In Vitro Diagnostics, Design for Manufacturability: 3 Steps For Successful Transition

For medical engineering teams that are developing and designing in vitro diagnostic products, there are crucial steps in ensuring your products’ design for manufacturability elements are perfected for timely, efficient and compliant production and delivery.

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Topics: ivd product development, medical manufacturing

Innovate: Develop a Fully-Automated Immunoassay Analyzer

When asked to develop the concept for a fully automated, random-access immunoassay analyzer, KMC Systems began the development phase with defining system requirements and conducted user research in order to determine the most important product features. 

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

3 Game-Changing Advancements in IVD Product Development

You know that medical technology advancements to IVD product development reduce cost, increase efficiency and speed time to market.

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Topics: In Vitro Diagnostics, ivd product development, ivd instrument development, ivd medical instrumentation, medical instrumentation development, medical device development

White Paper: 3 Strategies for Assessing IVD Product Development

The importance of having a multi-disciplined approach to IVD medical instrumentation development is outlined in a recently published white paper. In it, KMC Systems engineers, Jack Kessler and Jerry Sevigny, and senior program manager, Spencer Lovette, discuss three key elements in assessing IVD medical product feasibility and how, “assigning marketing, engineering, or operations as the sole source for defining new product features and functions can yield not only radically different products but, more importantly, products that do not meet customer needs.”  


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Topics: IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical product definition, ivd medical instrumentation, IVD medical product development

Testing IVD Medical Instrument Feasibility During Development

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Topics: KMC360, KMC Systems, medical device design, IVD instrument development program, ivd product development, ivd instrument development, Medical Product Design, Medical instrument Design, Simulation in product development, simulation based design, Medical device simulation modeling

KMC Weighs in on In-Vitro Diagnostic Design and Development Trends.


In a feature article by Medical Product Outsourcing (MPO)entitled “More Usable, by Design”, Jim Stommen writes that fewer bells and whistles are included in new in-vitro diagnostic design. He goes on to say that “doing more with less gets the royal treatment and cost-control and functionality reign as King and Queen.”

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Topics: KMC Systems, News, IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical contract manufacturing, proven process, in vitro diagnostic device design, medical device, IVD Business Strategy Conference

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.

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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