BMET9990: Semester 2, 2022

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Units BMET9990 Semester 2 2022 [Normal day]

Unit of study_

BMET9990: Biomedical Product Development

Semester 2, 2022 [Normal day] - Remote

Overview

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

Unit code	BMET9990
Academic unit	Biomedical Engineering
Credit points	6
Prohibitions ?	BMET3990 or AMME4990 or BMET4990 or AMME5990 or AMME9990
Prerequisites ?	None
Corequisites ?	None
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)	Final exam Short + extended answer paper	25%	Formal exam period	24 hours
Outcomes assessed:
Tutorial quiz	Pre-tutorial quizzes 10 MCQs in 10 minutes	5%	Multiple weeks	10 minutes
Outcomes assessed:
Participation	Participation A variety of options will be given to show participation in activities	5%	Ongoing	_
Outcomes assessed:
Tutorial quiz	Mid-semester checkpoint test 30 MCQs in 30 minutes	15%	Week 06	30 minutes
Outcomes assessed:
Presentation	Pre-clinical plan Group presentation on a pre-clinical plan for biomedical product	15%	Week 09	15 minutes
Outcomes assessed:
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:
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:
= group assignment ? = 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 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.

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

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

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.

Outcomes
Graduate qualities

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
Learning outcomes

Responding to student feedback

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.

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

Responding to student feedback

Responding to student feedback

Disclaimer

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