ADVANCED DELIVERY DEVICES - Getting It Right: The Importance of End-User Research in the Design of a New Drug Delivery System

To design a drug delivery system that will truly resonate with patients, one must first understand the behaviors and motivations of the intended user groups. This requires insight into the unique experiences of those users by conducting research that will drive innovation in the design and development process to create a solution that works in a variety of situations.

Drug manufacturers agree that end-user research and human factors testing are critical when considering the design of a new drug delivery system, such as self-injection devices for diabetes patients. Historically, many companies have relied on patient focus groups to obtain information about user considerations for drug administration systems. However, focus groups don’t always offer the full picture on how patients use drug delivery devices at home, work, and other settings. Initiated partially by evolving regulatory requirements, pharmaceutical manufacturers have begun taking a more personalized approach to understanding end-user needs in various environments and ultimately developing products that can better help patients adhere to treatment regimens.

A common sense approach lies at the core of human factors engineering. In order to mitigate the risk associated with user error or misunderstanding, design options must be considered in the context of how a human interacts with the device and the world surrounding him or her at the time of use.

For the pharmaceutical delivery device industry, understanding how the human factors world defines and evaluates human capabilities is a large part of the puzzle. Design experts must try to understand the human condition of the user, an important consideration throughout the design process. Working with human factors and user-research professionals, designers can learn more about how an evolving disease state can affect device use in self-therapy 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 devices or interfaces. Such refinements can help to create a system that not only aids in the effective delivery of a drug product, but enhances the user experience and potentially gains brand loyalty for the pharmaceutical manufacturer during the entire course of treatment.

DESIGNING FOR THE HUMAN CONDITION

Human factors engineering and usability testing seeks to gain a thorough understanding of the potential users’ behaviors, motivations, and needs. Three main components for device testing will help optimize how people interact with technology: 1) device users, 2) device use environments, and 3) device user interfaces. Using in-depth statistical analysis, data aggregation and synthesis techniques should yield actionable opportunities for innovations and enhancements that will help make the delivery systems easy to use throughout the treatment regimen. For those with chronic conditions, the proper delivery system will help meet emotional and physical needs not only when first diagnosed, but also as they become comfortable with long-term care options.

Human factors experts should start by determining what must be known about the user and the device interaction before selecting one of the many research tools available. Methods include:

Qualitative: interviews, ethnographic observation, contextual inquiry, and concept evaluation

Quantitative: questionnaires, in-person surveys, and user-based performance testing

Analysis & Synthesis Outputs: affinity diagramming, product adoption road maps, and habits and ideal scenarios

Human Factors/Ergonomics: human error and risk analysis, usability testing, and heuristic analysis (encouraging a person to use the device on his/her own)

A strong framework for the development process can be gained through the use of discovery research, directional and preference testing, and usability testing. Customers’ needs and desires can be confirmed through discovery. Directional research allows users to evaluate product concepts, and usability testing helps to ensure that the delivery solution is appropriate for users. Usability testing offers a more robust framework that can be broken down into four major components. They are:

Physical Abilities: anthropometry (the measure of bodies, such as heights or the size of hands), biomechanics (what can be accomplished physically), and sensory abilities (vision, hearing, tactile sense)

Cognitive Abilities: how people process information, the capabilities of memory, the manner in which humans learn new things, and how habits are developed

State of Being: the general health of the expected user, disease states and co-morbidities, mental and emotional states, and motivation for learning new things

Experiences: educational background, knowledge of a particular disease state, and lifelong experiences with objects that will guide behavioral interactions with any delivery system

These components help make important connections in the relationship between the user and the device. Typically, the best data is gathered through interviews in the proper context. Seeing the user in the midst of daily distractions, such as caring for an aging parent and interacting with children, pets, ambient noise, temperature, and lighting, all help human factors experts better understand how the patient will use a device. Also, usability may change over time as the patient becomes more accustomed to a device.

Patient needs also must be defined appropriately. Three types of needs are important to the success of any development program. Different techniques can be used to elicit and discover these needs, which include:

Expected Needs: Needs that are meaningful to patients; direct observation inside the user’s environment is an effective way to document these types of needs

Expressed Needs: Needs that are simple for users to articulate; “think-alouds” and other narrative techniques are best to determine expressed needs

Exciting Needs: This type of “need” typically delights patients because they often do not think about the possibilities as technically possible. Reaction to emotive stimuli, scenarios and storytelling are ways to elicit emotionally based needs

While there are many methods available to test usability and reduce user-based risk, understanding how the patient interacts with the user interface can help ensure optimal device design. The ability to operate a device successfully depends on several conditions including the patients’ mental and emotional state, the environment in which they are using the device, and previous knowledge of and experience with similar devices. At West, taking all of these variables into account is critical to our design process. We employ human factors principles and conduct extensive usability testing during the device design phase that will not only meet the unique needs of our pharmaceutical partners, but more importantly, also ensure the device is safe, effective, and consistently delivers the intended treatment to patients.

To view this issue and all back issues online, please visit www.drug-dev.com.

Chris Evans is the Director of Innovation, Pharmaceutical Delivery Systems at West Pharmaceutical Services, where he manages teams for discovery/user research, human factors, and conceptual and intellectual property development. He has more than 20 years of experience in product development, with extensive expertise in healthcare packaging and device development. Mr. Evans earned his BS in Biology from the University of Maryland.