
Requisite Knowledge: Systems: Devices and Innovation
Devices and innovation
Learn the FDA process of bring new medical devices to market. Learn the tools to successfully innovate all the different aspects of your medical practice.
Expected completion time: 4 hours
Learning Objectives
- Understand NIH support of medical device development including the Small Business Innovation Research Program and Small Business Technology Transfer Program.
- Understand the NIH technical assistance programs – Niche Assessment and Commercialization Accelerator Programs.
- Learn about NIH Entrepreneurial Training Programs such as I-Corps at NIH and Concepts to Clinic: Commercializing Innovation (C3i).
- What does the FDA do, how does the FDA classify medical devices and the different types of Device Innovation submissions (510k, PMA etc.).
- Understand the Iterative Spiral Model of Healthcare Innovation
- Know the different reasons for failure and success in Innovation