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Who hasn’t finished a project, only to discover that you’d done something wrong and the whole thing would need to be redone? Perhaps you hadn’t checked your work along the way, confident that all would be well in the end. Imagine the costs involved if this scenario were to take place on a commercial production line. The Systems Engineering Approach to things helps ensure this doesn’t happen. Last time we wrapped up our discussion on the Production stage of the systems engineering approach to medical device design, and today we’ll cover the final stage, Utilization. The Utilization stage marks the point at which the medical device has been sold and is in actual use in the marketplace. Despite the fact that the product has at this point undergone many reviews and revisions and a great investment has been made into deciding whether or not to put it into production, changes can still take place in its design. Markets aren’t static, and products may be made to change due to stakeholders’, that is, those with a vested interest, changing requirements, whether those are aimed at further cost reduction, or perhaps to implement innovations to make the product more appealing to end users. Other reasons for change may be initiated by the sales and marketing departments. They keep their fingers on the pulse of consumer trends, and they may want the design modified according to market research and feedback they receive from dealers, service technicians, and end users. For example, the sales staff may have been apprised by end users that the keypad to their electronic muscle stimulating device needs modification. Patients have voiced they would prefer to here a clicking sound when depressing the buttons, in order to receive some auditory feedback. In addition, distributors of the device reported that although the electronic stimulators were functioning as intended, end users didn’t like the feel of the buttons. The lack of tactile feedback often led to confusion because they weren’t sure whether they had depressed the button or not. Another interesting discovery concerning lack of feedback was that product service technicians were reporting premature wearing out of the keypads. Absent the satisfying click sound, users were inclined to push on the pads too strenuously, which drove up warranty service costs. The medical device manufacturer’s stakeholders are always concerned with costs, and increased service costs definitely raise the red flag. Considerations like these typically arise after a medical device enters the Utilization stage. Fortunately, the objective of the systems engineering approach is to ensure that stakeholders’ needs are met in view of ever-changing requirements, even after the device has entered the marketplace. No matter what may happen during the life cycle of a product, the systems engineering approach is used every step of the way, from the Concept stage through to Utilization. That ends our discussion on the systems engineering approach to medical device design. Next time we’ll begin unraveling some of the mysteries and misconceptions behind patenting inventions. ___________________________________________
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Tags: buttons, commercial production, concept stage, cost reduction, electronic muscle stimulating device, engineering expert witness, forensic engineer, keypad, medical device design, medical device manufacturer, patenting inventions, premature wear, product life cycle, product service technician, Production Stage, service cost, stakeholder requirements, systems engineering, systems engineering approach, Utilization Stage
