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Mei Chen Spent Two Years on an FDA Filing for Soraya. Then the Rules Changed.

Mei Chen submitted Soraya's De Novo FDA filing in November 2024. Six months later, the regulatory environment shifted under her. The story of building women's health AI through the chaos of 2025-2026.

Mei Chen

Soraya

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Bootstrapping Hardware: The Micro-UPS Everyone Dismissed

Founder Storyhardware

6 min read·bootstrapping

Bootstrapping Hardware: The Micro-UPS Everyone Dismissed

Anil Sharma, an immigrant engineer, faced skepticism building a hardware product many called "too small." His vision for Axiom Dynamics wasn't grand-scale disruption, but precision in overlooked pain points—a micro-UPS adapter for commercial systems. This is his story of bootstrapping through doubt.

Anil SharmaAxiom Dynamics

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The real storiesbehind the build.

Mei Chen Spent Two Years on an FDA Filing for Soraya. Then the Rules Changed.

Every story, unfiltered.

Bootstrapping Hardware: The Micro-UPS Everyone Dismissed

Built something worth telling?

The real stories
behind the build.