Note: This unit version is currently being edited and is subject to change!
HTIN5002: Quality Frameworks for Health Innovation (2020 - Semester 2 Block Mode)
| 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
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| 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: |
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| 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: |
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| Assessment Description: |
Assignments assessing theoretical knowledge from lectures Team projects developing QMS- report submission, team pitches & final presentation (audit) |
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| Grading: |
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| 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.
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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 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.
