BMET4990: Semester 1, 2020

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Units BMET4990 Semester 1 2020 [Normal day]

Unit of study_

BMET4990: Biomedical Product Development

Semester 1, 2020 [Normal day] - Camperdown/Darlington, Sydney

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	BMET4990
Academic unit	Biomedical Engineering
Credit points	6
Prohibitions ?	AMME4990
Prerequisites ?	MECH2901 OR BMET2901
Corequisites ?	None
Assumed knowledge ?	1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level.
Available to study abroad and exchange students	Yes

Teaching staff

Coordinator	Colin Dunstan, colin.dunstan@sydney.edu.au

Type	Description	Weight	Due	Length
Presentation	Presentation and discussion	10%	Multiple weeks	n/a
Outcomes assessed:
In-semester test	Exam 1 Short answer online open book exam	20%	Week 06	60 minutes
Outcomes assessed:
Presentation	Project	25%	Week 08	n/a
Outcomes assessed:
Assignment	Essay	25%	Week 11	2000 words
Outcomes assessed:
In-semester test	Exam 2 Short answer online open book exam	20%	Week 12	60 minutes
Outcomes assessed:

Assessment summary

Exams: Open book exam on course material.
Assignment: Students are required to submit an assignment on a product development issue.
Presentation: Group presentation on preclinical and phase I clinical trial development for a drug or device.
Presentation and discussion: Individual presentation and discusssion of a published paper describing a biomedical discovery or technical advance.

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.

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	Product development and the regulatory environment	Online class (4 hr)
Week 02	Initial proof of principle studies	Online class (4 hr)
Week 03	Determining how medical products are distributed, degraded and cleared	Online class (4 hr)
Week 04	Determining medical product safety	Online class (4 hr)
Week 05	Good manufacturing practice	Online class (4 hr)
Week 06	Good manufacturing practice	Online class (4 hr)
Week 07	Clinical Phase 1: safety in humans	Online class (4 hr)
Week 08	Clinical phase 2: safety, biological activity and dose ranging	Online class (4 hr)
Week 09	Clinical phase 3: safety and clinical benefit	Online class (4 hr)
Week 10	Clinical phase 4: post-approval and making changes	Online class (4 hr)
Week 11	Challenges in the development of gene therapy products	Online class (4 hr)
Week 12	Challenges in the development of stem cell based medical products	Online class (4 hr)
Week 13	Testing of materials for use in devices	Online class (4 hr)

Attendance and class requirements

It is expected that students will attend and particpate in the tutorials. Lecture will be recorded but students are encouraged to attend the lectures. There will be a group presentation project. There will be some time provided in the tutorial sessions to work on this project but some time commitment outside the tutorial times is expected.

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

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. demonstrate expertise in working in a team environment to develop a medical product concept and a plan for its implementation in conformity with regulatory guidelines
LO2. demonstrate a broad understanding of biomedical product development within the regulatory framework
LO3. present a complex plan for development of a drug or medical device to initial testing in human subjects
LO4. understand the purpose and conduct of preclinical and clinical testing
LO5. develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice.

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.

The tutorial sessions will be developed to encourage more preparation and contribution by the students

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

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Disclaimer

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