Originally Published MDDI January 2007 PRODUCT DEVELOPMENT INSIGHT
The Value of Design Controls: A Concrete Example
To understand what is wrong with the iterative method of designing medical products, one need only look at the analogy of pouring concrete. Imagine a beautifully constructed sidewalk that is allowed to harden before its first use. The contractor designs it in a perfectly straight line, but doesn’t understand that the users will walk to different destinations and thus will require branches in the sidewalk. The contractor patches the sidewalk to address this need, but the patching introduces several new cracks and flaws that did not exist in the first implementation.
A landscaper eventually looks at the sidewalk and suggests that some gentle curves in the sidewalk would make the garden aesthetically more pleasing. The contractor jackhammers out half the sidewalk, introduces curves (where convenient for him to implement), and asks the landscaper to sign off on the changes. The landscaper doesn’t like where the curves were placed and recommends moving them about 20 feet farther down the sidewalk. The contractor reluctantly obliges, but in the process destroys more of the lawn and introduces more flaws to the patched concrete.
Ultimately, the customer is not happy because the sidewalk has cracks and bumps where the patches don’t join perfectly. The lawn is destroyed, the project took too long, and it all cost more than the contractor’s original estimate. To top it off, the customer wanted a stamped surface on the concrete, not a smooth finish. However, since the contractor did not ask about the finish, the customer didn’t get what he wanted.
When presented with the complaints, the contractor replies that if the customer had simply kept the original sidewalk, there would have been no problems. So is the result the customer’s fault? Is it the workman’s or the landscaper’s fault? Or was it caused by failing to control the quality of the design and development process?
Copyright ©2007 Medical Device & Diagnostic Industry
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