Akeeko Medical’s Leadership Co-Authors Review on Overcoming Barriers to Introducing New Surgical Technologies in Australia
Akeeko Medical is proud to share that our CEO and Co-founder, A/Prof Joseph Ischia, and Head of R&D, Dr Oneel Patel, have co-authored a significant new review paper titled “Barriers to Introducing New Transformative Surgical Technology into Australian Healthcare: A Comprehensive Review and Guide.” The review, led by first author Dr Matthew Alberto, also includes contributions from Dr Jennifer Xu and Prof Damien Bolton, and has been accepted for publication in the Société Internationale d’Urologie Journal (SIUJ), a leading peer-reviewed, open-access journal covering global advancements in urology and surgical technology.
This timely paper addresses the pressing challenges of introducing innovative surgical devices into the Australian healthcare system a complex process involving clinician scepticism, regulatory hurdles, institutional approval pathways, and ethical considerations around patient safety and expectations.
Learning from the Past: The Da Vinci Case Study
The authors explore the implementation journey of the Da Vinci Surgical System, highlighting its transformative promise alongside real-world barriers such as high setup costs, slow public sector uptake, and the substantial education and training burden. Despite these hurdles, the system’s success in the private sector provides valuable lessons for future MedTech innovators.
A Practical Guide to Implementation
A standout feature of the paper is its five-phase implementation roadmap—a practical guide tailored for clinicians, health administrators, and innovators aiming to bring novel surgical devices to market in Australia. These phases include:
Phase 1: Surgical Device Development – From problem identification to prototyping, patents, and feasibility studies.
Phase 2: Regulatory Compliance – Navigating the TGA’s Essential Principles, Conformity Assessments, and ARTG listing requirements.
Phase 3: Clinical Research & Ethics Approval – Gaining HREC approval, obtaining informed consent, and generating comparative clinical evidence.
Phase 4: Launch Readiness – Addressing IP, branding, reimbursement pathways, and preparing applications for the Prescribed List of Medical Devices and Human Tissue Products.
Phase 5: Post-Launch Activities – Focusing on marketing, supply chain management, real-world data collection, and post-market surveillance.
Why This Matters
The authors note that while there is no universal playbook for medical device innovation, the absence of a clear pathway often delays, or derails promising technologies. This paper offers a much-needed, step-by-step reference for navigating the Australian innovation ecosystem and accelerating safe, effective technologies into surgical practice.
Akeeko Medical remains committed to supporting surgical innovation and bridging the gap between technological potential and real-world impact.
