Heart disease is the leading cause of death in the United States[1] equally impacting all. Being Women’s Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.

One of the best approaches to the risk reduction of heart conditions is healthy living. Moderating our eating and drinking habits along with physical activity can have a tremendously positive effect on the quality of life of people[2]. However, hereditary factors can increase the risk of heart conditions regardless of lifestyle. New research[3] into health diseases has prioritized understanding the different symptoms and lived experiences of women and women of color suffering from the ailments of heart disease. While similar symptoms can be identified across patients with heart conditions, the nuanced differences between men and women can increase the knowledge for treatment innovation. In response to this, the FDA’s Office of Women’s Health (OWH)[4] has funded research to understand sex differences in drug and device development hoping that this will create awareness of gender bias in how drugs and devices are designed.

For medical device manufacturers, implicit gender bias is not new. Reports[5] have identified the implicit bias in two major conceptual design inputs: the mechanics and computational. This is an alarming discovery that has tasked manufacturers to rethink the clinical studies process and data collection used for training machine learning algorithms. With this newfound funding from OWH, there has never been a better time for manufacturers to pioneer new technology for heart diseases that take into consideration gender differences.

The challenges of auditing for gender bias in drug and device development can present obstacles. EMMA can support this by developing processes and bringing forth evidence of substantive equivalence in the continuous improvement of devices and clinical investigations for drugs that want to be audited for gender bias in FDA submissions. The demand for medical innovation for life-saving heart disease medicines and devices has never been so high. Similarly, the demand for equality. EMMA can help marriage the two demands, give us a call at 248-987-4497 or email us at info@emmainternational.com today to learn more.


[1] “Heart Disease Facts.” Center for Disease Control and Prevention (CDC). Heart Disease Facts | cdc.gov

[2]  “Know your Risk for Heart Disease.” Center for Disease Control and Prevention (CDC). Know Your Risk for Heart Disease | cdc.gov

[3] “Gender matters: Heart disease risk in women.” Harvard Medical School. 2017. Gender matters: Heart disease risk in women – Harvard Health

[4] Completed OWH-Funded Research Projects on Cardiovascular Disease. FDA. Completed OWH-funded Research Projects on Cardiovascular Disease | FDA

[5] “Fixing Medical Devices that are Biased against Race or Gender.” Wallis, Claudia. 2021.  Fixing Medical Devices That Are Biased against Race or Gender – Scientific American

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