Reimagining the Gynecological Exam: addressing disparities and empowering women
Dr. Nimmi Ramanujam, Calla Health, cervical cancer prevention, global impact and student leadership
In this episode of Spotlight on Women in Health Ventures, we interviewed Dr. Nimmi Ramanujam, director of the Center for Women’s Global Health Technologies at Duke University, and co-founder at Calla Health, which aims to empower women to take control of their gynecological health and well-being. With the Callascope, their innovative device for cervical imaging, Nimmi and her team are re-imagining the gynecological exam and bringing cervical cancer screening to women’s doorsteps.
Distant dream of cervical cancer eradication
“There is no reason for anyone to die of cervical cancer. “We have the biology figured out, and have all the steps of prevention and treatment.”
Cervical cancer is often caused by the human papillomavirus (HPV), and luckily there is a vaccine which protects against the virus’ main oncogenic types. Further, the disease can be screened for through regular HPV tests (recommended every 5 years for women above age 30), or Pap smears (recommended every 3 years for women aged 21–64). Nonetheless, screening guidelines can vary by setting and case. If screening yields an abnormal result, the patient may be referred to a colposcopy — an imaging exam that allows a trained physician to visualize the cervix, identify cancerous or precancerous lesions, and biopsy the tissue for pathology analysis. If the patient has a precancerous lesion, it can be removed through simple procedures like cryosurgery (freezing of the lesion) or a loop-electrosurgical excision procedure (LEEP). If an invasive cancer is diagnosed at an early stage, chances of survival and cure are high.
If there is a vaccine, screening, and effective treatment, how come 270,000 women are dying of cervical cancer every year?
The truth is the outcomes related to cervical cancer have improved dramatically over recent years. For example, the United States observed a 54% reduction in the incidence of cervical cancer between 1973 and 2007. Even so, those in lower socioeconomic groups have a 2–3 fold increased risk of developing the disease than their affluent counterparts. Furthermore, low- and middle-income countries (LMICs) face challenges in implementing screening procedures, and are responsible for 85% of cases worldwide. In low resource settings, the healthcare workflow can vary significantly. Sometimes, Pap smears may not be available, so providers resort to visual inspection with acetic acid (VIA) screening and diagnosis — in which a trained professional applies acetic acid to the cervix, and suspected areas turn white. In other clinical settings, Pap smears are available, but the colposcopy device is expensive, and hence are only offered in tertiary hospitals which are distant from patients’ homes. In addition, lack of knowledge, shame, patriarchal cultures, and lack of female healthcare professionals are associated with poor access to gynecological services.
Regardless of being in a highly ranked hospital in the United States or in a small clinic in a village in Tanzania, most women dread the stainless steel duck-bill speculum used in gynecological exams to push open the vaginal walls. While visiting a clinic in Moshi, Tanzania, trying to understand how she could address high cervical cancer rates, a local physician mentioned to Nimmi something about getting rid of the so-feared speculum.
The speculum was invented by James Marrion Sims — infamous father of modern gynecology who tested surgical techniques and devices on female slaves without consent, and has been a feature of gynecological exams ever since. Yet, since 2013, Nimmi and her team of engineering, literature, global health, and sociology students have embarked on an adventure to re-imagine the gynecological exam without its mainstay speculum.
Calla Health: Closing the gap between where women live and where healthcare is
Through a women-centric model for cervical cancer screening, Calla Health used human-centered design to consolidate the three steps of cervical cancer screening into one and bring the solution to women’s homes. Through the process, they did not look for a solution in books, instead they focused on talking to people — female patients around the world, healthcare professionals in all sorts of different settings — to understand what they were looking for in a new cervix imaging device.
Nimmi realized that the conventional colposcope kept the provider a foot away from the cervix.
“Did it really have to be this way?” Nimmi questioned.
Soon, her team settled on the idea of a pen-like camera that could be inserted in the vagina and take an up close picture of the cervix. Because the camera would be so close to its target, it could be much smaller while keeping the same image quality and detail. And this was how the POCket Colposcope came about: a tampon-shaped device with a LED ring with a camera in the middle at the tip.
Nimmi shares that it took several years to get the design right.
“It wasn’t like someone just said let’s build a tampon colposcope, and it was ready.”
After numerous iterations of the POCket Colposcope, and clinical testing in over eight countries, it has been granted FDA 510k approval in 2018.
Calla Health did not stop there. While the POCket Colposcope was well-received, Nimmi was still passionate about addressing the speculum. As a result, a new design saga began to think about new ways to push open the vaginal walls to visualize the cervix.
Nimmi had an “Aha” moment walking through Whole Foods, when she came across a Calla Lily. The Callascope, which mimics the shape of the Calla Lily, became a support system for the POCket Colposcope. The flower’s funnel shape allows the vaginal ways to be widened near the cervix only, which grants greater levels of comfort to patients. In addition, women can use the device to self-exam at home. The image of the cervix is transmitted to a physician via telemedicine for evaluation or it sent to an artificial intelligence platform that detects potential precancerous and cancerous lesions.
The device is under clinical trials, and so far, patients in the United States, Ghana and Peru have expressed excitement, feeling empowered with the ability to self-exam and relieved with a more gentle instrument for the gynecological exam.
Sustainability and Scalability: The two pillars for creating impact
Throughout the interview, Nimmi revealed that sustainability and scalability are the pillars of any health solutions. “We want to adopt a model to save more lives,” she reflected, but sustainability involves figuring out who will pay for the device. And to convince someone that they should sponsor the intervention, you need to show how it compares to the status quo, how cost-effective can it be, and whether its implementation would require policy changes.
On the other hand, “what is the point of sustainability if it will not reach everyone in the world?” Nimmi questioned.
In her work, reaching the most remote and marginalized places is key. Even though Calla Health was not strategic at first to partner with local government, they now realize the importance of well-known figures, who have either worked in government or have local influence. In Peru, the Callascope has found support from Dr. Patricia García — former Minister of Health — who is passionate about changing the cervical cancer landscape in her country. Besides the excitement of the community health workers in Dr. García’s HOPE Project — Nimmi has faced pushback from gynecologists, whose careers involve colposcopies and gynecological exams. She understands that these providers may feel threatened by the Callascope autonomous proposal, and therefore, Calla Health is trying to understand how to mitigate the concerns of OB/GYNs.
“Just because you save lives, it does not mean everyone buys into your solution and model,” Nimmi confesses.
Students as protagonists
Nimmi realizes that Calla Health would not exist without her students. In fact, Mercy Aseidu, one of her doctoral students, was the leader in the Callascope’s development and is co-founder of Calla Health. For Nimmi, mentorship is about empowering people and helping them feel ownership over the project. She tends to give students autonomy to explore their own ideas, but is constantly available to troubleshoot and brainstorm with them. Nimmi is a firm believer in lateral organization, treating her students as colleagues, and offering everyone a seat at the table where major discussions and breakthroughs are made. She has found immense power in this collaborative model, and in fact about 30% of her students in the past 3 years have developed solutions that are now being commercialized.
“Students get to experience design, manufacturing, regulatory processes, directly. So they will not be intimidated when it is there time to create impact,” Nimmi says proudly.
Her center is also unique as it welcomes students across all fields (humanities, social and natural sciences), even though it is technically an engineering group. Nimmi realizes that it all comes down to passionate individuals solving pressing social problems, and that engineering or other fields are just the tools and lens we use to tackle them.
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Story written by Luiza Perez and Priya Kumar.
