|
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. ___________________________________________
|
Posts Tagged ‘concept stage’
Systems Engineering In Medical Device Design – Finished Design
Sunday, December 30th, 2012 Last time we opened our discussion on the Development stage of the systems engineering approach to medical device design and discovered that the best design concept is the one that meets all stakeholder requirements. Let’s use the flow chart shown in Figure 1 to illustrate what comes next in this stage.
Figure 1To begin the transformation from concept to completed design, engineers review documentation created during the Concept stage, including design notes, concept sketches, and of course the final requirements specification which has been approved by all stakeholders. Once the review is completed, it serves as a guide to the creation of detailed design documentation, including mechanical drawings, electrical schematics, and wiring diagrams. A bill of materials, or BOM, is also created, listing all parts needed to produce the final product. Each part designated within the BOM is associated with a specific manufacturer or supplying vendor, and each has been qualified with regard to price, availability, functionality, and quality. The design documentation and BOM are also subject to a review by a fresh set of eyes, engineers who have no involvement in the project. If they should discover a problem, the design is rejected and sent back to the design engineers for revision. This process of evaluation and correction are repeated until the design successfully passes a final review. Only then can the fully approved finished design move on to the production stage. Next time we’ll continue our discussion of the Development stage, moving our concept medical device further along its journey to the Production stage. ___________________________________________ |
