In-Vitro Diagnostics Instrument Value Proposition Validation

Developing a new In-Vitro Diagnostics (IVD) instrument requires a well formed value proposition just like any other new product. Understanding the customer needs by conducting user research and usability testing is a fundamental first step in creating the marketing requirements document for a new IVD platform. The job of the marketer to analyze that data and then specify just the required features, and functions of a new platform that will provide the benefits to support the value proposition can be challenging. And we all know from experience that there have been times when the marketing requirements have included every feature under the sun ! Let’s not be too hard on our fellow marketers for the kitchen sinking method of defining feature/function requirements though because there were no tools to optimize or provide tangible guidance for relevant feature selection relative to cost or associated development risk … that is until now.

KMC Systems has developed custom simulation tools that analyze and optimize IVD platform concept architectures and feature trade offs early in the architecture concept phase. This simulation tool has proven to be very effective in exposing concealed requirements relationships, design conflicts, and technical risks ultimately reducing development and program schedule risk.

Rapid product development can employ virtual prototyping and simulation based design which is commonly used across many different product markets in the design disciplines of mechanicalelectrical, and software engineering. However, simulation used as a systems level tool to optimize IVD platform concept architectures and evaluate features/functions as a part of a robust business case analysis is new.

At a recent MASSMedic In-Vitro Diagnostics Forum, Walter Gilde, Business Development Manager at KMC Systems, presented a primer on the benefits of this simulation tool being used in the development of IVD instrument platforms.

This proven process provides a more robust business case analysis, optimizing parameters before the design begins leading to cost effective instrument platforms and tests. Systems level simulation validating the marketing value proposition just makes sense.

KMC IVD Development White Paper


KMC Systems, medical device design, medical device manufacturing

Topics: medical device design, IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, proven process, rapid product development, in vitro diagnostic device design