Description This session provides a practical roadmap for transforming a clinical idea into a marketable medical device. We will navigate the critical pathway from initial concept and prototyping to intellectual property, regulatory approval (FDA/CE), and commercialization strategies.

Outcome Objectives Participants will be able to:

1. Outline the key stages of the medical device development lifecycle.

2. Identify critical regulatory and intellectual property considerations.

3. Describe strategies for funding and commercializing a new device.

Background Many groundbreaking medical ideas fail not due to clinical merit, but due to the complexities of the development and regulatory process. This guide provides the essential business and legal framework needed to successfully bring innovation to patients.