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by EpicEng 2725 days ago
It's more nuanced than that. I've spent 13 years working for two successful healthcare/biotech companies, both having attained FDA clearance (one class I and two class III devices) while I was there. I was brought on as the 21st employee and then the 17th employee. At no time could these have ever been considered large companies.

Products like LIMS and hospital systems are hard to replace because of vendor lock in and the cost to replace it all, not regulatory hurdles.