Few would describe a pelvic exam as a pleasant experience. However, it is an essential way to screen for serious conditions such as cervical cancers. According to the CDC, over 90 percent of cervical cancers are preventable with early screenings, yet the disease kills one woman every two minutes. For those with access to healthcare, an appointment may require long wait times, the inconvenience of visiting the doctor’s office, and the anxiety and discomfort that many women experience during the actual exam. Still, this represents one of the best-case scenarios.

For women living in under-resourced countries, who comprise 85 percent of cervical cancer mortalities, this routine checkup may bring additional challenges. Traveling to a medical center could involve hours on public transportation. Mothers experience an additional layer of stress as they arrange for childcare while they attend the appointment. And there is the potential stigma of the exam itself in certain cultures. These factors create an insurmountable barrier for some women, and they may choose to forgo the checkup entirely.

In 2011, Nimmi Ramanujam, Marlee Krieger, and a dedicated team of researchers from Duke University’s Global Health Institute embarked on a vital and complicated project to address these issues. The result was the Pocket Colposcope. Intended to serve women in under-resourced countries, the Pocket Colposcope is a lightweight tool individuals can use to screen for cervical cancer.

The research team kept the intended user in mind throughout the design, testing, and implementation process. They pursued a human-centered design approach, which upheld three key tenets: hear, create, and deliver. Diverse perspectives influenced the project’s trajectory as the research team interviewed OB-GYNs from low-, middle-, and high-income countries.

Quality was key, and the research team began the initial trials for the Pocket Colposcope at Duke University’s 1J Gynecology Clinic for years before involving any vulnerable or marginalized groups. Vetting the device domestically was a crucial step before taking it overseas or to low-income countries. Prioritizing the health and experience of minoritized and under-resourced communities represents a welcomed departure from previous reproductive health research, including that of James Marion Sims, who conducted painful experiments on enslaved Black women to advance his research in the mid-19th century. These examinations could last for hours, and the enslaved women did not have access to anesthesia to dull the pain. Sims began using his procedures on white women only after conducting very public and agonizing experiments on Black women.

The 20th century saw a similar story unfold in Puerto Rico when two white American scientists, Gregory Pincus and John Rock, developed a birth control pill in the mid 1950’s. Pincus and Rock pitched a narrative of family planning to the women in Puerto Rico, but colonial dynamics drove the process. Seeking out marginalized populations, Pincus and Rock tested the oral contraceptive on impoverished women. These women consented to the pill but didn’t know that they were vetting the pill for potentially dangerous side effects before it was distributed to white women in the U.S.

The Pocket Colposcope team ensured the safety and efficacy of the tool before using it to serve vulnerable populations. Marlee Krieger, the Executive Director of Duke’s Center for Global Women’s Health Technologies, shared, “If it's not good enough for me, my daughter, or my mother, I don't want to deploy it on any other woman.”

Following a user-centered approach, the team developed an optical tool equipped with a camera and light that allows users to take a picture of the cervix. From there, they can upload the image to a cloud-enabled database where a healthcare professional can provide a medical opinion on what they see. A mobile application that supports the downloading, transmission, and storage of these images accompanies the tool. The Pocket Colposcope’s thin cylindrical shape reduces discomfort and consists of a handle, a probe, and a USB cord. The handle contains three buttons: one to activate the light, one to operate the camera, and one to refine the image. With its slight angle, the handle minimizes strain for the patient or for the person administering the exam. This demonstrates how the research team prioritized the user experience for both the patient and the care provider when they engineered the Pocket Colposcope.

The implementation process was similarly thoughtful and user centric. Through extensive interviews, the team actively engaged stakeholders including doctors, caregivers, and patients from a range of countries. Feedback on early iterations came from a broad swath of geographies: from Charlottesville and Chennai; from North Carolina and Nairobi. Now in its sixth generation, the Pocket Colposcope reflects insights from those who have used and administered the device in a range of settings.

The Pocket Colposcope has served over 1,000 patients in nearly a dozen countries with a common baseline of high incidence rates of cervical cancer. Cultural context informed every decision of the process as each country follows unique combinations of healthcare practices and attitudes toward reproductive health. These differences become especially apparent in the implementation stage. For example, in original marketing materials the research team encouraged the involvement of midwives and other medical professionals beyond OB-GYNs. Ideally, this would help facilitate a decentralized approach where patients could travel to local clinics in rural areas to receive a screening rather than finding a way to medical centers in larger cities.

This “task shifting” appealed to communities in sub-Saharan Africa but received pushback in Peru. Doctors in Lima hesitated to allow people without medical degrees to administer an examination without a doctor or nurse present. They wanted to promote accessibility but feared that the language suggested their removal from the screening process entirely. In response, the team repositioned marketing materials. Instead of explicitly recommending that individuals shift responsibilities, the literature suggested that members of the broader medical community could administer screening through the Pocket Colposcope.

Going forward, the project will shift its focus to execution and commercialization. During the past several years, corporations and angel investors have expressed interest in the Pocket Colposcope. But there is always a catch. These parties usually demand a price hike in exchange for their investment since securing higher profits is the key priority for potential partners. The Pocket Colposcope team has declined several such offers, which violate their core mission to help save lives from a preventable disease.

To maintain agency over the pricing and distribution of the device, the research team has repositioned itself. As of February 2019, the commercial arm of the Pocket Colposcope operates under the Calla Health Foundation. Under this new organization, the team can license the Pocket Colposcope technology from Duke University. Currently, the Foundation relies on awards and grants for funding. But that will change soon. Opportunities to monetize their efforts may be on the horizon. The team is preparing to launch the Pocket Colposcope for commercial purchase in Fall 2021 at a projected cost that is less than 5 percent of the traditional colposcope.

Maintaining low prices and improving accessibility enables the Pocket Colposcope to fulfill its fundamental mission: to empower people and save lives. Perhaps most importantly, this project lays the groundwork for innovation while acknowledging historical inequities in order to challenge and combat them.

Image credit: Histological section showing cervical cancer, specifically squamous cell carcinoma in the cervix. Tissue is stained with pap stain and magnified x200. (National Cancer Institute | Public Domain).