Healthcare is a heavily regulated industry and as such only large companies are able to successfully navigate the bureaucracy. The only way to usurp coercive monopolies is by creatively destroying it (e.g. uber)
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.
The regulatory requirements for security and interoperability are all things that every EHR vendor ought to be doing anyway. Regulations aren't a significant obstacle to new market entrants.
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.