US Export Opportunities & Tariff Insights Webinar
This webinar brings together key trade and regulatory experts to unpack recent changes impacting Australian medical technology companies seeking to enter or grow in the US market. With new tariffs and regulatory updates reshaping the landscape, this session will provide timely insights and practical pathways for navigating these shifts.
Background
The USA has traditionally been the first ‘go-to market’ for Australian early-stage, growth, and expansion-stage medical device companies. Aside from the sheer size and value of the US healthcare market, the 2005 US-Australia Free Trade Agreement (USFTA) facilitated trade in medical devices by reducing or eliminating tariffs, improving transparency in government procurement, and promoting regulatory cooperation between the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The FDA regulatory framework was relatively well understood in terms of various approval pathways.
Objective
- To provide up to date insights into the challenges for AU medical device export companies created by the new tariffs regime and changes to the FDA.
- To enable AU medical device export companies to explore alternative market entry and access pathways.
- Practical strategies for market access, entry, and manufacturing validation in the US.
Learn Outcomes
- How recent US tariff changes could impact your business
- Practical strategies to manage export regulations
- Key insights to unlock growth opportunities in the US market
This event is highly relevant for both emerging startups and established MedTech companies.
Featured Speakers
- Tara Booth, Assistant Secretary, US Trade Taskforce – Department of Foreign Affairs and Trade (DFAT)
- Gabrielle Hall, Consul-General and Trade and Investment Commissioner, Houston, Austrade
- Stuart Elliott, Executive Director – Planet Innovation
- Cornelia Rooks, Senior Regulatory Specialist, Registrar Corp
Free webinar for members and non-members.
Additional Information
Speaker Profiles
Tara Booth, Assistant Secretary, US Trade Taskforce – Department of Foreign Affairs and Trade (DFAT)
Tara Booth is Deputy Lead of the US Trade Taskforce in the Australian Department of Foreign Affairs and Trade.
Tara is an international trade lawyer, negotiator and diplomat. She is an experienced litigator with expertise in World Trade Organization (WTO) dispute settlement.
Tara has completed a posting to Australia’s Permanent Mission to the WTO in Geneva as Legal Counsellor and represented Australia in trade negotiations, including the ASEAN-Australia-New Zealand Free Trade Agreement and the China-Australia Free Trade Agreement.
Tara holds a Masters of Law from the University of Queensland and a Bachelors in Arts and Law (Hons.) from Queensland University of Technology.
Gabrielle Hall, Consul-General and Trade and Investment Commissioner, Houston, Austrade
Gabrielle is Australia’s Consul-General and Trade and Investment Commissioner to Houston, Texas. Her current sectors of focus include energy, health and space and consular remit covers the USA’s southern states of Texas, Oklahoma, Arkansas and Louisiana.
Prior to landing in Houston, Gabrielle most recently worked in Austrade’s Investment Division focused on attracting productive foreign direct investment from the Americas Region to Australia. She has also previously been A/g Trade Commissioner in Santiago, Chile and completed short-term assignments with Austrade in Mexico (2019) and Colombia (2016).
Gabrielle also has deep trade experience having supported a broad range of Australian exporters with their international strategies, through her time in Austrade’s Trade Division.
Prior to joining Austrade, Gabrielle worked as a locally engaged staff member for the foreign governments of Uruguay and Chile in Australia.
Gabrielle has an energetic toddler, and speaks fluent Spanish.
Stuart Elliott, Executive Director – Planet Innovation
Stuart is a co-founder of Planet Innovation, a leading healthtech innovation and commercialisation company. He works with global MedTech companies to bring medical devices from concept to market, with strong experience in US regulatory and manufacturing environments.
Cornelia Rooks, Senior Regulatory Specialist, Registrar Corp
Cornelia Rooks holds a Bachelor of Science in Biology and a Master of Arts in Health Care Management. She is currently a Senior Regulatory Specialist at Registrar Corp, where she helped bring medical products under Registrar’s FDA purview. During her career, she worked in psychopharmacology research, taught Physical Science, and held various roles in the Federal Government. After joining the FDA, she worked in the Center for Biologics Evaluation and Research (CBER) as a Scientific Reviewer and Inspector, focusing on Blood and Blood Products. She also worked in the Center for Drug Evaluation and Research (CDER) in Adverse Event Reporting and lastly within the Center of Devices and Radiological Health (CDRH). There she was a Scientific Reviewer and Branch Chief within the Office of In Vitro Diagnostics (OIVD) whose responsibilities were premarket submission reviews to include but not limited to Premarket Notifications (510ks) and Premarket Approvals (PMAs) as well as post-market activities. Mrs. Rooks represented CDRH as Executive Secretary of the Clinical Chemistry and Clinical Toxicology Advisory Panel as well as CDRH representative to the Good Guidance Practices Taskforce. She concluded her FDA career as Division Director overseeing Risk Communication and Human Factors Engineering teams for medical device reviews. These teams worked with scientific reviewers within CDRH to evaluate use-related risk analyses, human factors/usability information and validation study data submitted as part of various types of premarket and post-market submissions.
