Testing IVD Medical Instrument Feasibility During Development
With the priorities of getting to market faster and lowering development costs, KMC obtains critical information early in the IVD medical instrument development process to avoid bottlenecks, interaction conflicts, performance surprises and optimize the best instrument architecture.
By taking the time to listen to the voice of the customer, engaging with users, and performing IVD instrument concept testing, KMC is able to develop a more precise definition of an IVD medical instrument's features and functions. Simulation modeling provides the tools needed to optimize the IVD instrument's architecture during the concept phase and provides confidence that a thorough feasibility analysis was completed.
Specifically, the simulation modeling process unveils instrument behavior that can enhance or hinder architectural development. Optimizing architecture during the concept phase provides many advantages to the instrument development process, such as:
- Compares operational performance tradeoffs (throughput, operator interaction, flexibility)
- Exposes architectural-related deficiencies, process limitations and technical risks
- Uncovers potential surprises in system behaviors and interactions
- Explores different processing and control approaches
- Allows quantitative evaluations of scheduling algorithms
- Identifies cost-benefit tradeoffs
Being able to compare throughput results with successive runs of a high volume of assays enables the modeler to accelerate IVD medical product architectural decisions. Furthermore, addressing the “what ifs” in the architecture evaluation, enables the design team to identify architectural challenges and throughput performance issues early on in the process. Sophisticated algorithms can be incorporated to investigate alternative complex design specifications.
Reducing time-to-market and lowering development costs are critical to successful IVD medical instrumentation development and design. Medical device manufacturers welcome off-the-shelf (OTS) technologies as a viable option to developing new instrument architecture more cost effectively.
KMC Systems has successfully incorporated OTS technologies that provide usable solutions with a broad spectrum of footprints and configurations across many chemistry processes and diagnostic technologies. With the designs proven and verified, KMC has been able to reduce custom development, testing, and integration costs of medical device product development.
KMC’s recent article, “Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process,” published in IVD Technology (January 23, 2013), provided some summaries of cases successfully leveraging simulation modeling in the early design process of medical product design.
One example included a robot which was used to transfer samples between several processing stations. In the first simulation, the robot allowed for a delay in the sample moving from station to station. Another model tested had the robot holding one sample and had each sample being tracked individually. This resulted in a delay in the process, so the model identified that a queuing location was required to make room for an outgoing sample before an incoming second sample should be brought into the receiving station. The simulation confirmed an additional queuing station was needed to achieve the best performance results. The revised design concept resulted in greater throughput performance at a slightly higher development cost. The value being that the customer could decide if the benefit of this improved performance feature was worth the additional cost.
Simulation modeling is simply:
Asking the right “what ifs”
Listening to the user requirements and understanding the interaction with human factors
Evaluating the cost-benefit analysis and alternative design options
Communicating and reacting to all critical performance issues and behaviors
Coordinating and collaborating all simulation and design developments across the design team
Confirming that the performance is aligned with the device’s design objectives and user requirements
KMC explores the alternative architectural solutions in the concept stage of development to achieve optimal design performance and put the best prototype forward. Simulation helps create a platform that allows the developer to exceed initial design specifications and performance objectives and successfully bring medical device instruments to market faster.
To learn more about the ways KMC utilizes model simulation to produce significant bottom line results that improves business plan forecasts, read our two-part blog series:
Part One: “Optimizing Medical Device Design with Simulation Modeling”
and Part Two: “KMC pioneers the use of simulation modeling to reduce medical device design risk and save CEOs money."
For a look at how simulation and concept development fit into KMC's Total Product Life Cycle, You can download our TPLC Chart !