Increasing Access to Laparoscopic Surgery in Low-income Countries (2020-2021)

Background

Laparoscopic surgery is the standard of care in high-income countries but is unavailable in most low- and middle-income countries. It avoids large incisions by using a small camera and fine instruments. Patients with appendicitis, gallbladder disease, intestinal problems, various cancers and reproductive problems can benefit from this type of surgery, which is associated with decreased pain, improved recovery time, fewer wound infections and shorter hospital stays. Unfortunately, laparoscopic surgery is not available in most low- and middle-income countries because of prohibitive costs for equipment and maintenance, and many patients must therefore undergo impoverishing health expenditures and lost wages as they recover from surgery.

Project Description

To increase access to laparoscopic surgery, this project team will continue to develop a low-cost and reusable laparoscope suitable for use in low- and middle-income countries. Building on the work of previous teams, the 2020-2021 team will move the design from a prototype toward a viable commercial product.

The ReadySuite is a comprehensive set of prototypes including the ReadyView Laparoscope, ReadyMentoring capabilities and ReadyLift Retractor. ReadyMentoring allows surgeons in different locations to interact audibly and visually during surgery and enables information exchange and remote mentoring. ReadyLift gently lifts the abdominal wall, which eliminates the need for carbon dioxide, pressure regulation and continuous electricity.

The team will continue to create a business model that includes marketing ReadyView in high-income country markets and the ReadySuite for low- and middle-income country markets. Team members will improve the ReadyView laparoscope by providing a 30-degree viewing angle, which will increase visualization to see around corners. After modifications of the device, a series of targets will be imaged to measure the image quality of ReadyView and compare it with a standard-of-care laparoscope.

Additionally, team members will engage in usability testing with collaborators. The team will collect data on current laparoscopic cases performed in Uganda, Myanmar and Papua New Guinea, including what types of cases are being performed laparoscopically, what problems surgeons are having with equipment and what complications are occurring. Anticipated Outputs Patents for prototypes; business model and company formation; peer-reviewed publications; presentations; partnership with design firm; Food and Drug Administration and Medical Device Regulation approvals

Timing

Fall 2020 – Summer 2021

  • Fall 2020: Modify laparoscope and features; initiate FDA and MDR approval process; partner with engineering design firm; collect data on current laparoscopic cases
  • Spring 2021: Continue FDA and MDR approval process; test ReadySuite in animal model; provide preclinical data; design prospective clinical trial to test ReadySuite
  • Summer 2021 (optional): Selected students travel to Uganda to interview surgeons and continue data collection

See earlier related team, Sustainable Laparoscopic Surgery for Low-Income Countries: FDA Approval and Business Model for Access (2019-2020).

 

Image: Previous team members pose with their laparascopes.

Laparoscope.

Team Leaders

  • Sarah Dunn Phillips, Margolis Center for Health Policy
  • Tamara Fitzgerald, School of Medicine-Surgery: Pediatric General Surgery
  • Jenna Mueller, Pratt School of Engineering-Biomedical Engineering

/graduate Team Members

  • /graduate
  • Alexander Gunn, Biomedical Sciences
  • Enakshi Sunassee, Biomedical Engineering-PHD

/undergraduate Team Members

  • /undergraduate
  • Arushi Biswas, Biomedical Engineering (BSE)
  • Sarah Hubner, Political Science (AB), Global Health (AB2)
  • Caroline Maloney, Biology (BS)

/yfaculty/staff Team Members

  • Amos Loh Hong Pheng, Duke-NUS Medical School

/zcommunity Team Members

  • Kids OR
  • Julius Mugaga, Makerere University - Kampala
  • John Sekabira, Mulago Hospital, Uganda
  • Robert Ssekitoleko, Makerere University-Kampala