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Fortune
Fortune
Erika Fry

A simple device could prevent thousands of maternal deaths. Why did it take so long to get to market?

Jessie Becker Alexander (Credit: Kevin Fiscus for Fortune)

As she prepared her medical-device startup for a make-or-break clinical trial, one of Anne Morrissey’s first thoughts was, There’s no way we can do this clinical trial.

There were the usual challenges that test any health care startup, including financial worries—did they have enough money to hire a team, train staff, compensate investigators, gather sufficient data? But there were also some uniquely convoluted ones. Like: When and how could they get informed consent from patients on the verge of giving birth?

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