injectable drug delivery systems that are easier to use and can directly facilitate positive patient outcomes.

More than ever, patient input is shaping this trend and leading system manufacturers to more proactively explore new ways to deliver these very important drugs. Additionally, the partnership between packaging and delivery system and drug manufacturers has strengthened, as delivery systems are designed and developed with an expertise that gives both patient use and drug interaction equal priority.

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