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Unit of study_

BMET3660: Biomanufacturing

Semester 1, 2022 [Normal day] - Camperdown/Darlington, Sydney

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

Unit code BMET3660
Academic unit Biomedical Engineering
Credit points 6
Prohibitions
? 
MECH3660 OR AMME3660
Prerequisites
? 
84 credit points completed
Corequisites
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

Yes

Teaching staff

Coordinator Daniele Vigolo, daniele.vigolo@sydney.edu.au
Type Description Weight Due Length
Final exam (Open book) Type C final exam hurdle task Final examination
Final Exam
30% Formal exam period 1 hour
Outcomes assessed: LO2 LO3 LO4 LO5 LO6 LO7
Assignment group assignment Laboratory assignment 1
Group submission
5% Multiple weeks n/a
Outcomes assessed: LO1 LO3 LO4 LO5
Assignment group assignment Laboratory assignment 2
Group submission
5% Multiple weeks n/a
Outcomes assessed: LO1 LO3 LO4 LO5
Tutorial quiz Quiz 1 - online expectations
Online quiz
0% Week 02 n/a
Outcomes assessed: LO1 LO7
Assignment group assignment Assignment 1: quality management/biomanufacture
Group submission
15% Week 05 n/a
Outcomes assessed: LO1 LO7 LO6 LO3 LO2
Tutorial quiz Quiz 2: quality, processes, design
Online quiz
20% Week 06 n/a
Outcomes assessed: LO2 LO7 LO6 LO4 LO3
Tutorial quiz Quiz 3 - microfluidics, image analysis, 3D printing
Online quiz
15% Week 09 n/a
Outcomes assessed: LO1 LO7 LO6 LO5 LO4 LO3 LO2
Assignment group assignment Assignment 2: image analyses
Group submission
10% 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

The assessments will consist in:

- a formative (non-weighted) quiz on the expectations of the unit;

- 2 weighted online quiz composed by open and multiple choice questions;

- Assignment 1: submission of either an essay or a video prepared each group of students related to quality management/biomanufacture;

- Assignment 2: submission of a group report/essay in which each group will perform image analysis exploiting specific software discussed in the lectures;

- Lab Assignment 1: submission of the evidence of the completion of the lab work on the fabrication of a neurostimulator;

- Lab Assignment 1: submission of the evidence of the completion of the lab work on the biocontamination;

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 sydney.edu.au/students/guide-to-grades.

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
Multiple weeks Laboratory - weeks 2-13 Practical (2 hr) LO6 LO7
Week 01 1. Unit introduction/manufacturing processes; 2. Quality management systems (QMS) and ISO13485 Lecture (2 hr) LO1 LO2
Week 02 1. What could possibly go wrong? Case studies in QMS; 2. A philosophical approach to medical implant design Lecture (2 hr) LO2 LO3 LO4 LO5
Week 03 1. Bugs and the biomedical industry; 2. Pyrogens, pathogens and particles Lecture (2 hr) LO4 LO5
Week 04 Sintering and its role in medical device manufacture Lecture (2 hr) LO1 LO2 LO3
Week 05 1. Microfluidic organ-on-a-chip; 2. Bio-ink and cell printing Lecture (2 hr) LO1 LO6 LO7
Week 06 1. Manufacturing automation; 2. Image analysis, features and character recognition Lecture (2 hr) LO1 LO6 LO7
Week 07 1. Introduction to 3D printing; 2. 3D printing for different stages of development of a biomedical device Lecture (2 hr) LO1 LO2 LO3 LO4 LO6
Week 08 Biomaterial engineering from biopolymers Lecture (2 hr) LO1 LO2 LO3
Week 09 Failure modes and effects analysis (FMEA) Lecture (2 hr) LO2 LO3 LO4 LO5 LO6
Week 10 1. Joining processes in medical device manufacture; 2. Moulding processes in medical device manufacture Lecture (2 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 (2 hr) LO3 LO4 LO5 LO6 LO7
Week 13 1. Nano manufacturing; 2. Ethics debate Lecture (2 hr) LO1 LO7

Attendance and class requirements

Attendance: There are multiple laboratories scheduled during the semester. All of these are compulsory and are to be attended at the scheduled time according to each students individual timetable. 

 

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. Ability to 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 your 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 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO2
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.4 (L2). Discipline research knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Discernment of knowledge development and research directions within the engineering discipline
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO3
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO4
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO5
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO6
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic approaches to the conduct and management of engineering projects
LO7
Stage 1 Competency Standard for Professional Engineer (UG) - EA
1.1 (L2). Scientific knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) Comprehensive, theory based understanding of the underpinning natural and physical sciences and the engineering fundamentals applicable to the engineering discipline.
1.2 (L2). Mathematical and computational methods. (Level 2- Attaining required standard (Bachelor Honours standard)) Conceptual understanding of the mathematics, numerical analysis, statistics, and computer and information sciences which underpin the engineering discipline.
1.3 (L2). Specialist discipline knowledge. (Level 2- Attaining required standard (Bachelor Honours standard)) In-depth understanding of specialist bodies of knowledge within the engineering discipline.
1.4 (L2). Discipline research knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Discernment of knowledge development and research directions within the engineering discipline
1.5 (L2). Discipline context knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Knowledge of contextual factors impacting the engineering discipline
1.6 (L2). Discipline professional practice knowledge. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Understanding of the scope, principles, norms, accountabilities and bounds of contemporary engineering practice in the specific discipline.
2.1 (L2). Complex problem-solving. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of established engineering methods to complex engineering problem solving
2.2 (L2). Use of engineering techniques, tools and resources. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Techniques, tools and resources
2.3 (L2). Engineering design. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) Application of systematic engineering synthesis and design processes.
2.4 (L2). Engineering project management. (Level 2- Attaining required standard (Bachelor Honours standard AQF8)) 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.

Where there are limitations to the number of people in a given laboratory session (e.g. Covid-19 restrictions), one member from each laboratory group will attend and others will join by Zoom or other online method of interaction and participation.

Work, health and safety

A number of minor hazards exist in the laboratory sessions. These will be discussed at the start of each 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.