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Unit of study_

BMET3921: Biomedical Design and Technology

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.


Academic unit Biomedical Engineering
Unit code BMET3921
Unit name Biomedical Design and Technology
Session, year
Semester 2, 2021
Attendance mode Normal day
Location Remote
Credit points 6

Enrolment rules

AMME5921 OR BMET5921 OR MECH3921 OR BMET9921
MECH2901 or BMET2901 or MEDS2001 or PHSI2X07 or BDSN2001
Assumed knowledge

A basic understanding of human physiology and anatomy and an understanding of the engineering design process. Students are recommended to have completed 36cp of 2000-level or higher units before attempting this unit.

Available to study abroad and exchange students


Teaching staff and contact details

Coordinator Sandhya Clement,
Lecturer(s) Sandhya Clement ,
Type Description Weight Due Length
Assignment Industry report
A brief report detailing a guest lecture/ site visit/ biomedical company.
10% Multiple weeks About 2-3 pages per report.
Outcomes assessed: LO3
Assignment Logbook
A regularly updated document on individual’s contribution to the project.
20% Multiple weeks About 5-10 pages per fortnight.
Outcomes assessed: LO6 LO7
Assignment group assignment Technical Design Report (Draft)
A draft technical report on the proposed technology solution.
5% Week 07 No maximum length.
Outcomes assessed: LO1 LO9 LO8 LO7 LO6 LO5 LO4 LO2
Online task Quiz
Canvas based quiz covering lecture material.
20% Week 11 60 minutes
Outcomes assessed: LO3 LO4 LO6 LO8 LO9
Presentation group assignment MedTech Innovation Presentations
A video presentation of the device design.
10% Week 13 4-10 minutes (to be confirmed)
Outcomes assessed: LO1 LO8
Assignment group assignment Technical Design Report (final)
A technical report on the proposed technology solution.
25% Week 13 No maximum length.
Outcomes assessed: LO1 LO9 LO8 LO7 LO6 LO5 LO4 LO2
Assignment Peer Evaluation
Peer review: Peer Evaluation will be used to moderate the total group mark.
10% Week 13 n/a
Outcomes assessed: LO2 LO5
group assignment = group assignment ?
Quiz: Canvas based quiz where students will answer questions covering lecture material and may take the form of multiple choice, true/false, matching questions, and short answer questions. It worth 20% of the total marks.
Industry report: one short report (about 2 pages) based on the either industry events such as site visit or guest lecture held during the semester or an independent research on a biomedical company of your choice. The report will be focused on articulating industry needs and pathways for growth and this will be assessed for 10% of total marks based on a rubric published in the Canvas.
Logbook: A regularly updated document that details an individual’s personal contributions to different aspects for the group project. This logbook which will be assessed triweekly (end of Week 4,7,10 and 13) till the end of the semester against a rubric (published in Canvas) and this assessment accounts for 20% of the total marks.
Technical Design Report: A detailed biomedical device design report, to be developed in a team. Submissions will be progressive. A progress report worth 5% will be used to provide feedback for the final report which accounts for 25% of the total marks.
MedTech Innovation Presentation: A team video presentation of the device design. This assessment accounts for 10% of the total marks.
Peer Evaluation: Feedback from team members about the contribution of each individual and is accountable for 10% of the total marks.

Detailed information for each assessment can be found on Canvas.


Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name

Mark range


High distinction

85 - 100



75 - 84



65 - 74



50 - 64



0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

A late penalty of 5% of the maximum awardable marks will be applied per day (or part thereof). After 10 calendar days, work will not be marked and will receive a zero.

Special consideration

If you experience short-term circumstances beyond your control, such as illness, injury or misadventure or if you have essential commitments which impact your preparation or performance in an assessment, you may be eligible for special consideration or special arrangements.

Academic integrity

The Current Student website provides information on academic honesty, academic dishonesty, and the resources available to all students.

The University expects students and staff to act ethically and honestly and will treat all allegations of academic dishonesty or plagiarism seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic dishonesty. If such matches indicate evidence of plagiarism or other forms of dishonesty, your teacher is required to report your work for further investigation.

WK Topic Learning activity Learning outcomes
Multiple weeks Presentations and discussions with representatives from companies and other organisations in the medical technology and healthcare domain Online class (2 hr) LO3
Week 01 Unit introduction and meeting your group Lecture (2 hr) LO5 LO6 LO7
Week 02 The design process Lecture (2 hr) LO5 LO6 LO7
Week 03 Regulatory, clinical, and ethical considerations Lecture (2 hr) LO3 LO4 LO9
Week 04 Verification and validation Lecture (2 hr) LO6 LO7 LO8
Week 05 Project consultation Workshop (2 hr) LO3 LO4 LO6 LO8 LO9
Week 06 Project consultation Workshop (2 hr) LO1 LO2 LO3 LO4 LO5 LO6 LO7 LO8 LO9
Week 07 Prototyping and scaling-up Lecture (2 hr) LO2 LO3 LO6 LO7 LO8
Week 08 Intellectual property and commercialisation Lecture (2 hr) LO3 LO4 LO9
Week 09 Clinical readiness and deployment Lecture (2 hr) LO2 LO4 LO6 LO7 LO8
Week 10 Special Activity Online class (2 hr) LO2 LO3 LO4 LO8 LO9
Week 11 Quiz Online class (2 hr) LO3 LO4 LO6 LO8 LO9
Week 12 Trial Presentations Rehearsal (2 hr) LO1 LO7 LO8 LO9
Week 13 Final Presentations Presentation (2 hr) LO1 LO7 LO8 LO9
Weekly Group project: in-class time. Online options will be provided. Workshop (1 hr) LO1 LO2 LO5
Group project: outside of class time Independent study (6 hr) LO1 LO2 LO5

Attendance and class requirements

Students are expected to attend a minimum of 90% of all timetabled activities.

See the Faculty resolutions for more information:

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Required readings

Students may find the following book to be a useful reference. 

Biodesign : the process of innovating medical technologies.

Yock, Paul G., editor.; Zenios, Stefanos A., editor.; Makower, Josh, editor.; Brinton, Todd J., editor.; Kumar, Uday N., editor.; Watkins, F. T. Jay, editor.; Denend, Lyn, author.; Krummel, Thomas M., editor.; 2015. 

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University’s graduate qualities and are assessed as part of the curriculum.

At the completion of this unit, you should be able to:

  • LO1. present research to peers through seminars and group discussions
  • LO2. collaborate with project stakeholders from outside the engineering domain
  • LO3. understand the biomedical engineering industry both locally and globally
  • LO4. articulating the regulatory, legal, and ethical considerations in relation to biomedical device design and use (e.g. in clinical trials), as well as intellectual property issues
  • LO5. demonstrate the ability work cohesively in a team, integrating inputs from different sources in the pursuit of a design solution
  • LO6. understand and be able to plan the biomedical design process, including design iteration and testing protocols
  • LO7. create a detailed design brief for a biomedical device that addresses a specific problem, with reference to international standards
  • LO8. use evidence to justify methodological and design choices with reference to prior art
  • LO9. understand the therapeutic, rehabilitation, and clinical contexts in which biomedical devices are required to operate, and the role of regulation within these contexts.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
Student feedback informed some changes to this unit since it was last offered. Details will be explained in class.

Site visit guidelines

Site visit guidelines will be published on Canvas (may not apply due to COVID).


The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

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