GLHLTH 396: Connections in Global Health: Laparoscopic Surgery in Low and Middle Income Countries – FDA Approval

SYNOPSIS: The ultimate goal of this multiyear Bass Connections project is to develop a low-cost, reusable laparoscope suitable for use in LMICs. 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 went 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.

READER REQUIREMENTS: Students are divided into 5 groups 2-3 students each with different focus areas. This course requires highly specialized experts and specialists in the fields of global health and health intervention, laparoscopic surgeons, surgeons specialized in global health care, biomedical engineering, medical business experts, policy makers, software engineers and developers.

WRITING ASSIGNMENTS:

The Ready View team developed an affordable, durable, portable laparoscope and will write a scientific research article publishable in a surgery or biomedical journal based on their findings. Readers would be experts in the field of laparoscopic surgery.

The Ready Lift team developed a method to lift the skin up without using gas to make room for the laparoscopic surgery underneath. The team writes a scientific research article on their findings, publishable in surgery or biomedical journals.

The Software team develops software to operate the laparoscope. Their findings will be written in the style of a user manual. This team will need guidance from a reader familiar with the publication of software research.

The Business Model team will devise a business model to establish a company for this medical device and will write an academic article aimed at publication in a business-oriented journal. This team needs an expert reader who will be able to guide students to options for publication.

The Regulatory team will research regulatory affairs in Sub-Saharan African countries. This team will need guidance from a reader with expertise in regulatory affairs.

INSTRUCTOR SUGGESTIONS FOR READERS: As this course is divided into five teams with distinct projects we will need several readers with expertise in scientific publications, software development, business expertise, and regulatory knowledge.

INTRODUCTORY MEETING: Please schedule your introductory meeting as soon as possible after you have received the matching email. Find details for the introductory meeting http://dukereaderproject.org/students/intro-meeting/

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