METS1025 Medical Device Manufacturing Techniques (On Hold)
This course introduces the student to manufacturing in the medical device industry. Topics covered include the roles of regulation, documentation, identification and traceability, procedures and process control, and product acceptance in the device industry. Common device materials, joining methods, catheter assembly, basic test methods, packaging, and sterilization are discussed. Basic skills in microscope use, ergonomics, wire preparation and termination; soldering and rework; ESD management; adhesive preparation, application, and curing; and trouble-shooting are developed.
Course Requirements and Evaluation
Refer to Course Syllabus for detailed information regarding the requirements and evaluation standards for this course. The Course Syllabus will be distributed the first week of the course.
Learning Outcomes
The following outcomes will be addressed in the course:
Summarize characteristics unique to medical device manufacturing
Critique samples of manufacturing documentation
Construct compliant manufacturing documentation
Identify "critical components" or "critical functions" of assemblies
Assign identification and traceability data to medical devices during assembly
Utilize manufacturing procedures in a compliant environment
Document acceptance status of manufactured assemblies
Practice assembly operations under a microscope
Practice ergonomic principles
Prepare wires for termination
Produce soldered joints to workmanship standards
Produce electronic assemblies under ESD-compliant conditions
Practice adhesive application processes
Troubleshoot common production problems
Demonstrate Good Manufacturing Practices throughout skill-building activities
Characterize common medical device materials
Outline medical device joining methods
Analyze catheter assembly process variables
Outline assembly test methods
Examine medical device packaging
Characterize medical device sterilization techniques
Text and References
A list of textbooks required for this course is available at the bookstore.
Course Scheduling
The scheduled hours of instruction include sixteen hours for each lecture credit, thirty two hours for each lab credit and forty hours for each credit of supervised occupational experience (SOE). Lecture credit may include formal or impromptu lectures, demonstrations or discussions with the entire class or with small groups or individuals. Refer to the Credit Details section of this course outline for the credit breakdown.
Accommodations Statement
Access Services - Reasonable accommodations are available to qualified students with documented disabilities. Upon attending an intake meeting with Access Services, qualified students will receive a letter listing the approved accommodations that they may provide to their instructors. If you have a documented disability that may require accommodations, contact HTC Access Services at
AccessServices@hennepintech.edu or
https://hennepintech.edu/current-students/access-services/index.html.
Campus
Brooklyn Park Campus and Eden Prairie Campus: 952-995-1300
Credit Details