You're working within a highly regulated environment related to human health. I haven't been following this specific piece of equipment in detail but according to my scientist wife new lab gear in general requires the hardware, manufacturers have to come in and setup the instrument, give training to staff, run studies (for weeks) to ensure the new instrument performs to specifications. Plus whatever additional mumbo jumbo the government is imposing in this sector.
She said for mass spectrometry the manufacturer actually staffs an ploys on site to physically run and maintain the instrument as it's extremely complicated.
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