ENG5007 · Translation and commercialisation of medical technologies

Overview

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.

Offerings

The Handbook publishes no offerings for this unit.

Assessment

The Handbook lists an examination for this unit.

Continuous assessment: 70% Final assessment: 30% This unit contains hurdle requirements that you must achieve to be able to pass the unit. You are required to achieve at least 45% in the total continuous assessment component and at least 45% in the final assessment component. The consequence of not achieving a hurdle requirement is a fail grade (NH) and a maximum mark of 45 for the unit.

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

Learning outcomes

1. Develop a preliminary regulatory and reimbursement strategy for registration of a medical technology in a number of jurisdictions.
2. Discuss in detail the key elements of a clinical trial design for medical devices.
3. 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.
4. Critically assess and describe ethical considerations of relevance to the development and commercialisation of medical technologies, therapeutics and diagnostic devices.
5. Appreciates heath economic considerations for a medical technology, therapeutic or diagnostic test.
6. Critically review the advantages and disadvantages of various development pathways for a medical technology.

Workload

The minimum total expected workload to achieve the learning outcomes for this unit is 144 hours per semester typically comprising a mixture of 3-6 hours of scheduled learning activities and 6-9 hours of independent study per week. Scheduled activities may include a combination of teacher-directed learning, peer-directed learning and online engagement. Independent study may include associated readings, assessment and preparation for scheduled activities.

Student experience, not official rules. Nothing here changes what the Handbook says.