4 Types of FDA Inspections and What They Mean to Medical Manufacturers

There are many different criteria which medical manufacturing companies and medical instrument companies are required to meet for FDA approval. One of these areas is the inspection of medical device manufacturers.  If you are in the medical instrumentation industry, how do you successfully and seamlessly bring compliant medical devices to market? 

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Topics: KMC Systems, Medical Product Manufacturing, medical device manufacturing, medical device design and manufacturing, medical device quality assurance

KMC Engineers Design for Manufacturability to Trim Medical COGS

This is the second in our Reducing Medical Manufacturing COGS series detailing how KMC Systems reduces customer Cost of Goods Sold during the medical device manufacturing process through its Design-for-Manufacturability software. The DFMA® software is just one aspect of KMC's cost-saving Design for X (DFx) process.

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Topics: KMC Systems, medical device design, Medical Product Manufacturing, medical device manufacturing, Reducing your COGS, dfm, design for manufacturability, medical manufacturing COGS, medical manufacturing

KMC's MES and Robust Medical Device Quality Assurance System

This is the second in a three-part series on KMC Systems' medical device quality assurance practices.

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Topics: KMC Systems, Medical Product Manufacturing, medical device manufacturing, medical device design and manufacturing, medical device quality assurance

KMC’s Medical Device Manufacturing Quality Assurance Program

This is the first in a three-part series on KMC Systems' medical device quality assurance practices.

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Topics: KMC Systems, Medical Product Manufacturing, medical device manufacturing, medical device quality assurance, medical product quality assurance

Medical Device Contract Manufacturer Involvement ... When?

Do you struggle with determining when is the right time to involve a medical device contract manufacturer ?

This can be the most important decision in determining whether your product meets all your manufacturing goals and is released to market on time. Ron Jellison, KMC Systems' VP of Business Development, spoke at the 4th Annual MPO Symposium in 2011 to the importance of how to get the medical device contract manufacturer (CM) involved at the right time.

 

"We've been involved as early on as the time the OEM selected the designer where they also made the determination of who the manufacturer was going to be.." Jellison said. He went on to say while this is not the most common model, it can be very effective. This allows the manufacturer to be involved in the design reviews and give input into the design of the product. This makes sure that once the product has been transitioned to manufacturing, the product easily fits the manufacturing and testing capabilities for a smooth production and product launch.

Jellison also touched on a more common scenario; "The most common model is where the CM is selected prior to the completion of the development process. For example, you may have an engineering prototype build, then you may be doing another interim build prior to a release to manufacturing, where you involve a CM. This has been a successful model that has worked for us as well."

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Topics: KMC360, medical device manufacturer, medical device contract manufacturer, KMC Systems, medical device contract manufacturing, Medical Product Manufacturing, medical device, medical device outsourced manufacturer, outsourced manufacturer

How Does a Medical Contract Manufacturer Vet an Opportunity?

Have you ever thought about how a medical device manufacturer would vet a business opportunity?

Vetting a business opportunity is a critical first step in building a relationship between an OEM and a Supplier.


In the October issue of MPO, a feature article written by Jim Stommen entitled "Let the Vetting Begin" offers insight to the early interactions of an OEM and a supplier as they both evaluate the business partnering relationship. This topic was also discussed recently at the 4th Annual MPO Symposium during the "Building the Bridge Between OEM Design and Outsourced Manufacturing" panel session.

Ron Jellison, Executive Director of Business Development for KMC Systems was one of the panelists that offered insight to the vetting process used at KMC Systems, Inc.

"When evaluating a large OEM business opportunity we look at the types of products in their portfolio, the competition in their industry, their product sales/distribution channel, and the alignment of our quality system to theirs. For a start-up company, having confidence with the management team and their technical, financial and schedule objectives is an essential foundation for a successful business partnering relationship. " stated Jellison.

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Topics: medical device manufacturer, medical device contract manufacturer, KMC Systems, medical device contract manufacturing, Medical Product Manufacturing, medical device manufacturing, medical contract manufacturing, Total Product Life Cycle, medical device, medical device outsourced manufacturer

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

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