91705 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
Requisite(s): 91400 Human Anatomy and Physiology
Anti-requisite(s): 68205 Advanced Medical Device Technology AND 69502 Medical Devices and Diagnostics
Description
This subject introduces the science behind devices encountered in medical practice, as well as emerging technologies expected to contribute to the future of medical diagnosis and treatment. The topics covered include biomedical implants, devices for in vitro diagnostics, biomaterials and biocompatiblity, microfluidic devices for medicine, pandemic viral diagnostics, how to run clinical trials of medical devices, 3D bioprinting in medical applications, portable devices, and medical device regulations and standards. Furthermore, it examines the ethical, legal, social, cultural, and economic impacts of introducing devices into medical practice. It introduces medical device regulatory frameworks and medical device classification, and examines issues relating to the design and implementation of clinical trials.
Subject learning objectives (SLOs)
Upon successful completion of this subject students should be able to:
| 1. | Identify the scope and role of medical devices and the medical device industry in our health care system. |
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| 2. | Explain the processes involved in the national and international regulatory environment for medical devices and their importance. |
| 3. | Describe the principal, functional components of modern medical devices used in monitoring of physiological function, diagnosis and treatment. |
| 4. | Understand the key scientific principles underpinning measurement of physiological signals on various industry-related scenarios. |
| 5. | Research the key scientific principles pertaining to implantable technologies on various industry-related scenarios. |
| 6. | Research, analyse, synthesise, condense and disseminate complex scientific, technical and regulatory information within the framework of our modern health care industry. |
| 7. | Analyze and evaluate 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
Medical Devices and Diagnostics is a 6th stage core subject for the Medical Science Course and double degrees with Medical Science within the Faculty of Science. It builds upon the knowledge acquired from Human Anatomy and Physiology (91400) and offers students the chance to consolidate and integrate complex scientific principles from the physical and biological sciences. It also considers regulatory and industry constraints, within the context of diagnostic and therapeutic technologies that form the foundation of modern healthcare.
GA1. Disciplinary Knowledge
This subject will provide disciplinary knowledge through lectures and workshops, and assess the understanding of this knowledge through online quizzes, a written mini-review manuscript, group presentations, and workshop-related tasks. The lectures will be delivered by UTS and guest lecturers who possess expertise and knowledge of the underlying principles of operation of medical devices, hospital applications, research and development, and regulatory requirements of medical devices. The workshop tasks, based on the lectures and independent research, will involve analysing critical factors related to the adoption and utilization of devices in medical practice. This includes exploring broader technological, ethical, and social considerations.
GA2. Research, inquiry and Critical Thinking
Workshop tasks, employing an inquiry-oriented and critical approach, will be dedicated to the examination and discussion of the complexities and interplay between science and technology. This will involve analysing emerging and pivotal medical devices and diagnostics. A separate workshop session will be specifically focused on critically evaluating published materials pertaining to scientific, technological, and clinical evidence for specific medical devices. This research-centric approach will contribute to the preparation of both the mini-review (assessment task #2) and the group presentation (assessment task #3).
GA3. Professional, Ethical and Social Responsibility
Students will be expected to analyse and present their findings on the scientific, technical, regulatory, and clinical evidence related to significant medical devices. They will also be required to write a mini-review and deliver a group presentation based on their research. These activities mirror those encountered in professional practice and medical research. By engaging in these tasks, students will not only consolidate their prior knowledge of professional skills such as time management and personal organization, but also develop an assessable time management plan that aligns with their overall study load. Furthermore, these activities serve as a means to integrate subject-specific material delivered through lectures with the critical review skills acquired through workshop-related activities, which are designed to foster student creativity.
GA4. Reflection, Innovation, Creativity
Both the mini-review (assessment task #2) and the group presentation (assessment task #3) are structured to provide students with the flexibility to explore a diverse array of topics and fields concerning medical devices and diagnostics. This allows students to unleash their creativity fully when presenting their work. Several workshops are specifically designed to facilitate student reflection on the message and style they wish to convey. We encourage students not only to prioritise 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. This subject offers a distinctive chance to present subject-specific aspects of a topic and enhance knowledge of delivering effective presentations. This will be accomplished through critical appraisal of sample presentations available online. By engaging in these activities, students' communication skills will be further developed and assessed, with detailed assessment criteria provided.
Although this subject involves numerous expert lecturers and provides students with the opportunity to interact with professionals and professional organisations directly, this particular attribute will not be directly assessed.
Teaching and learning strategies
The subject content will be delivered through online lectures and interactive workshops conducted online. The lectures will primarily focus on the fundamental principles of science, engineering, development, and regulation pertaining to key medical devices and diagnostic technologies. Through the assessment tasks and workshops, you will actively engage in the evaluation of scientific and medical literature, testing of smartphone-based medical apps, group analysis of medical device and diagnostic issues, as well as the development of writing and presentation skills.
Most of the lectures will be conducted by experienced UTS faculty members who possess expertise in various aspects of medical and engineering research. Additionally, guest speakers who are skilled and experienced in the industry, regulations, and compliance will deliver some of the lectures.
The workshops will complement the lectures by clarifying the lecture material and providing support for the assessment tasks. During these workshops, you will have the opportunity to receive formative feedback from the teaching associates on your written mini-review (Assessment Task 2) prior to submitting the final version of the manuscript. Furthermore, you will also be provided with feedback on the development of your group presentations (Assessment Task 3). During the presentation sessions for Assessment Task 3, you will have the chance to both deliver 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
- Understanding the fundamental principles that underpin monitoring and diagnostic devices, with specific focus on technologies utilising light and electric signals in interaction with the human body
- Exploration of the characteristics of biomaterials and the key principles applied to implantable devices
- Examination 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 |
|---|---|
| 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: Mini-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: | ?2000-3000 words, 10-20 references, at least 1 figure/table |
| Criteria: | Students will be assessed on their ability to research and critique relevant publications as well as their ability to provide logical and fair analysis on the merits of the medical device or diagnostic technology chosen based on these publications. Written communication skills will also be evaluated. Detailed marking criteria will be posted on MDD subject 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: | 6 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 subject, you MUST achieve an overall mark of at least 50%
Required texts
Materials pertinent to the lectures will be placed on UTSOnline
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/