ALS 426: Medical Device Development and Market Release
Course Number: ALS 426
Course Name: Medical Device Development and Market Release
Year: Second-year
Semester: Spring
No. Units: 0.5
Faculty/Instructor(s): Gail D. Baura
Description
This course presents an overview of the Design Control process for product development, which is mandated by the Good Manufacturing Practices of the Food and Drug Administration (FDA). To complement Design Control, market release and post-market surveillance topics are also highlighted. Additionally, five case studies of device and diagnostic companies are provided for real world examples of how companies deal with device regulation. During the last hour of every class meeting, students work with the instructor to draft the beginning of a regulatory document, based on an innovative new device the instructor has selected for the semester.
A group project based on the Philips Intellivue MP 50 monitoring system enables students to propose a new MP 50 module, and construct a corresponding documents.
Prerequisites
ALS 435 U.S. Regulatory Process
Topics Covered
- Clinical outcome studies
- Design Control
- Risk analysis
- 510(k) PMA review
- Registration & listing with FDA
- Regulated advertising
- Reporting & tracking
- Patent infringement
- Company case studies
Learning Objectives
After completing this course, students should:
- understand and be able to execute the components of the Design Control Process.
- comprehend processes associated with market release and post-market surveillance.
- be familiar with history of human subject experimentation, and appreciate the need for subsequent regulation.
Grading
Class attendance and discussion 10%
Group project I: PRS 20%
Group project II: risk analysis 20%
Group project presentation 15%
Final exam 35%
Required Texts