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. 

Read More

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

News: KMC's Walter Gilde is Presenting at Evolution of Advanced IVDs

KMC Systems will be exhibiting and presenting at Evolution of Advanced IVDs in San Diego, California from September 19th-20th. Join Walter Gilde, Business Development Manager, KMC Systems, during lunch on Tuesday September 19 for his presentation on Simulation Reduces Risk Earlier in IVD Instrument Development Programs. 

IVD instrument development programs carry degrees of risks depending on marketing requirements, business value proposition and/or technology maturity. Utilizing an early reliable risk assessment tool is vital to the success of an IVD instrument development program.


Conventional planning processes and tools do not provide sufficient depth of analysis to elucidate all marketing requirements or sufficient insight to discover underlying design shortcomings in proposed concepts. Ideally, one would identify an optimal concept by making early informed feature/function trade-offs.

Read More

Topics: IVD instrument development program, News, Simulation in product development

Lean Manufacturing in situ - Lean Medical Manufacturing

Lean is a Team Effort. Everyone Needs to Be On Board. 

One of the key benefits of a successful lean medical device manufacturing program is the synergistic effect realized from a committed and focused team. In fact without the commitment of the entire team a lean system can fail. It is this interdependency of team members that fuels the team spirit, an essential element of lean medical manufacturing program success.

Let’s talk about lean manufacturing in situ and team …

Back in the day (~480 BC) the famous Greek battleship commander Themistocles gained acclaim for leading the attack and ultimately destroying the Persian fleet. His fleet of trireme ships were of an eloquent design. They provided the superior evasive speed and ramming power to be victorius in the battle of Salamis. 

So one might ask … How did they power this ship?  (hint – this is where the team part comes in). 

The standard warship in Greece at that time was the trireme, a vessel which had three banks of oars with one man to each oar. The total crew of a trireme was about 200, of whom 170 were oarsmen.

Immediately, I’m thinking how did they ever coordinate their rowing  strokes? … especially when the need for course correction was necessary !!

Read More

Topics: medical device manufacturer, KMC Systems, medical device contract manufacturing, medical device lean manufacturing, lean manufacturing

News: KMC Systems is Presenting at Next Generation Dx

 

 

KMC Systems will be exhibiting and presenting at Next Generation Dx in Washington DC from August 21-22. Stop by booth #19 to hear our latest innovations in contract design, manufacture, and field support services for medical devices and instrumentation. 

IVD instrument development programs carry degrees of risks depending on marketing requirements, business value proposition and/or technology maturity. Early simulation has proven effective in exposing concealed requirements, design conflicts, and technical risks. Simulation provides a platform to resolve these issues, revise the concepts, make informed tradeoffs before substantial development expenditures and capital commitments are made.

Join Walter Gilde, Business Development Manager, KMC Systems, on Wednesday August, 22 at 3:05pm for his presentation on Simulation Reduces Risk Earlier in IVD Instrument Development Programs.

Read More

Topics: IVD instrument development program, News, Simulation in product development

KMC Weighs in on In-Vitro Diagnostic Design and Development Trends.


In a feature article by Medical Product Outsourcing (MPO)entitled “More Usable, by Design”, Jim Stommen writes that fewer bells and whistles are included in new in-vitro diagnostic design. He goes on to say that “doing more with less gets the royal treatment and cost-control and functionality reign as King and Queen.”

Read More

Topics: KMC Systems, News, IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical contract manufacturing, proven process, in vitro diagnostic device design, medical device, IVD Business Strategy Conference

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.

Read More

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 
Read More

Topics: medical device contract manufacturing, lean manufacturing, lean manufacturing practices, lean medical device manufacturing

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. 

Read More

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

Read More

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.

Read More

Topics: KMC360, KMC Systems, News