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Fall 2007
| Instructor: |
Robert M. Johnson: Biography: Robert M. Johnson (651) 962-5758 (UST) (651) 962-6419 (Fax) rmjoh37@aol.com (E-Mail) Michael Shoup |
| Time: | Section 01, Monday, 6:00 – 9:00 p.m. |
| Location: | St. Paul Campus, OSS 122 |
| Required Text: | Reading materials and FDA's Quality Systems Manual (QS Manual) will be distributed the first day of class; additional reading materials will be distributed throughout the semester. There will be a small charge for these applied to the student's bill. |
| Course Description: | This course is designed to provide an introductory overview of the medical device industry, and it’s unique design and manufacturing challenges. The course first examines the industry itself, reviewing basic industry statistics, current trends, and the many types of products that make up the medical device industry. It then helps students understand the fundamental systems that are used in the design, development, and manufacture of medical devices and how these relate to regulations governing the development and manufacturing processes. Finally the course explores in detail some of the unique aspects of manufacturing a medical product such as special material and process selection considerations, clean rooms, sterile packaging, sterilization processes, clinical testing, lot traceability and manufacturing controls. |
| Course Objectives: |
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| Learning Outcomes: |
Upon successful completion of course, the students will be able to demonstrate
a basic understanding of taking a medical device through the following phases
of production:
The student will also have basic knowledge of the medical device industry and its history. |
| Course Methodology: |
The course makes extensive use of outside reading assignments, videos,
guest experts, and tours of local device manufacturers to provide practical
illustrations of these topics.
Reading materials will be provided. Students are expected to read the materials provided under each "Session Tab" before that session. Students are also expected to read designated chapters from the QS Manual before that session. Additional materials may handed out during each session, such as additional reading materials, lecture notes, and discussion questions for the group work at the end of each session. |
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Major Assignments: |
Students will also select a term project that allows them to apply what they have learned to a real or hypothetical medical device product. This device will be used as the basis for group discussions, presentations, and the term paper. |
| Grading Policy: |
Final Exam ............................. 25% Tour Assignments ................. 15% Class Presentations ............. 25% Term Project Final Report ..... 30% Team Participation ................ 5% |
| Academic Integrity: |
All students are expected to understand and follow the University of St
Thomas policies on Academic Integrity. These are described at: http://www.stthomas.edu/engineering/graduate/policies Exams: Exams are one of the instruments used to evaluate the knowledge gained by an individual student of the class subject matter, and the progress towards meeting the outcomes of the class and the degree. To this end all exams (in class or take home) are intended to represent the effort of the individual and not a group effort unless specifically stated otherwise. |
| Students with Disabilities | Qualified students with documented disabilities who may need classroom accommodations should make an appointment with the Enhancement Program – Disability Services office during the first two weeks of the semester. Appointments can be made by calling 651-962-6315 or in person in O’Shaughnessy Educational Center, room 119. |
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Attendance Policy: |
Students are expected to attend all class sessions. Circumstances which prevent attendance will be honored up to two instances. Absences in excess of two times may result in a lower grade for the course. Contact the instructor when a special situation arises. All absences require that the instructor be informed in advance. |
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Date/Session |
Topic |
Subtopics |
QS Manual |
Instr. | Proj. Work |
|
10/22/07 #7 |
1. Process Selection 2. Risk Management |
1. Manufacturing process review 2. Failure Modes and Effects Analysis (FMEA) |
1. Bob 2. Mike |
Team presentation on Session #5 SMC tour assignment due |
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10/29/07 #8 |
Packaging and Sterilization |
- Sterile packaging forms and materials - Types of sterilization used for single-use products - Types of sterilization used for reprocessed/reusable products |
Chapter 13 | Guest speaker: Charlie Jones | Team presentation on Session #7 |
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11/5/07 #9 |
Tour - HCMC Hospital | ||||
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11/12/07 #10 |
Testing and Validation |
-Test method and spec development -Design verification and validation -Process validation |
Chapter 4 | Mike |
Team presentation on Session #8 HCMC tour assignment due |
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11/19/07 #11 |
Manufacturing Scale-Up |
-Developing a manufacturing strategy -Cleanrooms -Quality systems -Supplier selection and validation -Combination products |
Chapter 8 (p. 1-22) Chapter 10 (p. 1-23) |
Mike | Team presentation on Session #10 |
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11/26/07 #12 |
Tour - Starkey Labs, SurModics | Term Papers Due | |||
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12/3/07 #13 |
1. MN Bio 2. Review |
1. Guest Speaker: Dale Wahlstrom 2. Bob |
Starkey Labs, SurModics tour assignments due
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12/10/07 #14 |
1. Final Exam 2. Term Paper Questions 3. Course Evaluations |
Term papers returned |
