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Unit of study_

BMET9990: Biomedical Product Development

Semester 2, 2021 [Normal day] - Remote

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

Unit code BMET9990
Academic unit Biomedical Engineering
Credit points 6
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


Teaching staff

Coordinator Colin Dunstan,
Type Description Weight Due Length
Presentation Presentation and lead discussion
10% Multiple weeks n/a
Outcomes assessed: LO1 LO4 LO3 LO2
Online task Quiz 1
Short answer online open book exam
20% Week 06
Due date: 15 Sep 2021 at 11:00

Closing date: 15 Sep 2021
60 minutes
Outcomes assessed: LO2 LO4 LO3
Presentation group assignment Project
25% Week 08 n/a
Outcomes assessed: LO1 LO2 LO3
Assignment Essay
25% Week 11 n/a
Outcomes assessed: LO2 LO3 LO4
Online task Quiz 2
Short answer online open book exam
20% Week 12
Due date: 13 Aug 2021 at 11:00

Closing date: 13 Aug 2021
60 minutes
Outcomes assessed: LO2 LO4 LO3
group assignment = group assignment ?

Assessment summary

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

For more information see guide to grades.

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.

Academic integrity

The Current Student website  provides information on academic integrity 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 integrity breaches seriously.  

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

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

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.

WK Topic Learning activity Learning outcomes
Week 01 Introduction to the themes in product development Online class (4 hr) LO2 LO3
Week 02 The regulatory environment Online class (4 hr) LO2 LO3
Week 03 Concept to initial validation Online class (4 hr) LO2 LO3 LO4
Week 04 Good manufacturing practice - initial process design Online class (3 hr) LO2 LO4
Week 05 Good manufacturing practice - building a robust process Online class (4 hr) LO2 LO4
Week 06 Initial proof of principle studies (in vitro and in vivo) Online class (4 hr) LO2 LO3 LO4
Week 07 Detailed validation of biological activity in animals Online class (4 hr) LO1 LO2 LO3 LO4
Week 08 Product distribution, clearance and degradation studies Online class (4 hr) LO1 LO2 LO3 LO4
Week 09 Safety/toxicology studies Online class (4 hr) LO1 LO2 LO3 LO4
Week 10 Clinical phase 1 safety in humans Online class (4 hr) LO2 LO3 LO4
Week 11 Clinical phase 2 safety, biological activity, dose ranging Online class (4 hr) LO2 LO3 LO4
Week 12 Clinical phase 3 safety and clinical benefit Lecture and tutorial (4 hr) LO1 LO2 LO3 LO4
Week 13 Phase 4 post-approval, making changes Online class (4 hr) LO1 LO2 LO3 LO4

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 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. work in a team to develop a plan for progressing a biomedical discovery to initial clinical testing
  • LO2. understand biomedical product development within the regulatory framework including: developing manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice
  • LO3. understand the role of progressive preclinical and clinical testing and their dependence on product of increasing quality
  • LO4. understand how to evaluate a case study on a biomedical development failure to determine contributing inadequacies in product testing, design or quality control.

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

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

The structure of the tutorials will be changed to introduce more preparation and participation by the students in response to previous student comments


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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