Democratizing Gastroschisis Care in Uganda through Partnership (2026-2027)

Background

Gastroschisis is a life-threatening birth defect in which a baby is born with the intestines protruding through an opening near the umbilicus. In high-income countries, treatment — which typically involves placing the intestines into a sterile, spring-loaded silo and gradually reducing them into the abdomen before surgical closure — results in survival rates above 96%. In sub-Saharan Africa, however, survival remains below 10%.

A major driver of this disparity is the lack of access to standard medical silos. A commercially available silo costs around $240, nearly ten times the average monthly income in Uganda. To address this gap, a prior Duke-Makerere student team created and bench-tested a functional, ultra-low-cost prototype using a urine collection bag and a female condom ring. While this design established proof of concept, a medically approved version is required before safe clinical use.

This next phase focuses on transforming the prototype into a medical-grade device that can be manufactured locally, safely sterilized and approved by the Uganda National Drug Authority (NDA). Expanding silo access is an essential step in improving survival for infants with gastroschisis.

Project Description

This project brings together engineers, clinicians, midwives, global health experts, manufacturers and regulatory partners from Duke and Makerere University to redesign, validate and prepare a new gastroschisis silo for regulatory approval in Uganda.

Work will proceed across three major areas:

Silo design revision
The team will refine the current prototype to meet requirements of the International Organization for Standardization and the NDA. This will include selecting biocompatible plastics, identifying appropriate construction methods such as heat-sealing, designing engineering tests (including water-tightness and tensile strength) and drafting manufacturing process instructions and a bill of materials.

Sterility and packaging protocols
In partnership with ShiShi International — a Ugandan medical device manufacturer with a new gas sterilization unit — the team will develop sterilization and packaging procedures that meet NDA requirements for locally produced devices.

Ugandan regulatory preparation
The team will compile the full regulatory file needed for NDA approval, including documentation timelines, inspection checklists and a Failure Modes Effects Analysis (FMEA) to assess and mitigate risks. Regulatory approval is an essential prerequisite for a future first-in-human study at Mulago Hospital.

This year’s project focuses exclusively on device development and does not involve human subjects research.

Anticipated Outputs

• Updated, medical-grade gastroschisis silo ready for regulatory submission
• Manufacturing process instructions and bill of materials for local production
• Sterility and packaging protocols
• Validation data demonstrating feasibility, usability and acceptability
• Peer-reviewed publications and conference abstracts with student co-authors
• Foundational data to support an NIH R01 integrating midwife–led silo application

Student Opportunities

This international project will include 2 graduate students and 4-5 undergraduate students from Duke, along with 2-4 students from Makerere University. Students from engineering, pre-medical pathways, global health, business and project management backgrounds are encouraged to apply.

Students will have opportunities to:

• Redesign and prototype a low-cost medical device
• Conduct engineering tests and evaluate design performance
• Develop sterility and packaging procedures with a Ugandan manufacturing partner
• Compile regulatory documentation and conduct an FMEA
• Co-create business models for sustainable introduction of the silo
• Participate in interdisciplinary teamwork across cultures and time zones
• Build leadership skills through team-building, presentations and cross-cultural engagement
• Contribute to publications, conference abstracts and policy–relevant outputs

Selected students may travel to Uganda in Summer 2026 or 2027 to collaborate with engineers at Makerere University and work onsite with ShiShi International.

Timing

Summer 2026 – Summer 2027

Summer 2026 (optional)

• Travel to Uganda to begin developing sterilization protocols and explore material sourcing

Fall 2026

• Update silo design to meet medical-grade standards
• Refine testing protocols and develop sterilization and packaging procedures

Spring 2027

• Finalize silo design and bill of materials
• Prepare full regulatory submission file, timeline and FMEA
• Begin writing manuscripts

Summer 2027 (optional)

• Travel to Uganda for regulatory support and prototype testing
• Apply final modifications based on field observations

Crediting

Academic credit available for fall and spring semesters