ENN561 Industry Practice in MedTech
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: | ENN561 |
|---|---|
| Prerequisite(s): | Completion of 192 credit points in EV10 or Admission to (EV57 or EN57) |
| Credit points: | 12 |
| Timetable | Details in HiQ, if available |
| Availabilities |
|
| CSP student contribution | $1,192 |
| Domestic tuition unit fee | $5,364 |
| International unit fee | $6,684 |
Unit Outline: Semester 2 2026, Gardens Point, Internal
| Unit code: | ENN561 |
|---|---|
| Credit points: | 12 |
| Pre-requisite: | Completion of 192 credit points in EV10 or Admission to (EV57 or EN57) |
| Coordinator: | Paige Little | j2.little@qut.edu.au |
Overview
It is essential that Engineers working in the medical device, healthcare and health services sectors have professional knowledge of the regulatory frameworks which govern medical technology development and implementation, both in Australia and Internationally. Medical device technology encompasses a broad range of items, so understanding how to navigate the complex regulatory and governance structures which administer this environment is essential for Engineers working in this Sector.
This unit provides an in-depth exploration of the regulatory, governance, and ethical frameworks that underpin the development and implementation of medical technology for human health applications. Learning will also emphasise data management protocols, quality control standards, & sustainability practice, which are essential features of regulatory approval pathways, and further to this, introduce circular economy in the context of healthcare technology.
Learning Outcomes
On successful completion of this unit you will be able to:
- Explain regulatory frameworks which govern medical technology development and implementation, such as compliance requirements for TGA, FDA, EU MDR.
- Critically interpret the role of regulatory affairs in guiding medical technology development, with evaluation of data governance, design controls, cybersecurity, and post-market.
- Apply knowledge of the regulatory affairs to critically assess exemplar case studies of medical device technology success and failures.
- Develop a regulatory strategy for a hypothetical medical technology, integrating principles of design/quality control, data management, patient safety and ethics.
Content
The content of this unit includes:
- Unit introduction and context for learning
- Regulatory bodies in Australia and beyond – Australian Therapeutic Goods Administration (TGA), USA Federal Drug Administration (FDA), and EU Medical Device Regulation (MDR) and CE (Conformite Europeenne).
- Data governance and privacy – in clinical contexts and in medical device development context (guest lecture from a Health Institution)
- Quality management and design controls in medical technology development
- Post-market surveillance: what to report and why/role of registries
- Fundamental concepts of sustainability, and circular economy in the healthcare sector
- Artificial Intelligence and digital health tools: regulations, governance, and patient choice (guest lecture from a Health Professional Body)
- Ethics and medical technology: There’s a patient for every technology.
- Critical analysis of regulatory pathways for safe implementation of medical technology: Successes and failures.
Learning Approaches
In this unit you will undertake critical analysis of case studies of regulatory success and failures, and explore the frontier technologies affecting healthcare treatments and delivery – AI-driven medical technologies and digital health – in the context of regulatory affairs. This unit will equip you with tools to navigate medical technology approval pathways, critically assess technology development in the context of consumers and regulatory affairs, and appreciate the impact of emerging technologies on the healthcare landscape.
In this unit you can expect to experience the following timetabled activities:
- Formal lectures from experienced professionals to give insight into knowledge, skills, and attributes. You have the opportunity to ask questions during these lectures.
- Tutorial classes that will give you the opportunity to work collaboratively with your peers to solve problems. They will be facilitated by a tutor and will provide an opportunity to test your understanding and gain feedback on your work.
These activities will be detailed by week of semester on the unit schedule. You can also expect to be provided with learning resources, including video presentations and readings, on a unit Canvas site, which you can access to complete your learning in this unit. At the beginning of the unit, you will be made aware of the ways in which you can ask questions or seek clarification from the unit coordinator, lecturers and tutor.
You are expected to:
- Engage with timetabled learning activities on campus and ask questions.
- Engage with online resources outside of timetabled learning activities. They will be available on the unit Canvas site. You will receive regular email announcements regarding the release of
these resources.
- Complete two medical technology related projects on regulatory affairs. While there will be time during timetabled tutorial classes, you will also need to undertake independent work outside of this time to complete assessment tasks.
- Prepare for learning activities according to the unit schedule, and follow up on any work not completed.
- Complete assessment tasks by working consistently throughout the semester and meeting the due dates that are published via the unit Canvas site.
Feedback on Learning and Assessment
During tutorial classes you will share your formative Ideas, either individually or as a group, for your two written assessments, and you will receive feedback from your tutor. You are encouraged to view your tutorial group as a learning community and to share and discuss emergent ideas relating to the unit learning objectives. Each assessment submission will be graded against criteria and standards that will be shared with you at the beginning of semester through Assessment Task Descriptions and Marking Rubrics. Marked assessment will include feedback given by the 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, and to deploy work practices that align with current practices in medical technology development and implementation. You will be assessmed via:
- Regulatory Case Study.
- Regulatory Compliance proposal
- Written exam during Exam block
Unit Grading Scheme
7- point scale
Assessment Tasks
Assessment: Regulatory case study
You’ll be provided with a case study of a medical technology that represents regulatory challenges and asked to provide a critical review of why the regulatory compliance process was not immediately approved/successful.
This assignment is eligible for the 48-hour late submission period and assignment extensions.
The ethical and responsible use of generative artificial intelligence (GenAI) tools is authorised in this assessment. See the relevant assessment details in Canvas for specific guidelines.
Assessment: Regulatory compliance proposal
You will be provided with a hypothetical medical technology, and using learning concepts of design/quality control, data management, patient safety/ethics, provide a regulatory strategy.
This assignment is eligible for the 48-hour late submission period and assignment extensions.
The ethical and responsible use of generative artificial intelligence (GenAI) tools is authorised in this assessment. See the relevant assessment details in Canvas for specific guidelines.
Assessment: Examination (written)
This assessment will take the form of an individual examination during the central examination period at the end of semester, where you will show your overall learning in the unit.
The use of generative artificial intelligence (AI) tools is prohibited during the assessment.
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
Learning materials in this unit and links to online resources will be managed from its Canvas site.
Risk Assessment Statement
You shall not enter project sites without the Unit Coordinator's approval. You shall not to contact members of the public, public officers or staff associated with any project without permission of the Unit Coordinator. More detailed information will be provided in your Week 1 information class.
Course Learning Outcomes
This unit is designed to support your development of the following course/study area learning outcomes.EN57 Master of Biomedical Systems and Technology
- Demonstrate and apply advanced specialist discipline knowledge, concepts and practices in the context of contemporary Biomedical Engineering practice, Technologies and Systems thinking.
Relates to: Regulatory case study , Regulatory compliance proposal , Examination (written) - Employ advanced technical knowledge, informed by contemporary practice, and inclusive of user and system needs, to the design and critical analysis of innovative solutions to Biomedical challenges in Healthcare.
Relates to: Regulatory case study , Regulatory compliance proposal , Examination (written) - Apply innovative, systematic frameworks to plan, design, manage and deliver projects where knowledge of Biomedical Systems and Technology are critical to enacting change in Healthcare.
Relates to: Regulatory case study , Regulatory compliance proposal - Demonstrate ethically and socially responsible practice, recognising the importance of personal accountability, reflective practice, and collaborative design, when working with stakeholders, both individually and as a group, from diverse disciplines.
Relates to: Regulatory case study , Regulatory compliance proposal
EN79 Graduate Diploma in Engineering Studies
- Demonstrate and apply advanced discipline knowledge, concepts and practices as they relate to contemporary Engineering practice
Relates to: Regulatory case study , Regulatory compliance proposal , Examination (written) - Analyse and evaluate Engineering problems using technical approaches informed by contemporary practice and leading edge research to achieve innovative, critically informed solutions
Relates to: Regulatory case study , Regulatory compliance proposal , Examination (written) - Apply innovative, systematic approaches to plan, design, deliver and manage Engineering projects in a way that assures sustainable outcomes over their whole lifecycle
Relates to: Regulatory case study , Regulatory compliance proposal - Demonstrate ethically and socially responsible practice, recognising the importance of personal accountability and reflective practice when working in individual and collaborative modes
Relates to: Regulatory case study , Regulatory compliance proposal