Preclinical and Clinical Study Design
BME56100
Credit Hours:
3Learning Objective:
By the end of the course, you will be able to:- Identify testing strategies for the design and development of a safe and effective medical device.
- Methods of Evaluation: Homework, Projects, Participation in discussions
- Demonstrate knowledge of quality, regulatory, marketing, and business considerations/perspectives in designing and implementing a preclinical and clinical study strategy.
- Methods of Evaluation: Homework, Projects, Quizzes, Participation in discussions
- Outline the course of medical device development, from feasibility through post-market sustainability, and identify the major milestones throughout the process.
- Methods of Evaluation: Homework, Projects, Quizzes, Participation in discussions
Description:
Medical devices are developed, manufactured, and distributed in a highly regulated environment. This course concerns the preclinical and clinical study design processes for obtaining FDA marketing approval for biomedical devices. Prior to marketing a medical device, specific governmental approval is required depended on the type of device and the risk associated with the device. This course is part of a three-course series dealing with various aspect of regulatory science of medical devices. Regulatory science considers the scientific and technical foundations that support the practical testing and regulations that ensure the safety and effectiveness of medical devices.
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 US FDA requirements, and using a risk-basked 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.
Topics Covered:
| Topic | Overview of Planned Content |
|---|---|
| Device Development and Design | Market evaluation, User needs, Disease state, Design input requirements, Acceptance criteria, Failure modes, Verification and validation, in vitro diagnostics |
| Bench and Animal Testing | Standards and guidances, Statistics, Test development, Study design, Test protocols and reports, Types of bench tests, Animal studies, Biocompatibility testing |
| Clinical Testing | Clinical study strategy, Clinical study design, Clinical statistics, Clinical study protocols, Real-world evidence, Early feasibility studies, Patient preference, Post-market surveillance, Clinical data strategy |
Prerequisites:
NoneApplied / Theory:
75/25