Engineering during the “Fuzzy Front End” of Development

What’s the “fuzzy front end”? It’s the phase between first consideration of an opportunity and when it’s deemed ready to enter a structured development process. A common characteristic of the “fuzzy front end” is the desire to create and evaluate multiple concept alternatives on the road to selecting a single preferred approach. It’s pursuing multiple concepts that often pose a special chicken-or-the-egg challenge for engineering because you: Don’t have a complete design to assess feasibility. Can’t fully assess feasibility without a complete design. This dilemma means engineers must thoughtfully assess competing concepts to identify areas of high risk. They also need to perform sufficient engineering to prove/disprove that a concept can be made to work during a subsequent engineering phase. By nature, we engineers are a cautious lot. But during the fuzzy front end, engineers must balance the need for caution and skepticism with the need to take and accept risk. A well-run fuzzy front end can ensure alignment on communication and acceptance of risk. One valuable tool engineers can rely on during the fuzzy front end is the Concept Failure Mode Effects Analysis or Concept FMEA. Most engineers will be familiar with FMEAs but are used to seeing them used much later in the development process. During the fuzzy front end, the objective of a Concept FMEA is to use the collective wisdom of the design team to identify and prioritize aspects of the design, which ...
Source: MDDI - Category: Medical Devices Authors: Tags: BIOMEDevice Boston Design Source Type: news