Have you ever used a piece of equipment that just didn’t fit your hand properly, or wondered if a medical test was actually calibrated for your biology? For many women, this happens every day.
Our Regulatory and Quality Consultant, Laura Taylor, recently wrote about this exact issue for the February 2026 edition of Regulatory Rapporteur, the official journal of The Organisation for Professionals in Regulatory Affairs Ltd. Her article explores why the industry must shift from designing for an “average” user to embracing inclusive, sex-gender-based design from day one.
The Problem with the "Average" User
For decades, medical technologies have been engineered around a standard user profile that defaults to male anthropometry and physiology. While these devices might meet basic regulatory requirements, they often fail to perform optimally across diverse patient and clinician populations.
Inclusive design involves recognising that sex-based biological variations meaningfully shape how a device works. This includes ergonomic differences, such as hand size and grip strength, as well as critical physiological factors like anatomical differences and hormonal cycles that influence biomarker baselines.
Two Sides of the Coin: Ergonomics and Physiology
Laura illustrates the real-world impact of these differences through two clear scenarios:
The Physical Barrier: A manufacturer of laparoscopic instruments discovered that female surgeons were experiencing disproportionate hand fatigue and reduced control. The device’s activation forces and handles had been optimised for a larger, typically male, hand span. By redesigning the instrument with adjustable grips, the manufacturer resolved a significant safety risk and improved precision for all users.
The Physiological Barrier: A diagnostics company developing a portable hormonal assay found that its calibration algorithm consistently underestimated hormone levels in women. Because the algorithm was trained on male-dominated datasets, it risked providing false-negative interpretations for early endocrine disorders. Retraining the system with a sex-balanced dataset that factored in the menstrual cycle was crucial for restoring accuracy.
Using the Rules We Already Have
The good news is that we do not need to invent new rules to fix these issues. Existing frameworks provide a strong foundation when viewed through a diversity lens.
Under ISO 14971 (Risk Management), user diversity can be classified as a legitimate hazard source; if a device requires consistent manual force, the risk to users with smaller hand spans must be proactively addressed. Similarly, IEC 62366-1 (Usability Engineering) mandates that usability testing groups be balanced and truly reflective of the actual clinical and patient populations.
The Global Regulatory Shift
Regulators worldwide are recognising that inclusivity is an essential component of regulatory science.
EU & UK: The EU MDR and IVDR require devices to be suitable for their entire intended population. Meanwhile, the UK MHRA is increasingly engaging with patient groups to tackle disparities and enable equitable innovation.
North America: Health Canada has established the Scientific Advisory Committee on Health Products for Women (SAC-HPW) to provide patient-centred advice on device regulation. In the US, the FDA’s Women’s Health Research Roadmap actively encourages sex-disaggregated data in clinical investigations.
Embedding inclusivity into your Quality Management System—through standard operating procedures (SOPs) for human factors testing and demographic tracking in post-market surveillance—is no longer just a best practice. It is a pathway to stronger clinical outcomes, better market access, and a distinct commercial advantage.
To read Laura’s practical strategies in full, you can find her complete article in the February 2026 edition of Regulatory Rapporteur.
How Advena Can Support Your Compliance Journey
Adapting to these inclusive design requirements and evolving global standards requires expert guidance. Whether you need comprehensive Medical Device Consultancy, support with your Quality Management Systems, or a dedicated UK Responsible Person, our team of experts is ready to assist. We simplify the regulatory process so you can focus on innovation and patient safety.
Explore our full range of services and learn how we can partner with you to achieve seamless regulatory compliance. For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page at www.advenamedical.com, email (info@advenamedical.com) or phone (01926 800153) to start a conversation today.
