The University of Sydney - Engineering

Unit:	AMME9990: Biomedical Engineering Technology 1 (6 CP)
Mode:	Normal-Day
On Offer:	Yes
Level:	Postgraduate
Faculty/School:	School of Aerospace, Mechanical & Mechatronic Engineering
Unit Coordinator/s:	A/Prof Dunstan, Colin
Session options:	Semester 1
Versions for this Unit:	2018 - Semester 1 2017 - Semester 1 2016 - Semester 1 2015 - Semester 1 Go

Campus:	Camperdown/Darlington
Pre-Requisites:	None.
Prohibitions:	AMME5990.
Brief Handbook Description:	Elective Unit of Study: 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. The objectives are: 1. To gain a broad understanding of biomedical product development within the regulatory framework. 2. To understand the challenges and difficulties of Good Manufacturing Practice. 3. Understand the purpose and conduct of preclinical and clinical testing. 4. To understand how each of these components fit together to support regulatory filings.
Assumed Knowledge:	Junior level chemistry, intermediate level biology, and specific knowledge of cell biology at least at the junior level, and preferably at the intermediate level.
Additional Notes:	The primary teaching delivery method will be lectures. This UoS builds on the assumed knowledge of engineering principles and junior and intermediate biology. The purpose of this UoS is prepare students for the challenges presented in taking innovative ideas and successfully converting them to valuable products.

Lecturer/s:	A/Prof Dunstan, Colin
Timetable:	AMME9990 Timetable
Time Commitment:	# Activity Name Hours per Week Sessions per Week Weeks per Semester 1 Lecture 2.00 1 13 2 Tutorial 2.00 1 13 3 Project Work - own time 4.00 1 13
T&L Activities:	Lectures: Practical Work:

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method	Attribute Developed
Developed through the group project activities.	Design (Level 4)
Developed through private study associated with the lecture material.	Information Seeking (Level 4)
Developed through the scheduled seminars.	Communication (Level 4)
Developed through the lecture material.	Professional Conduct (Level 4)
Developed through the group project activities.	Project and Team Skills (Level 4)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table 2018.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

Design (Level 4)
Engineering/IT Specialisation (Level 3)
Professional Conduct (Level 4)
Project and Team Skills (Level 4)

Assessment Methods:	# Name Group Weight Due Week Outcomes 1 In session exam 1 No 20.00 Week 6 1, 2, 3, 2 Project Yes 25.00 Week 8 2, 3, 4, 3 Essay No 25.00 Week 11 1, 2, 3, 4 In session exam 2 No 20.00 Week 12 1, 2, 3, 5 Presentation and lead discussion No 10.00 Multiple Weeks 1, 2, 3, 4,
Grading:	Grade Type Description Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at http://sydney.edu.au/policies . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures:	See the policies page of the faculty website at http://sydney.edu.au/engineering/student-policies/ for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.

Recommended Reference/s:

Note: References are provided for guidance purposes only. Students are advised to consult these books in the university library. Purchase is not required. Development of FDA regulated medical products Title: Development of FDA regulated medical products Author/s: Elaine Whitmore ISBN: 0-87389-613-0 Edition: 1st Publisher: ASQ, Quality Press Publish Year: 2004 Publish Location: Milwaukee Note: In library Drugs form discovery to approval Title: Drugs form discovery to approval Author/s: Rick Ng ISBN: 978-0470-10510-9 Edition: 2nd Publisher: John Wiley & Sons Inc Publish Year: 2009 Publish Location: New Jersey Note: In Library

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar https://web.timetable.usyd.edu.au/calendar.jsp

Week	Description
Week 1	Introduction to the themes in product development
Week 2	The Regulatory Environment
Week 3	Concept to initial validation
Week 4	Good Manufacturing Practice – initial process design
Week 5	Good Manufacturing Practice – building a robust process
Week 6	Initial proof of principle studies (in vitro and in vivo)
	Assessment Due: In session exam 1
Week 7	Detailed validation of biological activity in animals
Week 8	Product distribution, clearance and degradation studies
	Assessment Due: Project
Week 9	Safety/toxicology studies
Week 10	Clinical Phase 1 Safety in humans
Week 11	Clinical Phase 2 Safety, Biological activity, dose ranging
	Assessment Due: Essay
Week 12	Clinical Phase 3 Safety and clinical benefit
	Assessment Due: In session exam 2
Week 13	Phase 4 post-approval, making changes.

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course	Year(s) Offered
Master of Professional Engineering (Biomedical)	2015, 2016, 2017, 2018
Master of Engineering (2024 and earlier)	2015, 2016, 2017, 2018

---

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute	Practiced	Assessed
Design (Level 4)	Yes	23%
Engineering/IT Specialisation (Level 3)	No	32.25%
Information Seeking (Level 4)	Yes	0%
Communication (Level 4)	Yes	0%
Professional Conduct (Level 4)	Yes	32.25%
Project and Team Skills (Level 4)	Yes	12.5%
Maths/Science Methods and Tools (Level 3)	No	0%

These goals are selected from Engineering & IT Graduate Outcomes Table 2018 which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table 2018 for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.