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

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode o ...  Show more

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), ...  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 ...

Today's guest is Nishtha Jain, Head of Innovation and Digital Technology at Takeda Pharmaceuticals. Her role expands across Global R&D Quality in driving digital and data initiatives from concept to execution, leveraging emerging technologies and design principles. She joins u ...