University of Technology Sydney

42060 Biomedical Industry Frameworks

Warning: The information on this page is indicative. The subject outline for a particular session, location and mode of offering is the authoritative source of all information about the subject for that offering. Required texts, recommended texts and references in particular are likely to change. Students will be provided with a subject outline once they enrol in the subject.

Subject handbook information prior to 2025 is available in the Archives.

UTS: Engineering: Biomedical Engineering
Credit points: 6 cp

Subject level:

Postgraduate

Result type: Grade and marks

Description

This subject introduces students to the various frameworks, procedures and regulations that are commonplace within the biotech/medical device industry. Students learn to identify standard mechanisms associated with quality systems, regulatory affairs, design processes and risk analyses essential to operating within the industry. Further, they gain skills to apply the relevant tools within each of these areas. Students gain an understanding of regulatory environments both within Australia and overseas. This subject provides a foundation for students to enter the regulated environment of biotech businesses and to operate from an informed position within them.

Subject learning objectives (SLOs)

Upon successful completion of this subject students should be able to:

1. Analyse the biomedical industry regulations to understand the various aspects of health-related systems and products. (B.1)
2. Identify standard mechanisms associated with quality systems. (D.1)
3. Evaluate regulatory affairs, design processes and risk analysis. (B.1)
4. Analyse regulatory environments both within Australia and overseas. (C.1)
5. Present findings to a variety of audiences including stakeholders. (E.1)

Course intended learning outcomes (CILOs)

This subject also contributes specifically to the development of the following Course Intended Learning Outcomes (CILOs):

  • Socially Responsible: FEIT graduates identify, engage, and influence stakeholders, and apply expert judgment establishing and managing constraints, conflicts and uncertainties within a hazards and risk framework to define system requirements and interactivity. (B.1)
  • Design Oriented: FEIT graduates apply problem solving, design thinking and decision-making methodologies in new contexts or to novel problems, to explore, test, analyse and synthesise complex ideas, theories or concepts. (C.1)
  • Technically Proficient: FEIT graduates apply theoretical, conceptual, software and physical tools and advanced discipline knowledge to research, evaluate and predict future performance of systems characterised by complexity. (D.1)
  • Collaborative and Communicative: FEIT graduates work as an effective member or leader of diverse teams, communicating effectively and operating autonomously within cross-disciplinary and cross-cultural contexts in the workplace. (E.1)

Contribution to the development of graduate attributes

Engineers Australia Stage 1 Competencies

Students enrolled in the Master of Professional Engineering should note that this subject contributes to the development of the following Engineers Australia Stage 1 competencies:

  • 1.3. In-depth understanding of specialist bodies of knowledge within the engineering discipline.
  • 1.6. Understanding of the scope, principles, norms, accountabilities and bounds of sustainable engineering practice in the specific discipline.
  • 2.3. Application of systematic engineering synthesis and design processes.
  • 3.1. Ethical conduct and professional accountability.
  • 3.2. Effective oral and written communication in professional and lay domains.

Teaching and learning strategies

Workshop class sessions including interactive class discussions and collaborative activities.
Readings on core topics and assignments.
Case studies.
Students will be able to work in teams and will receive feedback about the progress of their work. Summative and informative feedback will be provided for each assessment task.

Content (topics)

  1. Industry Overview – regulated industries, local and international biotech industry, product types and latest innovations, industry trends
  2. The Design & Development Process – phases of the process, their purpose and intent
  3. Regulatory Affairs and its role in the business – regional bodies, essential principles, requirements for products, gaining approval
  4. Quality Management Systems (QMS) – standards, device control files, quality systems, customer facing systems
  5. Risk Management – definition and importance, standard tools, adverse events
  6. Intellectual Property (IP) – importance, considerations, patents
  7. Ethics – clinical trials, animal testing, gaining customer feedback
  8. Local and USA regulatory markets and regulatory submissions

Assessment

Assessment task 1: Pitch

Intent:

Students to pitch their topic for the project – provides the opportunity to consider the customer needs first rather than the technology solution. Pitching a new MedTech idea, concisely. Defining a MedTech market need, customer, and conducting initial market research.
Objective(s):

This assessment task addresses the following subject learning objectives (SLOs):

5

This assessment task contributes to the development of the following Course Intended Learning Outcomes (CILOs):

E.1

Type: Presentation
Groupwork: Group, group assessed
Weight: 5%
Length:

Time limit = 4 minutes (+ 1-minute Q&A)

Assessment task 2: Design for User Case Study

Intent:

Provides specific case study of “design for user” in medical device technology.
Understanding design for the user, and how it may be considered within new medical technology developments.
Objective(s):

This assessment task addresses the following subject learning objectives (SLOs):

2, 3 and 4

This assessment task contributes to the development of the following Course Intended Learning Outcomes (CILOs):

B.1, C.1 and D.1

Type: Case study
Groupwork: Individual
Weight: 40%

Assessment task 3: Final presentation

Intent:

Provides a complete end-to-end MedTech device development portfolio, from conception of the idea to implementation to market. Group presentation of group work and findings.
To provide an overview of the end-to-end process required to deliver a new MedTech device to market.
Objective(s):

This assessment task addresses the following subject learning objectives (SLOs):

1, 2, 4 and 5

This assessment task contributes to the development of the following Course Intended Learning Outcomes (CILOs):

B.1, C.1, D.1 and E.1

Type: Presentation
Groupwork: Group, group assessed
Weight: 15%
Length:

Time limit = 8 minutes (+ Q&A)

Assessment task 4: Final report

Intent:

Provides a complete end-to-end MedTech device development portfolio, from conception of idea to implementation to market. Individual report is based on group-project topic. To provide an overview of the end-to-end process required to deliver a new MedTech device to market.
Objective(s):

This assessment task addresses the following subject learning objectives (SLOs):

1, 2, 3 and 4

This assessment task contributes to the development of the following Course Intended Learning Outcomes (CILOs):

B.1, C.1 and D.1

Type: Report
Groupwork: Group, individually assessed
Weight: 40%
Length:

15 page limit, including FMEA (plus references & cover sheet).

Minimum requirements

In order to pass the subject, a student must achieve an overall mark of 50% or more.