Women’s health is not a niche: why MedTech must rethink how it designs for half of the population

Women’s health has long been underserved in medical device innovation, but the landscape is finally shifting. For decades, women’s needs were either treated as niche – limited to areas such as reproduction or menstrual health; or as deviations from a male “standard”, resulting in solutions that were ill‑fitted, under‑researched, or simply overlooked. Now, rising awareness and a growing demand for equity is driving long‑overdue momentum across the MedTech industry. 

In this blog, I explore what’s changing, why designing effectively for women requires more than surface‑level adjustments, and how early‑stage insights and Human Factors engineering can create better, more equitable solutions for all. 

The wake‑up call: why women’s health is getting renewed attention

For years, thought leaders and researchers have highlighted the systemic inequality baked into healthcare data and design. Advocates like Caroline Criado Perez (Invisible Women, 2019) have drawn attention to the “gender data gap” – the tendency to treat male‑derived information as the universal baseline. Her bestselling book Invisible Women: Data Bias in a World Designed for Men helped make those disparities widely visible, offering both a wake‑up call and a roadmap for change. 

Today, the MedTech industry is listening. Companies are recognizing the unmet needs, and enormous opportunities, in better serving the 51% of the world’s population whose lived experiences have been historically ignored or generalized. 

The risks of assuming “one size fits all”

A recurring issue in MedTech is non‑representative clinical evidence. Too often, data sets are male‑centric or do not break down results by sex, masking crucial differences. 

When designing devices for women, evidence must reflect: 

• Physiological and hormonal variations across menstrual cycles, pregnancy, postpartum, and menopause 

• Inclusion of pregnant and lactating women, which regulators such as the FDA and ICH are increasingly supporting to fill long‑standing information gaps 

• Representation across age, ethnicity, and broader health status, ensuring that insights reflect the full spectrum of women’s experiences 

If these nuances are overlooked, device performance can be misinterpreted, risks go undetected, and real‑world usability challenges remain hidden. 

Early insights and Human Factors: where real Innovation begins

By the time a product reaches late‑stage development, small adjustments rarely address the systemic differences that shape women’s needs. “Women’s versions” of devices often feel like apologies, scaled‑down or cosmetically altered iterations that fail to solve the underlying challenges. 

Real innovation starts much earlier. 

At Ensera Design, our Human Digest program brings women, patients, and healthcare practitioners into ongoing dialogue with our development teams. Through this early engagement, we’re able to build genuine empathy, uncover unmet needs, and understand the environmental and contextual factors that influence real‑world use. It also helps us recognize where bias might be shaping decision making, strengthens regulatory readiness by grounding decisions in lived experience, and ultimately supports long‑term market success. 

Human Factors engineering plays a critical role here, ensuring solutions are rooted in real human experience rather than assumptions, shaping products that truly work for the people they’re designed to serve. 

Common pitfalls: bias, assumptions, and missed opportunities 

Unconscious bias is a natural part of being human, we all rely on mental shortcuts to make sense of a complex world. The challenge is not that bias exists, but that it can quietly shape decisions if we don’t actively look for it.  

For organizations entering the women’s health space for the first time, this can show up in many ways: leaning on assumptions rather than evidence, applying male‑centric benchmarks as if they were universal, overlooking hormonal or lifecycle‑related differences, or drawing conclusions from user groups that don’t fully represent the women a product is meant to serve. Recognizing these patterns isn’t about placing blame; it’s about acknowledging the realities of product development and giving teams the tools to move beyond them.  

When assumptions are replaced with diverse, evidence‑driven insights, products become safer, clinical relevance increases, and commercial success becomes far more achievable. 

Looking ahead: women’s health will shape the future of MedTech

We’re at an exciting moment. After centuries of underrepresentation, there is significant ground to make up, but the momentum is finally here. The future of MedTech innovation will require development teams that reflect the diversity of the people they serve, evidence generated from truly representative populations, greater investment in technologies designed specifically around women’s needs, and a shift away from “universal by default” solutions that often overlook critical differences. If today’s growing recognition continues to translate into meaningful investment, the next decade could redefine what equitable healthcare innovation looks like. 

How Ensera Design can help

If you’re developing a women’s health device or planning early research, it’s worth asking: what assumptions might be shaping our approach, and how can we design more thoughtfully for the women we aim to serve? At Ensera Design, we know that when we expand our perspective beyond a single user group and take a more inclusive design approach, the benefits extend far beyond women’s health; improving safety, usability, and performance for everyone. Our team works across early‑stage insight generation, Human Factors engineering, systems design, and clinical‑ready development guidance and assistance to ensure women’s needs are deeply understood and built into solutions from the start.

Maartje Pel, Director of Research and Design at Ensera Design, holds a master’s degree in industrial design from Delft University. A collaborative and integrative leader, she brings multidisciplinary teams together to translate insight into meaningful innovation. Maartje has recently been featured in MD&DI. To read the full article click here: Redefining Women’s Health as a Medtech Growth Opportunity