#332: Regulatory Strategy and the Advantage o...

In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The dis ...  Show more

In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore h ...  Show more

Today's guest is Urvashi Tyagi, Advisor and Former CTO at ResMed. Urvashi joins us on today's podcast with Emerj Senior Matthew DeMello to discuss the unique challenges healthcare leaders face in driving software development efficiencies for medical devices and customer-facing ...

In this episode with Doreen Bedrossian Samaha, Global Clinical Application Manager at Erbe Elektromedizin GmbH, we explore the dynamic and evolving landscape of medical technology through the lens of a woman who is making significant contributions in the field. 

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Today's guest is Nishtha Jain, Head of Innovation and Digital Technology at Takeda Pharmaceuticals. Nistha returns to the program to discuss the transformative impact of AI across the pharmaceutical value chain. She and Emerj Editorial Director Matthew DeMello explore how AI i ...