Short Title:Medical Device Design 1
Full Title:Medical Device Design 1
Language of Instruction:English
Module Code:MDDS H3000
 
Credits: 5
NFQ Level:8
Field of Study:Engineering, Manufacturing and Construction
Module Delivered in no programmes
Reviewed By:FIONA CRANLEY
Module Author:OWEN SINNOTT
Module Description:This module develops a knowledge of the engineering design process, encompassing specification, analysis, creative thought, and methods of selection from design alternatives. Students will be equipped with the knowledge to write basic design specifications for a product or task. They will undertake analytical calculations to design and/or select machine elements from a stand alone and system wide perspective, and apply selection methodologies to compare different design proposals. Students will also be tutored in the requirements for safety, ergonomic and environmental issues. They will expand their concurrent engineering knowledge into the areas of design for manufacturing, and assembly etc.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Produce formal design specifications for simple devices.
LO2 Compare alternative design proposals using decision analysis techniques.
LO3 Design and/or select machine elements using analytical techniques.
LO4 List and describe the ergonomic, human factors and environmental factors affecting a particular design.
LO5 Describe how design for manufacture and assembly (DFM/A) methodologies are applied in the design of a product.
LO6 Identify safety hazards based on international standards and directives, associated with medical equipment.
Pre-requisite learning
Co-requisite Modules
No Co-requisite modules listed
 

Module Content & Assessment

Content (The percentage workload breakdown is inidcative and subject to change) %
Medical Device Design and Manufacture:
Introduction to Medical Device design, Medical device classifications, Health Products Regulatory Authority, importance of ethics in medical design relevant approval processes, device standards, prototyping & application performance testing, medical assessment techniques in respiration, cardiac, surgical noninvasive devices. Good Manufacturing Practice.
10.00%
Barriers to creative thought:
Definition of mental barriers. Classification of mental barriers. Puzzles which highlight barriers.
5.00%
Approvals Process:
European medical device directives, 21CFR800, FDA applications and approval processes, importance of ethics in device testing, management and assessment of medical technology, risk factors, safety, quality and management of medical equipment. Impact of product recalls.
10.00%
Concept selection:
Concept screening, selection matrices, concept rating, concept ranking.
15.00%
Design process review:
General structure of design specifications. Statement of problem, “must requirements”, “want” requirements, criteria for excellence. Setting target and final specifications, needs-metrics matrix.
10.00%
Design Selection:
Requirements for engineering design calculations, industrial standards, safety factors, sizing structural elements, sizing welded joints. Component selection: threaded fasteners, locking devices, bearings, seals. Using web based supplier data
20.00%
Specification and selection of system elements:
Analysis of electro-mechanical or electro-hydraulic systems. Effects of element efficiencies. System component selection and specification.
10.00%
Safety requirement:
Protection of personnel, mechanical hazards, non-mechanical hazards, risk assessment. Protection of equipment, mechanical safety devices, thermal and electrical safety devices. EU machinery directive, US OSHA requirements, safety standards and compliance.
10.00%
Ergonomics:
Deifinition of ergonomics, the human-machine relationship, human factors, instrumentation and control layouts, machine construction, anthropometric data.
5.00%
Design for manufacturing and assembly:
The DFM method, minimising costs, use of standard components, redesign to minimise processing, integration of parts, minimisation of assembly directions, self-aligning and self locating parts, minimising complexity. Design for Environment (DFE).
5.00%
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Written Report Concept screening and selection exercise using formalised concept selection methodology. (Group report) 1,2 10.00 Week 4
Assignment Assess hip implant design with respect to stress shielding, compare material suitability, and identify if stress shielding will be evident. 2,3,4,5 10.00 Week 8
Written Report Analysis of engineering factors contributing to accidents/failures. (Individual lab assessment in class)   5.00 Week 11
Written Report Analysis of ergonomic factors contributing to faults/failures. (Individual lab assessment in class)   5.00 Week 12
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,5,6 70.00 End-of-Semester

IT Tallaght reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Course material 4.00 Every Week 4.00
Independent Learning No Description 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Course material 4.00 Every Week 4.00
Independent Learning No Description 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • M.B. Weinger, M.E. Wiklund 2011, Handbook of Human Factors in Medical Device Design [ISBN: 978-080585627]
  • J.D. Bronzino, D.R. Peterson 2015, Medical Devices and Human Engineering (The Biomedical Engineering Handbook), 4th Ed., CRC Press [ISBN: 978-143982525]
  • K.T. Ulrich, S.D. Eppinger 2016, Product Design and Development, (Int'l Ed), 6th Ed., McGraw-Hill [ISBN: 978-007802906]
  • P.R.N Childs 2013, Mechanical Design Engineering Handbook, 2nd Ed., Butterworth-Heinemann [ISBN: 978-008097759]
  • R. Budynas, J. K. Nesbit, 2014, Shigley’s Mechanical Engineering Design (S.I. Edition), 10th Ed., McGraw-Hill [ISBN: 978-981459528]
  • P.J. Ogrodnik 2014, Class 1 Devices: Case Studies in Medical Devices Design, 1st Ed., Academic Press [ISBN: 978-012800028]
  • P.J. Ogrodnik 2016, In Vitro Diagnostic Devices: Class 1 Sterile and Measuring Devices, 1st Ed., Academic Press [ISBN: 978-012800025]
This module does not have any article/paper resources
This module does not have any other resources