Minding the Gap: A Human Factors Approach to Developing More Inclusive Medical Devices
Event Type
Oral Presentations
TimeWednesday, April 141:10pm - 1:30pm EDT
LocationMedical and Drug Delivery Devices
DescriptionTopic introduction and background

“Product inclusion is not merely a box to check. It is a mind-set and a culture of commitment to building products and services for underrepresented users.” – Anne Jean-Baptiste

When developing a medical device, manufacturers are required to identify the device’s intended users and, therefore, criteria to characterize such individuals. Manufacturers often focus on the highly typical user characteristics related to the product they are developing. For example, an intended user of a product used to treat diabetes might be the “average” diabetes patient: perhaps someone with education levels generally representative of the broader population and with some additional visual and dexterity impairments. A manufacturer’s definition of “average” has often historically referred to an individual without physical impairments who can speak, read, and write in English, and presents as a white man.

However, such descriptions often leave out a significant percentage of the world and quite often a significant percentage of the intended user population. This description of the intended user is often not comprehensive enough to capture the range of human diversity and might result in a product that excludes members of the intended user population. Therefore, it is imperative a manufacturer consider all human characteristics, particularly those most often underrepresented, that might play a role in a product’s usability. A more inclusive approach to product development will increase the number of individuals who can use a product, thereby resulting in improved business results and healthcare access.

These underrepresented human characteristics might be considered physical (e.g., limb amputations, vision), cognitive (e.g., learning processes, language), psychosocial (e.g., race, gender), or perhaps an intersection of one or more of these attributes. The connection between some of these characteristics and usability is clearer than others. For example, someone with a visual impairment might experience unique difficulties interacting with a pen-injector, such as checking the medication’s color or reading the device instructions. In contrast, psychosocial characteristics, such as race, impact a product’s usability in a less visible way, and require continued learning and research to understand. While existing HFE practices consider human characteristics, designing products with inclusivity in mind is yet another way to expand upon these considerations and create a useable and satisfying product experience for a wider percentage of the intended user population.

Medical device manufacturers play a crucial role in driving the future of healthcare access, including designing products that reach all patients, regardless of identity or ability. It is clear that systemic injustice facing Black and Brown communities in the United States currently exists, resulting in extreme health inequities among these populations. This presentation will highlight methods and tools HF researchers and designers might employ to contribute to the dismantling and eradication of such injustice in our society and, therefore, expanding healthcare access to patients nationwide.

Lecture overview

What are the benefits of developing more inclusive products? When should a medical device manufacturer incorporate an inclusive mindset into the device development process? How can a medical device manufacturer evaluate how inclusive their existing products are designed?

In this lecture, we will leverage our consulting and in-house medical device development experiences in working toward developing more inclusive medical devices to:

• Define what it means to be “inclusive” in the medical device development process

• Discuss the advantages (including ethics and business) of designing medical devices inclusively

• Identify and discuss methods to evaluate a product’s inclusivity, both proactively during the design process and retroactively for products already on the market

• Identify and discuss methods to expand a product’s inclusivity

• Consider the potential regulatory imperative to employ these methods in the future. The FDA’s “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs” guidance document suggests inclusive design might be more of a requirement for HF-related aspects of medical device development

It is important to consider inclusivity at all stages of the device development process, including while developing all components of a user interface (e.g., hardware, labelling). A proactive focus on inclusivity can address opportunities for improvement before the product goes to market. Additionally, a retroactive focus on inclusivity can confirm that an existing product still accounts for many human characteristics impacting usability and if design modifications are necessary.

Such examples of methods to improve upon and evaluate a product’s inclusivity include (but are not limited to):

• Perform activities with intended users with historically underrepresented identities, such as:

. o In-person interviews

. o Co-creation sessions

. o Usability testing

• Seek opportunities to engage professionals with experience developing more inclusive products to educate product development team about inclusivity

• Heuristic analyses of products according to identity-based inclusive design metrics

As we plan to discuss in this lecture, incorporating an inclusive mindset throughout a manufacturer’s product life cycle will not only yield better patient results, but also better business results, attracting more customers overall and increasing customer satisfaction.

As HF professionals, we know that understanding and embracing human differences is central to the field. Implementing methods to address a product’s inclusivity is yet another way to gain a deeper understanding and embrace such differences. Moreover, these methods will provide an opportunity for medical device manufacturers to commit to actively addressing diversity, equity, and inclusion in their products and democratize product development.
Senior Human Factors Specialist
Human Factors Specialist
User Researcher Associate