Trip to Uganda

Updated: Sep 7, 2019

Jenna Mueller, PhD.

This Bass Connections project’s goal is to develop a low-cost, reusable laparoscope appropriate for use in a low-income country. Its design will allow images to be transferred over the internet, enabling surgeons in high- and low-income countries to interact in real-time during surgical cases, thus allowing for remote mentoring or “tele-mentoring”. The project is divided into four components: laparoscopic design and safety; considerations in global surgery; low-cost laparoscope design and testing; and implementation of tele-mentoring. For Implementation of tele-mentoring, a subset of the team traveled to Uganda.

The goals of the trip:

  • Learn about surgery in Uganda

  • Gather feedback on designs and prototypes from surgeons and engineers

  • Develop collaboration with Makerere University

  • Learn about regulatory process in Uganda

  • Examine local manufacturing resources

  • Uganda Industrial Research Institute

We met with Makere to discuss potential collaboration. After speaking with Makere, our outcomes are as follows:

  • Explore manufacturing resources in Uganda

  • Build additional prototypes of the ReadyView Laparoscope with materials and resources available in Uganda

  • Design and test a bedside standing clamp to use with the Laparotract

  • Help identify funding to implement clinical studies in Uganda

With this collaboration, the course has been renewed for a second year. The ultimate goal 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.

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