Note: This unit version is currently under review and is subject to change!

BMET9990: Biomedical Product Development (2019 - Semester 1)

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Unit: BMET9990: Biomedical Product Development (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:
Campus: Camperdown/Darlington
Pre-Requisites: None.
Prohibitions: AMME4990 OR BMET4990 OR AMME5990 OR AMME9990.
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: 1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-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: BMET9990 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. (4) Design (Level 4)
Developed through private study associated with the lecture material.
Developed through the scheduled seminars.
(6) Communication and Inquiry/ Research (Level 4)
Developed through the group project activities. (7) Project and Team Skills (Level 4)
Developed through the lecture material. (8) Professional Effectiveness and Ethical Conduct (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.

(7) Project and Team Skills (Level 4)
1. Ability to work in a team to develop a plan for progressing a biomedical discovery to initial clinical testing
(8) Professional Effectiveness and Ethical Conduct (Level 4)
2. A broad understanding of biomedical product development within the regulatory framework including:Developing manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice (ISO-14385)
(2) Engineering/ IT Specialisation (Level 3)
3. Understanding of the role of progressive preclinical and clinical testing and their dependence on product of increasing quality.
(3) Problem Solving and Inventiveness (Level 4)
4. Understand how to evaluate a case study on a biomedical development failure to determine contributing inadequacies in product testing, design or quality control.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 In session exam 1 No 20.00 Week 6 2, 3, 4,
2 Project Yes 25.00 Week 8 1, 2, 3,
3 Essay No 25.00 Week 11 2, 3, 4,
4 In session exam 2 No 20.00 Week 12 2, 3, 4,
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
  • Drugs form discovery to approval

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 (Accelerated) (Biomedical) 2019, 2020
Master of Professional Engineering (Biomedical) 2019, 2020
Master of Engineering 2019, 2020

Course Goals

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

Attribute Practiced Assessed
(7) Project and Team Skills (Level 4) Yes 12.5%
(8) Professional Effectiveness and Ethical Conduct (Level 4) Yes 32.25%
(6) Communication and Inquiry/ Research (Level 4) Yes 0%
(4) Design (Level 4) Yes 0%
(2) Engineering/ IT Specialisation (Level 3) No 32.25%
(3) Problem Solving and Inventiveness (Level 4) No 23%

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.