He is responsible for building partnerships and expanding market access for domestic and international companies, governments, and institutions at AUScelerate. With a background in the life sciences sector, he has extensive experience in international collaboration and supporting companies’ market entry strategies, including partnerships with Korean organizations such as KHIDI.

This presentation introduces key characteristics of the Australian medical device market, including its market size and import dependent structure—factors that make Australia an attractive market for Korean medical device companies. It will also examine Australia’s market entry environment, public and private procurement systems, and distribution pathways, and explain the strategic value Australia can offer within a broader global market expansion strategy.

He is a global medical device regulatory expert with more than 30 years of experience in MedTech. His background includes serving as a medical device evaluator at the TGA, a CE Lead Auditor at TÜV SÜD, and working within Canada’s medical device regulatory authority. He has collaborated with the FDA for over 30 years and currently contributes as a technical advisor to the TGA on AI and SaMD regulatory matters.

This presentation examines the similarities and differences between Australia’s medical device regulatory framework and Korea’s system, as well as the role of TGA and MFDS within IMDRF and the broader environment of international regulatory harmonization. It will outline strategic pathways for Korean companies entering the Australian market, including practical approaches such as pre submission consultation with the TGA. The session will also discuss how Australia’s regulatory system can be leveraged as a strategic stepping stone for global market expansion.

He is the Co Founder and Clinical Director of Mobius Medical, a specialized CRO conducting clinical trials for medical devices, pharmaceuticals, and biotech companies in Australia, New Zealand, and the United States. He supports global market entry strategies by overseeing early stage clinical trial design, protocol development, site selection, project management, and regulatory reporting, leveraging extensive experience in generating clinical evidence for innovative technologies.

This presentation introduces Australia’s fast and efficient clinical trial environment and how Korean medical device companies can leverage it for global market entry. It will cover clinical trial design aligned with regulatory pathways in major markets such as the United States, strategies for generating robust clinical evidence, and the strategic advantages offered by Australia’s R&D incentives and clinical infrastructure in accelerating global commercialization.

To be updated

Drawing on Lunit’s global market expansion experience, this session explores overseas commercialization strategies for medical AI. In particular, it highlights the breast cancer screening program conducted in New South Wales, Australia, and discusses key insights for global expansion.