Validation and Contract Manufacturing – The Make or Break Relationship

Bob Marshall, chief editor of Med Device Online, recently published the fourth article in a series of five about medical device development and FDA approvals. In this article, he addresses the importance of validation and manufacturing transfer in the scheme of preparing for FDA inspections. “You have proven your concept, fully specified your design, and verified that the design output satisfies your design input requirements,” he states, “It is time for the most pivotal portion of the product development life-cycle. I like to call this fourth stage; validation/manufacturing transfer.” He calls this phase the dress rehearsal for commercialization.

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Topics: medical contract manufacturing

The Benefits of Co-located Engineering and Manufacturing Teams

Need engineering and manufacturing expertise to bring your product from concept through production? It helps to chose a firm that offers both engineering and manufacturing as part of a total product lifecycle approach. Keeping your project under one roof optimizes invention and mitigates risk during the transition from engineering and design to production. Medical Device Developments spoke with KMC's Mike Kallelis about this very topic.

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Topics: medical contract manufacturing, Total Product Life Cycle, medical engineering

Top 5 Criteria for Choosing a Medical Contract Manufacturer

Top 5 Criteria for Choosing a Medical Contract Manufacturer

If you're a medical instrument company considering medical contract manufacturing service providers for your next project, the following criteria can set you up for a successful partnership. These top five tips will help you to create a list of challenges and concerns and conduct a comparative analysis based on the following: 

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Topics: medical device contract manufacturing, medical contract manufacturing, medical device design and manufacturing

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

There's Still Time To Register for the PCR Instrumentation Webinar!

Webinar: Utility of a Rapid, 6-Color, Randomly-Accessible, Real-Time PCR Instrument

November 11, 2014, 1 pm to 2 pm EST 

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Topics: medical contract manufacturing, medical device development, real-time PCR instruments

Webinar: The Development, Design of Rapid Real-Time PCR Instrumention

Challenge: develop and design a new rapid, real-time PCR instrument with multiple rapid, randomly accessible thermal blocks and easy to use software that provides researchers and laboratory clinician’s flexibility in workflow with results in 20 minutes.

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Topics: medical device design, medical contract manufacturing, medical device design and manufacturing, medical device contract design, medical device development and design, real-time PCR instruments

ERP and Kanbans go together for Medical Device On-Time Delivery

This is the third in a three-part series on how to improve medical device on-time delivery performance.

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Topics: medical device contract manufacturing, medical device manufacturers, lean medical device manufacturing, medical contract manufacturing, medical device on-time delivery performance, medical contract manufacturer, supply chain management

KMC Systems' Top Medical Device Manufacturing Posts of 2013

KMC Systems has had an eventful and successful 2013, and we hope you have, too!

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Topics: medical device contract manufacturer, medical device contract manufacturing, medical device manufacturing, medical contract manufacturing, KMC Systems; medical device; medical device blog, medical contract manufacturers, contract medical manufacturing, medical manufacturing companies

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

KMC’s Lean Medical Manufacturing Philosophy, Practice

Part 1 of a two-part series

Applying its lean manufacturing practices to medical devices and instrumentation, KMC Systems Inc. is achieving significant time-to-market, cost and quality improvements for its customers. “Lean manufacturing helps us trace, create and maintain efficiencies with regards to labor and material expenses,” David Burns, KMC’s assembly manager, explained. “Using lean principles, we are better able to show the customer more accurately what it costs to build and test the device and deliver on that.”

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Topics: medical device manufacturer, KMC Systems, medical device contract manufacturing, medical device lean manufacturing, lean manufacturing, medical device manufacturing, lean medical device manufacturing, medical contract manufacturing, medical device development and manufacturing, lean manufacturing practices