69502 Medical Devices and Diagnostics
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Subject handbook information prior to 2024 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Anti-requisite(s): 91705 Medical Devices and Diagnostics
Description
This subject is a postgraduate version focusing on medical devices. It covers the introduction of scientific principles underlying medical devices in medical practice, as well as emerging technologies that are expected to shape the future of medical diagnosis and treatment. The subject encompasses a wide range of topics, including biomedical implants, devices used in in vitro diagnostics, medical lasers, electrophysiology and electrocardiograms (ECG), microfluidic devices for medicine, pandemic viral diagnostics, clinical trials of medical devices, medical devices for DNA and RNA detection, and medical device regulations and standards. The subject explores the ethical, legal, social, cultural, and economic implications of integrating devices into medical practice. It introduces medical device regulatory frameworks and classification systems, while also addressing the challenges associated with designing and implementing clinical trials.
Subject learning objectives (SLOs)
Upon successful completion of this subject students should be able to:
| 1. | Evaluate the scope and role of medical devices and medical device industry in our health care system. |
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| 2. | Assess the significance of the processes involved in the national and international regulatory environment for medical devices and their importance. |
| 3. | Investigate the principal, functional components of modern medical devices used in monitoring of physiological function, diagnosis and treatment. |
| 4. | Contextualise the key scientific principles underpinning measurement of physiological signals and implantable technologies on various industry-related scenarios. |
| 5. | Synthesise and disseminate complex scientific, technical and regulatory information within the framework of our modern health care industry. |
| 6. | Critically analyse the ethical, social, cultural and economic considerations related to an introduction and use of medical devices. |
Course intended learning outcomes (CILOs)
This subject also contributes specifically to the development of following course intended learning outcomes:
- Explain how diseases arise and disrupt normal physiological function and appraise the technologies used to diagnose, treat, and cure diseases. (1.1)
- Collect, accurately record, interpret, and draw conclusions from data to solve real-world medical problems, and infer how the results of medical research can be translated to improve patient outcomes. (2.1)
- Evaluate ethical, social, and cultural issues in medical science in local and global contexts and work responsibly, safely and with respect to diversity and regulatory frameworks. (3.1)
- Reflect upon, independently evaluate, and critically appraise current evidence-based literature to identify medical problems or unmet medical needs and creatively translate medical research results to improve the clinical care of patients. (4.1)
- Effectively communicate medical science knowledge and research information, and the importance thereof, to a range of audiences using a variety of modes, independently and collaboratively. (5.1)
Contribution to the development of graduate attributes
The Medical Devices and Diagnostics postgraduate program is designed to facilitate postgraduate studies in the Medical Science Course and in double degrees with Medical Science within the Faculty of Science. It builds upon the knowledge acquired from regulation and standards, clinical trial evidence, biomaterials, biocompatibility, and medical applications, offering students the opportunity to learn and practice sustainable scientific writing, presentation, and reporting. The subject also emphasizes understanding regulatory and industry constraints within the context of diagnostic and therapeutic technologies that form the foundation of modern healthcare. This provides a solid foundation for students seeking to advance their careers in fields related to medical devices.
GA1. Disciplinary Knowledge
This subject will deliver disciplinary knowledge through a combination of lectures and workshops. The knowledge acquired will be assessed through online quizzes, a written review manuscript, group presentation, and workshop-related tasks. The lectures will be conducted by UTS faculty as well as guest lecturers who possess expertise in the underlying principles of medical device operation, hospital applications, research and development, and regulatory requirements. The workshop tasks will involve analysing crucial factors related to the adoption and utilisation of devices in medical practice, encompassing broader technological, ethical, and social considerations. These tasks will be informed by the lectures and independent research conducted by the students.
GA2. Research, inquiry and Critical Thinking
Workshop tasks will be designed to encourage an inquiry-oriented and critical approach, focusing on the examination and discussion of the complexities and interactions between science and technology. These tasks will involve analysing both emerging and key medical devices and diagnostics. A dedicated workshop session will specifically concentrate on critically evaluating published materials related to the scientific, technological, and clinical evidence for specific medical devices. This research-centric approach will directly contribute to the preparation of both the review preparation (assessment task #2) and the group presentation (assessment task #3).
GA3. Professional, Ethical and Social Responsibility
Students will need to analyse and present their findings on the scientific, technical, regulatory, and clinical evidence of key medical devices. They will also be required to write a review and deliver a group presentation based on their findings. These activities are commonly encountered in professional practice and medical research. Engaging in these tasks will allow students to consolidate their prior knowledge of professional skills such as time management and personal organisation. They will develop an assessable time management plan that aligns with their overall study workload. Furthermore, these activities will serve as a means to integrate subject-specific material learned through lectures with the critical review skills acquired during workshop-related activities. This integration will support the development of students' creativity in approaching the subject matter.
GA4. Reflection, Innovation, Creativity
Both the review writing (assessment task #2) and the group presentation (assessment task #3) have been designed to provide students with the freedom to explore a wide range of topics and fields pertaining to medical devices and diagnostics. This allows them to fully express their creativity in presenting their work. Several workshops have been designed specifically to help students reflect on the message and style they wish to convey in their presentations. We strongly encourage students to not only consider safety and ethics but also to delve into the innovative and cutting-edge scientific and engineering aspects of medical devices and diagnostics.
GA5. Communication
Assessment will focus on evaluating critical analysis, independent thinking, and effective written communication skills. The subject provides a valuable opportunity for students to present subject-specific aspects of a topic and enhance their knowledge of delivering effective presentations. This will be accomplished through the critical appraisal of online example presentations. Students' communication skills will be further developed and assessed, with detailed assessment criteria provided.
Although the subject offers students the chance to interact directly with expert lecturers and professional organizations, it should be noted that this particular attribute will not be directly assessed.
Teaching and learning strategies
The subject content will be delivered through online lectures and workshops. The lectures will cover the fundamental principles of science, engineering, development, and regulation of important medical devices and diagnostic technologies. The assessment tasks and workshops will involve evaluating scientific and medical literature, testing smartphone-based medical apps, conducting group analysis of medical devices and diagnostic issues, and developing writing and presentation skills. Most of the lectures will be delivered by experienced UTS faculty members who specialise in various areas of medical and engineering research. Additionally, guest speakers who possess expertise in the industry, regulations, and compliance will also deliver some lectures.
The workshops will follow the lectures and serve the purpose of clarifying the lecture material and providing support for the assessment tasks. During the workshops, you will have the opportunity to receive formative feedback from teaching associates on your written review (Assessment Task 2) before submitting the final version of the manuscript. You will also receive feedback on the development of your group presentations (Assessment Task 3). Moreover, during the presentation sessions for Assessment Task 3, you will have the chance to give and receive feedback from your peers in the subject.
Content (topics)
- Regulation of medical devices and diagnostic technologies, as well as the evaluation of their clinical evidence.
- Exploration of the fundamental principles that underpin monitoring and diagnostic devices, with a specific focus on technologies that interact with the human body through light and electric signals.
- Understanding the characteristics of biomaterials and the key principles applied to implantable devices.
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Investigation of emerging medical devices and diagnostic technologies.
Assessment
Assessment task 1: Fortnightly Online Quizzes
| Intent: | This assessment task contributes to the development of the following graduate attributes: 1. Disciplinary Knowledge 2. Research, Inquiry and Critical Thinking |
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| Objective(s): | This assessment task addresses subject learning objective(s): 1 and 2 This assessment task contributes to the development of course intended learning outcome(s): 1.1 and 2.1 |
| Type: | Quiz/test |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 10 multiple choice questions per fortnightly quiz. |
| Criteria: | You should demonstrate mastery of disciplinary knowledge and critical thinking by selecting the correct answers in the multiple choice questions. |
Assessment task 2: Review Manuscript
| Intent: | This assessment task contributes to the development of the following graduate attributes: 2. Research, inquiry and Critical Thinking 3. Professional, Ethical and Social Responsibility 4. Reflection, Innovation, Creativity 5. Communication |
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| Objective(s): | This assessment task addresses subject learning objective(s): 1, 3, 4, 5, 6 and 7 This assessment task contributes to the development of course intended learning outcome(s): 2.1, 3.1, 4.1 and 5.1 |
| Type: | Literature review |
| Groupwork: | Individual |
| Weight: | 40% |
| Length: | 5000-6000 words, 20-30 references, at least 2 figure/table |
| Criteria: | Students will be assessed based on their research skills and ability to critically analyze relevant publications. They will also be evaluated on their capability to provide logical and impartial analysis of the chosen medical device or diagnostic technology, based on the information obtained from these publications. Additionally, their written communication skills will be assessed. Detailed marking criteria will be available on the MDD subject's Canvas site. |
Assessment task 3: Group Video Presentation
| Intent: | This assessment task contributes to the development of the following graduate attributes: 3. Professional, Ethical and Social Responsibility 4. Reflection, Innovation, Creativity 5. Communication |
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| Objective(s): | This assessment task addresses subject learning objective(s): 2, 3, 6 and 7 This assessment task contributes to the development of course intended learning outcome(s): 3.1, 4.1 and 5.1 |
| Type: | Presentation |
| Groupwork: | Group, group and individually assessed |
| Weight: | 30% |
| Length: | 10 minute presentation. |
| Criteria: | You will be assessed by your peers and tutor on topic knowledge, extent of research and discussion, and video communication skills. Detailed marking criteria will be posted on MDD subject Canvas site. |
Minimum requirements
To be able to pass this subjecct, you MUST achieved an overall mark of at least 50%.
Required texts
Materials pertinent to the lectures will be placed on CANVAS.
References
- Yock, P., Zenios, S., Makower, J., Brinton, T., Kumar, U., Watkins, F., . . . Kurihara, C. (2015). Biodesign: The Process of Innovating Medical Technologies. Cambridge: Cambridge University Press.
- Bronzino, J. (Ed.), Peterson, D. (Ed.). (2014). Medical Devices and Human Engineering. Boca Raton: CRC Press.
- Schreiner, S. (Ed.), Bronzino, J. (Ed.), Peterson, D. (Ed.). (2016). Medical Instruments and Devices. Boca Raton: CRC Press.
- Paul H. King, Richard C. Fries, Arthur T. Johnson. (2018). Design of Biomedical Devices and Systems, 4th edition. Boca Raton: CRC Press.
- Theodore R. Kucklick. (2012). The Medical Device R&D Handbook, 2nd edition. Boca Raton: CRC Press.
- Peter Ogrodnik. (2019). Medical Device Design, 2nd edition. Innovation from Concept to Market. Academic Press.
- Gail Baura. (2011). Medical Device Technologies: A Systems Based Overview Using Engineering Standards, 1st edition. Academic Press.
- TGA web site - http://www.tga.gov.au/index.htm
- WHO website- http://www.who.int/medical_devices/en/