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White Papers / Tech Papers

Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process

How Optimum Architecture Design Enhances the Product Development Process and Product Performance

Released By KMC Systems

Understanding User Needs 

We’ve all seen that classic Tire Swing cartoon that depicts the various departmental interpretations for a tire swing product. Interpretations can vary wildly. The practice of having marketing, engineering, or operations as the sole source for defining new product features and functions not only can yield differing resulting products but, more importantly, this can result in a product that does not meet the customer needs. Human factors and usability are now recognized as critical elements for successful medical product development. Medical product developers of IVD instrumentation must demonstrate and document how considerations for human factors and usability were an integral part of the medical product development process. 

Aside from meeting regulatory requirements, there is a persuading business argument for performing user needs field research and concept preference testing early. Proposed instrument feature and function confirmation can be obtained early in the conceptual stage of instrument development to avoid the potential for costly major redesign iterations and schedule delays downstream. The risk of having poor market acceptance after an instrument launch is greatly reduced by engaging a representative sample of users and “listening” to the voice of the customer. These early interactions with the customer/user provide and vet a more robust definition of the desired instrument feature and functions. 

The quality and clarity of the desired IVD instrument features and functions that result from these early efforts enable the development team to then conceive, analyze, optimize and select suitable hardware/ software architecture solutions. 

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