Tagged medical-devices
3 pieces
- · 7 min read
Tracker or Model: The Wearable Fork
Two wearables can look identical and be different products. One computes a quantity the sensing can actually resolve; the other infers a quantity it cannot, and covers the gap with a model. The fork is decided when the sensing is chosen, months before there is data, and it determines what you are allowed to claim.
- · 7 min read
What a Regulator Asks About Your Biosignal Front End That Your Bench Never Did
Your bench asks whether the signal looks right. A reviewer asks what the system does when it is wrong, across every unit you will ship, in conditions you did not choose. Those are different questions, and the second one is answered in the analog front end months before there is software to test.
- · 7 min read
Change the Model, Restart the Submission
In most software, retraining is a Tuesday. In a regulated device it can be a regulatory event, and the cost is not the retraining but the clearance cycle it can trigger. That asymmetry should change your architecture, not just your paperwork, because the decisions that determine how often you must retrain are made long before the first submission.