Monash University

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Reason: Under embargo until 25 October 2026. After this date a copy can be supplied under Section 51(2) of the Australian Copyright Act 1968 by submitting a document delivery request through your library

Understanding clinical needs and the clinical use case during early medical device innovation using early health technology assessment

posted on 2023-10-25, 07:27 authored by RITESH RIKAIN SATYAJIT WARTY
Medical device innovation (MDI) processes, such as needs determination and developing the clinical use case (CUC), are highly complex. Inadequately defined CUCs are responsible for several of the most significant challenges that medical technology innovators face. Despite this, there are few resources that provide guidance to innovators during these early stages of MDI. Using the action research methodology, this thesis proposes a guide and MDI framework for helping innovators determine unmet needs and develop the CUC. These resources were applied to three real-world case studies. The resulting insights were shown to improve each ventures' strategies, translating to improved venture outcomes.


Principal supervisor

Ben Mol

Additional supervisor 1

Deborah Fox

Additional supervisor 2

Vinayak Smith M M

Year of Award


Department, School or Centre

Clinical Sciences at Monash Health

Additional Institution or Organisation

Obstetrics and Gynaecology

Campus location



Doctor of Philosophy

Degree Type



Faculty of Medicine, Nursing and Health Sciences