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Unit outline_

BMET9660: Biomanufacturing

Semester 1, 2021 [Normal day] - Remote

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
Type Description Weight Due Length
Final exam (Open book) Type C final exam hurdle task Final examination
20% Formal exam period 1 hour
Outcomes assessed: LO3 LO4 LO5 LO6 LO7 LO2
Assignment group assignment Laboratory assignment 1
5% Multiple weeks n/a
Outcomes assessed: LO1 LO3 LO4 LO5
Assignment group assignment Laboratory assignment 2
5% Multiple weeks n/a
Outcomes assessed: LO1 LO3 LO4 LO5
Tutorial quiz Quiz 1 - online epectations
0% Week 01 n/a
Outcomes assessed: LO1 LO7
Tutorial quiz Quiz 2: quality, processes, design
20% Week 04 n/a
Outcomes assessed: LO2 LO7 LO6 LO4 LO3
Assignment group assignment Assignment 1: quality management/biomanufacture
15% Week 05 n/a
Outcomes assessed: LO1 LO7 LO6 LO3 LO2
Tutorial quiz Quiz 3 - automation
20% Week 09 n/a
Outcomes assessed: LO1 LO7 LO6 LO5 LO4 LO3 LO2
Assignment group assignment Assignment 2 - automation
15% Week 10 n/a
Outcomes assessed: LO1 LO7 LO6 LO3 LO2
hurdle task = hurdle task ?
group assignment = group assignment ?
Type C final exam = 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.

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
Multiple weeks Laboratory - weeks 2-13 Practical (2 hr) LO6 LO7
Week 01 Unit introduction/manufacturing processes Lecture (1 hr) LO1 LO2
Quality Management Systems (QMS) and ISO13485 Lecture (1 hr) LO1 LO2
Week 02 A philosophical approach to medical implant design Lecture (1 hr) LO2 LO3 LO4 LO5
What could possibly go wrong? Case studies in QMS Lecture (1 hr) LO2 LO3 LO4 LO5
Week 03 Bugs and the biomedical industry Lecture (1 hr) LO4 LO5
Pyrogens, pathogens and particles Lecture (1 hr) LO4 LO5
Week 04 Sintering and its role in medical device manufacture Lecture (1 hr) LO1 LO2 LO3
Week 05 Manufacturing automation: intro to automation and testing Lecture (1 hr) LO1 LO6
Manufacturing automation: automated inspection systems Lecture (1 hr) LO1 LO6
Week 06 Manufacturing automation: VBAI - finding features Lecture (1 hr) LO1 LO6
Manufacturing automation: VBAI - measuring features and character recognition Lecture (1 hr) LO1 LO6
Week 07 Manufacturing automation: VBAI - image analysis and intro to motion systems Lecture (1 hr) LO1 LO6
Manufacturing automation: data acquisition and LabVIEW Lecture (1 hr) LO1 LO6
Week 08 Manufacturing automation: data processing with LabVIEW Lecture (1 hr) LO1 LO6
Manufacturing automation: analogue sampling and LabVIEW Lecture (1 hr) LO1 LO6
Week 09 Failure modes and effects analysis (FMEA) Lecture (1 hr) LO2 LO3 LO4 LO5 LO6 LO7
Week 10 Joining processes in medical device manufacture Lecture (1 hr) LO1 LO2 LO6
Moulding processes in medical device manufacture Lecture (1 hr) LO1 LO2 LO6
Week 11 Fabrication methods in medical devices Lecture (2 hr) LO1 LO2 LO6 LO7
Week 12 Materials processing in medical device manufacture Lecture (1 hr) LO3 LO4 LO5 LO6 LO7
Nano manufacturing Lecture (1 hr) LO3 LO4 LO5 LO6 LO7
Week 13 Microfluidics Lecture (1 hr) LO1 LO7
Ethics debate Lecture (1 hr) LO1 LO7

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 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
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

Alignment with Competency standards

Outcomes Competency standards
LO1
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO2
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO3
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO4
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO5
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO6
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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
LO7
Stage 1 Competency Standard for Professional Engineer (UG) - EA
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

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

Change in unit of study coordinator

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.

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