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Showing posts from January, 2026

Preventing Medical Electronics Failures: Lessons from the Most Common Safety Issues

Designing electronics is tough. Designing electronics that keep people alive is a whole different ballgame. In the consumer world, if a phone glitches, you just restart it. In the world of Medical Devices Development , a glitch can actually hurt someone. The FDA and European regulators are extremely strict for a reason. Yet, every year, we see recalls and redesigns because of fundamental safety oversights. It isn't always because the idea was bad; usually, it’s because the execution missed a tiny, critical detail. Here are the five most common safety failures that engineers see in the lab. 1. Electrical Shock Hazards (Leakage Current) This is the big one. Electronics run on electricity, and the human body conducts electricity very well. If the internal power isn't properly isolated from the patient, you get leakage current. For a healthy person, a tiny shock might be annoying. For a patient with a catheter in their heart, a few microamps can be fatal. Meeting IEC 60...