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A Case-Study Based Course on “Device Evaluation and FDA Approval”

Abstract

Preclinical evaluation of new devices and therapies is an integral part of research and development in the medical device industry, and the regulatory process for FDA approval is a major driving force behind much that goes on in a company setting. A large number of graduating biomedical engineers enter this medical device industry or a related environment upon graduation from our institution. Although these engineers are equipped to address many of the technical challenges that will arise, there is currently limited formal training in or exposure to the regulatory process that is required to bring new devices to market. Knowledge of the typical progression through preclinical testing, as well as an understanding of clinical trial guidelines and the FDA regulatory process would allow students to work more effectively and productively in industry or other medically-related positions. Therefore, a course has been designed entitled “Device Evaluation and FDA Approval” as an upper division elective at our institution. The goal of this course is to expose students to the overall process of FDA approval, including aspects of both preclinical and clinical testing, in order to prepare them to succeed in a regulatory-based environment.

This is a case-study based course, where cases range from small in-class examples that facilitate active student engagement in the material, to large cases that span multiple lessons and incorporate out of class assignments and projects. Cases are selected and presented such that students gain insights into the progression and complexities of “real-life” devices, while learning in vitro and in vivo preclinical evaluation techniques, clinical trial guidelines, FDA processes and requirements, and overall regulatory constraints.

Introduction

FDA regulations are a large part of many facets of life in the medical device industry. In roles ranging from business and management positions to manufacturing and process engineers, and from marketing to research and development scientists or engineers, many medical device career paths will incorporate some interaction with FDA regulation. Currently, our institution graduates a large number of engineers that enter this medical device arena, and previously no formal instruction was offered in the area of FDA approval processes. Although several institutions have implemented entire degree programs focused on regulatory affairs1, the goal at our institution was to design a single course as an upper division elective that would expose students to the overall process of device evaluation and FDA approval. The purpose of this paper is to outline and describe the format, activities, and implementation of this new course at our institution.

Format and Content of the Course

This is a quarter-long course that is designed to meet for two 2-hour classroom sessions each week. The course is geared towards senior level undergraduate or master’s level students in

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Cardinal, K. (2008, June), A Case Study Based Course On "Device Evaluation And Fda Approval" Paper presented at 2008 Annual Conference & Exposition, Pittsburgh, Pennsylvania. 10.18260/1-2--3768