EGB319 Medical Device Design
To view more information for this unit, select Unit Outline from the list below. Please note the teaching period for which the Unit Outline is relevant.
| Unit code: | EGB319 |
|---|---|
| Prerequisite(s): | EGB210 or EGB220 or ENB215 or ENB229 |
| Equivalent(s): | ENB319 |
| Credit points: | 12 |
| Timetable | Details in HiQ, if available |
| Availabilities |
|
| CSP student contribution | $1,164 |
| Domestic tuition unit fee | $4,968 |
| International unit fee | $6,252 |
Unit Outline: Semester 1 2025, Gardens Point, Internal
| Unit code: | EGB319 |
|---|---|
| Credit points: | 12 |
| Pre-requisite: | EGB210 or EGB220 or ENB215 or ENB229 |
| Equivalent: | ENB319 |
| Coordinator: | Devakar Epari | d.epari@qut.edu.au |
Overview
Professional medical engineers work with medical devices at different stages of their life-cycle. Doing so requires specialist understanding of the regulatory requirements for medical devices.
In this unit, you will work together with peers to propose and evaluate designs to address an unmet clinical need. In assuming a team role you will be exposed to the various duties that medical engineers may fulfill in professional practice. The impacts of the regulatory environment on medical device design will be explored as well as the importance of quality and risk management.
EGB319 Medical Device Design builds on EGB210 Fundamentals of Mechanical Design to develop your engineering design skills, with particular emphasis on medical device concept development, EGH435 Modelling and Simulation for Medical Engineers will add quantitative design skills to enable refinement of medical device designs.
Learning Outcomes
On successful completion of this unit you will be able to:
- Evaluate the effectiveness of the mechanical design of specified medical devices at a developed level
- Apply medical and engineering standards in mechanical design of medical devices and systems, at a developed level
- Communicate engineering procedures and methodologies used for mechanical design of medical devices through documentation, at a developed level.
- Actively participate in effective engineering teamwork for mechanical design of medical devices including project management, at a developed level.
Content
Medical Device Product Development Process
- Biodesign - Need selection and concept development
- Regulatory Requirements for Medical Devices
- Quality Management and Design Control
- Risk Management for Medical Devices
- Useability Engineering for Medical Devices
- Design/testing/prototyping/production cycle;
- Design for Manufacture and Assembly
Engineering Professional Skills
- Teamwork
- Project and self-management
- Written Communication in Engineering Design
This unit will include content, case studies and examples of the ways in which the work of professional engineers connects to Aboriginal and Torres Strait Islander people’s status as First Nations owners of land and seas. This may include:
- connection with regulatory requirements such as the Cultural Heritage duty of care required under the Queensland Aboriginal Cultural Heritage Act 2005, or
- engineering industry partners who have an organisational commitment through Reconciliation Actions Plans which bring responsibilities to engineers working with them.
Learning Approaches
This unit features experiential project-based learning approaches
- A time-tabled "Studio" will provide an opportunity for face-to-face work with your peers and to engage with the Teaching Team.
- To complement timetabled activities you will be provided with other learning resources (e.g. videos, readings, project management tools) that you can access flexibly to complete your learning in this unit.
You are expected to
- View of all learning materials in a timely manner
- engage with your peers, preferably face-to-face, to develop medical device concepts
- provide leadership to your team with respect to your assumed team role
- document your individual work in a design journal including critical reflections
Feedback on Learning and Assessment
Formative Feedback
- Your team will receive formative feedback on the progress of your design during the design studio via discussions with the Teaching Team
- You will receive feedback on your portfolio mid-semester
Summative Feedback
Each assessment submission will be marked against criteria and standards which be shared with you at the beginning of the semester through Assessment Task Descriptions and Marking Rubrics. Marked assessment will include feedback from markers against the criteria.
Assessment
Overview
Assessment in this unit has been designed to give you the opportunity to show your learning against the unit learning outcomes.
As a team you will undertake a Project to design a medical device. An oral presentation will assess your ability to communicate key aspects of the design, A Technical File (or design dossier) will capture your ability to document a regulated design process according to industry norms and Design Report will assess your ability evaluate and critique your proposed design. A peer assessment of teamwork will assess your participation, contribution and leadership to the project.
You will keep and submit a Portfolio or individual design journal that captures your engagement with the learning resources and their application to the design project. Higher level learning is exhibited in reflections on aspects of the design process and professional competences such as teamwork and self-management.
Unit Grading Scheme
7- point scale
Assessment Tasks
Assessment: Design Project
You work work collaboratively in defined roles to propose and evaluate medical device concepts to address an unmet clinical need.
This is an assignment for the purposes of an extension.
Assessment: Design Journal
You will document your engagement with the Learning Resources and their application in your individual contributions to the Design Project. In addition, you will reflect on the application of design tools as well as the application of strategies to address issues in teamwork and project/self-management.
This is an assignment for the purposes of an extension.
Academic Integrity
Academic integrity is a commitment to undertaking academic work and assessment in a manner that is ethical, fair, honest, respectful and accountable.
The Academic Integrity Policy sets out the range of conduct that can be a failure to maintain the standards of academic integrity. This includes, cheating in exams, plagiarism, self-plagiarism, collusion and contract cheating. It also includes providing fraudulent or altered documentation in support of an academic concession application, for example an assignment extension or a deferred exam.
You are encouraged to make use of QUT’s learning support services, resources and tools to assure the academic integrity of your assessment. This includes the use of text matching software that may be available to assist with self-assessing your academic integrity as part of the assessment submission process.
Breaching QUT’s Academic Integrity Policy or engaging in conduct that may defeat or compromise the purpose of assessment can lead to a finding of student misconduct (Code of Conduct – Student) and result in the imposition of penalties under the Management of Student Misconduct Policy, ranging from a grade reduction to exclusion from QUT.
Resources
You are required to use the following:
- The unit website on QUT's Canvas (learning materials that support timetabled activities and assessment tasks)
- QUT Library Databases
- QUT Cite| Write: You can access QUT cite/write online (Free download from QUT library)
Resource Materials
Recommended text(s)
Elahi, Safety Risk Management for Medical Devices
Ogrodnik, Medical Device Design - innovation from concept to market, 2nd Edition
Zenious, Makower, Yock, Biodesign - The process of innovating medical technologies, 2nd Edition
Risk Assessment Statement
You will be informed of any requirements pertaining to a safe workplace. In lectures, tutorials and such, the information will include location of fire exits and meeting points in case of fire. If you do not follow legitimate instructions or endanger the safety of others or do not act in accordance with the requirements of the Workplace Health and Safety Act, you will be required to leave the session.
Standards/Competencies
This unit is designed to support your development of the following standards\competencies.
Engineers Australia Stage 1 Competency Standard for Professional Engineer
1: Knowledge and Skill Base
Relates to: Design Project
Relates to: Design Project
Relates to: Design Project
2: Engineering Application Ability
Relates to: Design Project, Design Journal
Relates to: Design Project, Design Journal
Relates to: Design Project
Relates to: Design Project, Design Journal
3: Professional and Personal Attributes
Relates to: Design Project
Relates to: Design Project
Relates to: Design Project, Design Journal
Relates to: Design Project
Relates to: Design Project, Design Journal
Relates to: Design Project, Design Journal
Course Learning Outcomes
This unit is designed to support your development of the following course/study area learning outcomes.EN01 Bachelor of Engineering (Honours)
- Make decisions ethically within the social, cultural, and organisational contexts of professional engineering practice.
Relates to: Design Project - Engage stakeholders professionally and communicate the outcomes of your work effectively to expert and non-expert audiences using appropriate modes.
Relates to: Design Project - Display leadership, creativity, and initiative in both self-directed and collaborative contexts of professional engineering practice.
Relates to: Design Project, Design Journal - Manage projects to solve complex engineering problems, using appropriate information, engineering methods, and technologies.
Relates to: Design Project, Design Journal - Deploy appropriate approaches to engineering design and quality.
Relates to: Design Project - Engage with and apply regulatory requirements relating to safety, risk management, and sustainability in professional engineering practice.
Relates to: Design Project - Demonstrate a thorough understanding of one engineering discipline, its research directions, and its application in contemporary professional engineering practice.
Relates to: Design Project