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 ?	BMET2901 or MEDS1002 or MEDS2XXX or ANAT2XXX or PHSI2XXX or MEDS2XXX
Corequisites ?	None
Prohibitions ?	AMME4990 or BMET4990 or AMME9990 or BMET9990
Assumed knowledge ?	1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level
Available to study abroad and exchange students	Yes

Teaching staff

Coordinator	Hamish Fernando, hamish.fernando@sydney.edu.au
Tutor(s)	Michael Wong, michael.wong@sydney.edu.au

Assessment

The census date for this unit availability is 31 August 2026

Details
Criteria

Type	Description	Weight	Due	Length	Use of AI
Interactive oral	Final interview Final interview assessing selected content across semester	30%	Formal exam period	15 minutes	AI prohibited
Outcomes assessed:
In-person written or creative task	Tutorial quizzes 6 quizzes from weeks 2 to 7, applying content from pre-class podcasts/videos. Best 5 of 6 selected for final weighting.	4%	Multiple weeks	5 minutes	AI prohibited
Outcomes assessed:
In-person written or creative task	Reflective exercises Reflection on learnings across the various aspects of the unit including podcasts, in-class discussions, assessments, networking events. Connection to professional development as a biomedical engineer.	15%	Multiple weeks	_	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:
Attendance - accreditation or faculty requirement	Tutorial attendance A minimum of 6 tutorials must be attended between weeks 1 and 8	0%	Ongoing	_	Not applicable
Outcomes assessed:
In-person written or creative task	Tutorial quizzes First of 6 quizzes from weeks 2 to 7, applying content from pre-class podcasts/videos. Best 5 of 6 selected for final weighting.	1%	Week 02	5 minutes	AI prohibited
Outcomes assessed:
Creative work	Development Briefing Video presenting product's full journey from initial concept through to submission-readiness, built from the design work, results, and decisions that groups have produced across the semester.	30%	Week 12	10 minutes	AI allowed
Outcomes assessed:
Q&A following presentation, submission or placement	Advisory Panel Hearing (Q&A) Live Q&A where groups defend the Development Briefing.	10%	Week 13	10 minutes	AI prohibited
Outcomes assessed:
= hurdle task ? = group assignment ? = early feedback task ?

Assessment summary

Tutorial Attendance: 0% hurdle

Six of eight tutorials must be attended to sit for interview assessments.

Weekly Checks: 5%, hurdle
Short in-class knowledge checks based on each week's podcast content. HURDLE: a minimum pass average is required to remain eligible for interview assessments.

Reflective Logbook: 15% (5% draft, week 8; 10% final, week 13)
Weekly, handwritten, closed-book reflections completed at the end of each tutorial, tracking shifts in thinking and connections to personal and professional values. Draft submitted week 8 for formative feedback; final submission in week 13 includes a capstone reflection.

Development Briefing (Video): 30%
Group video presenting the product's full development journey from concept through submission-readiness, built from design work and results generated across weeks 2-7. Modelled on a regulatory Briefing Document.

Advisory Panel Hearing (Q&A): 10%, hurdle
Live panel session where groups defend the Development Briefing, with questions directed to individuals - but discussion between group members allowed. Modelled on a regulatory Advisory Committee hearing. HURDLE: failing this component will result in a 50% penalty being applied to the individual's Development Briefing video score.

Practice Interview: 10%
Formative mock interview based on content from weeks 1-8, with feedback ahead of the final interview.

Final Interview: 30%
Mock interview during exam week assessing selected content across the semester, independent of individual project work.

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
Multiple weeks	Project work + interview preparation (weeks 9-12)	Tutorial (8 hr)
Ongoing	Podcast discussions and pre-class preparation = 2 hours x 12 weeks	Self-directed learning (24 hr)
Please select a valid week from the list below	Self-study 2 hours x 12 weeks	Self-directed learning (12 hr)
Week 01	Intro, Discovery, Concept, Funding, IP/novelty	Workshop (2 hr)
Week 01	Intro, Discovery, Concept, Funding, IP/novelty	Tutorial (2 hr)
Week 02	Rules & Ethics (ethics + standards/regulatory landscape)	Workshop (2 hr)
Week 02	Rules & Ethics (ethics + standards/regulatory landscape)	Tutorial (2 hr)
Week 03	Building Quality In (design controls, risk management/FMEA, GMP, QC, biocompatibility, human factors)	Workshop (2 hr)
Week 03	Building Quality In (design controls, risk management/FMEA, GMP, QC, biocompatibility, human factors)	Tutorial (2 hr)
Week 04	Preclinical	Workshop (2 hr)
Week 04	Preclinical	Tutorial (2 hr)
Week 05	Phase 0–2 / Early Feasibility Study	Workshop (2 hr)
Week 05	Phase 0–2 / Early Feasibility Study	Tutorial (2 hr)
Week 06	Phase 3 / Pivotal Study	Workshop (2 hr)
Week 06	Phase 3 / Pivotal Study	Tutorial (2 hr)
Week 07	Phase 4/PMS + submission	Workshop (2 hr)
Week 07	Phase 4/PMS + submission	Tutorial (2 hr)
Week 08	Asset management	Lecture (2 hr)
Week 08	Reflective exercises	Tutorial (2 hr)
Week 13	Project Q&A	Workshop (2 hr)
Week 13	Wrap-up + reflection	Tutorial (2 hr)

Attendance and class requirements

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

Attendance required in at least 6 of 8 tutorials between weeks 1-8 in order to sit for the interview assessments.

Non-completion of Sparkplus peer-review before panel Q&A in week 13 will result in a 10% deduction to video mark.

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.

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 elements in the biomedical product industry
LO5. Be able to effectively communicate knowledge to technical and lay stakeholders.
LO6. Engage with industry professionals and peers to critically reflect on and develop your professional identity, values, and approach to biomedical 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.

Added project on the product development pathway to more strongly connect unit to the development process. Keeping reflective components but dropping the weight and number - this time only a draft and final. Dropping quiz weight to 5%.

Additional information

Weekly networking sessions will be run for students to meet industry professionals. More information will be provided on Canvas and in class.

Disclaimer

Important: the University of Sydney regularly reviews units of study and reserves the right to change the units of study available annually. To stay up to date on available study options, including unit of study details and availability, refer to the relevant handbook.

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

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links

BMET3990: Biomedical Product Development

Semester 2, 2026 [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

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Disclaimer

On this page

Useful links