What are the Five Keys to Safety-Critical Design in Medtech?
MD&DI says: In the 1980s, the Therac-25 radiation therapy system exposed a group of six patients to 10,000% more radiation than was prescribed due to a simple data entry mistake. The error resulted in at least three deaths. The incident demonstrated the extremely high stakes for medical device manufacturers – missteps are measured in people injured or killed and often result in lawsuits and endless litigation. The now infamous Therac-25 example highlights the care that must be taken when designing for the medical industry and the importance of approaching the process with a safety-centric perspective that extends beyond basic compliance.