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HTIN5002: Quality Frameworks for Health Innovation (2019 - Semester 2 Block Mode)

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Unit: HTIN5002: Quality Frameworks for Health Innovation (6 CP)
Mode: Block Mode
On Offer: Yes
Level: Postgraduate
Faculty/School: School of Computer Science
Unit Coordinator/s: Boughton, Elizabeth
Session options: Semester 2 Block Mode
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: 36cp 3000-level UoS and 70+ WAM
Brief Handbook Description: This unit will allow students from a broad range of technical backgrounds to be equipped with insight and skills which are vital for founding MedTech companies. Students will understand the unique quality, legal and regulatory frameworks within which medical research, clinical innovation and medical device development occurs. The opportunities for innovation abound, however, a higher degree of stringency is demanded compared to general consumer products.

Therefore, a robust quality framework approach is required in order to ensure approval and market acceptance of the device.

The concept of Continual Improvement is at the heart of a MedTech Company and covers all areas of development, production, testing, clinical trials and post-market surveillance.

This subject takes a "bottom up" approach; that is-

*How should technical personnel who are developing a MedTech device ensure their solution is safe, innovative and effective?

*How do we setup quality processes which are ISO13485 and ISO14971 compliant?

*What are the day-to-day documentation requirements?

*How do we ensure good design ideation, design, verification & validation?

*How should an interdisciplinary team of engineers, scientists, IT personnel and clinicians work together?

*How do we manage a MedTech company, and plan it's future?

*How do we develop an effective Intellectual Property strategy?

Good understanding of these practices will lead to innovative solutions which maximise patient outcomes while minimising harm.

This subject is taught by instructors experienced in MedTech startups and larger companies, including a number of industry guest speakers. Engaging activities and class discussions with industry mentors will be a key feature of this course. Practical research and development case studies will be utilised to identify interplay between frameworks and outcomes.

Throughout semester, students will work in teams to develop a Quality Management System for a startup idea, and will undertake a mock audit at the final workshop. Audits will be marked and feedback will be given by an experienced regulatory consultant. This subject will interest students who are keen to start the next Cochlear, Resmed or Optimized Ortho.

Graduating students will understand the central importance of concise, consistent and coherent documentation of activity within quality frameworks to occur on a regular basis. This subject is delivered in block mode, meaning classes are intensive over 4 Saturdays throughout semester. This is the most suitable venture creation subject for Biomedical Engineering and Masters of Health Technology Innovation students.
Assumed Knowledge: None.
Timetable: HTIN5002 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Workshop 8.00 1 3
2 Workshop 4.00 1 1
3 Independent Study 6.00 13
T&L Activities: 4 Intensive Saturday Workshops which include:

Lectures, interactive activities and team work

Throughout semester there is also individual assignments, team work and online activities.

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
Developed through lectures, workshops and assessment. Evaluating Quality and Efficacy. (Level 2)
Developed through practical projects and presentation Managing Practical Implementation (Level 2)

For explanation of attributes and levels see Graduate Outcomes Matrix for Health Technology Innovation .

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.

Evaluating Quality and Efficacy. (Level 2)
1. Understanding the rationale and the practical set up of quality frameworks for research and development associated with health technology innovation
2. Create traceable documentation systems to ensure outcomes of safety and efficacy of health innovation.
3. Understanding how to systematically run and document clinical trials, regulatory pathways and engage with ethical/legal issues
Managing Practical Implementation (Level 2)
4. Communication skills through report writing and oral presentations
5. Analyse potential pathways for IP protection and commercialisation
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Individual Assignments No 50.00 Multiple Weeks 1, 2, 3, 4,
2 Team Pitches Yes 10.00 Week 6 1, 2, 3, 4, 5,
3 Final Group Report Yes 25.00 Week 13 1, 2, 3, 4, 5,
4 Final Group Presentation Yes 15.00 Week 10 2, 4,
Assessment Description: Assignments assessing theoretical knowledge from lectures

Team projects developing QMS- report submission, team pitches & final presentation (audit)
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: IMPORTANT: School policy relating to Academic Dishonesty and Plagiarism.

In assessing a piece of submitted work, the School of Computer Science may reproduce it entirely, may provide a copy to another member of faculty, and/or to an external plagiarism checking service or in-house computer program and may also maintain a copy of the assignment for future checking purposes and/or allow an external service to do so.

Other policies

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.
Recommended Reference/s: Note: References are provided for guidance purposes only. Students are advised to consult these books in the university library. Purchase is not required.

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 2 Lecture: WORKSHOP 1: SATURDAY 11TH AUGUST 9am-5pm

DEVELOPER FRAMEWORK SETUP

Quality as a Health Priority

Interdisciplinary Innovation as a Health Priority

Quality Management Frameworks

Ideation, Design & Development Process, Risk Management

Workshop includes industry speakers, in-class activities & team work
Week 4 Lecture: WORKSHOP 2: SATURDAY 25TH AUGUST 9am-5pm

QUALITY ENGINEERING SYSTEMS IMPLEMENTATION

Infrastructure Setup (Good manufacturing practice, good laboratory practice & procurement)

Verification & Validation

Clinical Trials & Regulatory Affairs

Workshop includes industry speakers, in-class activities & team work
Week 6 WORKSHOP 3: SATURDAY 8TH SEPTEMBER 9am-5pm

LEGAL FRAMEWORKS FOR HEALTH-TECHNOLOGY TRANSLATION

Intellectual Property Management

Traceability & Auditing

Legal Framworks
Assessment Due: Team Pitches
Week 10 Assessment Due: Final Group Presentation
Week 11 WORKHSOP 4: SATURDAY 13TH OCTOBER 9am-1pm

TEAM AUDITS

Teams will have opportunity to complete their assessment.

Team presentations & audit
Week 13 Assessment Due: Final Group Report

Course Relations

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

Course Year(s) Offered
Master of Health Technology Innovation 2015, 2016, 2017, 2018, 2019, 2020
Biomedical Engineering / Law 2013, 2014
Biomedical Engineering / Arts 2013, 2014
Biomedical Engineering / Commerce 2013, 2014
Biomedical Engineering / Medical Science 2013, 2014
Biomedical Engineering / Project Management 2013, 2014
Biomedical Engineering / Science 2013, 2014
Biomedical - Chemical and Biomolecular Major 2013, 2014
Biomedical - Electrical Major 2013, 2014
Biomedical - Information Technology Major 2013, 2014
Biomedical - Mechanical Major 2013, 2014
Biomedical - Mechatronics Major 2013, 2014
Biomedical Mid-Year 2016, 2017, 2018, 2019, 2020
Biomedical/ Project Management 2019, 2020
Biomedical 2016, 2017, 2018, 2019, 2020
Biomedical / Arts 2015, 2016, 2017, 2018, 2019, 2020
Biomedical / Commerce 2015, 2016, 2017, 2018, 2019, 2020
Biomedical / Medical Science 2015, 2016, 2017
Biomedical / Music Studies 2016, 2017
Biomedical / Project Management 2015, 2016, 2017, 2018
Biomedical /Science 2015, 2016, 2017, 2018, 2019, 2020
Biomedical/Science (Health) 2018, 2019, 2020
Biomedical / Law 2015, 2016, 2017, 2018, 2019, 2020
Biomedical/Science (Medical Science Stream) 2018, 2019, 2020
Graduate Diploma in Health Technology Innovation 2015, 2016, 2017, 2018, 2019, 2020

Course Goals

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

Attribute Practiced Assessed
Evaluating Quality and Efficacy. (Level 2) Yes 68.5%
Technical Design & Problem-Solving (Level 2) No 0%
The Health Care Context & New Technology (Level 2) No 0%
Analysis of Complex Systems (Level 2) No 0%
Managing Practical Implementation (Level 2) Yes 31.5%

These goals are selected from Graduate Outcomes Matrix for Health Technology Innovation which defines overall goals for courses where this unit is primarily offered. See Graduate Outcomes Matrix for Health Technology Innovation 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.