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Unit outline_

BMET4990: Biomedical Product Development

Semester 1, 2020 [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
? 
MECH2901 OR BMET2901
Corequisites
? 
None
Prohibitions
? 
AMME4990
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: LO1 LO5 LO4 LO3 LO2
In-semester test Exam 1
Short answer online open book exam
20% Week 06 60 minutes
Outcomes assessed: LO2 LO5 LO4 LO3
Presentation Project
25% Week 08 n/a
Outcomes assessed: LO1 LO2 LO3 LO4 LO5
Assignment Essay
25% Week 11 2000 words
Outcomes assessed: LO2 LO4 LO5
In-semester test Exam 2
Short answer online open book exam
20% Week 12 60 minutes
Outcomes assessed: LO2 LO5 LO4 LO3

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 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 Product development and the regulatory environment Online class (4 hr) LO2 LO3
Week 02 Initial proof of principle studies Online class (4 hr) LO1 LO2 LO3 LO5
Week 03 Determining how medical products are distributed, degraded and cleared Online class (4 hr) LO1 LO2 LO3 LO4 LO5
Week 04 Determining medical product safety Online class (4 hr) LO1 LO2 LO3 LO4 LO5
Week 05 Good manufacturing practice Online class (4 hr) LO1 LO2 LO3 LO5
Week 06 Good manufacturing practice Online class (4 hr) LO1 LO2 LO3 LO5
Week 07 Clinical Phase 1: safety in humans Online class (4 hr) LO1 LO2 LO3 LO4
Week 08 Clinical phase 2: safety, biological activity and dose ranging Online class (4 hr) LO1 LO2 LO3 LO4
Week 09 Clinical phase 3: safety and clinical benefit Online class (4 hr) LO2 LO3 LO4
Week 10 Clinical phase 4: post-approval and making changes Online class (4 hr) LO2 LO4
Week 11 Challenges in the development of gene therapy products Online class (4 hr) LO2 LO4
Week 12 Challenges in the development of stem cell based medical products Online class (4 hr) LO2 LO3 LO4 LO5
Week 13 Testing of materials for use in devices Online class (4 hr) LO2 LO3 LO5

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 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 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
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

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.