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

Lean Manufacturing in situ

(Lean Manufacturing Practices in Medical Device Manufacturing)

Employees, a company’s most important asset, must take the initiative to discover opportunities that will create and deliver results-oriented value to their customers.  Studies have shown that employees have a genuine desire to make contributions to the business, but to do so they must:

  • understand the business value proposition
  • be focused on value to the customer and company
  • be empowered in the decision making processes that affects their job 
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Topics: medical device contract manufacturing, lean manufacturing, lean medical device manufacturing, lean manufacturing practices

News: ESA Receives Patriot Award from New Hampshire ESGR

Elbit Systems of America, Inc., (ESA) recently received the Patriot Award from New Hampshire Employer Support of the Guard and Reserve (ESGR).  Employers qualify for recognition when they practice leadership and personnel policies that support employee participation in the Guard and Reserve and in addition, support Guard and Reserve employee families during mobilizations.  To honor those employers who assist their Guard and Reserve employees, ESGR has initiated several recognition programs, one being the Patriot Award. 

The company was nominated for the award by Neil Benson, Plastics Engineer for KMC Systems, Inc., Merrimack, New Hampshire, an Elbit Systems of America Company. As a National Guard Sergeant 1st Class, Benson has served three tours of duty with the United States Army National Guard.  He was deployed to Afghanistan in 2006 and again in 2007 where he was critically injured.  Despite a long and intense recovery, Mr. Benson supported orders received for deployment to Iraq in 2011. 

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Topics: KMC Systems, News

News: KMC Systems is Exhibiting at BIOMEDevice Boston 2012

Join KMC Systems at BIOMEDevice Boston , booth #841, April 25-26, at the Boston Convention and Exhibition Center (BCEC) in Boston, MA.   Learn about KMC360®, the company’s suite of services offered for contract design & development, manufacturing and field support.    KMC relies on its 30+ years of medical industry experience and established methodologies to efficiently design and develop complex products and systems for the in-vitro diagnostic, surgical/therapeutic and laboratory automation markets.

Attend BIOMEDevice, the Industry’s Resource for Medical Product Design and Manufacturing, where KMC Systems, booth # 841 will showcase its comprehensive company capabilities.

 

Click here for your complimentary Exhibit entrance pass

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Topics: KMC360, KMC Systems, News

News: KMC Systems Featured in Medical Product Outsourcing March 2012

 

KMC Systems, Inc. is featured in the article entitled A Diagnosis in Flux.”  of the March 2012 issue of Medical Product Outsourcing (MPO).

Born and Raised in Diagnostics, page 60, highlights the birth of KMC Systems coupled with its management’s perspective in the in-vitro diagnostics space.  Both Ron Jellison, Executive Director of Business Development and Walter Gilde, Manager Business Development, are quoted within the article.

“We have manufactured products that touch virtually every segment of the clinical laboratory – clinical chemistry, immunochemistry, immunopathology, hematology, microbiology, molecular diagnostics, coagulation, you name it, “Gilde said.

Jellison stated, “In the last decade, you really have seen the coming to fruition of a lot of the molecular research into molecular diagnostics with the advent of new amplification methods,” he stated.

For 30+ years, in Merrimack, New Hampshire, KMC Systems has partnered with leading and emerging medical device companies to successfully bring in-vitro diagnostic, surgical, therapeutic and laboratory automation products to market.  Our comprehensive KMC360® program supports OEMs medical instrument needs for design, manufacturing and field support.

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Topics: KMC360, KMC Systems, News

News: Senator Shaheen Visits KMC Systems, Inc.

Senator Jeanne Shaheen recently visited KMC Systems, Inc. an Elbit Systems of America company.  The Senator’s visit to the Merrimack site included interaction with employees along with a tour of the facility.  KMC Systems highlighted the product development and manufacturing services they offer by visiting with development teams and showcasing an automated nucleic acid diagnostic instrument manufacturing work cell.

 Senator Shaheen has been committed to serving the citizens of New Hampshire for decades and is known for her common-sense leadership, hard work and dedication to improving the lives of the middle class.  As the only woman in U.S. history to be elected both a Governor and a United States Senator, she has served in the United States Senate since 2009 and is a member of the Senate Committees on Armed Services, Foreign Relations, Energy and Natural Resources, and Small Business and Entrepreneurship.

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Topics: KMC Systems, News

News: Hope Springs Eternal ...

Welcomed warm rays of sunshine  … tulip bulb sprouts emerging  … returning birds chirping … all obvious signs that spring is now upon us. 

Memories of a friends’ routine reminder about my need to prepare for the opening of fishing season was a familiar sign that spring was here again. I miss those friendly reminders.  Now with the obvious signs of spring, I am reminded of those times and the fish tales we both would tell.

I am intrigued by the analogies of fishing and inbound website marketing … how many hits did you get ? … do you have the right offerings (bait) ? … is your content (chum) attracting the right customer (fish) ? … are you fishing in the right stream ?

Now, my friend would have looked upon this analogy with concern for my sanity, and would have attempted to ground me with more appropriate discussions of the bait that would guarantee landing a “big one” on opening day.

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Topics: KMC360, KMC Systems, News

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

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