Testing IVD Medical Instrument Feasibility During Development

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

Medical device design and manufacturing partner supports IVD trends

KMC Systems, Inc. is dedicated to protecting and saving lives through advancing health care technologies that help people on more personal and customizable levels.  Working closely with OEMs and start-ups, KMC Systems continually pioneers innovative solutions to meet the increased medical device design and manufacturing market demand.

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Topics: KMC Systems, medical device design, IVD instrument development program, In Vitro Diagnostics, ivd instrument development, medical device design and manufacturing, medical device, proven processes

News: KMC Systems Welcomes Laboratory Automation Professionals to SLAS 2013

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Topics: KMC360, medical device manufacturer, medical device contract manufacturer, KMC Systems, medical device contract manufacturing, News, medical device design

KMC Engineers have "The Knack" ... and a rich life beyond the cubicle

 Posted by Patty Duffey and Gail Jones

October 23, 2012

Engineers are sometimes lightheartedly teased for their intense and intuitive focus on solving or fixing mechanical and electrical things, as mimicked here in "The Knack." Yet, many of our engineers also excel at taking on new challenges and activities beyond work with confidence and ease.

From home schooling four children, coaching and building their own homes to beekeeping, gardening and wine-making, KMC Systems, Inc.'s engineers engage in a multitude of other pursuits.

The company’s policy of every other Friday off enables many to expand upon their external interests. Some believe their life outside of work makes them even more productive at their jobs.

Below is a glimpse of four employees who bravely shared how they use their time off to the fullest extent. Collectively, they have more than thirty hobbies and each is passionate about both their professional and personal lives.

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Topics: Medical Instrument Rapid Product Development, KMC360, IVD instrument development program, Medical instrument Design, KMC Systems, medical device design

KMC Pioneers Medical Device Simulation Modeling To Reduce Risk

This is Part II of a two-part series. See Part I here

By helping medical device developers and OEMs visualize an instrument’s performance  before design even begins, KMC Systems, Inc.’s unique instrument model simulation process helps CEOs create realistic, end-result business plans that save time and money upfront.

 The simulation process employed by KMC brings together “the best of three worlds”-- marketing, engineering and operations --as a sole source for evaluating and defining product features and functions. Assessing options in a model at the concept stage is faster and less expensive than implementing changes during hardware and software integration.


 Why KMC as the “model experts” ?

Based on the vision of Spencer M. Lovette, KMC program manager, who foresaw a way for bringing the simulation modeling expertise used in other industries to diagnostics, KMC’s approach cannot be easily duplicated.    

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Topics: Medical Instrument Rapid Product Development, IVD instrument development program, medical device, proven process, KMC Systems, medical device design, Simulation in product development, simulation based design, Medical device simulation modeling

The 7 Cs in Simulation Modeling for Medical Device Design

How important is simulation modeling in the medical instrumentation and laboratory diagnostic industry? This dynamic process helps medical device manufacturers and OEMs mitigate risks, accelerate time-to-market, create better products and reduce development and deployment costs. The businesses that embrace the power of the technology will have an easier time remaining competitive in the medical product marketplace.
This is the first of a two-part series. See Part II here. 

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Topics: Medical Instrument Rapid Product Development, KMC360, Medical instrument Design, medical device, KMC Systems, In Vitro Diagnostics, medical device design, simulation based design, collaborative innovation, in vitro diagnostic device design, medical contract manufacturing, ivd instrument development

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

Is Your Medical Device Design Ready for Manufacturing?

Successful medical device design follows a proven process that complies with the applicable regulatory standards. ISO 13485 requires that a comprehensive management system be established and maintained to monitor and control/mitigate risks from product inception through design transfer and into production, referred to by the FDA as Total Product Life Cycle (TPLC). There are various stage gate reviews during the TPLC with the Manufacturing Readiness Review being the final gate for the design transfer to production.

By the time a medical device design is ready to transfer to a medical manufacturing/production environment, many if not all of the identified risks should have been eliminated or mitigated (i.e. by design, process control, labeling). The design history file is complete with supportive verification testing data and the documentation to procure, fabricate, tool, build, and test has been released in support of a production lot build. But ... are you ready ?

manufacturing readiness review is a key tool of a proven process that provides the insight to determine whether the output of the design process coupled with the manufacturing, supply chain, and quality team preparedness meet all the requirements to move to a production manufacturing environment.

Moving through this gate without completing all the elements could cause costly engineering changes, rework and product recalls in the future. Moving too slowly through this gate could cause product launch delays and potentional erosion of market share. This is why a well planned and executed medical product development process with meaningful medical product design stage gates/reviews which culminate in a manufacturing readiness review will lead to a smooth transfer from medical device design to production.

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Topics: Medical Product Manufacturing, Medical Product Design, medical device design, medical device manufacturing, medical contract manufacturing