From the colon to the lungs, and everywhere in between, most medical devices are made for the average-sized male. But, the “one size fits all” approach falls short when it comes to women’s healthcare. When devices tailored for the male body are used in female patients, negative health outcomes abound. Here’s why we need sex-specific medical device sizes and protocols.
Over 60 million women (44%) in the United States are living with heart disease which is the number one killer of women in the US responsible for 1 in every 5 female deaths. Artificial hearts are used to support patients while waiting for a donor heart transplant. The medtech company, SynCardia, gained FDA approval for the first artificial heart in 2014. Unfortunately, this first model fits less than 20% of women’s chest cavities. A smaller version was later approved in 2020 but still fits less than 50% of women. There are dramatic disparities in heart disease between men and women including women dying at consistently higher rates than men while waiting on a donor list and only 20% of heart transplant recipients being women. The inability to provide mechanical hearts to females of average or below-average chest cavity sizes is a devastating blow to women’s ability to survive heart disease.
Colon cancer, the third leading cancer in the U.S., causes approximately 24,000 female deaths annually. The cancer and pre-cancerous polyps are detected by colonoscopy, a routine procedure using a thin, flexible tube to examine the colon and small intestine. Female colons and intestines are unique, often having more twists and turns than males because the space is shared with their reproductive organs. This makes the procedure more challenging, especially if scar tissue from surgeries like c-sections or hysterectomies is present.
Because of these challenges, and lack of adequate tools, colonoscopies in females are completed less often compared to males leaving them at risk of undetected polyps and cancer. Many gastroenterologists will resort to using pediatric scopes in female patients to enable them more flexibility and precision when navigating the intestines.
But if approximately 7 million people per year could have a more thorough colonoscopy, then why has this critical tool been overlooked?
Another unexpected place to find sex differences in medical devices is ventilators. Everyone has different-sized lungs and therefore require customized volumes of air. The amount of air is determined by an equation that incorporates the patient’s height. If a ventilator is not calculated correctly, the patient can sustain lung damage caused by miscalculated pressures or volumes.
Since patients needing intubation are in critical condition, it is an accepted practice for medical professionals to guess the patient’s height. Studies have shown a consistent overestimation of height, particularly in the shortest patients. Since females are, on average, 10 to 15 cm shorter than males, this guessing error affects them more. Additionally, some studies have found that women who are put on breathing machines might suffer more from a condition called acute respiratory distress syndrome (ARDS), and might even have higher mortality rates, and worse long-term health outcomes. To fix this, formulas for ventilation amounts need to anticipate this bias and provide estimates for male and female patients accordingly.
These medical devices represent just a fraction of the opportunity we have to improve female healthcare. It’s time that we inventory the entire healthcare system and ask, “If sex was considered, would this device or procedure be different?” This type of assessment would likely reveal a plethora of opportunities for innovation, improved health outcomes, and decreased healthcare costs.