Graham Reynolds and Chris Evans 03.20.13
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:
Such techniques include:
Function and task analysis systematically breaks down the device use process to identify critical aspects that may result in hazards to users and patients. Such testing also may identify possible hazards associated with the device, which allows manufacturers to address these issues during the design phase. Best practices suggest that human factors testing should be conducted early in the design process to provide feedback that will help to create an optimal design.
Heuristic analysis provides for careful consideration of accepted concepts for design and operation of the user interface of the device. General standards for use—such as depressing a plunger—may provide clues into how the device can become more intuitive for the end user.
Finally, expert reviews rely on clinical and human factors experts to analyze device use, identify problems and make recommendations for revisions to the design. Again, it is important to conduct human factors testing early in the design phase so that the final device functions not only properly, but also with the ease and characteristics intended users will expect.
Early Testing Offers Optimal Results
While many pharmaceutical companies realize the need for human factors work, they often assume that testing should be completed near the final stages of production. Early engagement with a company that understands the device and container and how it works together is absolutely critical. Manufacturers no longer can assume that the patient is at fault if a “self-therapy” does not work. Delivery device functionality should be intuitive, so that when the product reaches the hands of its intended user, it can be effective even if the user has not fully read or understood the instructions for use.
Testing early and often allows manufacturers to optimize the device and create the perfect mix of device and user “burden.” While it is possible to create a complex device that will function automatically for the patient, building such complexity into a device challenges the manufacturer in terms of packaging and delivering the drug cost effectively. Devices that are simple externally often are very technical internally, which may price the system out of the market. Instead, manufacturers should seek an ideal mix of burdening the user with the appropriate amount of tasks that he or she is capable of doing, and then burdening the device with another set of tasks that will help to ensure proper delivery. This mix will create a system that not only is priced right for the market, but also easy to use for most people.
Building a Better Delivery System
Early testing can inform the design and development process. The results can
refine the process during product development and provide a deeper understanding of how the elements fit together. From the moment a primary containment selection is made targeting commercial production, a drug delivery system then becomes an integral part of a drug’s therapeutic effect.
Many new and desirable treatments require higher component quality. In addition, biologic drug products often are of a higher viscosity and may require a high-volume dose that cannot easily be delivered through traditional methods. A successful integrated system must consider not only the needs of the end-user, but also how the drug product interacts with its primary containment system. Effective delivery requires an optimum delivery rate and frequency, as well as a primary container that maintains effectiveness, safety and optimum quality during a period of time. Such compatibility with the containment system, and a design optimized to the drug delivery also may help to enhance the patient experience and increase long-term adherence to therapy.
Understanding all key elements of a drug delivery system provides the cornerstone that enables such a system to achieve the goals of encouraging adherence and fostering brand loyalty between patient and manufacturer, while mitigating product and development risks. Drug manufacturers should seek a partner who can apply proprietary technologies, manufacturing excellence and patient understanding to their drug products. Such partnerships will help drug marketers offer successful, integrated solutions, benefitting manufacturers, clinicians and patients alike.
Graham Reynolds is vice president, Marketing & Innovation, for West Pharmaceutical Services Inc. (www.westpharma.com), where he leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies to enhance West’s portfolio. Graham holds a degree in Polymer Technology from Trowbridge College in the United Kingdom. Chris Evans is director of Innovation, Pharmaceutical Delivery Systems, at West Pharmaceutical Services.
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.
Such techniques include:
- Contextual inquiry;
- Interviews and focus groups;
- Function and task analysis;
- Heuristic analysis; and
- Expert review.
Function and task analysis systematically breaks down the device use process to identify critical aspects that may result in hazards to users and patients. Such testing also may identify possible hazards associated with the device, which allows manufacturers to address these issues during the design phase. Best practices suggest that human factors testing should be conducted early in the design process to provide feedback that will help to create an optimal design.
Heuristic analysis provides for careful consideration of accepted concepts for design and operation of the user interface of the device. General standards for use—such as depressing a plunger—may provide clues into how the device can become more intuitive for the end user.
Finally, expert reviews rely on clinical and human factors experts to analyze device use, identify problems and make recommendations for revisions to the design. Again, it is important to conduct human factors testing early in the design phase so that the final device functions not only properly, but also with the ease and characteristics intended users will expect.
Early Testing Offers Optimal Results
While many pharmaceutical companies realize the need for human factors work, they often assume that testing should be completed near the final stages of production. Early engagement with a company that understands the device and container and how it works together is absolutely critical. Manufacturers no longer can assume that the patient is at fault if a “self-therapy” does not work. Delivery device functionality should be intuitive, so that when the product reaches the hands of its intended user, it can be effective even if the user has not fully read or understood the instructions for use.
Testing early and often allows manufacturers to optimize the device and create the perfect mix of device and user “burden.” While it is possible to create a complex device that will function automatically for the patient, building such complexity into a device challenges the manufacturer in terms of packaging and delivering the drug cost effectively. Devices that are simple externally often are very technical internally, which may price the system out of the market. Instead, manufacturers should seek an ideal mix of burdening the user with the appropriate amount of tasks that he or she is capable of doing, and then burdening the device with another set of tasks that will help to ensure proper delivery. This mix will create a system that not only is priced right for the market, but also easy to use for most people.
Building a Better Delivery System
Early testing can inform the design and development process. The results can
refine the process during product development and provide a deeper understanding of how the elements fit together. From the moment a primary containment selection is made targeting commercial production, a drug delivery system then becomes an integral part of a drug’s therapeutic effect.
Many new and desirable treatments require higher component quality. In addition, biologic drug products often are of a higher viscosity and may require a high-volume dose that cannot easily be delivered through traditional methods. A successful integrated system must consider not only the needs of the end-user, but also how the drug product interacts with its primary containment system. Effective delivery requires an optimum delivery rate and frequency, as well as a primary container that maintains effectiveness, safety and optimum quality during a period of time. Such compatibility with the containment system, and a design optimized to the drug delivery also may help to enhance the patient experience and increase long-term adherence to therapy.
Understanding all key elements of a drug delivery system provides the cornerstone that enables such a system to achieve the goals of encouraging adherence and fostering brand loyalty between patient and manufacturer, while mitigating product and development risks. Drug manufacturers should seek a partner who can apply proprietary technologies, manufacturing excellence and patient understanding to their drug products. Such partnerships will help drug marketers offer successful, integrated solutions, benefitting manufacturers, clinicians and patients alike.
Graham Reynolds is vice president, Marketing & Innovation, for West Pharmaceutical Services Inc. (www.westpharma.com), where he leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies to enhance West’s portfolio. Graham holds a degree in Polymer Technology from Trowbridge College in the United Kingdom. Chris Evans is director of Innovation, Pharmaceutical Delivery Systems, at West Pharmaceutical Services.