Latest / The Med Device Cyber Podcast
From Idea to FDA Clearance: What Nobody Tells Medtech Founders with Darcy Bachert
Building medical device software is hard. Building it the right way is harder. And getting it through FDA approval while managing cybersecurity requirements? That's what Darcy Bachert has been doing for 17 years.
Darcy runs Prolucid Technologies, an ISO 13485-certified software development firm in Toronto. They work with medtech companies across North America, Europe, and Australia.
And in that time, he's seen the same mistakes repeatedly.
The biggest one? Founders build products that solve problems nobody has. Or they build something physicians won't adopt because it adds complexity instead…
The skinny
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