| I once worked with a medical device design engineer who, although talented enough, was not adept in the subtle yet indispensable skill of verbal communication. He lacked a concise, organized approach to his projects, and his problem solving skills were unilateral and obtuse, that is to say, his only aim was to satisfy his personal requirements, what he felt was important. Creative problem solving and brainstorming with customers as to what they desired did not fall within his repertoire. As a result customer complaints and a long string of product failures eventually led to him losing his position.
Where specifically had he failed? The net result of his approach was that he designed devices that did not deliver the desired customer results. They also had a varying tendency to be either unnecessarily expensive to produce, unreliable to operate, or difficult to service. All concerned with the product were often dissatisfied, from customers to service technicians. This caused the company we worked for to incur considerable expense to rectify his design errors. The company also lost some of their customer base to competitors. Sadly, none of this would have happened if my coworker had used a systems engineering approach in designing his projects.
Before we get any further into a discussion on systems engineering, let’s get a handle on what is meant by a system. In a nutshell, a system is a combination of interacting components that are organized to achieve one or more specific purposes. The components can be tools, machine parts, electronics, people, or any combination thereof. For example, hundreds of parts can be combined by a manufacturer into a system to form a medical device such as an x-ray film developing machine, the end result of which is to produce a film of diagnostic quality.
The system part of Systems Engineering stays true to this definition. It is an interdisciplinary approach to complex engineering projects which guides all activities during the course of a product’s life cycle, from conception to production. While doing so it will integrate and monitor work processes between all departments involved, with a constant eye towards optimization of processes and reduction of costs in order to satisfy stakeholder requirements.
A key objective of systems engineering is to produce systems that satisfy stakeholder needs by producing reliable, cost effective, and safe products capable of performing tasks as designated by the customer. Within the medical device arena stakeholders include patients, nurses, doctors, the US Food and Drug Administration (FDA), device service technicians, device dealers, as well as the device manufacturer.
Next time we’ll begin our exploration of how systems engineering addresses the medical device design process with a discussion on the first of its five stages, known as Concept.
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