Course Meeting Times
Lectures: 2 sessions/week, 1.5 hours/session
Prerequisites
One of the following courses, which fulfill the General Institute Requirement (GIR) in Biology:
- 7.012 Introductory Biology
- 7.013 Introductory Biology
- 7.014 Introductory Biology
- 7.015 Introductory Biology
- 7.016 Introductory Biology
one of the following courses, which fulfill the GIR in Chemistry:
- 3.091 Introduction to Solid-State Chemistry
- 5.111 Principles of Chemical Science
- 5.112 Principles of Chemical Science
and one of the following courses, which fulfill the GIR in Physics:
- 8.01 Physics I
- 8.011 Physics I
- 8.012 Physics I
- 8.01L Physics I
or permission of instructor
Course Description
This design course teaches a systematic approach for development of an implantable or injectable medical device to treat a specific and well-defined clinical problem, criteria for preparing applications to the US Food and Drug Administration for approval to conduct clinical trials, and the steps to start a company to make it available to the patient. Students work in teams to develop the design for an FDA Class III medical device or combination product (incorporating drugs and/or biologics). The emphasis is on the science and engineering underlying the design of novel treatments for problems in any one of the 78 organs of the body.
Consideration is given to design features that will enable patient access globally, including in resource-challenged settings:
- FDA regulations of Class III medical devices
- Intellectual property and the pathway to a startup
The course was created by Professors Myron Spector and Ioannis V. Yannas in 1995, and has since been taught annually. The course content is updated regularly to include new knowledge acquired by the scientific, engineering, and clinical communities.
Topics
Part I: Principles of Implant Design; Targets for Treatment; Bioactive Agents
- Paradigm for design of medical devices
- Considerations of anatomy, histology (makeup of tissues and organs), physiology, and pathology
- An understanding of the newly acquired knowledge of the cell and molecular biology that underlies the problem and provides targets for treatment
- The three tools for facilitating healing and regeneration: biomaterials; cells and their constituents; and regulatory molecules (e.g., drugs and growth factors)
- Steps to model the clinical problem to guide the selection of the tools: “unit cell processes”
Part II: Federal Regulation of Medical Devices
- FDA requirements, including classification of the device, indications and intended use, biocompatibility testing, and clinical trial design
Part III: Medical Problems and Their Solutions
- Principles for full or partial permanent replacement or regeneration of tissues and organs, with select case studies
- Examples of medical problems in a wide array of organs, and approaches for their treatment using implantable and injectable medical devices
Part IV: Commercialization of Medical Devices
- Intellectual property
- Steps to start a company
Readings
Readings for the course comprise lecture notes, PowerPoint slides, and journal articles.
Grading
The final grade is based on the following elements
- 20% Quiz (written)
- 20% Oral progress report/ oral quiz
- 10% for team performance
- 10% for the individual oral quiz
- 10% FDA report (written)
- 25% Final oral presentation
- 25% Final written report
“Credential” Letter
An option for select students, who are not enrolled at MIT or Harvard, is to obtain a letter grade for taking this course, certified in a letter from Professor Spector. The grade would not be recognized by MIT or Harvard; there will be no official record of the grade at the institutions. In exercising this option, the student would meet periodically by Zoom with Professor Spector, who would also administer and grade the written and oral quizzes, and grade the 3 reports. Students interested in this option should contact Professor Spector at mspector@mit.edu.
