Medical Device Start-up Fundamentals

BIOENGR X 432.1

This course introduces students to the many complex moving pieces of launching a new business centered on the creation of a novel, regulated medical device.

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What you can learn.

Gain an overview of the medical device start-up launch and development process
Learn best practices for integrating major product development milestones with business growth
Understand how a wide range of strategic business decisions have direct impact on the design and development of a medical device (and vice versa)

About this course:

This course seeks to introduce students to the many complex moving pieces of launching a new business centered on the creation of a novel, regulated medical device. Over the course of the class, students will systematically complete a high-level business plan for a fictional new medical technology, as well as a product requirement document with each requirement cross-referenced to an element in the business plan. Upon completing this course, the student gains a broad understanding of how a product is designed and developed can enable or hinder the growth of a young company. This is critical contextual information for anyone seeking to build an engineering career in startups.