Ep. 4 - Regulatory Efficiency Under Pressure: A Founder-Expert Perspective
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Ep. 4 - Regulatory Efficiency Under Pressure: A Founder-Expert Perspective
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On this episode of MedTech Smarts with Rita, Anna Crooke, Rita King, and Shavini Fernando dive into the realities of bringing a medical device to market. Drawing on Shavini’s journey with OxiWear, a pioneering pulse oximeter, the conversation explores the hurdles of FDA submissions, the pressure of investor expectations, and why early collaboration is critical. The discussion highlights how transparency, strategic planning, and strong partnerships between founders, investors, and regulatory experts are essential to turning innovation into lasting success in the medical device industry.
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