Disruptive Innovation and Policy in Healthcare (2025-2026)

Although cases of cervical cancer in the United States have declined in recent decades, significant disparities persist between rural and urban areas.

Duke’s Center for Global Women’s Health Technologies has developed two innovations for their global cervical cancer prevention initiative. The Pocket Colposcope is a low-cost, portable cervical cancer screening device that reduces structural barriers by shifting early detection from physicians in urban centers to providers in community settings. A sister technology, the Callascope, allows speculum-free physician-administered or patient self-exams for cervical cancer screening. Both devices have already been successfully implemented in midwife-run health clinics in Peru and Kenya. 

This project’s goal was to identify how these technologies might be adopted in the United States to encourage prevention efforts among underserved populations and reduce cervical cancer disparities. To do this, the team divided into three subteams to explore the market and policy strategies required for implementation of these devices in the US.

The market analysis subteam conducted preliminary research to identify potential customers for the Pocket Colposcope. Based on these insights, they narrowed their focus to primary-care healthcare providers in rural community health centers. They conducted field interviews with local gynecologists and family medicine physicians to develop strategies for implementation in these settings.

The regulatory and reimbursement subteam wrote a brief highlighting the regulatory landscape for medical devices. They identified a key regulatory strategy to FDA-clear (U.S. Food and Drug Administration) the Callascope and researched payment reimbursement considerations for the Pocket Colposcope, which has already been FDA-cleared.

The business and communication strategy subteam developed a comprehensive framework for the commercialization of the Pocket Colposcope, structuring a subscription revenue model designed to minimize adoption barriers while maximizing long-term recurring revenue. Going forward, the team will identify different distribution channels and revenue diversification opportunities across direct institutional sales, global health partnerships and value-added resellers to support the product's long-term commercial scale-up.

Timing

Fall 2025 – Spring 2026

Team Outputs

Disruptive Innovation and Policy in Cervical Cancer Screening Technologies (Poster presentation at the Fortin Foundation Bass Connections Showcase, April 15, 2026)

Disruptive Innovation and Policy for Cervical Cancer Prevention (Team profile)

Pocket Colposcope (University of Minnesota’s Great Medtech Pitch Competition; Minneapolis, MN; April, 2026)

Go to Market Plan for the Pocket Colposcope, including a guide for implementation for primary care providers in rural community-health centers 

Customer decision roadmap and customer outreach/promotion plan for the Pocket Colposcope

Regulatory brief and key strategy to streamline FDA clearance of the Callascope

Financial model to track the Pocket Colposcope’s projected growth

Commercialization plans for both the Colposcope and Callascope

See related team, Maternal Empowerment Through Cervical Health Monitoring (2026-2027).