BMET5992: Semester 2, 2020

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Units BMET5992 Semester 2 2020 [Normal day]

Unit of study_

BMET5992: Regulatory Affairs in the Medical Industry

Semester 2, 2020 [Normal day] - Camperdown/Darlington, Sydney

Overview

Supply of medical devices, diagnostics and related therapeutic products is regulated in most jurisdictions, with sophisticated and complex regulatory regimes in all large economies. These regulations are applied both to manufacturers and designers and to biomedical engineers undertaking device custom manufacture or maintenance in clinical environments. This UoS will explore the different regulatory frameworks in the 'Global Harmonisation Task Force' group of jurisdictions (US, EU, Canada, Japan, Australia), as well as emerging regulatory practices in Asia and South America. Emphasis will be on the commonality of the underlying technical standards and the importance of sophisticated risk management approaches to compliance.

Unit details and rules

Unit code	BMET5992
Academic unit	Biomedical Engineering
Credit points	6
Prohibitions ?	AMME4992 OR AMME5992
Prerequisites ?	None
Corequisites ?	None
Assumed knowledge ?	MECH3921 OR BMET3921 OR AMME5921 OR BMET5921 and 6cp of 1000-level Chemistry and 6cp of Biology units
Available to study abroad and exchange students	Yes

Teaching staff

Coordinator	Gregg Suaning, gregg.suaning@sydney.edu.au
Lecturer(s)	Lisa Emerson, lisa.emerson@sydney.edu.au
Lecturer(s)	Milica Talic, milica.talic@sydney.edu.au

Type	Description	Weight	Due	Length
Tutorial quiz	Quiz quiz	25%	Week 06 Due date: 29 Sep 2020 at 15:00 Closing date: 29 Sep 2020	50 minutes
Outcomes assessed:
Online task	Final Examination examination	50%	Week 11	2 hours
Outcomes assessed:
Assignment	Major Assignment	25%	Week 12	Throughout the semester
Outcomes assessed:
= hurdle task ?

Assessment summary

Quiz: Assessment will be based on ability to correctly answer a set of questions in an open-book, open-note quiz with a time limit.
Assignment: Assessment will be based on final project report and seminar presentation. The submission will include a regulatory strategy report on nominated product to include design and production risks and validations, and premarket submission requirements for global product launch for a nominated medical device or diagnostic.
Final Examination: Assessment will be based on ability to correctly answer a set of questions in an open-book, open-note examination with a time limit.

Detailed information for each assessment can be found on Canvas.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name	Mark range	Description
High distinction	85 - 100
Distinction	75 - 84
Credit	65 - 74
Pass	50 - 64
Fail	0 - 49	When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

Deduction of 5% of the maximum mark for each calendar day after the due date.
After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

5% for each day late after the due date. After ten (10) days, the mark becomes 0.

Academic integrity

The Current Student website provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Weekly schedule

WK	Topic	Learning activity
Week 01	Introduction to instructors, course and assessment. What is a medical device and why regulate – some history and an introduction to global regulations. What is quality and regulatory? Video: The Walking Wounded Tutorial: What went wrong? Common observed problems.	Lecture and tutorial (3 hr)
Week 02	Introduction to regulations and the the regulatory submission. EU, AU, US, CHINA Classification, Technical Files and Essential Principles/Requirements/GSPR. FDA 510(k) and PMA processes. Tutorial: Classifications and Essential Requirements for your device	Lecture and tutorial (3 hr)
Week 03	QMS Part 1: Design Controls - design and development planning, design input, design review, design verification design validation, design transfer, design changes, design history file Tutorial: Determining user needs and translating into requirements	Lecture and tutorial (3 hr)
Week 04	Risk in devices and how to manage them – ISO 14971 and related standards. Tutorial: Determining risk of your device	Lecture and tutorial (3 hr)
Week 05	QMS Part 2: Management, Resources, Doc Control, Issue Management (NCR, complaints, CAPA, audit, data analysis), typical and expected problem solving tools. Tutorial: Solving non-conformances	Lecture and tutorial (3 hr)
Week 06	Quiz	Lecture and tutorial (3 hr)
Week 07	Mid-semester break	Lecture and tutorial (3 hr)
Week 08	OFF SITE: QMS Part 3: Manufacturing Process Controls Medical device careers in Australia (Tour or Virtual Tour of Cochlear Limited)	Field trip (3 hr)
Week 09	The Ventilator Project - Prof Gregg Suaning - High-speed R&D + alternative avenues of meeting regulatory requirements. Tutorial: Lessons learned	Lecture and tutorial (3 hr)
Week 10	Useful technical standards: Electrical Safety, Biocompatibility, Sterilisation, Packaging QMS Part 4: Postmarket. Reimbursement, market acceptance, continuing compliance: adverse events, registries, recalls. Tutorial: Develop a BioC test plan/total test plan for your device	Lecture and tutorial (3 hr)
Week 11	QMS Part 5: Software - software as a medical device, OTS, IT vs QMS, supplier management, manufacturing and process validation Tutorial: Exercise: Software recalls	Lecture and tutorial (3 hr)
Week 12	Assessment due Presentations on assignment	Presentation (3 hr)
Week 13	Assessment due Presentations on assignment	Presentation (3 hr)

Attendance and class requirements

Attendance is required in all activities. Lectures will be a mix of pre-recorded and ‘live’ streaming in 2020. Live streaming lectures are interactive and accordingly require attendance at the prescribed meeting time. Any lecture recordings made available are for revision only and not a substitute for attendance during the scheduled lecture time.

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

Outcomes
Graduate qualities

At the completion of this unit, you should be able to:

LO1. define a timeline and meet deadlines for completion of a complex project
LO2. understand and adhere to standard medical practices and ethical requirements as part of a product formulation
LO3. present findings of a design project in a concise fashion to peers
LO4. formulate a biomedical product and adjust to suit specific requirements
LO5. demonstrate a broad understanding of international regulatory requirements and the technical and engineering basis of these regulations as they relate to the practice of biomedical engineering in both industrial and clinical environments.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1	Depth of disciplinary expertise Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.
GQ2	Critical thinking and problem solving Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.
GQ3	Oral and written communication Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.
GQ4	Information and digital literacy Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.
GQ5	Inventiveness Generating novel ideas and solutions.
GQ6	Cultural competence Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.
GQ7	Interdisciplinary effectiveness Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.
GQ8	Integrated professional, ethical, and personal identity An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.
GQ9	Influence Engaging others in a process, idea or vision.

Outcome map

Learning outcomes	Graduate qualities
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

The 2020 version of BMET5992 is entirely reconfigured from previous versions with new UoS coordinator and guest lecturers from industry.

Additional information

Library access to standards

Additional costs

The unit may involve watching a video that is currently available via Netflix. Students may be asked to sign up for one month (or to use promotional offers) to watch one of the videos to be discussed in the unit. Est. cost: $0 to $15

Site visit guidelines

Should the circumstances permit, a site visit to Cochlear will be arranged. As at the time of writing, this appears unlikely in which case a 'virtual tour' will be given with Q&A with Cochlear staff during the session.

Work, health and safety

Social distancing measures will apply to all in-person (if any) components to this unit insofar as a tangible risk of Covid-19 spreading exists.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Additional costs

Site visit guidelines

Work, health and safety

Disclaimer

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