| “Ask and you shall receive,” like “Make your thoughts known,” have the same objective, to initiate a dialogue between someone with a vision and those who can get the job done. In other words, if you don’t ask for it, you’re probably not going to get it, and the moving force behind it all is communication. Communication is as important in design engineering as it is in marriage.
Last time we learned that a system is a combination of interacting components organized to achieve one or more specific purposes and that communication is a key ingredient in the process. Now let’s see how the systems engineering approach is used within the medical device design process. The systems engineering approach consists of five key stages, the first being Concept. In this stage the objective is to identify all stakeholders, that is, those who have a stake in the outcome, then exhaustively define and capture their requirements. Crucial to this stage is a good line of communication between design engineers and stakeholders. This usually takes the form of brainstorming sessions in which all parties meet to toss around ideas. These ideas eventually solidify into design requirements. Once the design requirements are identified, they are incorporated into the first draft of a working specification. This specification will be written using plain English to minimize any potential misunderstandings. Within the specification each requirement is not only well defined, but traceable back to whoever proposed it. To this end, all requirements are listed in tandem with the names of stakeholders proposing them. Accountability is the main concern here. Next time we’ll talk more about these design requirements, and how they must serve the needs of functionality, performance, and constraint. ____________________________________________
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Tags: constraint, design requirements, design specification, engineering expert witness, forensic engineer, functionality, medical device design, performance, stakeholders, systems engineering
