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We Were Wrong to Call It a Medical Device

DEV Community·EmoPulse·about 1 month ago
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Earlier this week, I reviewed a pitch deck draft and caught myself: “non-invasive medical-grade biometric sensing.” I paused. That phrase had been carved into every narrative I’d built since day one. Then I remembered what Dr. Vasina told me six months ago, over a crackling EU-to-Chicago Zoom call: “You’re not a medical device. Stop saying you are.” She wasn’t shutting down ambition. She was protecting rigor. And she was right. Most founders, especially in deep tech, chase the halo of “medical.” It sounds authoritative. It implies validation, precision, trust. But slapping a medical label on something that doesn’t meet MDR or SaMD standards isn’t just misleading—it erodes credibility. It invites regulatory landmines. It confuses engineers, investors, and eventually, users. I wanted the prestige without the predicate. Vasina called that out fast.…

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