The Invisible Half: Uncovering & Addressing Gender Data Bias in Medical Devices
Mar 8, 2025
This article was written in collaboration by Archana Penumudi, Tanner O’Brien, and Haroula Tzamaras, PhD.
Background
Medical devices serve diverse populations worldwide, yet user differences in physical size, gender, race, and other characteristics often remain unconsidered during the design process. This oversight, particularly concerning gender differences, represents a significant data bias that can compromise device safety and effectiveness. While data bias affects numerous industries, its impact in medical devices presents unique challenges that disproportionately affect marginalized groups, with women facing particular disadvantages.
Caroline Criado-Perez, in her seminal book "Invisible Women," illuminates the root of this problem: "...the lives of men have been taken to represent those of humans overall. When it comes to the lives of the other half of humanity, there is often nothing but silence" [1]. These silences represent critical data gaps that reflect the systematic exclusion of women's perspectives in product design and development.
In medical human factors specifically, gender-based data bias manifests when women's needs and characteristics are overlooked during usability engineering. This oversight leads to devices that may not accommodate female users effectively, resulting in:
Increased difficulty in device operation
Higher rates of adverse effects
Greater likelihood of misdiagnosis
Potentially dangerous treatment outcomes
In each of these cases, women may face higher rates of misdiagnosis, be thought of as incompetent due to struggles to use a device or receive treatments that are less effective — even potentially dangerous. Adding to this, specific evidence from studies focused on women surgeons found in 2014 that “women surgeons were more likely to experience discomfort and seek treatment” [2] and in 2022 found that “women and small handed surgeons report difficulty with laparoscopic instruments and that it affects the ability to learn procedures” [3]. These studies, being almost 10 years apart, indicate that the MedTech industry still has work to do.
Industry Considerations in Human Factors
Despite these significant implications, current regulatory frameworks show notable gaps. The U.S. Food and Drug Administration (FDA) does not mandate manufacturers to submit human factors data addressing sex-based differences. While the FDA's 2016 guidance, "Applying Human Factors and Usability Engineering to Medical Devices," emphasizes safety and efficacy based on intended user characteristics, it lacks specific requirements for considering diverse user populations [4].
Consequently, there are no clear guidelines for designing usability studies that identify use-related risks associated with sex-based differences, nor is there an established protocol for reporting how these differences may influence task outcomes during residual risk analysis.
Our blog series, "Designing for All: Uncovering & Addressing Gender Data Bias in Medical Devices," will examine this critical issue over the coming months. We will explore:
The scope and impact of gender data bias in medical device design
Technical examples and case studies
Current regulatory considerations and gaps
Solutions and future directions for improvement
By highlighting these challenges and potential solutions, we aim to contribute to the development of more inclusive and effective medical devices that serve all users equally.
References:
[1] Criado Perez, C. (2019). Invisible women: Data bias in a world designed for men. Abrams Press.
[2] Sutton E, Irvin M, Zeigler C, et al. The ergonomics of women in surgery. Surgical Endoscopy. 2014; 28:1051-5.
[3] Weinreich HM, Babu M, Kamil R, et al. Gender-differences of proceduralists in perception of hand-held surgical instrument fit – a cross-sectional survey. The American Journal of Surgery. 2022; 224:1482-7.
[4] U.S. Food and Drug Administration. (2016). Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff.
