The same problem outside the laboratory

Where this came from

We came to this from the preanalytical phase of laboratory diagnostics: how a specimen is collected, handled and transported before anybody analyses it. Most errors there are made before the instrument is switched on, and almost all of them are departures from an instruction that was written down correctly and then carried out from memory. That is the story on our about page.

The pattern is not medical

A torque figure on an assembly line. An isolation step before maintenance opens a machine. A load check before a lift. A cold-chain handover at a loading dock, where the requirement is that somebody looks, records and acts within a stated time.

Same shape every time: a correct written instruction, a person doing the work from memory under time pressure, and no contemporaneous record of what was actually done. Nothing in that shape is clinical.

So MedNAIS® is not a medical product

It is not a medical device. It does not diagnose, treat or monitor anybody and makes no decision about any patient. Healthcare and laboratories are one of four kinds of work it is addressed to, alongside manufacturing and maintenance, logistics and warehousing, and construction and workplace safety.

This site used to say otherwise on every page — "for labs", "healthcare technology company", a smartwatch described as a "preanalytical phase analyzer". That was our history mistaken for our scope.

A word about the cold chain, since we used to promise it

An earlier article here described MedNAIS Logger: a device with temperature, humidity, vibration and GPS sensors, sending live data over LTE-M with automatic deviation alerts. No such device exists, no part of MedNAIS reads a sensor, and nothing in the product monitors anything in transit.

What the product can do with a cold chain is the procedural half: the steps for a handover, the code of the container scanned, the reading a person takes and types in, the timed wait, and the record afterwards of who did what and when. That is worth having. It is not a temperature logger, and we should not have written as though it were.

Judge it on your own work

The demonstration runs four short procedures — a warehouse, a production line, a laboratory, a building site — without an account. If the shape fits something you do, the rest follows; if it does not, no article of ours should persuade you otherwise.