6 points, SCA Band 2, 0.125 EFTSL
Postgraduate - Unit
Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.
- Second semester 2019 (On-campus)
The aim of this unit is to provide an overview of the various aspects of translation and commercialisation of medical technologies in order to provide specific training that is highly relevant to the medical technology industry. The topics covered in the unit include policy and the International and national regulatory environment, medical device reimbursement, bioethics, intellectual property, product development and manufacturing, and health economics. The topics will be taught in part by practitioners who are highly skilled in their fields. The course material will be provided in the form of lectures and analysis of case studies.
On successful completion of this unit, students will be able to:
- Develop a preliminary regulatory and reimbursement strategy for registration of a medical technology in a number of jurisdictions.
- Discuss in detail the key elements of a clinical trial design for medical devices.
- Describe in detail the key elements of how intellectual property pertaining to developments in medical devices, therapeutics and diagnostics are regulated in a number of jurisdictions.
- Critically assess and describe ethical considerations of relevance to the development and commercialisation of medical technologies, therapeutics and diagnostic devices.
- Appreciates heath economic considerations for a medical technology, therapeutic or diagnostic test.
- Critically review the advantages and disadvantages of various development pathways for a medical technology.
NOTE: From 1 July 2019, the duration of all exams is changing to combine reading and writing time. The new exam duration for this unit is 2 hours and 10 minutes.
Continuous assessment: 70%
Examination (2 hours): 30%
Students are required to achieve at least 45% in the total continuous assessment component and at least 45% in the final examination component and an overall mark of 50% to achieve a pass grade in the unit. Students failing to achieve this requirement will be given a maximum of 45% in the unit.
3 hours lectures and applied classes and 9 hours of private study per week.
See also Unit timetable information