A Global perspective: Maximizing Cultural Inclusivity

This article was written in collaboration by Jenny Collinson, Director of Human Factors Strategy & Advisory and Dr. Lengwe Sinkala, Human Factors & UX Consultant at ClariMed.

The task of designing medical devices that are user-centered and culturally relevant in all launch markets calls for intentionality, collaboration and innovation. Although the world is often referred to as a 'global village'—a term coined by Marshall McLuhan in the 1960s—the cultural diversity represented by different user groups is a reality that must not be ignored.

Designing devices that are culturally inclusive allows medical companies to reach a broader group of people, addressing their shared beliefs, values, customs, and behaviors, and improving patient safety, usability, and accessibility.

Why Cultural Sensitivity Matters

• Diverse User Needs: Different cultures have varying levels of health literacy, language proficiencies, and healthcare expectations. A device tailored to meet these needs will not only be more usable but also more likely to be adopted.

• Culturally Appropriate Design: Ignoring cultural differences can lead to biased designs negatively impacting the development of medical devices. This can result in poor device usability and health inequities.

• Regulatory and Ethical Considerations: Many regulations, such as FDA and ISO standards, emphasize the importance of inclusivity and diverse testing in clinical studies. This guidance is just as important for usability studies. By adhering to these guidelines, companies demonstrate their commitment to promoting these crucial values and align themselves with the ethical expectations of regulatory bodies.

Key Cultural Factors to Consider

• Language and Communication: The instructions should be clear and available in multiple languages. Potential misinterpretations due to language nuances or translation errors should be taken into consideration and be addressed.

• Health Beliefs and Practices: Acknowledge how cultural views on health and medicine can influence device usage. Attitudes toward self-administered devices, reliance on traditional medicine, or stigma around certain conditions can heavily influence how medical devices are perceived or received in environments by the user and by patients. For instance, in some regions of Zambia, there is a belief amongst patients that a caesarean section should be avoided due to fears that it may result in the death of the mother. This belief can delay treatment and lead to serious consequences, such as the loss of both the mother and child. While this example isn’t directly related to medical devices, it underscores how cultural beliefs can influence health practices and should be considered when designing user-centered devices.

• Physical and Cognitive Variability: Ergonomics and anthropometrics should be considered to ensure that devices are physically accessible for users of all body types. For example, devices designed for specific populations may need to accommodate physical characteristics typical of those populations. A study led by Harvard Medical School researchers at Brigham and Women’s Hospital and Beth Israel Deaconess Medical Centre revealed that pulse oximeters, which measure oxygen saturation, may contribute to disparities in care based on the patient’s race. This underscores the need for devices to be designed inclusively to avoid inequities in medical outcomes. Additionally, for skin-worn devices such as wound dressings, designing them in a range of colors that more accurately match the diverse skin tones of end users can promote acceptance and compliance with treatment. For example, offering wound dressings that blend with a patient's natural skin tone—rather than defaulting to light pink or white—may reduce stigma and enhance user satisfaction. Cognitive factors also play a critical role in device design. Educational background and literacy levels can significantly influence how users interpret instructions or interact with devices. Ensuring instructions are simple, clear, and culturally relevant can help mitigate these barriers and improve usability for a diverse user base.

Best Practices for Incorporating Cultural Diversity

• Designing products to fit the users: Conduct early research into users, environments of use, and healthcare systems to ensure cultural appropriateness from inception.

• Diverse Participant Recruitment: Ensure that your study participants represent a wide range of cultural and demographic backgrounds.

• Localized Design and Testing: Adapt the design to fit cultural contexts (e.g., colors, symbols, user interfaces) and conduct usability testing in varied regions or settings.

• Inclusive Testing Protocols: Provide materials in native languages, use neutral scenarios, and avoid assumptions about user behavior.

• Collaborate with Local Experts: Engage local stakeholders to gain valuable insights into regional practices and expectations.

Challenges and Solutions
Potential challenges, such as difficulty in recruiting diverse participants and budget or time constraints for extensive testing should be addressed. Remote user studies via digital platforms can provide valuable insights even in hard-to-reach locations, while partnerships with local organizations can help overcome logistical and cultural barriers in recruitment.

We urge medical device companies to view cultural sensitivity not only as an ethical responsibility but also as a strategic advantage. Prioritizing this aspect can lead to improved usability, higher adoption rates, better patient outcomes, and greater market reach. Embedding cultural sensitivity in every stage of human factors studies. At ClariMed we strive to help companies bridge the gap between their medical devices and the diverse user groups they target. We also invite you to share your perspectives on improving inclusivity in medical device design as well as your experiences around cultural sensitivity and medical device design.