Medical device recalls are shockingly slow and ineffective. A startup says it has a better wayGuillermo Ramas started.
The current state of medical device recalls is painful to behold. Once a manufacturer issues a recall, it can take an average of two months just for the Food and Drug Administration (FDA) to publish the recall notice on its website.
It can take even longer for products come off the shelves.
In the meantime, these products might end up still being used—with deadly consequences. According to Guillermo Ramas’s calculations, some 600,000 recalled items are still currently on provider shelves, some of which have been recalled over two years ago.
Ramas is the CEO and founder of NotiSphere, a company that wants to facilitate faster recalls.
In 2018 Ramas, who had over two decades of healthcare experience, decided to volunteer for a task force to come up with recommendations to help the FDA improve its recall process.
He had a background in the provider side of healthcare, but hearing about what suppliers went through to issue recalls was eye-opening.
“I realized a lot of these pain points could be fixed with technology,” he said. He came up with the idea for NotiSphere in 2018, and in 2019 was selected for the Cedars-Sinai accelerator.
Ramas chatted with Fast Company about the current state of medical recalls and his vision for a better system. This interview has been edited for length and clarity.
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