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Unit of study_
BMET3990: Biomedical Product Development
2024 unit information
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
Managing faculty or University school:
Biomedical Engineering
| Code | BMET3990 |
|---|---|
| Academic unit | Biomedical Engineering |
| Credit points | 6 |
|
Prerequisites:
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MECH2901 or BMET2901 or [(MEDS2005 or MEDS1002 or ANAT2011) and (MEDS2001 or PHSI2007)] |
|---|---|
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Corequisites:
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None |
| Prohibitions:
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AMME4990 or BMET4990 or AMME9990 or BMET9990 |
| Assumed knowledge:
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1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level |
At the completion of this unit, you should be able to:
- LO1. Demonstrate a broad understanding of the series of events and key considerations that occur from the formulation of a biomedical product concept to its release into the market.
- LO2. Appreciate the similarities and differences between the device and pharmaceutical product development process
- LO3. Demonstrate expertise in working in a team environment to troubleshoot problems that occur during the product development process
- LO4. Understand the importance of standards, regulations, quality control processes, asset management, failure mode analyses, ethics and other non-technical elements in the biomedical product industry
- LO5. Be able to effectively communicate knowledge in an interview and within a job environment
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
| Session | MoA ? | Location | Outline ? |
|---|---|---|---|
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Semester 2 2024
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Normal day | Camperdown/Darlington, Sydney |
Outline unavailable
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Modes of attendance (MoA)
This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.
