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Ep 42: MedTechs's 10X Advantage - How Real-World Data Expands Device Impact
Manage episode 506830123 series 3635820
Summary Pre-market clinical trials are essential — but they don’t reflect how devices truly perform once they’re in the real world. In this episode of Boombostic Health, host Bradley Bostic sits down with Dr. Amelia Hufford, Co-Founder and SVP of Clinical and Regulatory Science at 3Aware, to unpack why real-world data (RWD) is critical to the survival of medical devices — and why mindset, not science, may be the biggest barrier holding MedTech back.
Amelia shares her 20+ year journey in scientific and clinical research, including a decade in MedTech leading regulatory and clinical affairs. She explains how RWD fills the gaps left by clinical trials, supports post-market surveillance, uncovers off-label use, and even opens the door to label expansion — giving manufacturers faster, less costly ways to prove safety and effectiveness.
The conversation dives into the risks of ignoring RWD, the opportunities it creates for innovation and revenue, and how this shift could save one-third of devices currently at risk of disappearing from the market.
What You’ll Learn in This Episode
Why pre-market clinical trials don’t fully reflect everyday device usage.
How real-world data provides insights into broader and more diverse patient populations.
Why manufacturers fear off-label data — and how it can actually unlock new markets.
The importance of treating RWD studies with the same rigor as traditional clinical research.
How RWD can accelerate innovation, improve patient outcomes, reduce costs, and support regulatory compliance.
Why It Matters Without embracing real-world data, the MedTech industry risks losing critical devices — some of which save lives in high-stakes scenarios. By shifting mindset and using RWD with scientific rigor, manufacturers can not only ensure patient safety but also unlock growth opportunities, accelerate label expansion, and meet regulatory demands more efficiently.
Resources & Links
Learn more about 3Aware
Connect with Dr. Amelia Hufford on LinkedIn
Follow Bradley Bostic on LinkedIn
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