How To Engage Employees in Lean Medical Manufacturing Practices

Part 2 of KMC's "Lean Medical Device Manufacturing" blog series

Aside from the improved cost, time-to-market and quality benefits for KMC customers, the lean medical device manufacturing philosophy in the medical manufacturing process also empowers employees.

 Manufacturing Support Team 

“One of the early concerns with introducing lean practices at KMC was that there may be a reduction in the work force,” David Burns, KMC’s assembly manager, said. “That’s a big misconception. In fact, lean medical device manufacturing actually has the reverse effect. By creating greater efficiencies, there is more opportunity to cross-train and make employees even more valuable to the company and the company more valuable to the employees. The more skill sets an employee has, the more valuable they are.”

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Topics: medical device contract manufacturer, medical device lean manufacturing, medical device manufacturers, lean manufacturing, medical device manufacturing, lean medical device manufacturing

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

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

How to Select a Medical Contract Manufacturer - MPO Roundtable

 At the 4th Annual MPO Symposium hosted by Medical Product Outsourcing (MPO) medical device manufacturers, regulatory, business development, and strategists gathered to discuss and share knowledge and explore outsourcing strategies for improved outcomes.

  

 

The "Building the Bridge Between OEM Design and Outsourced Manufacturing" session was staffed with an impressive panel of representatives and moderated by Ben Dunn, Managing Director of Covington Associates. Some sage advice was offered by one of the panelists, Ron Jellison, Executive Director of Business Development for KMC Systems, Inc. for how to select a medical device manufacturing partner.

Ron identified three key areas to focus on when considering a medical contract manufacturer during the product design phase:

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Topics: medical device manufacturer, medical device contract manufacturer, medical device manufacturers, medical device manufacturing, proven process, medical device, medical device outsourced manufacturer, outsourced manufacturer, proven processes, MPO

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