Systems Engineering In Medical Device Design – Finished Design

     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.  

 Systems Engineering Detailed Design Process

Figure 1

     To 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.   


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