This International Women’s Day, our Clinical Development Engineering Lead, Uresha Patel, discusses the importance of gender diversity in Medical Advisory Boards, and the development of medical devices.
In the MedTech industry, not only is it important to collaborate with a diverse range of corporate expertise but including the opinions and lived experiences of a diverse group of end users, during research and the design and development cycle is crucial. Particularly in MedTech, gender and ethnic diversity can lead to improvements in patient care, innovation and risk assessments [2].
Disregarding diversity only continues the cycle of health inequities and holds us back from developing meaningful tech to address unmet needs.
The growing awareness around social injustice and health inequity has highlighted the lack of diversity and inclusion in clinical research, such that regulatory bodies like the FDA have issued a new draft guidance for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials [3].
In the midst of this, representation among clinicians from underrepresented groups is important to provide informed perspectives on disease progression in underrepresented populations and characterising the clinical benefits and risk of a product under development.
Gender disparity in surgery is unfortunately still prevalent today with only 35% of surgical trainees and 14% of surgical consultants being female in the UK alone[4, 5], although females make up to around 60% of graduates from medical school [6]. Sadly, this is a global issue as the World Health Organisation reported similar figures on female representation in surgery [7].
The Clinical Development Engineers at CMR Surgical are making a conscious effort to design with diversity and inclusion in mind to accommodate the needs and preferences of people of all abilities and backgrounds. Such efforts are important to avoid unintended biases which could lead to compromised care.
Since one of the key roles of a Clinical Development Engineer is to assess the safety and performance of devices during the development process, it is important that we have included feedback from a diverse group of clinicians to cover behaviours and outcomes which are prevalent from as many subgroups as appropriate.
To address diversity and inclusion, the Clinical Development Engineers ensure studies are carried out by suitably selected and diverse experts. Validating products with more than one expert opinion from widely varying backgrounds is important to ensure we have captured the needs and demographics of a diverse group of clinicians. Factors that are taken into consideration when choosing experts for such studies include but are not limited to, surgical expertise and specialities, progress along the learning curve with Versius, subject matter expertise, gender and ethnicity.
In line with this, the Clinical Development Engineers will regularly seek expert advice throughout the design and development cycle to ensure clinical safety factors are considered as well as user preferences and analyse performance outcomes. To do this, Medical Advisory Boards (MABs) are often consulted. Despite the lack of females in surgery, we are proud that 80% of our MABs include
female representatives. Not only are our MABs gender diverse, but are also globally and ethnically diverse, ensuring more rounded viewpoints are encompassed.
Although the MedTech world is still far from being completely equitable in providing unbiased health care, we at CMR Surgical are making great strides to address such imbalances by ensuring that research, design and development activities in Clinical Development Engineering is inclusive and diverse.
References
Sundiatu Dixon-Fyle, K.D., Dame Vivian Hunt, and Sara Prince, Diversity wins: How inclusion matters. 2020: McKinsey & Company
Gomez, L.E. and P. Bernet, Diversity improves performance and outcomes. Journal of the National Medical Association, 2019. 111(4): p. 383-392.
Document, F.G., Diversity Plans to Improve Enrolment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. 2022, FDA FDA-2021-D-0789.
Moberly, T., A fifth of surgeons in England are female. BMJ, 2018. 363: p. k4530.
Newman, T.H., et al., Gender diversity in UK surgical specialties: a national observational study. BMJ Open, 2022. 12(2): p. e055516.
Moberly, T., Number of women entering medical school rises after decade of decline. BMJ, 2018. 360: p. k254.
Xepoleas, M.D., et al., The experiences of female surgeons around the world: a scoping review. Human Resources for Health, 2020. 18(1): p. 80.