Overview

This unit provides students with knowledge and skills in therapeutic product development to evaluate a products performance in prevention, treatment, diagnosis, and monitoring of the body for health purposes.

Requisites

Prerequisites

Rules

Pre-requisite
MBP10001 Technology and Data Acquisition
OR
ENG10004 Digital and Data Systems

Teaching periods
Location
Start and end dates
Last self-enrolment date
Census date
Last withdraw without fail date
Results released date
Semester 2
Location
Hawthorn
Start and end dates
04-August-2025
02-November-2025
Last self-enrolment date
17-August-2025
Census date
31-August-2025
Last withdraw without fail date
19-September-2025
Results released date
09-December-2025

Learning outcomes

Students who successfully complete this unit will be able to:

  • Describe the use and development of medical devices for biomedical and other scientific measurements, including drug delivery
  • Investigate the similarities and differences in the regulatory environment involved in developing a commercial product, including pre- and post-marketing phases of a potential drug candidate and medical device candidates life cycle
  • Apply principles of research ethics and complete an internationally recognised Good Clinical Practice certificate for participant safety
  • Describe the reporting requirements for adverse events reporting in clinical trials, including those related to the use of an Investigational Medical Device, from unexpected physiological responses to device deficiencies – reliability, safety, performance
  • Differentiate the different kinds of medical devices and critically evaluate clinical trial protocols in the context of the medical device development process

Teaching methods

Hawthorn

Activity Type Activity Total Hours Number of Weeks Hours Per Week
Online Modules 12 12 weeks 1
Live Online Lecture 6 6 weeks 1
On-campus Class 12 6 weeks 2
Specified Activities Various 36 6 weeks 6
Unspecified Activities Independent Learning 84 12 weeks 7
Total Hours: 150 Total Hours (per week): 17

Assessment

Type Task Weighting ULO's
Assessment Individual  10%  3,4 
Class Exercise Portfolio Individual/Group 50%  2,3,4,5
Final Semester Test Individual  40% 1,2,4,5

Content

  • Concepts of biomedical instrumentation
  • Drug & medical device development – regulatory bodies
  • Calibration and standards
  • Electrical safety
  • Medical device lifecycle
  • Clinical trial phases
  • Human research ethics and Good Clinical Practice
  • Similarities/Differences between pharmaceutical & medical device development
  • Adverse event standards and reporting
  • Graduate Attribute – Communication 1 - Verbal Communication 
  • Graduate Attribute – Communication 2 - Communicating using different media 
  • Graduate Attribute – Teamwork 1 - Collaboration and negotiation 
  • Graduate Attribute – Teamwork 2 - Teamwork roles and processes 
  • Graduate Attribute – Digital Literacies 1 - Information literacy 

Study resources

Reading materials

A list of reading materials and/or required textbooks will be available in the Unit Outline on Canvas.