3 Tips to Find the Best Medical Product Design Partner for Assay Development

You’ve worked non-stop on a brilliant chemistry project that will revolutionize the medical industry and drastically improve patients’ lives.

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Topics: KMC Systems, medical device design, Medical Product Design, medical device development

Medical Device Design Best Practices - Formula for Success

KMC Systems and Farm Product Development collaborate on medical device design - a formula for success

KMC Systems values its collaborative relationships with clients, R&D organizations and engineering consultants outside company walls, viewing these unique engagements as an integral part of the medical device product development process. 

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Topics: KMC Systems, medical device design, IVD instrument development program, In Vitro Diagnostics, Medical Product Design, collaborative innovation, Medical instrument Design, medical device

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

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

KMC's at Next Generation DX Summit

KMC Systems will be attending the Next Generation DX Summit in Washington DC from August 23-25.

Not only can you stop by our booth, Booth #5, for any questions, but we will be presenting as well!

On Thursday August 25, Jack Kessler PhD., one of our Sr. Systems Engineers, will be presenting on how to reduce risk earlier in IVD instrument development programs. 

 

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Topics: IVD instrument development program, Medical Product Manufacturing, Medical Product Design, Medical instrument Design

Strategies for Rapid Medical Device Development

Rapid product development offers an inherent competitive advantage in the field of medical instruments. There are a number of different strategies that have been utilized in order to achieve results in a minimal amount of time with varying levels of success.

Over time, one thing has become clear. In order to streamline the entire process of developing medical instruments, a holistic approach is critical. In particular a holistic approach with focus on technologies, processes, healthcare management and people. Here is a closer look at some strategies for successful medical instrument rapid product development and how a holistic approach can address them.

  1. When the ultimate desire is speed, one strategy is to leverage appropriate off the shelf technologies that will not only reduce the amount of development time needed , but will also have the product features that meets the needs of the end user at a value perceived price point.

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Topics: Medical Product Design, medical device development and manufacturing, medical device development, rapid product development, Medical Instrument Rapid Product Development

Analysis is an important part of rapid product development

Let's Talk About It!

 

What are you doing on March 7th and 8th ?

Hopefully you'll be taking advantage of the plethora of discussion topics and industry networking at the MedDevice Summit in Boston.

KMC Systems Inc. is a sponsor of MedDevice Summit and more importantly we are bringing some of our talented engineers to present as well.

We will be presenting and discussing two topics that will surely be of interest to you:

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Topics: Medical Product Design, rapid product development

Top Five Tips for Medical Product Design Transition to Manufacturing

Successful medical product design transition to manufacturing requires attention to detail to avoid unnecessary costs and schedule delays. Here are several tips and techniques to smooth medical product design transition to manufacturing and ensure products are delivered to market on time and on budget.

 

1) Start the transition process early

The first and perhaps most important tip to smooth the transition from design to manufacturing is to start early. Making changes to the product design once the hand off to manufacturing has occurred will only create additional costs and time delays. 

2) Assemble cross functional teams

Members of these teams must bring to bear a broad knowledge base. Combining their diverse skill sets and areas of expertise enables a holistic approach to device manufacturing and the regulatory approval process. Together, they devise well-defined goals and objectives for each phase of development that minimize manufacturing obstacles and ensure devices and instrumentation adhere to U.S. Food and Drug Administration (FDA) and European Union (EU) regulations.

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Topics: Medical Product Manufacturing, Medical Product Design