Preclinical and Clinical Study Design

The practice of Biomedical Engineering concerns itself with the design, development, and testing of medical devices that will be commercialized to improve or sustain life. Medical device companies, and the engineers they employ, have an ethical and legal responsibility to robustly examine the safety and performance of these devices through preclinical and clinical testing. This course covers the responsible conduct of preclinical and clinical study research necessary for obtaining marketing approval, with a focus on the US FDA requirements, and using a risk-based approach to ensuring safety and effectiveness of medical devices. Topics will include non-clinical benchtop testing, evaluation of device-tissue interactions and how they may be studied with pre-clinical animal models to predict safety and performance, statistical considerations for study design, and ethics related to responsible conduct of pre-clinical and clinical research.

BME56100

Credit Hours:

3

Learning Objective:

By the end of the course, you will be able to:
  1. Identify testing strategies for the design and development of a safe and effective medical device.
  2. Demonstrate knowledge of quality, regulatory, marketing, and business considerations/perspectives in designing and implementing a preclinical and clinical study strategy.
  3. Outline the course of medical device development, from feasibility through post-market sustainability, and identify the major milestones throughout the process.

Description:

The practice of Biomedical Engineering concerns itself with the design, development, and testing of medical devices that will be commercialized to improve or sustain life. Medical device companies, and the engineers they employ, have an ethical and legal responsibility to robustly examine the safety and performance of these devices through preclinical and clinical testing. This course covers the responsible conduct of preclinical and clinical study research necessary for obtaining marketing approval, with a focus on the US FDA requirements, and using a risk-based approach to ensuring safety and effectiveness of medical devices. Topics will include non-clinical benchtop testing, evaluation of device-tissue interactions and how they may be studied with pre-clinical animal models to predict safety and performance, statistical considerations for study design, and ethics related to responsible conduct of pre-clinical and clinical research.
Fall 2021 Syllabus

Topics Covered:

Overview of Medical Device Developments; Ethical Issues in Animal and Human Trials; Pre-Clinical Evaluation Strategies for Medical Devices; Experimental Design; Issues in Managing or Overseeing Human Clinical Trials; Integration of Studies for Regulatory Approval.

Prerequisites:

None

Applied / Theory:

Web Address:

https://mycourses.purdue.edu/

Web Content:

Syllabus, Grades, Lecture Notes, Homework Assignments & Message Board

Homework:

Periodic assignments.

Projects:

Non-clinical or clinical protocol or related submission

Exams:

Regular quizzes over material covered.

Textbooks:

Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.
Required: Biodesign: The Process of Innovating Medical Technologies, Paul G. Yock, Cambridge University Press, ISBN:9781107087354

Computer Requirements:

ProEd Minimum Computer Requirements

ProEd Minimum Requirements:

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Instructor(s)

Aaron Lottes

Email
lottes@purdue.edu