QLTY07037 2019 Medical Device Manufacturing

General Details

Full Title
Medical Device Manufacturing
Transcript Title
Medical Device Manufacturing
Code
QLTY07037
Attendance
N/A %
Subject Area
QLTY - Quality
Department
MENG - Mech. and Electronic Eng.
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
David Mulligan
Programme Membership
SG_EPLYP_J07 201900 Bachelor of Engineering in Engineering in Polymer Processing
Description

This course aims to provide the student with a broad understanding of the various medical devices available for the treatment and prevention of diseases, their control and regulation and their modes and methods of manufacture. It also aims to provide an overview of the medical device industry both globally as well as nationally.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate a knowledge and understanding of the medical device industry, the principal companies involved and the main product types being manufactured.   

2.

Explain the various principles and practices involved in the control and regulation of the medical device industry

3.

Describe the theory, practice and practical applications of polymer-based medical devices.   

4.

Describe the theory, practice and practical applications of medical devices manufactured from a variety of other materials such as metals, natural materials, composites.      

5.

Compare and contrast the principal steps involved in the manufacturing of a range of different medical device products.

6.

Explain the various principles and practices involved in the validation of medical device processes

Teaching and Learning Strategies

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Module Assessment Strategies

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Repeat Assessments

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Indicative Syllabus

Theory Syllabus:

1.0       Introduction to Medical Device Manufacturing. 

1.1       Global Medical Device Manufacturing and Emerging Trends. 

1.2       The Medical Technologies Industry in Ireland. 

1.3       The Future direction for the Medical Device Industry. 

2.0       Medical Device Classification and Certification. 

2.1       A review of the European Medical Device Directives. 

2.2       The classification of Medical Devices. 

2.3       The CE marking process for Medical Devices. 

2.4       FDA regulation of Medical Devices.


3.0       Polymer-based Medical Devices. 

3.1       A review of the main polymers and their applications. 

3.2       A study of polymer processing - thermoplastics vs. thermosetting polymers.

3.3       Injection molding, Blow Moulding, compression molding and polymer extrusion. 

3.4       Joining and bonding of plastics. 

4.0          Metals and other materials for Medical Device Products. 

4.1          The processing of metals - casting, forging, welding, machining, plasma spraying. 

4.2          Metal surface finishing techniques. 

4.3          Other materials for Medical Devices - ceramics and glasses, natural materials and composites. 

5.0          Typical Medical Devices and their Manufacturing. 

5.1          A study of the manufacture of coronary artery stents including drug-eluting stents. 

5.2          A study of the manufacture of heart valves. 

5.3          A study of the manufacture of catheters

5.3          A study of the manufacture of pacemakers and defibrillators. 

5.4          A study of the manufacture of prosthetics

5.5          The study of a variety of other Medical Devices including In Vitro Diagnostics and  biosensors.

6.0           Validation of Medical Devices

6.1           Introduction to Validation and Validation Principles

6.2           Process Validation of a medical device manufacturing process 

6.3           Test Method Validation

7.0           Other Support services for the manufacture of medical devices

7.1           Medical Device Sterilisation

7.2           Product Packaging and Labelling

 

INDICATIVE PRACTICAL/ PROJECT

The practical element associated with this module will be based on a project assignment. It will involve the detailed review and study of an aspect of medical device manufacturing, and the generation of a project report. Individuals will also have to deliver a team-based presentation of the main findings to the overall class. The project progess will be reviewed on an ongoing basis by the lecturer who will provide tutorials on project management and coordination, teamwork, report writing and project presentation techniques.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple Choice Assessment of Theory Continuous Assessment UNKNOWN 20 % OnGoing 1,2,3,4,5,6
2 Essay Project Assignment Continuous Assessment Project 20 % OnGoing 1,2,3,4,5,6
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Final Exam Final Exam UNKNOWN 60 % End of Year 1,2,3,4,5,6
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Theory 1 Weekly 1.00
Problem Based Learning Not Specified Assignment/Presention Preparation 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 3 Weekly 3.00
Total Part Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

Authors

Title

Publishers

Year

Ratner, B. D., Hoffman, A. S., Schoen, F., & Scheon, F. J.,

Biomaterials Science : An Introduction to Materials in Medicine

Academic Press

ISBN 978-0-12-374626-9

2012

Enderle, J. D., Blanchard, S. M., & Bronzino, J. D

Introduction to Biomedical Engineering

Academic Press

ISBN 978-0-12-374979

2011

Gail Baura

Medical Device Technologies: A system based overview using engineering standards

Academic Press

ISBN 978-0-12-374976-5

2011

International Society of Pharmaceutical Engineers.

Pharmaceutical Engineering Journal.

ISPE

Bi-monthly

 

Journal Resources

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URL Resources

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Other Resources

None

Additional Information

None