Courses/Tutorials

This tutorial will be held as part of the MICCAI 2023 Conference in Vancouver, Canada. (Oct 8-12, 2023). It will cover issues related to medical image analysis/image-guided intervention research and its transition to medical devices. We will discuss the implications of the medical regulatory process to both AI-development and software engineering.

Background

Going from academic research to the medical device industry is a natural transition for many people. If you have considered pursuing an industry role, or even starting your own medical device company one day, you’re not alone. But do you have a good grasp on the medical regulatory process and its implications for both research and development of medical software (including image-guided intervention) projects?

This workshop aims to help you gain a better understanding of the regulatory and software engineering requirements and processes that will position you for success as you transition to the medical device industry.

Learning Objectives

At the end of this tutorial, the students will:

1. Have a basic understanding of the core Medical Software Regulations in both the US/EU and internationally.

2. Understand issues related to software development in a regulated environment

3. Learn what the critical software engineering skills that are required to work in medical device industry.

4. Appreciate the differences in AI-research between research and production medical software

5. Learn how to transition university projects to clinical medical devices and understand the issues/benefits of the use of Open-Source Code in such projects.

6. Be aware of available resources for further study.

For more information see the official tutorial webpage hosted by Kitware at: https://www.kitware.com/miccai-2023/.