Engineering Expert Witness Blog

     Previously we’ve discussed FDA requirements for medical devices as they concern design controls with respect to design and development planning and design input procedures.  We’ll now focus on requirements for Design Output, Design Verification, and Design Review Procedures.

     Design Output and Design Verification Procedures go hand in hand to ensure that design output is properly documented, organized, reviewed, and evaluated in light of design input.  What this means is that medical device companies must scrutinize and evaluate what is going into the design process, then make a comparison to what is coming out.  The design is ultimately verified when all requirements for the medical device as previously set out have been met.

     “Design output” is just another name for work product after major phases of the design project are completed, such as when my wife determined which butter would produce the best pound cake.  Design output typically takes the form of specifications, notes, calculations, computer programs, mechanical drawings, electrical schematics, printed circuit board (PCB) layouts, bills of materials (BOM), mockups, prototypes, test data, and test reports.  These are then utilized by people outside engineering circles to manufacture components and assemble them into a final product.

     Design Review Procedures ensure that the design output is evaluated by others not directly involved in or responsible for the design work product, much as when family members served as a reviewing committee for my wife’s inquiries into taste preferences in pound cake.  Sometimes she’d even ask a friend or neighbor to put their two cents in, and companies, too, will at times go outside and hire consultants to perform this function.  By so doing, unbiased opinions are sought out, in the hopes that this fresh set of eyes will be more likely to spot errors, omissions, and misinterpretations that could prove disastrous if put into play.  Design reviews are typically conducted after each major phase of a design project is complete.

     Just as a recipe that looks good on paper may not necessarily taste good, a device design will often seem to work perfectly on paper, then prove otherwise when its manufacture begins or it’s used in the field.  Ideally bugs are worked out before the product hits production and, later, the marketplace.  Design Validation Procedures make use of prototypes for testing and careful evaluation under simulated or actual use conditions.  Does the design safely meet requirements for intended use?  Does it conform with industry standards?  If not, there’ll be a lot of wasted “dough” going into the trash — pun intended!

     Next time we’ll explore FDA requirements for Design Transfer and Design Changes.  We’ll also talk about procedures for Design History Files.

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