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BMET3921: Biomedical Design and Technology (2019 - Semester 2)

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Unit: BMET3921: Biomedical Design and Technology (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Senior
Faculty/School: School of Aerospace, Mechanical & Mechatronic Engineering
Unit Coordinator/s: Dr Kumar, Ashnil
Session options: Semester 2
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: (AMME2302 OR AMME1362) AND (MECH2901 OR BMET2901) AND (MECH2400 OR ENGG1960 OR AMME1960 OR BMET1960 OR ENGG1800).
Prohibitions: AMME5921 OR BMET5921 OR MECH3921.
Brief Handbook Description: This unit aims to give students an understanding of the design, development, manufacture and uses of biomedical engineering products in therapeutic, rehabilitation and clinical settings, within the context of the Australian and International biomedical industry. Students will gain an understanding of the entire process of creating a new biomedical engineering product, from design through to monitoring of the product, with reference to the biomedical device regulation in Australia and other major international markets.

The major learning activity will be focused around a team-based project to design a biomedical device. Each team will work on a biomedical design project to address a clinical need faced by a specific clinical sponsor/partner. The team will follow formal design protocols, to produce a detailed design brief that included design control, regulatory considerations, and commercialisation and intellectual property considerations. Lectures and other activities will supplement the experiential project work.

Course content will include:

- Biomedical design process (complementing the team-based project)

- Intellectual Property in the biomedical industry.

- Regulatory and clinical considerations in the biomedical industry.

- Commercialisation strategies in the biomedical industry.

- The Australian and international biomedical industry - an overview. Includes site visits.
Assumed Knowledge: A basic understanding of human physiology and anatomy and an understanding of the engineering design process.
Timetable: BMET3921 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 2.00 2 12
2 Presentation 2.00 1 1
3 Project Work - in class 1.00 1 12
4 Project Work - own time 6.00 13
5 Site Visit
T&L Activities: Lecture: Some weekly lecture slots may include guest lecturers, panel discussions, and other events.

Presentation: In the final week of semester, groups will present their design project in a seminar session.

Project Work - in class: Allocated time for group work with your team.

Project Work - own time: Groups and individuals within the groups are expected to continue working on the design project on their own time.

Site Visit: Depending on availability of industry sites.

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method Attribute Developed
Develop an understanding of the design and development processes in the creation of new biomedical technology devices by undertaking a design project.

Gain an understanding of the therapeutic, rehabilitation, and clinical contexts in which biomedical devices are required to operate through interaction with clinical stakeholders.
(2) Engineering/ IT Specialisation (Level 3)
Conducting literature reviews and patent searches to identify prior art, the gaps that are inherent to existing technology, and to recognise opportunities for innovation and inventiveness.

As part of design project, generating engineering specifications that address the constraints of the problem.

Using an evidence-based approach to justify the solutions proposed in the biomedical design project.
(3) Problem Solving and Inventiveness (Level 3)
Conducting a biomedical design project to develop a hands-on experience in the processes involved in the design cycle.

Developing an understanding of design iteration through progressive refinement of the proposed solution.

Applying biomedical device standards during the design process.

Documenting the design process as a record of development and inventiveness.
(4) Design (Level 3)
Developing good workplace dynamics by working in teams that may include a diverse group of backgrounds and expertise.

Creating the biomedical device design as an integration of system components to accomplish specific set of objectives, that may draw upon expertise from different disciplines.

Developing design solutions that reflect ethical considerations of accessibility and sustainability.

Developing design solutions that account for technical, clinical, social, cultural, and economic perspectives.
(5) Interdisciplinary, Inclusiveness, Influence (Level 3)
Communicating knowledge gained in the form of written assignments, group work, and the final seminar.

Working within a team, articulating design views and integrating with a range of team reflections.

Documenting the design process. Using online resources to conduct research that feeds into the design and documentation process.

Maintaining confidentiality through the design process, and in consultation with stakeholders.

Presenting evaluations and interpretations of uncertainties in the problem domain and design process, and clarifying requirements to determine research needs. Evaluate and interpreting prior art and domain knowledge to justify the technology and methods used in the proposed design.
(6) Communication and Inquiry/ Research (Level 3)
Engaging with external clinical stakeholders as technical specialists, eliciting the clinical need, the requirements of the biomedical device, obtaining clarifications as needed, and keeping them up to date regarding progress.

Being aware of and adhering to occupational health & safety requirements during any design, prototyping & test activity.

Exercising sound judgement with regards to the ethical, regulatory, clinical, and professional context of the biomedical and healthcare industries.

Developing an understanding of legal obligations including honesty in authorship of work and ideas, confidentiality during the design process particularly, relating to Intellectual Property protection.
(8) Professional Effectiveness and Ethical Conduct (Level 3)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table 2018.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

(6) Communication and Inquiry/ Research (Level 3)
1. Presenting research to peers through seminars and group discussions.
(8) Professional Effectiveness and Ethical Conduct (Level 3)
2. Effectively collaborating with project stakeholders from outside the engineering domain.
3. Understanding the biomedical engineering industry both locally and globally.
4. Articulating the regulatory, legal, and ethical considerations in relation to biomedical device design and use (e.g. in clinical trials), as well as Intellectual Property issues.
(5) Interdisciplinary, Inclusiveness, Influence (Level 3)
5. Demonstrating the ability work cohesively in a team, integrating inputs from different sources in the pursuit of a design solution.
(4) Design (Level 3)
6. Understanding and being able to plan the biomedical design process, including design iteration and testing protocols.
7. Creating a detailed design brief for a biomedical device that addresses a specific problem, with reference to international standards.
(3) Problem Solving and Inventiveness (Level 3)
8. Using evidence to justify methodological and design choices with reference to prior art.
(2) Engineering/ IT Specialisation (Level 3)
9. Understanding of the therapeutic, rehabilitation, and clinical contexts in which biomedical devices are required to operate, and the role of regulation within these contexts.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Quiz No 10.00 Week 9 3, 4, 6, 8, 9,
2 Assignment - Industry Report No 10.00 Multiple Weeks 3,
3 Logbook No 30.00 Multiple Weeks 6, 7,
4 Design Report Yes 30.00 Week 13 1, 2, 4, 5, 6, 7, 8, 9,
5 Presentation/Seminar Yes 10.00 Week 13 1, 8,
6 Professionalism Yes 10.00 Multiple Weeks 2, 5,
Assessment Description: Quiz: An online quiz covering lecture content up to Week 8.

Assignment - Industry Report: A report on ONE of the industry events held during semester (to be submitted the week after the event).

Logbook: Personal design logbook, which will be assessed fortnightly and at the end of semester.

Design Report: A detailed biomedical device design report, to be developed in a team. Submissions will be progressive. A progress report in Week 8 (worth 10%) will be used to provide feedback for the final report due in Week 13 (20%).

Presentation/Seminar. A team seminar presenting the device design.

Professionalism: Feedback from the project clients and tutors about the team throughout the semester.
Assessment Feedback: Feedback on project progress will be provided during the allocated in-class project work session, based on the progressively submitted reports and logbooks. In addition, teaching staff will be available for consultation outside of these times.

Quiz feedback will be provided via Canvas or in class.
Grading:
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at http://sydney.edu.au/policies . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at http://sydney.edu.au/engineering/student-policies/ for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.
Note on Resources: No textbook. Lecture notes will be provided.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar https://web.timetable.usyd.edu.au/calendar.jsp

Week Description
Week 1 Lecture: Unit Introduction and Meeting your Group
Week 2 Lecture: The Design Process
Week 3 Lecture: Regulatory, Clinical, and Ethical Considerations
Assessment Due: Logbook (progress)
Week 4 Activity*
Week 5 Lecture: Intellectual Property and Commercialisation
Assessment Due: Logbook (progress)
Week 6 Activity*
Week 7 Lecture: Verification and Validation
Assessment Due: Logbook (progress)
Week 8 Lecture: Prototyping and Scaling-Up
Assessment Due: Design Report (progress)
Week 9 Lecture: Clinical Readiness and Deployment
Logbook (progress)
Assessment Due: Quiz
Week 10 Activity*
Week 11 Activity*
Assessment Due: Logbook (progress)
Week 12 Other: Trial Presentations
Week 13 Other: Presentations
Other: MedTech Innovation Competition
Assessment Due: Logbook (final)
Assessment Due: Design Report
Assessment Due: Presentation/Seminar
Pre-Semester Course Orientation module on Canvas.

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Biomedical Mid-Year 2019, 2020, 2018
Biomedical/ Project Management 2019, 2020
Biomedical 2016, 2017, 2018, 2019, 2020
Biomedical / Arts 2019, 2020
Biomedical / Commerce 2019, 2020
Biomedical /Science 2019, 2020
Biomedical/Science (Health) 2019, 2020
Biomedical / Law 2019, 2020
Biomedical/Science (Medical Science Stream) 2019, 2020

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
(6) Communication and Inquiry/ Research (Level 3) Yes 8.75%
(8) Professional Effectiveness and Ethical Conduct (Level 3) Yes 26.5%
(5) Interdisciplinary, Inclusiveness, Influence (Level 3) Yes 8.75%
(4) Design (Level 3) Yes 39.5%
(3) Problem Solving and Inventiveness (Level 3) Yes 10.75%
(2) Engineering/ IT Specialisation (Level 3) Yes 5.75%

These goals are selected from Engineering & IT Graduate Outcomes Table 2018 which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table 2018 for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.