Abstract
This study investigates the impact of gender bias in Medical Device Design (MDD), with a
particular focus on surgical tool design and its consequences for biological female surgeons in
South Africa. Despite global progress in inclusive design, women remain underrepresented in
the anthropometric and ergonomic data used in the development of medical devices, leading to
discomfort, strain and increased injury risk in surgical practice.
Insights from a survey with South African female surgeons revealed persistent ergonomic
mismatches between tools and their users, reflecting broader global patterns of exclusion and
underscoring the “gender data gap” in MDD. These mismatches cause physical strain and
musculoskeletal issues, reinforcing symbolic and professional exclusion in surgery. Rooted in
the distinction between sex (biological attributes) and gender (sociocultural roles), the research
foregrounds the need for accurate, sex-disaggregated data to inform the design of tools that are
safe, comfortable and effective for all users in the operating theatre.
The central research question – How might we eliminate gender bias from the MDD process and
regulatory systems? – guides the study, supported by sub-questions that examine the specific
impacts of gender bias on South African female surgeons, the availability of existing inclusive
frameworks, and the potential for a new context-sensitive design model. In response, the study
aims to develop a practical and scalable framework to support gender-inclusive surgical tool
design in South Africa.
This study employed a multiple-framework methodology grounded in Inclusive Design,
underpinned by Human-Centered Design (HCD), Gender Mainstreaming, and Implementation
Science, drawing on both desktop and field research. Twelve sources (including frameworks,
models, standards, guidelines, and roadmaps) across four categories, namely, medical device
development, standards and regulations, inclusive MDD, and gender-inclusive design, were
analysed, cross-compared, and synthesised. While numerous frameworks exist, their practical
application often falls short, highlighting the need to bridge the gap between theory and practice.
Incorporating Implementation Science enabled triangulated comparisons and guided the
development of a localised framework responsive to South Africa’s regulatory context.
The resulting framework proposes an integrated, gender-responsive approach that aligns with
international design principles while addressing local policy and ergonomic contexts. By
embedding inclusive strategies within MDD practices and regulatory systems, the study offers
actionable guidance for designers, manufacturers, regulators, and policymakers. Although
limited in scope to Class 1 surgical tools, the framework provides a foundation for expanding
inclusive design practices across the broader medical device sector. Ultimately, this research
contributes to academic discourse and real-world application by challenging systemic oversights
and offering a structured pathway toward equitable innovation in healthcare.