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

Prerequisites

BIO10004 Anatomy and Physiology
OR
BME20001 Biomaterials and Biomechanics
OR
BME30001 MedTech Design and Innovation

Teaching periods
Location
Start and end dates
Last self-enrolment date
Census date
Last withdraw without fail date
Results released date
Semester 1
Location
Hawthorn
Start and end dates
02-March-2026
31-May-2026
Last self-enrolment date
15-March-2026
Census date
31-March-2026
Last withdraw without fail date
21-April-2026
Results released date
07-July-2026

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
TOTAL150

Assessment

Type Task Weighting ULO's
Oral PresentationIndividual 10 - 30% 1,2,3 
Oral PresentationIndividual 10 - 30% 3,4,5,6 
PortfolioIndividual 10 - 30% 1,2,3,4,5,6 
Report 1Individual 10 - 30% 1,2,3 
Report 2Individual 20 - 40% 3,4,5,6 

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.