Sustainable Laparoscopic Surgery for Low-Income Countries: FDA Approval and Business Model for Access (2019-2020)
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.
The ultimate goal of this multiyear Bass Connections project is to develop a low-cost, reusable laparoscope suitable for use in LMICs. In 2018-2019, the team developed a prototype that possesses three innovative features: a sustainable system, tele-mentoring and a gasless port for lift laparoscopy. The prototype is robust, low-cost (less than $1,000) and maintenance-free with wireless connectivity to facilitate image display on a laptop. The laptop used to display the laparoscopic images can be connected to the internet through Wi-Fi or cellular GSM signals, allowing surgeons in different locations to interact during surgery. And the device features a laparoscopic port that will grasp the abdominal wall and lift it from the outside. This will eliminate the need for carbon dioxide, pressure regulation and continuous electricity in settings where these resources are not readily available or are subject to interrupted supply.
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 described above.
- 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.
Revised laparoscopic system prototype; provisional patent applications for laparoscope and gasless laparoscopic port; FDA applications for laparoscope and gasless laparoscopic port; business model for dissemination of laparoscopic system in high- and low-income countries
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. The business model would include marketing the device in the U.S. at a higher price-point, so that the laparoscopic system can be sold in LMICs for a reduced cost (i.e., tiered pricing).
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.
All 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
See earlier related team, Low-cost Laparoscopy with Tele-mentoring for Low-income Countries (2018-2019).
Image: Duke Global Health Fellow helps with first laparoscopic hysterectomy in Tanzania; courtesy of Duke Obstetrics & Gynecology
/faculty/staff Team Members
Tamara Fitzgerald, School of Medicine-Surgery: Pediatric General Surgery*
Jenna Mueller, Pratt School of Engineering-Biomedical Engineering*
/zcommunity Team Members
Robert Miros, 3rd Stone Design
John Sekabira, Mulago Hospital, Uganda