Note: This unit is an archived version! See Overview tab for delivered versions.
AMME4990: Biomedical Product Development (2018 - Semester 1)
| Unit: | AMME4990: Biomedical Product Development (6 CP) |
| Mode: | Normal-Day |
| On Offer: | Yes |
| Level: | Senior Advanced |
| 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: | MECH2901 AND MECH3921. |
| 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. |
| 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. |
| Lecturer/s: |
A/Prof Dunstan, Colin
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| Timetable: | AMME4990 Timetable | ||||||||||||||||||||
| Time Commitment: |
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| T&L Activities: | Tutorial: Tutorials will be used for discussion of case studies illustrating drug and medical device development issues, and for the preparation of a group presentation of a development plan for an investigational new drug application. Independent Study: 4-5 hours per week outside of formal contact hours will be needed in order to successfully complete assignments and study. |
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 |
| To gain a broad understanding of biomedical product development within the regulatory framework. | Engineering/IT Specialisation (Level 3) |
| Understanding the purpose and conduct of pre-clinical and clinical testing. | Information Seeking (Level 4) |
| Spoken communication skills will be developed through the scheduled seminars. | Communication (Level 4) |
| Ability to develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice. | Professional Conduct (Level 4) |
| Teamwork and project management skills will be 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.
Professional Conduct (Level 4)
1. Understand the purpose and conduct of preclinical and clinical testing.
2. Achieve broad understanding of biomedical product development within the regulatory framework.
Design (Level 4)
3. Ability to develop 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 present a complex plan for development of a drug or medical device to initial testing in human subjects
5. Expertise in working in a team environment to develop a medical product concept and a plan for its implementation in conformity with regulatory guidelines
| Assessment Methods: |
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| Assessment Description: |
Assignment: Assignment on a product development issue. In session exams: 30 minute open-book exam/quiz on course material. Presentation/Seminar: 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 |
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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 and the regulatory environment. |
| Week 2 | Initial proof of principle studies (in vitro and in vivo) (pharmacology of medical products). |
| Week 3 | Determining how medical products are distributed, degraded and cleared (pharmacokinetics). |
| Week 4 | Determining medical product safety (toxicology) |
| Week 5 | Good Manufacturing Practice – building a robust process. |
| Week 6 | Good Manufacturing Practice – the importance of risk analysis and quality control |
| Assessment Due: In session exam 1 | |
| Week 7 | Clinical Phase 1 Safety in humans. |
| Week 8 | Clinical Phase 2 Safety, Biological activity, dose ranging. |
| Assessment Due: Presentation/Seminar | |
| Week 9 | Clinical Phase 3 Safety and clinical benefit. |
| Week 10 | Phase 4 post-approval, making changes. |
| Week 11 | Challenges in the development of gene therapy products |
| Assessment Due: Assignment | |
| Week 12 | Challenges in the development of stem cell based medical products |
| Assessment Due: In session exam 2 | |
| Week 13 | Visiting lecturer on testing of materials for use in devices |
Course Relations
The following is a list of courses which have added this Unit to their structure.
Course Goals
This unit contributes to the achievement of the following course goals:
| Attribute | Practiced | Assessed |
| Professional Conduct (Level 4) | Yes | 50.67% |
| Communication (Level 4) | Yes | 0% |
| Design (Level 4) | No | 25.33% |
| Project and Team Skills (Level 4) | Yes | 24% |
| Maths/Science Methods and Tools (Level 4) | No | 0% |
| Engineering/IT Specialisation (Level 3) | Yes | 0% |
| Information Seeking (Level 4) | Yes | 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.
