Stacy Richards

Recent Posts

Manufacturing Readiness Assessment Tool -Are You Ready for Production?

Whether partnering with a medical contract manufacturer or manufacturing in-house, transitioning from product development and design to the manufacturing phase of a project can have many challenges. This Manufacturing Readiness Review Checklist can be used as a transition tool to determine the readiness of a program to move into production.

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Topics: medical device manufacturing, medical contract manufacturing, design for manufacturability, 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

KMC Systems: Elbit Systems of America Named a World's Most Ethical Company

As a wholly owned subsidiary of Elbit Systems of America, KMC Systems is proud to announce that Elbit Systems Of America has been named a 2014 World's Most Ethical Company by the Ethisphere Institute. 

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Topics: KMC Systems

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

3 Technologies Changing Medical Contract Manufacturing Supply Chain

A report1 published by the IBM Institute for Business Value declares that three emerging technologies have the power to transition the world from “a hardware-based to a software-defined global supply chain” and that these technologies will radically alter the nature of manufacturing as we know it. 

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Topics: medical device manufacturer, medical device contract manufacturer, medical device contract manufacturing, News, medical device manufacturing, medical device design and manufacturing, medical device development and manufacturing, medical device development, medical product outsourcing, medical contract manufacturing, software engineering, mechanical engineering, robotics, medical robotics, medical device supply chain management, medical devices supply chain