American Pharmaceutical Review, February 2017

A patient-focused approach to the development of a drug is not a new concept in the pharmaceutical industry, but it is an evolving practice.

Human factors engineering (HFE) - also known as usability engineering, cognitive ergonomics, or user-centered design - is equal parts psychology and engineering. HFE is also helping improve the patient experience and smooth the path to personalized medications. The actual definition of HFE continues to evolve and change from year to year and industry to industry; however, the International Ergonomics Associate (IES) adopted the following overarching definition: “Ergonomics (or human factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data, and other methods to design in order to optimize human well-being and overall system performance.”¹

In the pharmaceuticals industry, HFE is growing in importance as companies seek ways to help patients better understand, connect with and, most importantly, take medications correctly and on schedule. More specifically, as the number of combination products - those consisting of a pharmaceutical or biopharmaceutical drug and a medical device of some kind - continues to increase, userfriendly delivery is increasingly important. In large part, this is due to the global rise in biopharmaceuticals and other injectables, and the demand for better self-administration options for these medications. It is now well known that adherence issues can increase medical costs by an estimated $300 billion a year and pharmaceutical companies are making significant investments to help this figure decrease.² From smart pills to paid incentives, the industry is pursuing just about every possible avenue, including maintaining teams of HFE experts.²

The central idea behind this ergonomics focus is that patients will be more likely to comply with dosing regimes if a medication - or, more accurately, its delivery method - has been designed around a deep understanding of the human condition, and specifically around the changes in chronic conditions at various stages of treatment. Though incentive programs and patient education efforts will remain effective, HFE helps proactively encourage adherence and demonstrates a deep understanding of patient needs.

Understanding the Patient Response to Illness and Treatment

As the use of HFE increases, so does its impact on patient safety and quality of life, largely thanks to the unique one-on-one approach to patient usability that is central to practice.³ Pharmaceutical companies are beginning to understand how a patient’s evolving response to disease can impact self administration and, as expected, the FDA is also taking notice of these efforts. The FDA’s draft guidance from February 2016 addresses human factors in relation to combination products in an effort to increase patient safety by ensuring that HFE is considered throughout the product development process.⁴ The FDA recognizes that HFE studies are an important part of use-related risk analyses that should occur with combination products, but a thorough focus on HFE is especially advantageous because it goes beyond physical risks and limitations.⁴

Every patient will likely react differently to the routine administration of a medication, but these reactions can also vary within a given patient as treatment progresses and the patient begins to process the reality of their condition. Patients typically move through four stages of chronic disease management: diagnosis, forced to act, basic competence and in control.³ It is important to thoroughly evaluate these four stages when considering drug delivery as different emotional factors uniquely influence each stage. For example, “diagnosis” often finds patients caught off guard, unfamiliar with the overall illness and care process, while those who manage to reach “in control” (a stage that many patients may never achieve) have been successfully managing their condition for many years and are well acquainted with all equipment and routines.³

It’s worth nothing, however, that each of these four management phases are, in turn, largely influenced by nearly every aspect of a patient’s life, including physical and cognitive abilities, overall state of being (e.g. stress, mental health, etc.) and life experiences that can be as broad as education level and marital/familial status. Typically, pharmaceutical companies turn to focus groups to get a better understanding of actual patient needs, but these groups are often too narrow for expanded results.³ Patients often find themselves having to administer injectable medications in various environments through the day and focus groups normally overlook or unintentionally minimize the variability that this creates.³

Human factors engineers embrace the stages of disease progression and pair this information with in-depth data aggregation and statistical analysis and, most critical to HFE, environmental research and observation. Observing patients in the day to day allows researchers to make both quantitative and qualitative assessments by documenting the patient’s response as well as myriad outside factors (temperature, noise, number of people present etc.).³ With firsthand experience of the patient’s daily life, researchers can recommend delivery device design options that minimize errors, make the experience as easy as possible and, ideally, help the device itself become something that patients want to use.

Engineered to Help Guarantee Compliance

Though the premise behind HFE is to eliminate a one-size-fits-all approach to drug delivery, standardization in the name of reliability, information flow and reduced training is a guiding principle of the practice.⁵ Proper HFE testing normally progresses iteratively and assesses a user’s physical interaction with the device and understanding of the packaging and instructions.⁴ The FDA divides testing (referred to as “human factors,” or “HF,” in the document) into two phases. First, HF formative studies are conducted as the delivery device and/or packaging are still being developed; second, an HF validation study confirms that the final combination product design successfully addresses all identified needs.⁴ Usability testing plays an important role in both phases. Use-related risk analyses account for all aspects of a device’s use, including users, uses, use-environment, therapeutic or diagnostic procedures, and similar products that may exist.⁴

With a thorough understanding of exterior factors, researchers can analyze patient habits, triggers for human error, potential risk scenarios and the resiliency of the system in the event of unforeseen issues.³ These analyses allow researchers to identify specific areas that may warrant a more critical HFE focus, streamlining the device development process. For example, prefilled syringes continue to remain the container of choice for many injectable, biopharmaceutical drugs that often have significantly higher patient dosing requirements than traditional medicines. Though guaranteeing the sterility of every dose remains critical, ensuring safe, accurate use in unsupervised environments is crucial and patient feedback and use observations have already led to the development of innovative solutions, including extended finger flanges, needles shields and auto injectors.⁶ However, understanding human interaction with a device does more than highlight potential problems. Observational studies also reveal workarounds, or shortcuts that patients or caregivers may take to bypass intended operations while rushing or faced with difficulties.⁵

To help guarantee that actionable data is created from these studies, analyses are frequently conducted with one of two methods; failure mode and effects analysis (FMEA) or fault tree analysis (FTA).⁴ Using the resulting data, devices can be designed to accommodate daily use and, when appropriate, forced functions - actions that must be completed before another action can begin - can be incorporated. Most importantly, routines can be standardized for ease of repetition and minimization of errors.⁵ These efforts lead to more user friendly products that can ultimately lead to increased brand loyalty.

Though HFE is still in its early years in the pharmaceutical industry, it has already proven to be beneficial. As we have previously reported from the 2016 Nice Insight CDMO Outsourcing Survey, with 45% of respondents outsourcing Packing Design and Development and 42% outsourcing Compliance and Adherence Solutions, it is clear the industry understands the importance of innovative, easy-to-use devices.⁷ For this trend to continue, the human side of the research that leads to these advancements will remain crucial moving forward. Real world solutions are best developed with a thorough understanding and careful analysis of real world situations and HFE experts, working closely with formulators, designers and engineers, are often best suited to provide this expertise. Additionally, the pharmaceutical industry is positioned to learn about existing HFE successes in the broader consumer space to continue offering medication delivery solutions that enhance and simplify the patient experience.

References

1. “Definitions of Human Factors and Ergonomics.” Human Factors and Ergonomics Society. Web.

2. Robbins, Rebecca. “Big Pharma’s big push to get patients to take their meds.” STAT. 4 Feb. 2016. Web.

3. Evans, Chris. “A Human Factors Road Map for Self-Injection Device Design.” Contract Pharma. 29 Jan. 2015. Web.

4. Food and Drug Administration. “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.” Feb 2016. Web.

5. “Human Factors Engineering.” Patient Safety Network. Jul 2016. Web.

6. Siew, Adeline. “Drug Delivery Systems for Biopharmaceuticals.” BioPharm International. 1 Aug 2016. Web.

7. The 2016 Nice Insight Contract Development and Manufacturing Organization Outsourcing Survey.