Five Keys to Safety-Critical Design in Medtech

This article will outline several keys to designing with safety in mind that address some of the most common blunders that threaten the development process. 1. Go Beyond the Standards The United States mandates compliance with standards for the software development lifecycle (SDLC) of safety-critical projects. The standard for the medical device SDLC is IEC 62304. It lays out detailed procedures for documenting and monitoring nearly every aspect of software specification, design, coding, and testing, as well as rigorous standards for oversight, compliance, and certification. In order to ensure safer software, designers need to reach beyond requirement validation and instead rely on the careful application of systematic and incremental steps applied to every level of development. Safe complex systems are only built on top of safe, simpler ones. Relying on the base level compliance standards to ensure safety is asking for trouble as complex systems spiral out of control. 2. Reduce Design Complexity Companies often reward managers who can produce systems under tight schedules and below budget. An emphasis on speed and reduced cost provides incentives to cut corners, fudge data, and ignore small red flags. Turnaround should matter far less than quality. While the focus should never be solely on timing and cost, there are opportunities to reduce spend while improving safety. The greatest improvements are usually seen when design complexity is reduced. This ...
Source: MDDI - Category: Medical Devices Authors: Tags: Design R & Source Type: news