MTE-40038 - Module Specification
School of Pharmacy and Bioengineering
Faculty of Medicine & Health Sciences
For academic year: 2023/24 Last Updated: 13 February 2024
MTE-40038 - Medical Device Design Principles
Coordinator: Peter Ogrodnik Tel: +44 1782 674996
School Office:
Programme/Approved Electives for 2023/24
Available as a Free Standing Elective
Co-requisites
None
Prerequisites
Bachelors degree (or equivalent proof of training) in an approved discipline with appropriate mathematical competence.
Barred Combinations
employ a systems engineering approach to medical device design and explain how transducers and operational amplifiers are used in medical devices, in terms of their physics or electronics; will be achieved by assessments: 1,2
outline the EU approach to medical device classification and demonstrate its relevance to and application in device design; will be achieved by assessments: 1,2
solve theoretical and practical problems in medical and biological engineering, in fields such as medical instrumentation, medical electronics and assistive technology; will be achieved by assessments: 1,2
assess the precautions necessary to reduce risks to staff, patients and others such as those arising from the design, construction, management and use of medical or laboratory devices, systems and procedures; will be achieved by assessments: 1,2
demonstrate an understanding of key safety concepts, such as electrical, mechanical, biological, radiobiological and chemical hazards and their effects; will be achieved by assessments: 1,2
describe, analyse and critically evaluate how device design principles are applied to specific types of medical devices, including how medical device standards and regulations are applied to achieve patient safety. will be achieved by assessments: 1,2
outline the EU approach to medical device classification and demonstrate its relevance to and application in device design; will be achieved by assessments: 1,2
solve theoretical and practical problems in medical and biological engineering, in fields such as medical instrumentation, medical electronics and assistive technology; will be achieved by assessments: 1,2
assess the precautions necessary to reduce risks to staff, patients and others such as those arising from the design, construction, management and use of medical or laboratory devices, systems and procedures; will be achieved by assessments: 1,2
demonstrate an understanding of key safety concepts, such as electrical, mechanical, biological, radiobiological and chemical hazards and their effects; will be achieved by assessments: 1,2
describe, analyse and critically evaluate how device design principles are applied to specific types of medical devices, including how medical device standards and regulations are applied to achieve patient safety. will be achieved by assessments: 1,2
Description for 2023/24
Students will gain an understanding of the systems engineering approach to medical
device design, including the role of ergonomics in the design of safe and reliable
medical devices. Students will learn the importance of standards and regulations for
medical device design and gain an overview of aspects of the mechanical, electrical
and software components of medical devices.
device design, including the role of ergonomics in the design of safe and reliable
medical devices. Students will learn the importance of standards and regulations for
medical device design and gain an overview of aspects of the mechanical, electrical
and software components of medical devices.
Aims
Interactive Lectures: 14 hours
Tutorials: 2
Non-contact private study:
Directed reading to support lectures: 63
Reading for essay preparation: 43
Compiling information and essay writing: 10
Tutorial preparation: 5
General study revision for examination: 13
Total: 150
Tutorials: 2
Non-contact private study:
Directed reading to support lectures: 63
Reading for essay preparation: 43
Compiling information and essay writing: 10
Tutorial preparation: 5
General study revision for examination: 13
Total: 150
Talis Aspire Reading List
Any reading lists will be provided by the start of the course.
http://lists.lib.keele.ac.uk/modules/mte-40038/lists
Intended Learning Outcomes
None
Study hours
Bachelors degree (or equivalent proof of training) in an approved discipline with appropriate mathematical competence.
School Rules
None
Description of Module Assessment
Poster Presentation
Students will prepare and present a poster covering aspects of safety and risk, and the regulatory framework surrounding medical devices/technology.
2: Coursework weighted 70%
Coursework Essay
The essay will be based on the evolution of the design of specific types of medical devices as influenced by changes in both standards and regulations concerned with the safety of such devices. Students must demonstrate self-directed literature evaluation and are given a choice in part of the essay to demonstrate originality in analysing specific safety aspects of the design of complex medical devices. Maximum 1500 words.