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Sustainable Laparoscopic Surgery for Low-Income Countries: FDA Approval and Business Model for Access (2019-2020)




September 01, 2019 - August 31, 2020

Project Objectives

In the 1980s, the field of surgery advanced with the development of laparoscopy. This technology allows surgeons to make two to four small incisions and operate with an intra-abdominal camera and instruments. Benefits of laparoscopic surgery compared to open surgery include decreases in pain, recovery time, intra-abdominal scar tissue, wound infections, abdominal scar size, wound breakdown and length of hospital stay. It is routinely performed in high-income countries; however, the surgery is expensive and demands a great amount of infrastructure to maintain equipment.

Patients in low- and middle-income countries (LMICs) with appendicitis, gallbladder disease, intestinal problems, various cancers and reproductive problems would benefit from laparoscopic surgery. Many patients undergo impoverishing health expenditure and lost wages recovering from surgery, and laparoscopy would reduce recovery time, enabling patients to return home and to work more quickly.

Infection is also a concern in LMICs, as antibiotics are expensive and the surgical ward is often a large room where 30 to 50 patients are recovering together. Laparoscopic surgery would render smaller incisions and shorter stays in the hospital, minimizing postsurgical infection.

Project Description
The ultimate goal of this multiyear Bass Connections project is to develop a low-cost, reusable laparoscope suitable for use in LMICs. In 2019-2020, this project team will advance the device from the prototype stage to a viable commercial product for patients in LMICs. Movement into the production phase will require the following tasks:

Analysis of feedback from Ugandan surgeons: The project team will make a trip to Uganda in May 2019 to present the laparoscopic system to LMIC surgical colleagues who will be the end users of the product. Based on their feedback and the performance of the laparoscopic system within the LMIC environment, the study team will modify the design.

Protection of intellectual property: Team members will work with the Duke Office of Licensing and Ventures to file patent applications for the relevant innovative features.

FDA approval: The new laparoscope should be eligible for approval under the 510(K) pathway since we can provide evidence that the proposed technology is substantially equivalent to a previously approved laparoscope. The prototype must be thoroughly tested for biological and electrical safety, image quality and failure modes and effects.

Creation of a business model: The team will develop a strategy to move from technology to product, which will involve market research, competitive analysis, identifying key stakeholders and early customers, an operation plan, marketing and launch strategy and a tiered pricing strategy for high-income countries compared to LMICs.

Anticipated Outputs
Revised laparoscopic system prototype; provisional patent applications; FDA applications; business model for dissemination of laparoscopic system in high- and low-income countries

Project Opportunities

Student Opportunities
Ideally, this team will be comprised of 4 undergraduates and 4 graduate students from Global Health, Engineering, Business, Law and Medicine. The ideal team composition will consist of three subteams:

Intellectual property: 1 law student and 1 undergraduate (global health/pre-law) responsible for working with the Office of Licensing and Ventures in the patent application process.

Technology improvement and FDA application: 1 graduate and 2 undergraduate engineering students, and 1 medical student. This team will modify the existing prototype according to feedback from our Ugandan surgical partners. They will test the safety and performance parameters of the prototype, which will be used to prepare the 510(k) FDA application.

Business model: 1 graduate and 1 undergraduate business student responsible for creating a business model for the laparoscopic system.

Students will have the opportunity to participate in designing a product that has the potential to transform surgical care in Africa, coauthor publications resulting from the study and present research findings at national conferences/meetings. Students will gain experience in global health research, development of research methodology and engineering design skills. They will also have the opportunity to engage in the human-centered design process.

Additionally, participants will gain familiarity with the U.S. Patent application process, the FDA application and approval process for medical devices and development of a business model within a global health context.

Graduate student Christopher Lam will be the team's project manager.

Students will have the opportunity to travel to Uganda to engage with stakeholders in Summer 2020.

Fall 2019-Summer 2020

Fall 2019: Review feedback on prototype laparoscope and identify necessary changes; review regulatory pathway and previous FDA 510(k) submissions; create invention disclosure form (IDF); begin developing business model (e.g., conduct market research, competitive analysis)
Spring 2019: Complete testing of new prototype; complete failure mode testing and effect analysis; prepare 510(k) document; submit IDF; apply for a provisional patent; complete marketing and launch plan; develop plan to assess usability
Summer 2020: Field visit to Uganda.

Independent study credit available for fall and spring semesters; summer funding available.

Project Application Process

Interested students should complete the application process through the Bass Connections portal. Please note that the application window will open on January 22 and close on February 15. Program leaders will be available to discuss projects with interested students at the Bass Connections Open house on January 22. Details can be found at https://bassconnections.duke.edu.

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