Module Details

Module Code: BIOE7013
Title: Biomedical Device Manufacture
Long Title: Biomedical Device Manufacture
NFQ Level: Intermediate
Valid From: Semester 2 - 2017/18 ( January 2018 )
Duration: 1 Semester
Credits: 10
Field of Study: 5212 - Biomedical Engineering
Module Delivered in: 2 programme(s)
Module Description: The module is aimed at those seeking employment in the Biomedical Device Sector, or those wishing to enhance their general knowledge of the industry. The module is structured around common medical disorders which are treated by biomedical devices manufactured in Ireland. On completion, participants will be familiar with a range of disorders, the anatomy and physiology associated with these disorders, the devices used in their treatment, and the processes and environments involved in the manufacture of these devices.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Describe the anatomy and physiology associated with a range of clinical disorders and the typical medical devices associated with the treatment of these disorders
LO2 Identify the Good Manufacturing Practices (GMP) to be implemented in a medical device manufacturing environment
LO3 Classify cleanroom requirements to meet industry standards for medical device manufacture
LO4 Describe appropriate sterilisation and packaging techniques for biomedical devices
LO5 Briefly explain the validation requirements for medical device design and manufacture
LO6 Identify the role and operation of relevant regulatory bodies within the medical device industry
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Anatomy
Anatomical terminology and organisation of skeletal, muscular, nervous and cardiovascular tissues. Classification of joints by form; relationships of form to function; examples from limb joints. Muscle groups and patterns of muscle organisation; functional anatomy of the principal joints (hip, knee, ankle, shoulder, elbow, wrist).
Medical Devices
Devices used in the treatment of neurovascular, cardiovascular, orthopaedic disorders and product development history.
Manufacturing Processes and Techniques
Introduction to manufacturing processes; injection moulding, extrusion, wiredrawing; catheter coating process, embolic coil manufacturing.
Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards.
Sterilisation Techniques
Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam - gravity displacement, porous load, ballasted cycles. Dry heat sterilisation/depyrogenation. Microbial inactivation/endotoxin inactivation.
Packaging
Functions of packaging, packaging requirements for sterilisation, physical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing.
Quality, Regulatory and GMP
Introduction to Manufacturing Quality and GMP, Medical Device Class (I/ II/ III), 510K products. ISO 13485 - Regulatory Documentation/submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/Medical Devices Directive, planning for audits. Supplier Quality, Incoming quality control.
Validation
Validation protocols - Installation, operational and performance qualification. Process validation, design Qualification, validation of sterilisation system, design verification, design validation.
Module Content & Assessment
Assessment Breakdown%
Coursework40.00%
End of Module Formal Examination60.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 30
Timing Week 8 Learning Outcomes 1,3,4
Assessment Description
Formal in-semester assessment on material covered to date
Assessment Type Written Report % of Total Mark 10
Timing Week 10 Learning Outcomes 1,2,3,4,5,6
Assessment Description
Written report on site visit or industry expert speaker session
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3,4,5,6
Assessment Description
End of semester final examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Class based tuition, Site visit and Laboratory visit Every Week 3.00 3
Independent Learning Non Contact Self directed learning Every Week 11.00 11
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Class based tuition, Site visit and Laboratory visit Every Week 3.00 3
Independent Learning Non Contact Self Directed Learning Every Week 11.00 11
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • R. S. Khandpur. (2014), Handbook of Biomedical instrumentation, 3rd. McGraw-Hill Education, New York, [ISBN: 9789339205430].
  • George K. Hung. (2009), Principles of the Bionic Man, Volume 5. Rutger's University, USA, [ISBN: 9812779787].
  • Lerouge, Sophie and Simmons, Anne. (2012), Sterilisation of Biomaterials and Medical Devices, 1st. Woodhead Publishing, [ISBN: 9781845699321].
Supplementary Book Resources
  • Joseph F. Hanlon, Robert J. Kelsey, Hallie Forcinio. Handbook of package Engineering, 3rd. CRC Press, [ISBN: 1566763061].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 2 Elective
CR_EBMDM_7 Certificate in Biomedical Device Manufacture 1 Mandatory