The MTPConnect Podcast

Author: MTPConnect

The MTPConnect Podcast Series connects with the people and the issues behind Australias growing medical technologies, biotechnologies and pharmaceuticals sector.
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Language: en-au

Genres: Health & Fitness, Life Sciences, Medicine, Science

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Tips on Navigating FDA Pathways for Medical Devices
Episode 206
Thursday, 26 February, 2026

If you’re a medtech company looking to take your innovation to the US and want some tips on US regulatory strategy, listen in as this podcast episode is for you.As part of MTPConnect’s support for the Australian Government’s Industry Growth Program, MTPConnect brought US regulatory expert Jeff Gibbs to Australia for a three-city tour for a seminar and workshop ‘Navigating FDA Pathways for Medical Devices’. Jeff is a Director at Hyman Phelps and McNamara – the largest law firm specialising in FDA issues, based in Washington DC, and brings his 40 years of expertise working with companies ranging from global manufacturers to start-ups.Jeff joins the podcast in Melbourne to discuss the device review process, the impact of recent changes at the agency under the new administration, how to get the most from your pre-submission, hot topics like cybersecurity, decision support software, biostatistics and clinical trial design and his top tips for success.