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SUBJECT OUTLINE 91705 Medical Devices and Diagnostics Course area

UTS: Science

Delivery

Spring 2019; City

Credit points 6cp Requisite(s)

(91400 Human Anatomy and Physiology AND ( 68041 Physical Aspects of Nature OR 68101 Foundations of Physics OR 68037 Physical Modelling)) These requisites may not apply to students in certain courses. See access conditions.

Result type

Grade and marks

Attendance: 4hpw (2hrs: workshop, 2hrs: lecture)

Subject coordinator Name: Dr. Martin Stewart Email: [email protected]

Teaching staff Lecturers: Martin Stewart: [email protected] Irina Kabakova: [email protected] Majid Warkiani: [email protected] Dayong Jin: [email protected] Olga Shimoni: [email protected] Suzanne Williams: [email protected] Tara Croft: [email protected] Jurgen Schulte: [email protected] Jackie Huang: [email protected] George Herok: [email protected] Teaching Associates: Domenica DiSalvo: [email protected] Gursharan Singh: [email protected] Sushil Kandel: [email protected] Eva Fendandez: (to be confirmed)

Subject 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. Topics covered include biomedical implants, devices for in vitro diagnostics, oximeters, medical lasers, electrophysiology and electrocardiograms (ECG), microfluidic devices for medicine, diagnostics based on DNA/RNA analysis, how to run clinical trials of medical devices, and medical device regulations and standards. Ethical, legal, social, cultural and economic impacts of the introduction of devices into medical practice are examined. Medical device regulatory frameworks and medical device classification are introduced; and issues relating to the design and implementation of clinical trials are examined. 16/07/2019 (Spring 2019)

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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. 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. Apply the key scientific principles underpinning measurement of physiological signals on various industry-related scenarios. 5. Apply 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: An understanding of the nature, practice and application of the chosen science discipline. (1.0) Encompasses problem solving, critical thinking and analysis attributes and an understanding of the scientific method knowledge acquisition. (2.0) The ability to acquire, develop, employ and integrate a range of technical, practical and professional skills, in appropriate and ethical ways within a professional context, autonomously and collaboratively and across a range of disciplinary and professional areas, e.g. time management skills, personal organisation skills, teamwork skills, computing skills, laboratory skills, data handling, quantitative and graphical literacy skills. (3.0) An understanding of the different forms of communication - writing, reading, speaking, listening - including visual and graphical, within science and beyond and the ability to apply these appropriately and effectively for different audiences. (6.0)

Contribution to the development of graduate attributes Medical Devices and Diagnostics is a 6th stage, the core subject for the Medical Science Course and double degrees with Medical Science within the Faculty of Science. It draws on the knowledge gained from Physical Aspects of Nature (68041) and Human Anatomy and Physiology (91400) and provides students with the opportunity to consolidate and integrate complex scientific principles from the physical and biological sciences together with regulatory and industry constraints, within the context of diagnostic and therapeutic technologies underpinning modern health care. GA1. Disciplinary knowledge and its appropriate application This subject will impart disciplinary knowledge through lectures and workshops and will assess this knowledge through a written report, oral presentation, workshop-related tasks, and examination. UTS and guest lecturers with expertise in and knowledge of the underlying principles of operation of medical devices, hospital applications, research and development and regulatory requirements of medical devices will deliver lectures. Based on the lectures and independent research, some of the workshop tasks will be devoted to an analysis of factors critical to the adoption and use of devices in medical practice, including broader ethical and social considerations. GA2. An inquiry-oriented approach Workshop tasks incorporating an inquiry-oriented approach will be devoted to the consideration and discussion of the complexities and interactions of science and technology through the analysis of failed medical devices. A dedicated workshop session will focus on a critical examination of published materials in the area of scientific, technological and clinical evidence for specific medical devices. GA3. Professional skills and its appropriate application 16/07/2019 (Spring 2019)

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Students will be required to research technical, regulatory and clinical evidence of specific medical devices, write a critical review and present their findings in an oral presentation. Such activities are typically encountered in professional practice. Through this activity, students will consolidate prior knowledge of professional skills of time management and personal organization through the self-development of an assessable time management plan within the context of their total study load. It also serves as a vehicle to integrate subject specific material, delivered through lectures with the critical review skills learned through the workshop-related activities. GA6. Communication skills Assessment of critical analysis and independent thinking as well as ability to communicate effectively through writing will be assessed, This subject allows a unique opportunity to present subject specific aspects of a topic and consolidate knowledge of how to present an effective PowerPoint presentation. This will be achieved by critical appraisal of example presentations online. Through these activities, students' communication skills will be developed further and assessed with detailed assessment criteria provided. While this subject, through the involvement of many expert lecturers, provides students with an opportunity to take the initiative and engage directly with these professionals and professional organizations, this attribute will not be directly assessed.

Teaching and learning strategies Subject content is delivered through an interactive discussion in a lecture venue. The lectures focus on the key principles of development and regulation of certain medical devices and diagnostic technologies. You will participate in the evaluation of case studies, demonstration of a medical devices (such as oximeter or ultrasound), and in-class game-based learning activities. Some lectures may have pre-lecture questions that you will have to complete so the lecturers can identify the difficult concepts and work further on these in the lecture. Some of the lectures are delivered by guest speakers who are skilled and experienced in the industry. Workshops follow the lectures and will both clarify lecture material and provide support for the assessment tasks. During the workshops, interactive activities tackling real case scenarios and selected published articles will involve small group and plenary discussions. During a workshop, you will have the opportunity to receive formative feedback from the teaching associates for your written critical review (Assessment Task 1) before submission of the final version of the manuscript. You will also provide oral and written feedback to group oral presentations (Assessment Task 2) of your peers.

Content (topics) Regulation of medical devices and diagnostic technologies and evaluation of their clinical evidence Fundamental principles underpinning monitoring and diagnostic devices through specific study of technologies based on light and electric signals interaction with the human body Characteristics of biomaterials and key principles applied to implantable devices Emerging medical devices and diagnostic technologies

Program Week/Session

Dates

Description

Week 1

22 Jul

Orientation and Preparation Week Notes: No lecture. Go to Subject Orientation in UTSOnline. Workshops begin in Week 4.

Week 2

29 July

Lecture: Medical Devices: industry and life cycle Irina Kabakova (UTS) Notes: Workshops begin in Week 4.

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Week 3

5 Aug

Lecture: Devices and Processes for Engineering Cell-Based Therapies Martin Stewart (UTS) Notes: Workshops begin in Week 4.

Week 4

12 Aug

Lecture: Microfluidic Devices in Medicine Majid Warkiani (UTS) Notes: Workshop: Preparation for Assessment task I: Mini-review manuscript

Week 5

19 Aug

Lecture: Light-based medical devices I – Medical lasers Irina Kabakova (UTS) Notes: no workshop

Week 6

26 Aug

Lecture: Light-based medical devices II – Oximetry Jurgen Schulte (UTS) Notes: Workshop: Preparation for Assessment task I: Mini-review manuscript

Week 7

2 Sep

Lecture: Light in Biomedical Materials and Devices Dayong Jin (UTS) Notes: No workshop. Mini-review is due 11:59 pm, Friday, 6 September

9 Sep

StuVac Notes: Enjoy your week off!

Week 8

16 Sep

Lecture: Clinical trials and evidence of medical devices Suzanne Williams (Mobius Medical) Notes: Workshop: App-based heart rate monitor

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(material will be assessed in final exam)

Week 9

23 Sep

Lecture: Medical device regulations and standards Tara Croft (UTS & Nanosonics) Notes: Workshop: Preparation and Feedback for Group Oral Presentations

Week 10

30 Oct

Lecture: In-vitro diagnostics Olga Shimoni (UTS) Notes: No workshop. It is highly recommended to use this time to work with your group on refining the presentation The due date for the group Powerpoint file is 11:59 pm, Monday, 7 October

Week 11

7 Oct

Lecture: Diagnostics based on RNA and DNA analysis - Online Lecture (Monday 7th of October is a public holiday - DO NOT PHYSICALLY TURN UP! Lecture is online ONLY) Jackie Huang (UTS) Notes: Workshop: Group Oral Presentation and Peer Marking

Week 12

14 Oct

Lecture: Pacemakers, Electrophysiology and Electrocardiogram (ECG) George Herok (UTS) Notes: Workshop: Group Oral Presentation and Peer Marking The due date for SparkPlus marks of your other group members is 11:59 pm, Friday, 18 October

Assessment Assessment task 1: Mini-review manuscript Intent:

This assessment task contributes to the development of the following graduate attributes: 1. Disciplinary knowledge and its appropriate application 2. An inquiry-oriented approach 3. Professional skills and their appropriate application 6. Communication skills.

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Objective(s): This assessment task addresses subject learning objective(s): 1, 2, 3, 4, 5, 6 and 7 This assessment task contributes to the development of course intended learning outcome(s): 1.0, 2.0, 3.0 and 6.0 Type:

Literature review

Groupwork: Individual Weight:

35%

Task:

The task is to construct a Mini-review manuscript covering a chosen medical device or diagnostic technology. It should be written in a format ready for publication in a peer-reviewed journal. Specific details will be placed on UTSOnline. Step 1: choose a medical device or diagnostic techology as your topic that you are interested in (for example: pacemakers). Step 2: read scientific/medical journal publications, wikipedia articles, news articles and/or books to learn about your topic. Step 3: figure out what you will write about and determine the structure. The structure can follow a basic outline such as: - start with the motivation. Why care about this topic? Why are pacemakers important? - introduce specific problem/question you will focus on within this topic. For example, your mini-review might focus on the designs of different pacemakers, comparing their pros/cons, and how future devices might address these issues. - explore the problem/question. This will be the bulk of the content of your mini-review. For example, you might compare the design of the 3 main pacemakers that are used. You must use journal publications to support all your arguments and statements. You will need to cite medical and scientific literature, not wikipedia articles or news articles. - summarize what we have learnt by analysing the literature. - conclude with a unique perspective or opinion based on what you have learnt. It could be a prediction about the future of pacemakers or whether or not another technology will make them obselete. This perspective needs to be grounded in the facts you have laid (and backed up with citations) earlier. Step 4: Write up the manuscript according to your structure and the message you want to communicate. Add one figure, which can either come from another journal article or, even better, you create this figure yourself. Make sure the figure has a caption. Step 5: Format your manuscript and reference list to look like a scientific publication. Step 6: Revise mistakes, get feedback from tutors (recommended), then submit.

Length:

2000-3000 words, 10-50 references

Due:

11:59 pm, Friday, 6 September 2019

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Criteria:

Students will be assessed on their ability to choose an interesting topic, digest the scientific and medical literature in that topic, identify opportunities for commentary, and write up a professional, innovative and compelling manuscript. Marks will be based on: 1) The content of the Mini-review - the analysis of the literature and formation of a quality contribution to the field. Are you saying something interesting and useful to people who want to learn about this field? Are you bringing a fresh perspective? 2) The professionalism and presentation of the Mini-review. The more it looks and feels like a real review paper the better your marks will be. Detailed marking criteria will be posted on UTSOnline.

Further The top 3 Mini-review manuscripts will be selected as being worthy of support for scientific information: publication. The subject coordinator will contact the winning students and to organize how to publish. Late submissions will be penalized at a rate of 20% per day. Manuscripts submitted 6 days or later after the due date will receive 0%. If you are unable to submit your critical review by the due date, you will need to produce appropriate documentary evidence (e.g. medical certificate) to avoid a penalty. If you have an unexcused missed critical review, you will receive a zero mark for this task.

Assessment task 2: Oral Presentation Intent:

This assessment task contributes to the development of the following graduate attributes: 1. Disciplinary knowledge and its appropriate application 2. An inquiry-oriented approach 3. Professional skills and their appropriate application 6. Communication skills.

Objective(s): This assessment task addresses subject learning objective(s): 1, 2, 3, 4, 6 and 7 This assessment task contributes to the development of course intended learning outcome(s): 1.0, 2.0, 3.0 and 6.0 Type:

Presentation

Groupwork: Group, group and individually assessed Weight:

35%

Task:

You will work in groups of three members to research, prepare, and deliver an oral presentation using Microsoft PowerPoint as a visual aid. You will participate in the formal marking and running of the seminar in a format analogous to that of a scientific conference. Detailed preparation instructions and seminar involvement and organisation will be given on UTSOnline and in workshop sessions. You should be able to clearly communicate to your peers the ethics, costs, safety, innovations, efficacy, rational use, or community issues of the medical device or diagnostic technology that your group will select to discuss in an oral presentation. Please be aware that 28% of this is a group mark while 7% derives from the individual contribution as judged by their fellow group members.

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Length:

10 minute presentation

Due:

Your group’s PowerPoint file should be uploaded to a media file-sharing website by 11:59 pm, Monday, 7 October, 2019 (see Further Information). Presentations will take place during the week 11 and 12 (see Program). SparkPlus scores for the other members of your group are due the end of week 12 at 11:59 PM, Friday, 18 October 2019. See also Further information.

Criteria:

You will be assessed by your peers and tutor on topic knowledge, extent of research and discussion, and oral communication skills. Individual contribution to the group task will be assessed using SparkPlus. SparkPlus may be used to moderate the individual grades. Detailed marking criteria will be posted on UTSOnline.

Further Submission of the PowerPoint files to media file-sharing website: Late submissions will decline information: at a rate of 20% per day. Late submissions received more than 5 days after the due date will receive 0%. If you are unable to submit your PowerPoint file by the due date, you will be need to produce appropriate documentary evidence (e.g. medical certificate) to avoid a penalty. If you have an unexcused missed submission of the PowerPoint file, you will receive a zero mark for this task. Participation during the oral presentation weeks: Attendance during the Oral Presentation and Peer Marking sessions (Weeks 11 and 12) is compulsory. If you have an unexcused absence during Weeks 11 and 12, you will receive a 10% deduction on your score for this task. If you are unable to deliver your presentation on the allocated date, please provide sufficient documentary evidence. There are no make up sessions for oral presentations. If you have an unexcused missed oral presentations, you will receive a zero mark for this task. If you fail to s...