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MECH3921: Biomedical Design and Technology (2018 - Semester 2)

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Unit: MECH3921: Biomedical Design and Technology (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Senior
Faculty/School: School of Aerospace, Mechanical & Mechatronic Engineering
Unit Coordinator/s: Dr Boughton, Philip
Session options: Semester 2
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: (AMME2302 OR AMME1362) AND MECH2901 AND (MECH2400 OR ENGG1960 OR AMME1960).
Prohibitions: AMME5921.
Brief Handbook Description: This unit aims to give students an understanding of the Australian and International biomedical industry and in the development, manufacture and uses of biomedical engineering products in therapeutic, rehabilitation and clinical settings. Students will gain an understanding of the process of biomedical regulation in Australia and other major international markets as well as the entire process of creating a new biomedical engineering product, from design through to marketing and monitoring of the product. Students will design a biomedical device including the preparation of a detailed design brief.

This will be done as a team project. Each team will work on a specific biomedical design project following formal design protocols, including design control, regulatory considerations, and commercialisation/IP considerations.

Course content will cover:

- Health impact and accessibility context for medical technology

- Biomedical Design & Development following ISO standard guidelines

- Intellectual Property and prior art research and considerations for development

- Ideation process for arriving at design specifiations from captured requirements and design risks.

- Ethical practices in design

- Clinical-readiness, sterilization, packaging, deployment and usage considerations

- Verification and validation

- Prototyping and scale-up considerations

- Regulatory and clinical considerations in the biomedical industry.

- Commercialisation strategies in the medical device sector.

- The Australian biomedical industry - an overview. Includes site visits.

- The global biomedical industry - an overview. Includes site visits.
Assumed Knowledge: A basic understanding of human physiology and anatomy and an understanding of the engineering design process.
Lecturer/s: Professor Ruys, Andrew
Tutor/s: Boughton, Philip - philip.boughton@sydney.edu.au
Timetable: MECH3921 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 4.00 2 12
2 Presentation 4.00 2 1
3 Independent Study 6.00 13
T&L Activities: Presentation: Group seminars in the final week of semester presenting design project.

Industry site visits.

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method Attribute Developed
Gain an understanding of the development, manufacture and uses of biomedical engineering products in therapeutic, rehabilitation and clinical settings. Understanding of designing in an ethical framework that accounts for accessibility & sustainability. Define the health challenge by reflecting on key questions which define the area and the degree of impact. Generating engineering specifications which meet the given constraints. Awareness of & adherence to occupational health & safety requirements during any design, prototyping & test activity. Engineering/IT Specialisation (Level 3)
Use of online database resources, patent searching and expert advisers for completion of design project. Understanding and articulating questions surrounding device clinical need and technical constraints. Information Seeking (Level 3)
Ability to communicate knowledge gained in the form of written assignments, group work and the final seminar. Ability to work within a team, including articulating design views and integrating with a range of team reflections. Documentation of the design process. An awareness of the importance of maintaining confidentiality through the design process, and in consultation with other parties. Communication (Level 3)
Understanding of the biomedical industry in terms of the companies, job roles, and the career and workplace dynamics. Understanding of the ethical, social & professional context of the biomedical and healthcare industries. Understanding of legal obligations including honesty in authorship of work and ideas, confidentiality during the design process particularly relating to Intellectual Property protection. Professional Conduct (Level 3)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table 2018.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

Engineering/IT Specialisation (Level 3)
1. Understand the development and regulation of biomedical products.
2. Understand medical device engineering following standards and quality management systems.
Design (Level 3)
3. Understand the biomedical design process.
4. Design a biomedical device or solution, in consultation with clinical users.
Communication (Level 3)
5. Present the challenge being addressed and subsequent design and development activity to peers through seminars.
6. Understand how to document design and development activity, including team meetings, research, prototyping/testing activities and external consultation.
Professional Conduct (Level 3)
7. Understand the biomedical engineering industry both locally and globally.
8. Understand clinical interaction, and planning of clinical and regulatory affairs.
9. Understand the development and testing protocols for biomedical devices.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Quiz No 10.00 Week 8 1, 2, 3, 7, 8,
2 Site Visit Reports No 10.00 Multiple Weeks 7,
3 Work Log No 30.00 Week 13 (Saturday, 11 pm) 2, 3, 4, 6, 9,
4 Team Progress Report Yes 20.00 Week 6 (Friday, 11 pm) 2, 3, 4, 5, 6, 8, 9,
5 Team Final Report Yes 20.00 Week 13 (Saturday, 11 pm) 2, 3, 4, 5, 6, 8, 9,
6 Presentation/Seminar Yes 10.00 Week 13 (During your timetabled class) 5,
Assessment Description: Site visit reports: Due Fri 4pm the following week
Grading:
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at http://sydney.edu.au/policies . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at http://sydney.edu.au/engineering/student-policies/ for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.
Note on Resources: No textbook.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar https://web.timetable.usyd.edu.au/calendar.jsp

Week Description
Week 1 Unit Introduction
Week 2 Super tutorial
Week 3 Super tutorial
Week 4 Super tutorial
Week 5 Super tutorial
Week 6 Super tutorial
Assessment Due: Team Progress Report
Week 7 Super tutorial
Week 8 Super tutorial
Assessment Due: Quiz
Week 9 Super tutorial
Week 10 Super tutorial
Week 11 Super tutorial
Week 12 Talk Trials
Week 13 Other: Team Seminars
Assessment Due: Work Log
Assessment Due: Team Final Report
Assessment Due: Presentation/Seminar

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Biomedical Engineering / Law 2013, 2014
Biomedical Engineering / Arts 2013, 2014
Biomedical Engineering / Commerce 2013, 2014
Biomedical Engineering / Medical Science 2013, 2014
Biomedical Engineering / Project Management 2013, 2014
Biomedical Engineering / Science 2013, 2014
Biomedical - Chemical and Biomolecular Major 2013, 2014, 2015
Biomedical - Electrical Major 2013, 2014
Biomedical - Information Technology Major 2013, 2014, 2015
Biomedical - Mechanical Major 2013, 2014, 2015
Biomedical - Mechatronics Major 2013, 2014, 2015
Biomedical Mid-Year 2016, 2017, 2018
Biomedical / Arts 2015, 2016, 2017, 2018
Biomedical / Commerce 2015, 2016, 2017, 2018
Biomedical / Medical Science 2015, 2016, 2017
Biomedical / Music Studies 2016, 2017
Biomedical / Project Management 2015, 2016, 2017, 2018
Biomedical /Science 2015, 2016, 2017, 2018
Biomedical/Science (Health) 2018
Biomedical - Electrical Major 2015
Biomedical / Law 2015, 2016, 2017, 2018
Mechanical (Biomedical) (till 2014) 2010, 2011, 2012
Mechanical Engineering (Biomedical) / Arts 2011, 2012
Mechanical Engineering (Biomedical) / Commerce 2010, 2011, 2012
Mechanical Engineering (Biomedical) / Medical Science 2010, 2011, 2012
Mechanical Engineering (Biomedical) / Project Management 2012
Mechanical Engineering (Biomedical) / Science 2011, 2012
Mechanical Engineering (Biomedical) / Law 2010, 2011, 2012
Biomedical/Science (Medical Science Stream) 2018

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
Engineering/IT Specialisation (Level 3) Yes 12%
Design (Level 3) No 21%
Information Seeking (Level 3) Yes 0%
Communication (Level 3) Yes 37%
Professional Conduct (Level 3) Yes 30%

These goals are selected from Engineering & IT Graduate Outcomes Table 2018 which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table 2018 for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.