Outline

Overview

The unit aims to teach the fundamentals of biomedical manufacturing processes, including traditional and advanced manufacturing technologies. This unit aims to develop the following attributes: to understand the fundamental principles of biomedical manufacturing approaches; to gain the ability to understand and select appropriate manufacturing processes and systems for biomedical applications; to develop ability to create innovative new manufacturing technologies for medical bionics and other applications in biomedical engineering; to develop ability to invent new manufacturing systems suitable for biomedical engineering implementation. At the end of this unit students will have a good understanding of the following: merits and advantages of individual manufacturing processes and systems used in the fabrication of medical devices and products that support human health and well-being; principles of developing new technologies for biomedical engineering applications; comprehensive applications and strategic selection of manufacturing processes and systems within the regulatory landscape of biomedical manufacturing. Unit content will include: Materials Processing: An introduction into the use of joining, moulding, and other manufacturing processes. Rapid Prototyping: An introduction into the most current prototyping methods currently in use. Manufacturing Processes: Common processes and their science (machining, moulding, sintering, materials processing, joining processes) and their relative merits and limitations.

Unit details and rules

Academic unit	Biomedical Engineering
Credit points	6
Prerequisites ?	None
Corequisites ?	None
Prohibitions ?	BMET3660 or AMME3660
Assumed knowledge ?	None
Available to study abroad and exchange students	No

Teaching staff

Coordinator	Gregg Suaning, gregg.suaning@sydney.edu.au
Lecturer(s)	Karina Taylor, karina.taylor@sydney.edu.au
Lecturer(s)	Gregg Suaning, gregg.suaning@sydney.edu.au

Type	Description	Weight	Due	Length
Final exam (Open book)	Final examination	20%	Formal exam period	1 hour
Outcomes assessed:
Assignment	Laboratory assignment 1	5%	Multiple weeks	n/a
Outcomes assessed:
Assignment	Laboratory assignment 2	5%	Multiple weeks	n/a
Outcomes assessed:
Tutorial quiz	Quiz 1 - online epectations	0%	Week 01	n/a
Outcomes assessed:
Tutorial quiz	Quiz 2: quality, processes, design	20%	Week 04	n/a
Outcomes assessed:
Assignment	Assignment 1: quality management/biomanufacture	15%	Week 05	n/a
Outcomes assessed:
Tutorial quiz	Quiz 3 - automation	20%	Week 09	n/a
Outcomes assessed:
Assignment	Assignment 2 - automation	15%	Week 10	n/a
Outcomes assessed:
= hurdle task ? = group assignment ? = Type C final exam ?

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	Description
High distinction	85 - 100
Distinction	75 - 84
Credit	65 - 74
Pass	50 - 64
Fail	0 - 49	When you don’t meet the learning outcomes of the unit to a satisfactory standard.

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.

Use of generative artificial intelligence (AI) and automated writing tools

You may only use generative AI and automated writing tools in assessment tasks if you are permitted to by your unit coordinator. If you do use these tools, you must acknowledge this in your work, either in a footnote or an acknowledgement section. The assessment instructions or unit outline will give guidance of the types of tools that are permitted and how the tools should be used.

Your final submitted work must be your own, original work. You must acknowledge any use of generative AI tools that have been used in the assessment, and any material that forms part of your submission must be appropriately referenced. For guidance on how to acknowledge the use of AI, please refer to the AI in Education Canvas site.

The unapproved use of these tools or unacknowledged use will be considered a breach of the Academic Integrity Policy and penalties may apply.

Studiosity is permitted unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission as detailed on the Learning Hub’s Canvas page.

Outside assessment tasks, generative AI tools may be used to support your learning. The AI in Education Canvas site contains a number of productive ways that students are using AI to improve their learning.

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.

Weekly schedule

WK	Topic	Learning activity
Multiple weeks	Laboratory - weeks 2-13	Practical (2 hr)
Week 01	Unit introduction/manufacturing processes	Lecture (1 hr)
Week 01	Quality Management Systems (QMS) and ISO13485	Lecture (1 hr)
Week 02	A philosophical approach to medical implant design	Lecture (1 hr)
Week 02	What could possibly go wrong? Case studies in QMS	Lecture (1 hr)
Week 03	Bugs and the biomedical industry	Lecture (1 hr)
Week 03	Pyrogens, pathogens and particles	Lecture (1 hr)
Week 04	Sintering and its role in medical device manufacture	Lecture (1 hr)
Week 05	Manufacturing automation: intro to automation and testing	Lecture (1 hr)
Week 05	Manufacturing automation: automated inspection systems	Lecture (1 hr)
Week 06	Manufacturing automation: VBAI - finding features	Lecture (1 hr)
Week 06	Manufacturing automation: VBAI - measuring features and character recognition	Lecture (1 hr)
Week 07	Manufacturing automation: VBAI - image analysis and intro to motion systems	Lecture (1 hr)
Week 07	Manufacturing automation: data acquisition and LabVIEW	Lecture (1 hr)
Week 08	Manufacturing automation: data processing with LabVIEW	Lecture (1 hr)
Week 08	Manufacturing automation: analogue sampling and LabVIEW	Lecture (1 hr)
Week 09	Failure modes and effects analysis (FMEA)	Lecture (1 hr)
Week 10	Joining processes in medical device manufacture	Lecture (1 hr)
Week 10	Moulding processes in medical device manufacture	Lecture (1 hr)
Week 11	Fabrication methods in medical devices	Lecture (2 hr)
Week 12	Materials processing in medical device manufacture	Lecture (1 hr)
Week 12	Nano manufacturing	Lecture (1 hr)
Week 13	Microfluidics	Lecture (1 hr)
Week 13	Ethics debate	Lecture (1 hr)

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

All readings for this unit can be accessed through the Library eReserve, available on Canvas.

Gregg Suaning, Karina Taylor and Guest Lecturers, Biomanufacturing.

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.

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

LO1. contribute to effective team processes
LO2. determine functional requirements of a product in terms of its application and suitability, etc
LO3. determine the basic manufacturing considerations necessary to realise the function, including the selection of materials and the manufacturing method, taking into account the strength, reliability and intended use in the provision of healthcare
LO4. discuss the merits and disadvantages of individual manufacturing methods in the context of suitability of use in biomedical engineering of devices
LO5. discuss the major problems in the current manufacturing practice and provide suggestions to overcome or improve them. You are encouraged to do an investigation which may include a visit to a manufacturer or laboratory within the university that carries out manufacturing operations
LO6. understand the fundamental principles of manufacturing technologies for biomedical engineering
LO7. demonstrate familiarity with quality management principles in biomedical manufacturing.

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

Alignment with Competency standards

Outcomes	Competency standards
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects
	Stage 1 Competency Standard for Professional Engineer (UG) - 1.1 (L3). Scientific knowledge. (Level 3- Exceeding required standard) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline. 1.2 (L3). Mathematical and computational methods. (Exceeding required standard) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline. 1.3 (L3). Specialist discipline knowledge. (Level 3- Exceeding required standard) In-depth understanding of specialist bodies of knowledge within the engineering discipline. 1.4 (L3). Discipline research knowledge. (Level 3- Exceeding required standard) Discernment of knowledge development and research directions within the engineering discipline 1.5 (L3). Discipline context knowledge. (Level 3- Exceeding required standard) Knowledge of contextual factors impacting the engineering discipline 1.6 (L3). Discipline professional practice knowledge. (Level 3- Exceeding required standard) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline. 2.1 (L3). Complex problem-solving. (Level 3- Exceeding required standard) Application of established engineering methods to complex engineering problem solving 2.2 (L3). Use of engineering techniques, tools and resources. (Level 3- Exceeding required standard) Techniques, tools and resources. 2.3 (L3). Engineering design. (Level 3- Exceeding required standard) Application of systematic engineering synthesis and design processes. 2.4 (L3). Engineering project management. (Level 3- Exceeding required standard) Application of systematic approaches to the conduct and management of engineering projects

Responding to student feedback

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

Change in unit of study coordinator

Additional information

Work, health and safety

A number of minor hazards exist in the laboratory. These will be discussed at the start of each laboratory session. All students are required to comply with Work, Health and Safety requirements.

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

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Required readings

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Alignment with Competency standards

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Work, health and safety

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect

Current students

BMET9660: Biomanufacturing

Semester 1, 2021 [Normal day] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Study commitment

Required readings

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Alignment with Competency standards

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Work, health and safety

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect