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The life sciences industry has long justified slow digital adoption through regulation. But as technology adoption accelerates faster than guidance, that logic is breaking down.
In this episode, Michelle Vuolo and Gilad Langer discuss why speed has become a defining challenge for pharma and medical device manufacturers. Drawing on experience from ISPE, quality leadership, and decades in regulated operations, they explore validation 4.0, cultural resistance to risk-based thinking, and how AI is reshaping quality and compliance work.
The conversation examines what it really takes for life sciences organizations to move faster without losing control — and why waiting for perfect regulatory clarity is no longer a viable strategy
Watch the full episode on YouTube: https://youtu.be/SPJz8_cFYM4
Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone who cares about what the future of frontline operations will look like across industries. This show is presented by Tulip, the Frontline Operations Platform. You can find more from us at Tulip.co/podcast or by following the show on LinkedIn.
Special Guest: Dr. Gilad Langer.
By Tulip4.9
6868 ratings
The life sciences industry has long justified slow digital adoption through regulation. But as technology adoption accelerates faster than guidance, that logic is breaking down.
In this episode, Michelle Vuolo and Gilad Langer discuss why speed has become a defining challenge for pharma and medical device manufacturers. Drawing on experience from ISPE, quality leadership, and decades in regulated operations, they explore validation 4.0, cultural resistance to risk-based thinking, and how AI is reshaping quality and compliance work.
The conversation examines what it really takes for life sciences organizations to move faster without losing control — and why waiting for perfect regulatory clarity is no longer a viable strategy
Watch the full episode on YouTube: https://youtu.be/SPJz8_cFYM4
Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone who cares about what the future of frontline operations will look like across industries. This show is presented by Tulip, the Frontline Operations Platform. You can find more from us at Tulip.co/podcast or by following the show on LinkedIn.
Special Guest: Dr. Gilad Langer.

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