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Feb 26, 2026 41 min

Tips on Navigating FDA Pathways for Medical Devices

from The AUScelerate Podcast Hosted by MTPConnect

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.

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What this episode covers

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 specialis...

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Tips on Navigating FDA Pathways for Medical Devices

0:00 41:00

Chapters

  1. 0:02 Introduction
  2. 0:33 welcome Jeff Gibbs
  3. 1:44 Changes to FDA
  4. 3:41 Changes to FDA policy
  5. 7:03 Digital Health Uncertainty And Cybersecurity
  6. 10:54 Why External Regulatory Advisors Matter
  7. 16:31 Pre-Submissions: Purpose And Best Practice
  8. 21:09 Timing Your Pre-Sub And Staging
  9. 23:28 Wellness Claims and Regulated Devices
  10. 27:03 Australian Data And Representativeness VS US Data
  11. 29:18 Regulatory Science Versus Pure Science
  12. 32:04 Home Use diagnostics and therapeutics and digital health trends
  13. 36:03 Insights From Aussie Start-up Consults
  14. 37:11 Top Tips
  15. 40:14 Closing Thanks And Takeaways

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This episode was published on February 26, 2026.

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