Course coordinator
Dr Alejandro Melendez-Calderon
Course overview
- Study period
- Semester 1, 2025 (24/02/2025 - 21/06/2025)
- Study level
- Undergraduate
- Location
- St Lucia
- Attendance mode
- In Person
- Units
- 2
- Administrative campus
- St Lucia
- Coordinating unit
- Elec Engineering & Comp Science School
This course is aimed at exposing engineering students to the innovation and development processes around medical devices. It aims at covering aspects in system engineering and design principles, medical device regulation, quality manufacturing systems, biomedical engineering ethics, and clinical validation. Students will also gain an appreciation on general working principles (engineering subsystems and associated biophysical processes) of selected medical devices across different risk categorization levels (Class-I-III), and current research trends.
This course will provide detailed coverage of the engineering aspects of medical devices. Key topics include:
- ﾠﾠﾠ Definition and categorisation of medical devices
- ﾠﾠﾠ Medical device innovation and product development cycle
- ﾠﾠﾠ Medical device regulations and certification
- ﾠﾠﾠ Ethical and safety considerations in medical devices
- ﾠﾠﾠ Engineering aspects of medical devices (Class I-Class III/AIMD)
- ﾠﾠﾠ Software, digital health and mobile apps as medical devices
- ﾠﾠﾠ Integration of medical devices and data management & utilisation in the modern hospital environment
Both current practice and research perspectives will be examined.
Invited lectures from relevant stakeholders (e.g. clinicians, patients, industry representatives) are organized. These activities are designed to expose students to medical device engineering and medical devices "in practice".
Students are expected to work on a team project, but also to conduct independent study and research to (i) prepare for scheduled sessions, and (ii) to deliver assessment items in the form of reports and presentations.
Course requirements
Assumed background
This is a level 6 course, and a solid engineering background in either Electrical, Mechanical or Chemical Engineering is required to succeed in this course. You will apply your engineering knowledge and practical skills (eg. signal processing, CAD, instrumentation, experimental design, programming, etc), to design and prototype a medical device. An interest in medical applications of engineering is essential.
Some introductory background in human biology, physiology and pathophysiology is useful preparation for course materials; and if you have not previously studied these materials you need a commitment and willingness to learn these topics on your own.
Prerequisites
You'll need to complete the following courses before enrolling in this one:
BIOE3001
Incompatible
You can't enrol in this course if you've already completed the following:
ELEC7901
Course contact
Course staff
Lecturer
Dr Alejandro Melendez-Calderon
Timetable
The timetable for this course is available on the UQ Public Timetable.
Additional timetable information
This course is designed to encourage live discussions during scheduled class time. Their format is designed for students to learn the most through interaction with the lecturer, demonstrators and colleagues during these live sessions. As such, students are highly encouraged to attend to the 4-hours of scheduled classes each week.ﾠ
Irrespective of how they are labelled in the timetable (WKS), sessions will include a mix of lecture, workshop and discussion style activities. It is expected that you attend each session ready and prepared to actively contribute to the class.
Invited lectures and Field trips will be organized during these scheduled sessions. Information about upcoming activities will be announced via Blackboard. Information will be provided well in advance to assist in scheduling, in case these activities fall outside scheduled classes.
UQ student policy expects that students spend 10-12 hours per week for each course to achieve a PASS grade. As such, students should plan to spend a minimum of 6-hrs of further self-study and research per week outside of scheduled class time. Students who want to achieve higher grades should anticipate spending much more time.
Aims and outcomes
This course is aimed at exposing engineering students to the innovation and development processes around medical devices. It aims at covering aspects in system engineering and design principles, medical device regulation, quality manufacturing systems, biomedical engineering ethics, and clinical validation. Students will also gain an appreciation onﾠgeneral working principles (engineering subsystems and associated biophysical processes) of selected medical devices across different risk categorization levels (Class-I-III), and current research trends.
Learning outcomes
After successfully completing this course you should be able to:
LO1.
Analyse and evaluate medical devices by identifying their medical need, value proposition, underlying medical condition, existing and emerging solutions, and operating principles, while assessing the technical basis of their functionality and subsystem integration.
LO2.
Critically investigate and evaluate medical devices by appraising their intended purpose, efficacy & efficiency in treating or diagnosing medical conditions, technical sub-components, safety risks and limitations, ethical considerations, and research directions.
LO3.
Apply specialized engineering knowledge and practices to ideate, design, prototype, and develop a medical device, including the identification of user needs, translation into technical requirements, validation and verification, application of relevant standards, and effective documentation practices to ensure compliance with Quality Management Systems.
LO4.
Explain in detail, the innovation and product development cycle of medical devices, including considerations for compliance with regulatory agencies and international standards across different classifications.
LO5.
Communicate effectively, both orally and in writing, the purpose, operation, technical functionality, regulatory considerations, and research directions of selected medical devices to technical, clinical, and lay audiences.
LO6.
Demonstrate the ability to implement professional engineering principles while effectively collaborating in a multi-disciplinary team, showing respect for diverse ideas, work styles, and backgrounds.
LO7.
Appraise and provide constructive feedback to peers’ work by employing a SPARK (Specific, Prescriptive, Actionable, Referenced and Kind) approach.
Assessment
Assessment summary
| Category | Assessment task | Weight | Due date |
|---|---|---|---|
| Participation/ Student contribution, Reflection |
1. Individual engagement and participation
|
10% |
Week 1 Wed - Week 13 Fri
Assessed throughout semester (see Task description) |
| Paper/ Report/ Annotation, Presentation |
2. Investigation on a medical condition & device
|
30% |
Presentations W4: 19/03 & 21/03 Final submission 7/04/2025 4:00 pm Peer-review session 16/04/2025 |
| Project |
3. Team Project
|
60% |
Milestone 1 (formative) 2/04/2025 - 4/04/2025 Milestone 2 (formative) 2/05/2025 Milestone 3 (final deliverables, summative) 30/05/2025 Milestone 3 (exhibition/examination, summative) 14/06/2025 - 21/06/2025
M1 and M2 deliverables are due by the start of the corresponding session of the respective Milestone week. M3 deliverables are due by the start of the Friday session. All milestones require a peer-assessment factor, which is meant to be submitted by the end of the Friday session, of the respective Milestone week. |
A hurdle is an assessment requirement that must be satisfied in order to receive a specific grade for the course. Check the assessment details for more information about hurdle requirements.
Assessment details
1. Individual engagement and participation
- Hurdle
- In-person
- Mode
- Activity/ Performance
- Category
- Participation/ Student contribution, Reflection
- Weight
- 10%
- Due date
Week 1 Wed - Week 13 Fri
Assessed throughout semester (see Task description)
- Learning outcomes
- L01, L04, L05, L06, L07
Task description
This course is intended to be dynamic and full of workshop-style activities. 10% of your final grade is based on engagement & participation.
All students are expected to attend and participate on the following scheduled sessions:
- Week 4 (Wednesday and Friday sessions) - Individual short presentations -> 20/100 marks
- Week 8 (Wednesday session) - Peer-review / feedback session on Individual Investigation -> 30/100 marks
If for extraordinary reasons you are unable to attend these specific sessions, you must seek alternative arrangements via approaching the course coordinator, to make sure your Individual engagement and participation does not get affected.
Participation in debates, presentations and activities organized during scheduled class, offline forum discussions in MS teams, project feedback sessions, etc. Teaching staff actively monitor individual participation throughout the semester and are aware of the degree to which students are contributing to the activities and team projects. --> 50/100 marks.
Hurdle requirements
The minimum requirement to pass this course is to achieve 50/100 marks for this component.Submission guidelines
Deferral or extension
You cannot defer or apply for an extension for this assessment.
The evaluation of this item includes participation of in-class activities or offline team discussions. Teaching staff actively monitor individual participation throughout the semester and are aware of the degree to which students are contributing to the the activities and team projects. As there are no submissions per-se for this component, no extensions are permitted. If for extraordinary reasons you are unable to attend these specific sessions, you must seek alternative arrangements via approaching the course coordinator, to make sure your Individual engagement and participation does not get affected.
Late submission
You will receive a mark of 0 if this assessment is submitted late.
2. Investigation on a medical condition & device
- In-person
- Mode
- Activity/ Performance, Oral, Product/ Artefact/ Multimedia, Written
- Category
- Paper/ Report/ Annotation, Presentation
- Weight
- 30%
- Due date
Presentations W4: 19/03 & 21/03
Final submission 7/04/2025 4:00 pm
Peer-review session 16/04/2025
- Other conditions
- Peer assessed.
- Learning outcomes
- L01, L02, L04, L05, L07
Task description
The main learning objective of this activity is for you to gain an in-depth knowledge of a medical device of your choice, and its associated value to the underlying medical condition and healthcare system. Besides the knowledge you will gain from your own investigation, you will learn from investigations of your peers, and they will learn from yours.
In consultation with the course coordinator, students will choose a diagnostic or therapeutic, commercially-available medical device that is currently used in clinical practice.
For assessment, students will deliver two components:
1) A 5-minute video submission reporting their learning outcomes, such as:
- Intended purpose and justification of the classification of the selected device according to TGA.
- The clinical need of the device and its value proposition.
- Underlying epidemiology of the medical condition being targeted, anatomy & physiology, pathophysiology, clinical presentation, clinical outcomes and economic impact.
- Operating principles (how this device works, including the "breaking the device down" into its engineering subsystems).
- Risks and limitations of the commercially-available device, and comparison with devices with similar intended use (existing and emerging solutions).
2) A 1-page report describing their research methodology, and extra pages for references.
In addition to the assessed task:
- To prepare for the week 7 assessed submission, students will deliver a short 2-3 min. presentation in Week 4 during scheduled classes (Wed & Fri). The presentation in Week 4 does not count towards this assessment component; it is intended to provide early feedback about the chosen device and approach, and to exchange knowledge among peers. Participation in this activity will count towards 1. Individual Engagement and Participation (20/100 marks).
- As a complementary learning activity, students will be asked to peer-review and provide critical feedback to a number of videos submitted by peers, and answer to questions from peers (Peer-review session). This activity will be done in Week 8 (Wednesday session). The objective of this activity is to learn about medical devices, not covered by the student's own investigation. Feedback from peers will be considered in the grade for this individual assessment component. The participation in the peer-review session and quality of the provided feedback, will count towards 1. Individual Engagement and Participation (30/100 marks).
Use of AI or MT
This assessment task evaluates students' abilities, skills and knowledge without the aid of generative Artificial Intelligence (AI) or Machine Translation (MT). Students are advised that the use of AI or MT technologies to develop responses is strictly prohibited and may constitute student misconduct under the Student Code of Conduct.
Submission guidelines
- Week 4 slides: Students will upload their power-point slide to MS Teams (under a corresponding folder), prior to the start of the Wednesday session.
- Week 7 submission (video + report): Students will submit their video and report within a corresponding submission link in Blackboard.
- Week 8 (peer-review): Students will submit peer feedback using a corresponding form, which will be made available within MS Teams.
Deferral or extension
You cannot defer or apply for an extension for this assessment.
The evaluation of this item includes scores and feedback from peers, which are collected during a scheduled class, in the week following submission. In preparation for this in-class activity, students must be able to receive their peers’ submissions by the deadline, so they can prepare with sufficient time prior to the feedback activity session. For this reason, this assignment has ADA approval for no extensions and 100% penalty.
Late submission
Assessment items received after the deadline will be subject to a late penalty of 100% after a grace period of 1-hour.
3. Team Project
- Hurdle
- Identity Verified
- Team or group-based
- In-person
- Mode
- Activity/ Performance, Oral, Product/ Artefact/ Multimedia, Written
- Category
- Project
- Weight
- 60%
- Due date
Milestone 1 (formative) 2/04/2025 - 4/04/2025
Milestone 2 (formative) 2/05/2025
Milestone 3 (final deliverables, summative) 30/05/2025
Milestone 3 (exhibition/examination, summative) 14/06/2025 - 21/06/2025
M1 and M2 deliverables are due by the start of the corresponding session of the respective Milestone week. M3 deliverables are due by the start of the Friday session.
All milestones require a peer-assessment factor, which is meant to be submitted by the end of the Friday session, of the respective Milestone week.
- Other conditions
- Peer assessment factor.
- Learning outcomes
- L01, L02, L03, L04, L05, L06, L07
Task description
The team project evaluates your ability to work in teams and apply your biomedical engineering skills to design and develop a simple medical device without neglecting commonly overlooked, yet extremely important aspects in Medical Device Engineering in relation to capture the user needs and translate those to technical specifications, adherence to standards and regulatory frameworks, safety and ethical considerations.
Your project will start with a predefined clinical need provided by a stakeholder (e.g. a clinician, a patient, etc.). Your task will be to dig into the stakeholder needs, and design and develop a functional prototype that addresses that need, within given constraints, while maintaining proper documentation according to standards. Within this project, you are required to implement (to the best of your ability) the frameworks covered in class, Design Control (ISO 13485) and Risk Management (ISO 14971) principles.
Assessment for the project is a sequence of milestones that run throughout the semester. The main mode of assessment will be different on each milestone:
3.1 Milestone 1 - Identify Needs (formative)
When: Week 6 (Wednesday session, 12pm-2pm & Friday session, 2pm-4pm)
What: Teams will deliver a 10-minute long presentation, where they describe the identified clinical need, value proposition, assumptions and project plan. Presentations will be followed by approximately 5 minutes of questions from the class and the teaching team. Scheduling of presentations will be done after team project formation in Week 3/4. Teams will also be assessed on their documentation progress related to the IDENTIFY phase. All team members will be required to submit a Peer-assessment.
3.2 Milestone 2 - Progress on Design Control and Risk Management documentation (formative)
When: Week 9 (Friday session, 2pm-4pm)
What: Teams will present their project progress to the teaching staff during the Friday-scheduled class of Week 9. Teams will be assessed on the status of their documentation concerning requirements, verification/validation, risk management, and OH&S and ethical considerations in relation to prototyping/testing. All team members will be required to submit a Peer-assessment.
3.3 Milestone 3 - Final deliverables, team project exhibition & oral examination (summative)
When: Deliverables are due by Week 13 (Friday session, 2pm) | Exhibition & Oral examination: will be scheduled during Exam period
What: Team project deliverables include:
- A 6-page (max.) report summarizing the clinical need for the medical device, and the design and development process;
- all supporting documentation (e.g. design considerations, requirements and technical specifications, adherence to standards and regulatory framework, safety and ethical considerations, testing, etc.);
- a power-point slide deck, where they describe their project, methodology and results for a wide-audience. The slide deck will be presented during the team project exhibition (5-minute presentation);
- a functional medical device prototype; and
- peer assessment factors and feedback to colleagues.
Use of AI or MT
This task has been designed to be challenging, authentic and complex. Whilst students may use AI and/or MT technologies, successful completion of assessment in this course will require students to critically engage in specific contexts and tasks for which artificial intelligence will provide only limited support and guidance. A failure to reference generative AI or MT use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI and MT tools.
Hurdle requirements
In order to pass the course (achieve an overall grade of 4 or higher), students must achieve, at least, marks greater than or equal to 45% of the total Team Project marks (marginal fail) in the Team Project Milestone 3 (after being weighted by peer-assessment and individual-assessment factors).Submission guidelines
Submission instructions will be announced on the course Blackboard.
Deferral or extension
You cannot defer or apply for an extension for this assessment.
Milestone 1 & 2 (formative)
No extensions permitted. This course uses team-based assessment of a project developed and iterated on with regular formative feedback over the semester.
Presenting work for review and feedback is a core component of this course. This course uses in-class presentations and discussions with teaching staff to demonstrate student learning and understanding of the project they are working on.
It is the team’s responsibility to make sure that the majority of the team members are able to present their progress in-class, during a scheduled slot.
Milestone 3 (summative)
No extensions permitted. This course uses team-based assessment of a project developed and iterated on with regular formative feedback over the semester. This type of assessment should have a version of the project deliverables submittable by the deadline.
The team project exhibition & oral examination is an identity verified examination, scheduled during Exam Week. Unless the student has been approved for a deferred examination, no extensions can be granted. The individual student will receive a 100% penalty for this item for a no-show to the exam, regardless of having had submitted their deliverables.
Individual grades to this item consider peer and individual assessment factors
Adjustments
If a team encounters extraordinary difficulties in meeting a deadline, they should contact the course coordinator (via email bioe6901@eecs.uq.edu.au) in advance of the due date. The team will be asked to meet with the course coordinator, and present their work, as it stands. If the team wishes to apply for an extension, the Head of School (HoS) or Director of Teaching and Learning (Director T&L) is the designated decision maker. The course coordinator will provide a recommendation to the HoS or Director T&L based on his/her observations and assessment of the work as presented. Problems with team management and performance, illness (or other issues) of an individual team member are NOT considered sufficient grounds for an extension on submission of a team assessment item. These issues should be actively managed by the team during the course of the semester.
Late submission
Milestone 1 & 2 (formative)
100% Late Penalty
Project milestones during semester are formative assessment of snapshots of the team’s current work-in-progress. These formative assessments occur during scheduled class, where students present and discuss the work that they have done; these activities cannot be postponed.
Milestone 3 (summative)
100% Late Penalty
Course grading
Full criteria for each grade is available in the Assessment Procedure.
| Grade | Cut off Percent | Description |
|---|---|---|
| 1 (Low Fail) | 0 - 19 |
Absence of evidence of achievement of course learning outcomes. |
| 2 (Fail) | 20 - 46 |
Minimal evidence of achievement of course learning outcomes. |
| 3 (Marginal Fail) | 47 - 49 |
Demonstrated evidence of developing achievement of course learning outcomes |
| 4 (Pass) | 50 - 64 |
Demonstrated evidence of functional achievement of course learning outcomes. |
| 5 (Credit) | 65 - 74 |
Demonstrated evidence of proficient achievement of course learning outcomes. |
| 6 (Distinction) | 75 - 84 |
Demonstrated evidence of advanced achievement of course learning outcomes. |
| 7 (High Distinction) | 85 - 100 |
Demonstrated evidence of exceptional achievement of course learning outcomes. |
Additional course grading information
In order to pass the course (achieve an overall grade of 4 or higher), students must achieve, (1) at least, a grade of 3 (marginal fail; marks greater than or equal to 45%) in the Team Project Milestone 3 (after being weighted by peer-assessment and individual-assessment factors); and (2) at least a grade of 4 (pass; marks greater than or equal to 50%) in the Individual Engagement and Participation component. Students who do not meet these two requirements will have their final grade capped at a 3.
Grades will not be rounded before final grades are awarded. i.e. a student who achieved an overall mark of 84.9% would be awarded a grade of 6.
Supplementary assessment
Supplementary assessment is available for this course.
Additional assessment information
TEAM PROJECT ASSESSMENT
All team members are required to provide meaningful contributions to the central concept being developed, and equally all team members need to contribute across the communication components of the assessment (for example documentation, reports, presentations etc). Where it is evident that a team member has contributed ONLY to the communication components and has had little to no meaningful input into the project concept, documentation, and its development, the course coordinator reserves the right to adjust individual grades accordingly via an Individual Assessment Factor (IAF). In such circumstances, it is also likely that these team members will receive a very low Peer-Assessment Factor (PAF), and will therefore be at high risk of failing the course overall (despite other team members doing well).
For team-based assessment items, teams are expected to develop effective conflict resolution strategies at the outset of the project to enable them to deal with situations where the workload is not shared equitably. Teaching staff are available to assist with conflict resolution if necessary. Team reviews will be conducted during the semester for individuals to comment on team progress and morale. The purpose of the team review is to appraise the individual contributions to the team, team effectiveness and attitudes - both for indications of conflict and to recognise high-performing teams. The results of these will, along with teaching staff observations, be used to support teams through conflict resolution. Ultimately the course coordinator reserves the right to adjust PAF and IAF marks for each group member in the event of varied contributions to the team effort.
Having Troubles?
If you are having difficulties with any aspect of the course material, you should seek help. Speak to course staff and/or the course coordinator.
If external circumstances are affecting your ability to work on the course, you should seek help as soon as possible. The University and UQ Union have organisations and staff who are able to help, for example, UQ Student Services are able to help with study and exam skills, tertiary learning skills, writing skills, financial assistance, personal issues, and disability services (among other things).
Complaints and criticisms should be directed in the first instance to the course coordinator. If you are not satisfied with the outcome, you may bring the matter to the attention of the School of EECS Director of Teaching and Learning.
Learning resources
You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.
Library resources
Find the required and recommended resources for this course on the UQ Library website.
Additional learning resources information
Notices
Notices regarding the course will be posted on Blackboard (http://blackboard.elearning.uq.edu.au/) and also distributed in the General channel on MS
Teams. You are expected to read these notices regularly (at least once a week and more often near deadlines for deliverables).
Web
The course web site is available on Blackboard (http://blackboard.elearning.uq.edu.au/). The course web site will contain important information on the weekly activities (under Learning Resources). You must be enrolled in the course to access some parts of the web site.
Course Communications
MS Teams will be used for course communication and for internal team collaboration. This can be used via the web interface, but students are encouraged to download the relevant native application for a better experience.
Learning activities
The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.
Filter activity type by
Please select
| Learning period | Activity type | Topic |
|---|---|---|
Not scheduled |
Seminar |
Invited talks Medical devices engineering is a very comprehensive and trans-disciplinary field. To give students the opportunity to learn from different stakeholders (e.g. clinicians, patients, industry representatives), invited talks / seminars will be organized throughout the semester. These will happen during scheduled hours. A detailed scheduled of activities will be available in Blackboard. Learning outcomes: L01, L02, L04 |
Not scheduled |
Excursion |
Field excursions One or two field excursions, within short reach of UQ (e.g. Metro North Health facilities), are planned within scheduled hours. Once confirmed, detailed scheduled of activities will be available in Blackboard. Learning outcomes: L01, L02, L04 |
Multiple weeks From Week 1 To Week 13 |
Workshop |
Live Workshops There are 4 hours of scheduled activities in this course. Irrespective of how they are labelled in the timetable, these sessions will include a mix of lecture, workshop and discussion style activities. These sessions will include presentation of the course material, and discussions where active student participation is encouraged. Background material will be provided by the lecturer. Invited lecturers/seminars and field excursion are also planned within workshop scheduled time. A detailed scheduled of activities will be available in Blackboard. Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Multiple weeks From Week 1 To Revision week |
Not Timetabled |
Active learning Students will be pointed to recommended articles, book chapters, and material that are relevant to the course's learning objectives. It is expected that students spend a good amount of time studying the recommended material. Students will be expected to do short presentations during scheduled class, and participate in discussion forums based on the recommended material. Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Multiple weeks From Week 3 To Week 13 |
Not Timetabled |
Team project Students will work on the conceptual design of a medical device based on a real clinical need. Students will apply medical device engineering practices learned throughout the course. Students will work in teams of 3-5 members. A major assessment component of this course is related to this activity. Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Policies and procedures
University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:
- Student Code of Conduct Policy
- Student Integrity and Misconduct Policy and Procedure
- Assessment Procedure
- Examinations Procedure
- Reasonable Adjustments - Students Policy and Procedure
Learn more about UQ policies on my.UQ and the Policy and Procedure Library.
School guidelines
Your school has additional guidelines you'll need to follow for this course:
Course guidelines
OH&S considerations during Field trips
Field trips may be organized for this course, and related OH&S guidelines will become available when these visits are finalised. Students must carefully observe such policies.
OH&S and Ethics consideration for team project
With students building a prototype it is essential you follow OH&S guidelines and inductions when using UQ tools and/or laboratory spaces. Student teams must discuss with the course coordinator if any intended construction is to be conducted outside of UQ lab spaces or which are not covered by existing UQ inductions or UQ OH&S guidelines prior to commencing construction.
Testing of prototypes on team members require individual risk assessments to be conducted or existing risk assessments to be applied, and consent from the team member being subject to testing the prototype. Testing of prototypes on humans (other than the course and team members), requires an Ethics Review - https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics/ethics-application. In this cases, testing must not proceed before approval (or exemption) by the Ethics committee. Please discuss with the course coordinator prior to conducting any human testing to confirm that you have addressed all requirements