Abstract 

Inclusive design is increasingly recognised as an essential component of medical device development, yet many devices continue to be designed around assumptions of a standard or ‘average’ user. These paradigms have historically been shaped by male physiological norms, resulting in devices that meet regulatory requirements but do not always perform consistently across diverse patient and clinician populations.  

This article explores how integrating women’s health considerations into design, human factors engineering and regulatory evidence can enhance safety, performance and compliance. It examines how existing frameworks, particularly ISO 14971 and IEC 62366, can be applied through a diversity lens to show physiological, ergonomic and experiential differences that may affect device usability and risk. 

Emerging regulatory expectations in the EU, UK, Canada and US are reviewed, alongside practical strategies for embedding inclusivity into quality systems and design controls. Two fictional case studies illustrate how sex-gender-based approaches can resolve performance discrepancies and improve regulatory assurance. 

The article concludes that sex-gender-based design is not only ethically and scientifically justified but is increasingly aligned with modern regulatory priorities, positioning manufacturers for more effective and equitable innovation.