SIUJ, Vol. 6, Pages 49: Barriers to Introducing New Transformative Surgical Technology in Australian Healthcare: A Comprehensive Review and Guide

Société Internationale d’Urologie Journal doi: 10.3390/siuj6040049

Authors:
Matthew Alberto
Jennifer Xu
Oneel Patel
Damien Bolton
Joseph Ischia

Background/Objectives: Introducing new transformative surgical technology involves navigating a complex process from design to implementation, often hindered by various barriers that delay the transition into clinical practice. This review critically examines the barriers, proposes a unified guide for medical device implementation in the Australian healthcare system utilising the validated Medtech Innovation Guide, and compares regulatory frameworks in Australia, the United Kingdom, and the United States of America. Methods: We conducted a literature review using MEDLINE and EMBASE with MeSH terms or emtree terms and keywords “new OR novel” AND “surgical device OR medical device OR health technology OR surgical technology OR surgical instrument OR transformative technology OR technological innovation OR technological change” AND “implementation OR adoption OR innovation adoption” AND “surgery OR surgical” AND “Australia”. We also assessed governmental websites (gov.au) and documents as well as the Royal Australasian College of Surgeons (RACS) website, policies, and position statements. Furthermore, Australian medical technology start-up companies were asked for any published roadmaps. Results: Four key stakeholder groups were identified: medical professionals, government, hospitals, and patients/consumers. Barriers include surgeon scepticism, regulatory hurdles (e.g., Australian Register of Therapeutic Goods), hospital clearance processes, and meeting patient expectations. To address these challenges, we propose a five-phase system: surgical device development (phase one), compliance with regulatory processes (phase two), research and experimentation (phase three), finalisation for product launch (phase four), and product launch and assessment (phase five). Conclusions: By following our five-phase guide, innovators may better navigate the complexities of integrating transformative surgical technologies into Australian healthcare. Although there are limitations, this approach is based on the validated Medtech Innovation Guide and may help both experienced and inexperienced practitioners better implement innovative technology; however, real-world validation is required.

Source link

Matthew Alberto www.mdpi.com