Medical and Regulatory Practice
Overview
This unit aims to provide students with an understanding of the regulatory framework around the design and supply of medical devices and therapeutic products. The unit has a strong applied focus including site visits and making use of real-world case studies.
Requisites
BME20001 Biomaterials and Biomechanics
BME30001 MedTech Design and Innovation
Only one of the above units must be completed
01-June-2025
Learning outcomes
Students who successfully complete this unit will be able to:
- Identify the main phases in the development and implementation of medical devices (K3, K4, K5, S1, S2, S3, S4, A2, A3, A4)
- Describe the regulations and standards that apply in the clinical and medical device design and manufacturing environments (K3, K4, K5, K6, S1, S2, S4, A1, A2)
- Identify the risks associated with the various stages of medical device development, including ongoing/post-market monitoring process
- Assess and Appraise quality management processes as used in the clinical and medical device manufacturing environments (K3, K5, K6, S1, S4, A1, A2, A4, A6, A7)
- Evaluate and discuss reimbursement processes in relation to medical devices s (K3, K5, S4, A2, A3, A5)
- Research on and Reflect on case studies of medical device failures and product recalls (K3, K5, K6, S1, S3, A1, A4, A5)
Teaching methods
Hawthorn
| Type | Hours per week | Number of weeks | Total (number of hours) |
|---|---|---|---|
| Face to Face Contact (Phasing out) Lecture | 2.00 | 12 weeks | 24 |
| Face to Face Contact (Phasing out) Tutorial | 2.00 | 12 weeks | 24 |
| Unspecified Learning Activities (Phasing out) Independent Learning | 8.50 | 12 weeks | 102 |
| TOTAL | 150 |
Assessment
| Type | Task | Weighting | ULO's |
|---|---|---|---|
| Oral Presentation | Individual | 10 - 30% | 1,2,3 |
| Oral Presentation | Individual | 10 - 30% | 3,4,5,6 |
| Portfolio | Individual | 10 - 30% | 1,2,3,4,5,6 |
| Report 1 | Individual | 10 - 30% | 1,2,3 |
| Report 2 | Individual | 20 - 40% | 3,4,5,6 |
Hurdle
As the minimum requirements of assessment to pass a unit and meet all ULOs to a minimum standard, an undergraduate student must have achieved:
(i) An overall mark for the unit of 50% or more, and(ii) At least 40% in the first report, and(iii) At least 40% in the second report.Students who do not successfully achieve hurdle requirements (ii) and (iii) will receive a maximum of 45% as the total mark for the unit.
Content
- Phases in the development and implementation of medical devices
- Medical device design and manufacturing environment (regulations and standards)
- Clinical environment (regulations and standards)
- Quality management (historical documentation, traceability, standards, etc.)
- Risk management (risk identification, ongoing/post-market monitoring)
- Reimbursement (cost benefit evaluation, who pays? approval processes and regulators)
- Intellectual property
Study resources
Reading materials
A list of reading materials and/or required textbooks will be available in the Unit Outline on Canvas.