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Unit outline_

BMET9990: Biomedical Product Development

Semester 2, 2022 [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
Type Description Weight Due Length
Final exam (Take-home short release) Type D final exam Final exam
Short + extended answer paper
25% Formal exam period 24 hours
Outcomes assessed: LO1 LO2
Tutorial quiz Pre-tutorial quizzes
10 MCQs in 10 minutes
5% Multiple weeks 10 minutes
Outcomes assessed: LO1 LO2
Participation Participation
A variety of options will be given to show participation in activities
5% Ongoing _
Outcomes assessed: LO3 LO2 LO1
Tutorial quiz Mid-semester checkpoint test
30 MCQs in 30 minutes
15% Week 06 30 minutes
Outcomes assessed: LO1 LO2
Presentation group assignment Pre-clinical plan
Group presentation on a pre-clinical plan for biomedical product
15% Week 09 15 minutes
Outcomes assessed: LO3 LO1 LO2
Assignment Technology entrepreneurship report
A short report on the additional challenges faced by entrepreneurs
10% Week 12
Due date: 23 Oct 2022 at 23:59
2 pages
Outcomes assessed: LO1 LO2 LO5
Assignment Biomedical product failure/withdrawal analysis
Report analysing a drug or device failure and withdrawal
25% Week 13
Due date: 30 Oct 2022 at 23:59
2000 words (+/- 10%)
Outcomes assessed: LO1 LO4 LO2
group assignment = group assignment ?
Type D final exam = Type D final exam ?

Assessment summary

  • Participation: Variety of options to show active participation in tutorials and unit in general 
  • Pre-clinical plan: Group presentation by tutorial groups with each student participating describing the pre-clinical program for a novel device or drug concept in Week 9
  • Technology entrepreneurship report: A short report discussing and reflecting on the additional challenges faced by an entrepreneur when trying to get a biomedical product to market.
  • Biomedical product failure/withdrawal analysis: Description and analysis of a drug or device withdrawal or recall (ie what happened???), 2000+/-10% words due in week 12
  • Mid-semester checkpoint quiz: Scenario-based/application MCQs based on content from weeks 1-5.
  • Final exam: 24-hour extended release exam requiring short-extended answers

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
Week 01 Introduction to Biomedical Product Development Lecture (2 hr) LO1 LO2
Week 02 Discovery and concept Lecture and tutorial (4 hr) LO1 LO2
Week 03 Pre-clinical research Lecture and tutorial (4 hr) LO1 LO2
Week 04 Clinical trials phase I and II Lecture and tutorial (4 hr) LO1 LO2
Week 05 Clinical trials phase III and IV Lecture and tutorial (4 hr) LO1 LO2
Week 07 Regulatory aspects: Standards, good manufacturing and quality control processes Lecture and tutorial (4 hr) LO1 LO2
Week 08 Ethical considerations Lecture and tutorial (4 hr) LO1 LO2
Week 09 Technology entrepreneurship Lecture (2 hr) LO1 LO2
Pre-clinical plan presentations Tutorial (2 hr) LO1 LO2 LO3
Week 10 Guest lecture Lecture (1.5 hr) LO1 LO2
Week 11 Guest lecture Lecture (1.5 hr) LO1 LO2
Week 13 Revision Tutorial (2 hr) LO1 LO2

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. Understand biomedical product development within the regulatory framework including: developing manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice
  • LO2. Understand the role of progressive preclinical and clinical testing and their dependence on product of increasing quality
  • LO3. Work in a team to develop a plan for progressing a biomedical discovery to initial clinical testing
  • LO4. Understand how to evaluate a case study on a biomedical development failure to determine contributing inadequacies in product testing, design or quality control.
  • LO5. Awareness of the additional challenges associated with entrepreneurship in the realm of biomedical product development

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.

Lecture and tutorial structure changed to cater to the nature and requirements of the cohort based on USS feedback. Assessment weighting changed to allow for gradually more challenging and higher-weight assessments as the semester moves along. Reflective assessments added.

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.