Note: This unit is an archived version! See Overview tab for delivered versions.
AMME9990: Biomedical Engineering Technology 1 (2018 - Semester 1)
| 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
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| Session options: | Semester 1 |
| Versions for this Unit: |
| 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
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| Timetable: | AMME9990 Timetable | ||||||||||||||||||||
| Time Commitment: |
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| 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)
1. Understand how to evaluate a case study on a biomedical development failure to determine contributing inadequacies in product testing, design or quality control.
Engineering/IT Specialisation (Level 3)
2. Understanding of the role of progressive preclinical and clinical testing and their dependence on product of increasing quality.
Professional Conduct (Level 4)
3. 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)
Project and Team Skills (Level 4)
4. Ability to work in a team to develop a plan for progressing a biomedical discovery to initial clinical testing
| Assessment Methods: |
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| Grading: |
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| 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.
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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 (including Grad Cert & Grad Dip) | 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.
