White Paper: 3 Strategies for Assessing IVD Product Development

The importance of having a multi-disciplined approach to IVD medical instrumentation development is outlined in a recently published white paper. In it, KMC Systems engineers, Jack Kessler and Jerry Sevigny, and senior program manager, Spencer Lovette, discuss three key elements in assessing IVD medical product feasibility and how, “assigning marketing, engineering, or operations as the sole source for defining new product features and functions can yield not only radically different products but, more importantly, products that do not meet customer needs.”  


1. A team approach to early definitions in IVD device development saves time, iterations Design for manufacturability. Defining human factors and usability requirements in the development stage of a project are critical elements to successful IVD medical product development, design and manufacturing. Evaluating feature and function early in the conceptual stage of IVD instrument development enables IVD medical product developers to avoid costly iterations, major redesigns and schedule delays downstream. The quality and clarity of IVD instrumentation features and functions that result from early definition allow development teams to “conceive, analyze, optimize, and select suitable hardware and software architecture solutions.”

2. Optimizing in-vitro diagnostic hardware and software architecture facilitates successIn the IVD white paper, Lovette, Kessler and Sevigny demonstrate that, “it is increasingly expensive to modify architecture as instrument development progresses. Therefore, optimizing architecture during the concept phase is critical to rapid and low-cost IVD product development.” Here are the four key steps to optimizing hardware and software architecture:
  1. Evaluate multiple candidate architectures

  2. Identify unforeseen surprises

  3. Facilitate architecture refinement 

  4. Enable evaluation of control schema

3. Simulation during IVD instrument development reveals bottlenecks

By enhancing a simulation model to accurately reflect the processes of an instrument, potential bottleneck issues and interaction conflicts are uncovered before the design process even begins. KMC performs simulation via a computer-based model in a manner that mimics the proposed system architecture to:

  • Describe the interaction between samples, reagents and disposables

  • Define required resources such as sample and reagent racks, ovens, pipettors, transports, detectors

  • Determine required activities such as washing, heating, detecting and mixing

How has advancing technology helped to propel success for the IVD medical instrumentation manufacturer? “The architectural complexity of real systems frequently exceeds the analytical ability of linear tools such as spreadsheets,” the article states, “simulation can confirm overall timing and throughput requirements and generate subsystem timing requirements, which serve as the design inputs for each subsystem.” The white paper provides deeper detail and specific examples of the insight and accuracy that can be achieved via simulation.“Simulation serves as virtual laboratory to develop and evaluate control schema. As with most sophisticated tools, results are highly dependent on the experience of the user. An expert modeler applies the appropriate level of detail to each objective from architecture selection through refinement, concept verification and generation of design input specifications. It is advantageous to field a dedicated, experienced staff of specialists to ensure the level of expertise required for the best results.”Off-the-shelf solutions reduce the cost of design iterationsLovette, Kessler and Sevigny stress the role of OTS solutions in IVD medical product development and design. “OTS components and systems can reduce the cost of design as long as the feature sets meet the design requirements. KMC Systems has experience with many vendor-based OTS products and has successfully integrated them along with complementary custom solutions. We have developed a family of KMC OTS solutions that provide scalable, flexible modules for diagnostic instruments with different footprints and configurations across many chemistry processes and detection technologies.”For more details on the Three Stategies for Assessing IVD Instrument Feasibility Early in the Design Process and benefits to optimizing hardware and software architecture during IVD medical product development download the IVD white paper. 
To learn more about KMC Systems IVD product development and IVD medical device design, download the IVD White Paper: 
KMC IVD Development White Paper

Topics: IVD instrument development program, In Vitro Diagnostics, ivd product development, ivd instrument development, medical product definition, ivd medical instrumentation, IVD medical product development