KMC Pioneers Medical Device Simulation Modeling To Reduce Risk

This is Part II of a two-part series. See Part I here

By helping medical device developers and OEMs visualize an instrument’s performance  before design even begins, KMC Systems, Inc.’s unique instrument model simulation process helps CEOs create realistic, end-result business plans that save time and money upfront.

KMC Medical Design Simulation

 The simulation process employed by KMC brings together “the best of three worlds”-- marketing, engineering and operations --as a sole source for evaluating and defining product features and functions. Assessing options in a model at the concept stage is faster and less expensive than implementing changes during hardware and software integration.

 

 Why KMC as the “model experts” ?

Based on the vision of Spencer M. Lovette, KMC program manager, who foresaw a way for bringing the simulation modeling expertise used in other industries to diagnostics, KMC’s approach cannot be easily duplicated.    

“Anybody could use a model simulation tool, but you need to have the people who know how to use the tool to bring value,” Lovette noted. “KMC has 35 years of experience with executing multiple and varied medical device development efforts consistently every year.”

KMC engineers are “expert modelers” who know how to apply the appropriate level of modeling detail suitable for each feature/function to evaluate an architecture selection for concept verification. Further model refinement then provides a concept baseline from which the instrument performance parameters establish design input specifications. (See part one of blog series).

“There is a gap in the medical instrumentation development process---people hurry to create instruments to do a certain function, but they are not always sure it will satisfy performance criteria and throughput targets until hardware is built,” Lovette explained. “It is more efficient to optimize concepts and address all architectural questions and issues before committing resources to the project. The simulation models are built to demonstrate the way the device will precisely work using specific events with cause-and-effect scenarios.”

Placing engineers upfront in the process helps validate the requirements definition and conceptual ideas so the business and development goals are on the same page.

“We bring a rational design approach married to marketing,” explained Jack Kessler, Ph.D., KMC senior principal systems engineer.  “We are the pioneers in bringing this level of simulation modeling to the diagnostic market.  We help CEOs reduce or eliminate risk potentially saving millions of dollars.  Model simulation is a modest cost way to buy insurance and demonstrate rigorously that the feature function sets of a product are valid.”

 

Beyond a spreadsheet

The KMC model simulation approach exceeds the ability of linear tools like spreadsheets by confirming overall timing and throughput requirements, then generating the requirements which serve as the design inputs for each subsystem.

Equally important, KMC can add a valuable upfront user research component with an early interaction communication process. By engaging a representative sample of users and “listening” to the voice of the customer, KMC can help its clients reduce the risks of poor market acceptance after an instrument is launched.  This critical communication step also provides a more robust definition of the desired internal features and functions.

Especially useful for the design of medium- to- advanced products, where multiple processes are occurring simultaneously or in parallel, KMC’s rigorous model simulation tools and processes improve a customers’ bottom line by:

  • assessing feasibility of new medical devices at early stage in the development process, before unnecessary designs or products are created
  • minimizing design changes, saving development deployment costs
  • accelerating products to market
  • meeting the user’s needs at a reasonable cost

 

Markets

KMC’s unique approach to medical instrument model simulation was well received last month when Walter Gilde, business development manager at KMC, presented its numerous benefits to those in the in-vitro diagnostic industry, a key market segment for the company.  Gilde, who has been with KMC since 1996, has more than 30 years of diagnostic instrumentation experience in the life science and in-vitro diagnostic industries.   

The pioneering of medical instrument model simulation during the business planning phase of a new product is just one way that KMC is leveraging its depth of experience and innovation by providing leading-edge product development services to the medical diagnostics industry.

This is Part II of a two-part series. See Part I here  

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Topics: KMC Systems, medical device design, IVD instrument development program, proven process, Medical Instrument Rapid Product Development, medical device, Simulation in product development, simulation based design, Medical device simulation modeling