Human Factors and women’s health: discussing difficult and embarrassing topics with female patients

Women’s health devices present some of the most sensitive and intimate scenarios in Human Factors research, from fertility trackers and pelvic‑floor trainers to gynecological equipment, wearables and vaginal self‑collection tools. While Human Factors principles, including those in the FDA’s Human Factors guidance (2016) and IEC 62366‑1:2015, emphasize real‑world use, context and user diversity, the reality is that conversations around these devices often feel deeply personal for participants and sometimes for researchers too.

Yet in my experience as a Human Factors Engineer working on the development of these important devices, these are often the conversations that matter most. They reveal the usability risks that formal guidance alone can’t surface, and they build the empathy required to design products that truly support women in accessing effective health treatments.

This article explores why sensitivity and empathy matter in this space and how Human Factors teams can structure safer, more respectful and more productive sessions with female participants.

1. Provide transparency and clarity to ensure full understanding 

Transparency is foundational, but especially crucial in intimate or private tasks. Participants should understand not only what they’ll be doing, but how and why.

I recall a session where a participant hesitated after signing consent. It emerged she misunderstood how a wearable vaginal model would be used over clothing during the study. Simply showing her the model before proceeding helped remove uncertainty and strengthened her willingness to engage.

The lesson: slow down, clarify, check comprehension early and always make opting out judgement‑free.

2. Lead with empathy

Women’s health conversations can carry social stigma. A welcoming tone, explicit reassurance and humanized framing can immediately shift the dynamic.

Simple language such as: “Some of this may feel unusual to discuss outside a medical setting, but your input genuinely helps how we develop products that support other women like you.” …helps normalize the conversation and emphasize shared purpose. Remind participants regularly: you are not evaluating them; the device is what’s being tested.

3. Ensure privacy  

Environmental cues can heighten anxiety. One‑way mirrors, visible observers or large viewing teams may create intimidation rather than comfort.

Small adjustments make a big difference:

• Seat participants facing away from mirrors
• Explain clearly who is observing, if anyone
• Keep spaces calm, quiet and private

These details reinforce dignity and psychological safety throughout the session.

4. Embrace “women designing for women” where possible

Evidence consistently shows that female participants are more candid with female moderators during intimate or reproductive‑health tasks. This shift is not only empathetic, it improves data quality.

• Honor requests for male colleagues to step out
• Where possible, involve female moderators or co‑moderators
• Consider team composition early in study design

5. Avoid confusing or ambiguous language

Medical or technical terminology can be easily misunderstood in sensitive contexts.

In one study I was involved in, the word “simulated” in a consent form was misread as “stimulated.” A participant’s daughter became worried her mother might undergo physical stimulation during the task. The misunderstanding was only resolved through careful re‑explanation.

The takeaway: use simple, precise language and test comprehension before proceeding.

6. Consider wearing scrubs

First impressions shape trust. Although Human Factors specialists are not clinicians, participants may expect medical attire when discussing reproductive health.

Wearing scrubs can:

• Make the environment feel more legitimate
• Reduce participant self‑consciousness
• Reinforce neutrality
• Provide a familiar context for sensitive discussion

A small cue, but often a powerful one.

How Ensera Design can help

If you’re developing a women’s health device or planning sensitive Human Factors research, start by asking: what assumptions are we making, and how can we create environments where women feel safe to speak openly about their experiences? Our team supports everything from early study design to empathetic moderation and translation of insights into actionable design decisions.

Maria Mawhinney is a Human Factors specialist at Ensera Design’s US studio, delivering evidence‑based insights across women’s health, MedTech and combination products.