Outline

Overview

Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This UoS will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.

Unit details and rules

Academic unit	Biomedical Engineering
Credit points	6
Prerequisites ?	None
Corequisites ?	None
Prohibitions ?	BMET3990 or AMME4990 or BMET4990 or AMME5990 or AMME9990
Assumed knowledge ?	1000 level chemistry, 2000 level biology, and specific knowledge of cell biology at least at the1000 level, and preferably at the 2000 level
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Michael Wong, michael.wong@sydney.edu.au

Assessment

The census date for this unit availability is 1 September 2025

Details
Criteria

Type	Description	Weight	Due	Length	Use of AI
Interactive oral	Final interview Final mock interview assessing selected content across semester	30%	Formal exam period	20 minutes	AI prohibited
Outcomes assessed:
Interactive oral	Practice interview Practice interview based on content from weeks 1-8	10%	Multiple weeks	10 minutes	AI prohibited
Outcomes assessed:
In-person written or creative task	Tutorial quizzes 4x MCQs applying the week's lecturette content	20%	Multiple weeks	5 minutes	AI prohibited
Outcomes assessed:
Portfolio or journal	Weekly logbook Weekly logbook	10%	Ongoing	Up to 1000 words	AI allowed
Outcomes assessed:
Written work	Values & Career Reflection Essay Values & Career Reflection Essay (10%) [Early feedback task]	10%	Week 03 Due date: 21 Aug 2025 at 23:59	Up to 1000 words	AI allowed
Outcomes assessed:
Written work	Networking reflection essay Networking reflection essay	10%	Week 09 Due date: 09 Oct 2025 at 23:59	Up to 1500 words	AI allowed
Outcomes assessed:
Portfolio or journal	Structured Reflection Essay Structured Reflection Essay. This essay will assess specific postgraduate qualities related to ongoing educational and vocational development relevant to professional engineering. See assessment rubric for further details.	10%	Week 13 Due date: 06 Nov 2025 at 23:59	Up to 2000 words	AI allowed
Outcomes assessed:

Assessment summary

Tutorial quizzes: Run between weeks 2-8. Each quiz has 4 MCQs applying the week's lecturette content, to be completed in 5 minutes. Best 5 of 7 quizzes selected for final score of 20%.
Weekly logbook: Ongoing component of reflective portfolio. Time in tutorials will be dedicated to support weekly reflections on course content and direction for final score of 10%.
Values & Career Reflection Essay: First assessment of reflective portfolio. Students will write an essay reflecting on their current views, goals, values in terms of their career plans.
Networking reflection essay: Second assessment of reflective portfolio. Students will have options for industry networking and have opportunity to reflect on their career trajectory, with a focus on non-technical knowledge (standards, regulations, aspirations etc). A short 1500 word reflection essay should be written based on key learnings and their impacts on student approaches to industry and related networks. This will be used to build up on the Values and Career Reflection essay.
Structured Reflection Essay: Third assessment of reflective portfolio. Opportunity for students to synthesise learnings and reflections throughout course, directed by biomedical product development principles and based on a reflective and values-based approach. This essay will assess specific postgraduate qualities related to ongoing educational and vocational development relevant to professional engineering. See assessment rubric for further details.
Practice interview: 10-minute interview run in place of tutorial hours in weeks 10–13, assessing selected content from weeks 1–9. Feedback should be used to work on the final interview.
Final interview: 15-minute interview assessing selected content across the semester.

Assessment criteria

Result Name	Mark Range	Description
High Distinction	85-100%	Demonstrates outstanding and comprehensive knowledge and ability for critical thinking
Distinction	75-84%	Demonstrates excellent and comprehensive knowledge and ability for critical thinking. actve participation in group discussion and leadership in group presentations
Credit	65-74%	Demonstrates good understanding and comprehensive knowledge and a good level of critical thinking and participation in discussions
Pass	50-65%	Demonstrates acceptable if limited knowledge and understanding
Fail	0-49%	Unsatisfactory level of knowledge, engagement in discussion and shows little evidence of critical thinking

For more information see guide to grades.

Use of generative artificial intelligence (AI)

You can use generative AI tools for open assessments. Restrictions on AI use apply to secure, supervised assessments used to confirm if students have met specific learning outcomes.

Refer to the assessment table above to see if AI is allowed, for assessments in this unit and check Canvas for full instructions on assessment tasks and AI use.

If you use AI, you must always acknowledge it. Misusing AI may lead to a breach of the Academic Integrity Policy.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

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:

Assignment: late penalty 5% per day after due date

Academic integrity

The University expects students to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

Our website provides information on academic integrity and the resources available to all students. This includes advice on how to avoid common breaches of academic integrity. Ensure that you have completed the Academic Honesty Education Module (AHEM) which is mandatory for all commencing coursework students

Penalties for serious breaches can significantly impact your studies and your career after graduation. It is important that you speak with your unit coordinator if you need help with completing assessments.

Visit the Current Students website for more information on AI in assessments, including details on how to acknowledge its use.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Support for students

The Support for Students Policy reflects the University’s commitment to supporting students in their academic journey and making the University safe for students. It is important that you read and understand this policy so that you are familiar with the range of support services available to you and understand how to engage with them.

The University uses email as its primary source of communication with students who need support under the Support for Students Policy. Make sure you check your University email regularly and respond to any communications received from the University.

Learning resources and detailed information about weekly assessment and learning activities can be accessed via Canvas. It is essential that you visit your unit of study Canvas site to ensure you are up to date with all of your tasks.

If you are having difficulties completing your studies, or are feeling unsure about your progress, we are here to help. You can access the support services offered by the University at any time:

Support and Services (including health and wellbeing services, financial support and learning support)
Course planning and administration
Meet with an Academic Adviser

Weekly schedule

WK	Topic	Learning activity
Ongoing	Approx. 4 hours per week x 12 = 48	Independent study (48 hr)
Week 01	Introduction to Biomedical Product Development	Lecture (4 hr)
Week 02	Discovery and concept	Lecture and tutorial (4 hr)
Week 03	Pre-clinical research	Lecture and tutorial (4 hr)
Week 04	Clinical trials phase I and II	Lecture and tutorial (4 hr)
Week 05	Clinical trials phase III and IV	Lecture and tutorial (4 hr)
Week 06	Device trials	Lecture and tutorial (2 hr)
Week 07	Standards, quality control processes and failure mode analyses	Lecture and tutorial (4 hr)
Week 08	Ethical considerations	Lecture and tutorial (4 hr)
Week 09	Revision	Tutorial (2 hr)
Week 10	Guest lecture	Lecture (2 hr)
Week 11	Guest lecture	Lecture (2 hr)
Week 12	Guest lecture	Lecture (2 hr)
Week 13	Guest lecture	Lecture (2 hr)

Attendance and class requirements

This course includes pre-recorded lecturettes have been scheduled to encourage a flexible learning approach.

Expectation for attendance at all weekly tutorials and non-recorded lectures.

At least 3 out of 4 guest lectures running between weeks 10-13 must be attended in order to sit for the final interview. Non-fulfilment of the guest lecture attendance requirements would result in forfeiture of the "Final interview (30%)" assessment and subsequently the grades associated with the assessment.

The Faculty of Engineering resolution on attendance requirements can be found here: Faculty of Engineering Faculty Resolutions 2022 (sydney.edu.au)

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

Recommended (but not mandatory):

Yock, Zenios, S. A., Makower, J., Brinton, T. J., Kumar, U. N., Watkins, F. T. J., Denend, L., & Krummel, T. M. (2015). Biodesign : the process of innovating medical technologies. (Yock, S. A. Zenios, J. Makower, T. J. Brinton, U. N. Kumar, F. T. J. Watkins, & T. M. Krummel, Eds.; Second edition / editors, Paul G. Yock, Stefanos Zenios, Joshua Makower, Todd J. Brinton, Uday N. Kumar, F.T. Jay Watkins ; principal writer, Lyn Denend ; specialty editor, Thomas M. Krummel ; web editor, Christina Q. Kurihara.). Cambridge University Press.

Learning outcomes

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.

Outcomes
Graduate qualities

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

LO1. Demonstrate a broad understanding of the series of events and key considerations that occur from the formulation of a biomedical product concept to its release into the market.
LO2. Appreciate the similarities and differences between the device and pharmaceutical product development process
LO3. Demonstrate expertise in working in a team environment to troubleshoot problems that occur during the product development process
LO4. Understand the importance of standards, regulations, quality control processes, asset management, failure mode analyses, ethics and other non-technical elements in the biomedical product industry
LO5. Be able to effectively communicate knowledge in an interview and within a job environment
LO6. Be able to connect with, and learn from, a variety of industry experts
LO7. Reflect on personal values, career aspirations, and professional identity as a biomedical engineer, and articulate how these influence decision-making, teamwork, and product development.
LO8. Critically evaluate insights gained through engagement with industry professionals, guest lecturers and peer connections, integrating these perspectives into a personalised approach to engineering practice .

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
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

Slight change to weighting in order to reflect difficulty of assessments. Slight change in layout to consider that midsem break falls after week 9 instead of last year week 8. Adding more guest lectures focusing on important aspects of the development chain not included last year. This unit of study is based on principals of introducing and developing mastery of technical and non-technical graduate qualities as outlined in the University of Sydney 2032 Strategy, with a focus on reflective and social connection principals and leveraged by regular in-person tutorials. It encourages the use of generative AI to enhance learning outcomes, but not as a substitute for the reflective and social connection principals described above. Updated and additional assessment details based on a non-technical, valued-based pedagogical approach, in line with updated University of Sydney Graduate Quality review.

Disclaimer

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

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Required readings

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links

BMET9990: Biomedical Product Development

Semester 2, 2025 [Normal day] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Use of generative artificial intelligence (AI)

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Support for students

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Required readings

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

On this page

Useful links