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How to Consider Diversity and Inclusion (D&I) When Applying Human Factors Engineering to Medical Products

Incorporating D&I in your medical device HFE, design and usability effort helps your product target the widest user base possible.

Two people observing a focus group

October 6, 2020

Looking forward, you can expect to see additional content from us on the topic of diversity and inclusion in this space, our Newsletter, and other media. This level of attention to the topic is part of our commitment to becoming a more diverse and inclusive team, and reflecting the evolved mindset in our human factors engineering consulting work.

How does diversity and inclusion (D&I) factor into the practice of human factors engineering, and particularly its application to medical product development?

For starters, D&I concerns overlap with accessibility concerns and, therefore, D&I may be considered a close cousin of universal design. According to the National Disability Authority, “Universal Design is the design and composition of an environment so that it can be accessed, understood and used to the greatest extent possible by all people regardless of their age, size, ability or disability.” By comparison, designing with D&I in mind means trying to accommodate the needs and preferences of people of all abilities and identities, distinguished by such factors as race, gender, sexual orientation, or perhaps age.

As a team, we’ve been discussing this question and believe the answer has two parts.

Part 1 – Addressing D&I in human factors engineering can promote safety and care consistency  

D&I considerations should be built into the practice of human factors engineering for all the right reasons, which include:

  • Human factors engineering is about learning about users and developing solutions (e.g., medical products) to meet user needs and preferences. Therefore, consciously or unconsciously biasing a design toward the needs of the majority while excluding others is antithetical; it goes against the professional discipline’s mantra to make products adapt to the intended users and not the reverse. What’s called for is an inclusive design approach, which starts with an inclusive mindset.
  • Unintended biases in medicine can result in the delivery of compromised care to specific groups. Human factors engineering can play a key role in shaping products that help caregivers and clinicians deliver consistent health care, such as when determining the optimal treatment for Black people experiencing end-stage renal disease and potentially requiring a kidney transplant. Certainly, there is an opportunity for improvement within the healthcare delivery system that is outside the scope of human factors engineering, but it may be that diagnostic tools, including computer-based decision aids, can also be improved. Of course, products intended for use by patients in the course of self-care might also be subject to improvement. See related article.
  • As human factors specialists work to prevent harmful use errors, they need to maintain awareness that certain types of harmful errors might be more prevalent within specific segments of the population. On a related note, an American Journal of Public Health article stated, “Negative implicit attitudes about people of color may contribute to racial/ethnic disparities in health and health care.” It seems likely, although unproven at this time, that disparities are linked to a higher incidence of harmful use errors by healthcare providers.
  • All medical product users should feel that designers considered them in the course of developing products (e.g., pen injectors, glucose meters, and blood pressure monitors) and various media (e.g., instructions for use, mobile apps, and disease management websites). One example of D&I-minded product development is producing two sizes of a surgical instrument so that individuals with particularly small hands do not have to cope with an instrument designed for the majority of people with larger hands. Another example is expanding the data entry fields of an electronic medical record to include a patient’s gender (e.g., man, woman, transgender, non-binary) and pronouns (e.g., he/him/his, she/her/hers, they/them/theirs), as well as a patient’s sex (e.g., male, female, intersex), both at birth and currently. These data entry fields should also provide patients the option to self-describe or not disclose that information by selecting the option “prefer not to say.”

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Part 2 – Specific ways human factors engineering can address D&I

Here are some practical steps that human factors engineering specialists can and should take to consider the needs and preferences of a broader user population. Notably, our Human Factors Research & Design team members are aware of the need to be more D&I focused and are motivated to take these steps. In some cases, it will require us to convince customers of the added value, and we will be pleased to do so.

  • User research. Ensure that user research includes participants with widely varying backgrounds, even when they might represent a small fraction (e.g., 1%–10%) of the total user population. Meeting this objective might require a demographic analysis that will help to identify small but important fractions of the user population. Such research includes field observations, diary studies, group interviews, and usability tests. It is likely to generate many insights on topics such as attractive features, technology availability and adoption patterns, preferred training solutions, and more.
  • Use-related risk analysis. In the course of use-related risk analysis, consider the influence of social determinants of health; that is, social and physical environments that affect health. Suffice it to say, certain segments of the general population deal with a great number of challenges that can directly or indirectly increase hazards and cause more severe harms. One example we can think of is the lack of access to a sufficient supply of single-use needles for delivering insulin with a pen-injector several times a day. As folks who conduct user research with a wide range of individuals, including those who might lack resources and face other disadvantages (e.g., poor access to transportation, poor access to pharmacies), we have heard from many who re-use needles because they cannot afford to buy a sufficient supply of fresh ones. Therefore, a D&I-enlightened use-related risk analysis should include the risk of needle re-use, reflecting an understanding of the hazardous situation that people of limited means might face.
  • User interface requirements development. Write user interface requirements to accommodate any potential limitations and constraints associated with people who are disadvantaged in specific ways, including those cited earlier as well as limited access to the Internet, lower health literacy, limited language or reading proficiency, and/or a reduced ability to pay for certain products. For example, such individuals might have to forego the use of blood pressure monitors, fresh needles for blood draws, test strips to check blood sugar level, and auto-injection devices that can make injections simpler and more accurate. Moreover, user interface requirements can help shape product features, so they are valuable to the widest possible segment of the user population.

Referring back to the example of re-using an injection needle, this hazardous situation might be avoided by specifying a pen-injector whose needle can only be used once and, importantly, developing a low-cost solution that makes the single-use needles more affordable. Yes, this solution might sound simplistic because it presupposes that a company could (1) produce lower-cost needles and (2) support their use by people who might still need to choose between low-cost needles and other necessities, such as food for themselves and/or their families. But, user interface requirements should challenge design teams to produce solutions that accommodate users’ needs, solve problems and address barriers, and protect users from unreasonable risk.

Here are a couple of examples of designing with D&I in mind:

  • Bandages – Perhaps it is a sign of the times and progress by some companies. Finally, some manufacturers are producing adhesive bandages (colloquially called by the brandname BAND-AIDs®) suited to people with different skin tones instead of just people with light-colored skin. Recently, one group of designers conceptualized a “chameleon bandage” that would change its color to match the user’s skin tone. Such a color-shifting bandage would probably be a very popular product if it is feasible. You can imagine how such solutions would please people who do not want to draw attention to a bandage that contrasts with the skin. Also, consider the message that placing a color-mismatched bandage on a child would send; that a product was designed for someone else and not them.
  • Instructions for use – A growing proportion of instructions for use accommodate people who might not speak the land’s dominant language. For example, to suit the US market, some instructions sheets are written simply and concisely in both English (the dominant language in the US) and Spanish. Also, instructional graphics that depict people interacting with the products show people of various races. It’s good to see.

In conclusion, our team is arguably closer to the starting line than finish line when it comes to applying human factors engineering with a D&I mindset. There is still much to be discovered in terms of how to do this well, and there might be a need for extensive research and perhaps even the development of new science. Clearly, inequities with regard to the use-related risks of products of all types, and associated with individual characteristics, is unacceptable.

We will keep our eyes wide open for opportunities to take this journey toward greater equity with our customers with the goal of making better medical products for all and driving healthcare quality improvements. In parallel, we will seize opportunities to make our own team more diverse and inclusive, which aligns with one of our parent organization’s (UL’s) major goals for 2020 and beyond.

 Michael Wiklund, CHFP, P.E., is General Manager of Human Factors Research & Design at Emergo by UL.


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