| This course is meant to teach the
essential elements of technology assessment and regulation of medical
devices through six lessons compiled from courses taught at Stanford
University. Each lesson includes between 40 and 60 minutes of
video content, and covers distinct elements of device assessment
and regulation, ranging from the role and mission of FDA in medical
device regulation, to clinical trial design, quality systems regulation,
and regulation in the European Union and Japan. Supplemental materials
provided with each lesson provide links to important references,
question and answer sheets, as well as worksheets to actively
apply the course content to real-world devices and situations.
Course Objectives
While this course was developed with BME students in mind, anyone
working on topics related to medical technology development and
commercialization could benefit from its content. After completing
this course, participants should be able to
- Understand fundamental concepts of medical technology assessment
and how they are applied in the context of regulatory decision-making
- Describe the role and mission of FDA in the regulation of
medical devices
- Describe the different regulatory pathways and their requirements
- Establish the regulatory requirements for market approval
for different types of technologies
- Identify the relevant outcomes, intended use, and alternative
therapies for a given technology
- Describe different types of clinical trials, along with their
advantages and disadvantages
- Understand the requirements of FDA’s Quality Systems
Regulation (QSR) and Good Manufacturing Practices (GMP) regulation,
and know how they are implemented
- Apply acquired knowledge about international regulation to
determine requirements for regulatory approval in Europe and
Japan.
System Requirements
To properly view the content on this site, the
following is required:
- A computer
- An active connection to the internet
- The latest version of Flash
Player
You may view the content by selecting the topics in the left
column in the order that they are listed.
Stanford University MS&E 256
Technology Assessment and Regulation of Medical Devices
Some of the lecture materials for this course were drawn from
lectures given in MS&E
256 (Technology Assessment and Regulation
of Medical Devices) (formerly MS&E 475). Successful commercialization
of medical technologies requires manufacturers to obtain regulatory
approval and payment for those technologies. This course gives
an overview of the regulatory and payer environment in the U.S.
and abroad, and introduces methods for health technology assessment
that are commonly used.
Stanford
University BIOE 374
Biodesign Innovation
Some of the lecture materials for this course
were drawn from lectures given in Bioengineering
374 (Biodesign
Innovation), a two-quarter series providing students with skills
essential for the development of new biomedical technologies.
This project-based course challenges students to take the critical
first steps in invention, patenting, early prototyping and development
of new concepts.
Faculty
Paul Yock, MD
Josh Makower, MD
Jan Pietzsch, PhD
Credits
This course has been created through the additional
efforts of
Christine Kurihara
Abigail Garner
We wish to thank the Medtronic
Foundation who provided
funding to support the development of this course.
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