#332: Regulatory Strategy and the Advantage of Diversity in MedTech

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

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#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling

In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late ...  Show more

#449: 7 Pitfalls of International MedTech Expansion

In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should a ...  Show more

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