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A New Inspection Paradigm

Inertia exists across numerous industries. Medical device manufacturers aren’t the only companies imbued with a sense that, “If we just do things the way we’ve always done them, we’ll be fine.” However, in an age of tightening healthcare budgets and the potential for tough choices to be handed down by governments, healthcare providers and consumers, the firms that survive will be those with the courage to adopt leaner and faster methods that improve quality while cutting costs. One such opportunity lies in different inspection methods.

The medical device industry has been abuzz with discussion of non-contact inspection methods, particularly White Light Scanning (WLS) and Computer Aided Inspection (CAI). This article will outline the technology that underlies WLS/CAI and explain the technique’s ability to:

1.  Increase confidence

2.  Decrease time to market (TTM)

3.  Help make better parts faster

4.  Reduce legal exposure through understanding the process capability in a comprehensive format that is readily comprehended by humans

Traditional inspection methods are closely bound to a FIT --> FORM -->FUNCTION paradigm in which a prototype or sample part is first compared to specified dimensions and GD&T (Geometric Dimensioning & Tolerances) callouts. After a precision manufactured part successfully passes through this first “logic gate,” the surface profile is compared to the nominal geometry from the Computer Aided Design (CAD) model. The part’s functionality is traditionally considered as the final criterion for compliance.

Computer Aided Design Model

With proper preparation, WLS technology can be applied to any material or surface finish, including translucent polymeric bearings. This color-plot illustrates the true part geometry relative to the nominal CAD highlighting GD&T profiles, as a precursor to complete dimensional inspection to the blueprint.