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Unit outline_

BMET9990: Biomedical Product Development

Semester 2, 2024 [Normal day] - Camperdown/Darlington, Sydney

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
? 
None
Corequisites
? 
None
Prohibitions
? 
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

No

Teaching staff

Coordinator Hamish Fernando, hamish.fernando@sydney.edu.au
Lecturer(s) Hamish Fernando, hamish.fernando@sydney.edu.au
The census date for this unit availability is 2 September 2024
Type Description Weight Due Length
Presentation Final interview
Final mock interview assessing selected content across semester
30% Formal exam period 20 minutes
Outcomes assessed: LO1 LO5 LO4
Presentation Practice interview
Practice interview based on content from weeks 1-8
10% Multiple weeks 10 minutes
Outcomes assessed: LO1 LO5 LO4
Small continuous assessment Guest lecture task
Report on one of the guest lecture tasks
15% Multiple weeks 3-4 pages
Outcomes assessed: LO4 LO1
Tutorial quiz Tutorial quizzes
5 MCQs applying the week's lecturette content
15% Ongoing 5 minutes
Outcomes assessed: LO1 LO4 LO2
Presentation Weekly tutorial challenge presentation
End-of-tutorial group presentation on topic-specific challenge
5% Ongoing 5 minutes
Outcomes assessed: LO1 LO3
Assignment Week 4 checkpoint
Evidence of successful connection with necessary industry experts
5% Week 04
Due date: 20 Aug 2024 at 23:59
_
Outcomes assessed: LO6
Assignment Week 7 checkpoint
Evidence of having expanded on knowledge via comms with industry
5% Week 07
Due date: 10 Sep 2024 at 23:59
_
Outcomes assessed: LO6 LO1 LO4
Assignment Job requirement reflection
Reflection of discussions with industry about employability criteria
15% Week 09
Due date: 24 Sep 2024 at 23:59
3-4 pages
Outcomes assessed: LO4

Assessment summary

  • Tutorial quizzes: 5 MCQs applying the week's lectorial content, to be completed in 10 minutes. Best 5 of 8 quizzes selected for final score of 15%. 
  • Weekly tutorial challenge presentation: Group presentation on topic-specific challenge worked on during tutorial. Best 5 of 8 presentations selected for final score of 5%. 
  • Job requirements reflection report: Students reach out to 2/3 dream companies to discuss expectations of employees within those industries, with a focus on non-technical knowledge (standards, regulations etc). A short 3-4 page reflection report should be written based on key learnings and their impacts on student approaches to industry. Week 4 and week 7 checkpoints will be used to build up to this. 
  • Guest lecture task: Students pick one guest lecture from which they will write a report on an associated activity. Submission will be due one week after the guest lecture. 
  • Practice interview: 10-minute interview run in place of tutorial hours in weeks 10-13, assessing selected content from weeks 1-9. Feedback should be used to work on the final interview. 
  • Final interview: 15-minute interview assessing selected content across the semester. 

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.

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 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.

Support for students

The Support for Students Policy 2023 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 2023. 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

WK Topic Learning activity Learning outcomes
Ongoing Approx. 4 hours per week x 12 = 48 Independent study (48 hr) LO1 LO2 LO3 LO4 LO5
Week 01 Introduction to Biomedical Product Development Lecture (4 hr) LO1
Week 02 Discovery and concept Lecture and tutorial (4 hr) LO1 LO2 LO3
Week 03 Pre-clinical research Lecture and tutorial (4 hr) LO1 LO2 LO3
Week 04 Clinical trials phase I and II Lecture and tutorial (4 hr) LO1 LO2 LO3
Week 05 Clinical trials phase III and IV Lecture and tutorial (4 hr) LO1 LO2 LO3
Week 06 Device trials Lecture and tutorial (2 hr) LO1 LO2
Week 07 Standards, quality control processes and failure mode analyses Lecture and tutorial (4 hr) LO1 LO2 LO3 LO4
Week 08 Ethical considerations Lecture and tutorial (4 hr) LO1 LO3
Week 09 Revision Tutorial (2 hr) LO1 LO2 LO3
Week 10 Guest lecture Lecture (2 hr) LO1 LO4
Week 11 Guest lecture Lecture (2 hr) LO1 LO4
Week 12 Guest lecture Lecture (2 hr) LO1 LO4
Week 13 Guest lecture Lecture (2 hr) LO1 LO4

Attendance and class requirements

At least 3 out of 4 guest lectures running between weeks 10-13 must be attended in order to sit for the final interview. Non-fulfilment of the guest lecture attendance requirements would result in forfeiture of the "Final interview (30%)" assessment and subsequently the grades associated with the assessment.

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.

Required readings

Recommended (but not mandatory): 

Yock, Zenios, S. A., Makower, J., Brinton, T. J., Kumar, U. N., Watkins, F. T. J., Denend, L., & Krummel, T. M. (2015). Biodesign : the process of innovating medical technologies. (Yock, S. A. Zenios, J. Makower, T. J. Brinton, U. N. Kumar, F. T. J. Watkins, & T. M. Krummel, Eds.; Second edition / editors, Paul G. Yock, Stefanos Zenios, Joshua Makower, Todd J. Brinton, Uday N. Kumar, F.T. Jay Watkins ; principal writer, Lyn Denend ; specialty editor, Thomas M. Krummel ; web editor, Christina Q. Kurihara.). Cambridge University Press.

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. 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 non-technical elements in the biomedical product industry
  • LO5. Be able to effectively communicate knowledge in an interview and within a job environment
  • LO6. Be able to connect with, and learn from, a variety of industry experts

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

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

Slight change to weighting in order to reflect difficulty of assessments. Slight change in layout to consider that midsem break falls after week 9 instead of last year week 8. Adding more guest lectures focusing on important aspects of the development chain not included last year.

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.