Introducing Medical Devices to Market with the Help of Systems Engineering

Ensuring successful introduction to market is no small feat. Product development first starts with accurately documenting requirements prior to design, which secures the developed product will meet the intended use. 

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This is a leading role in medical device development, which systems engineering masters.  KMC Systems has developed a Systems Engineering team that provides a wealth of cross-functional expertise – to create cost effective, manufacturable and compliant designs.

KMC's system engineers coordinate this activity and perform system-level analysis of critical functions and performance. This analysis can include the following:

  1. system timing and throughput
  2. feature/instrument performance simulation
  3. critical interfaces and tolerances
  4. thermal/optical performance
  5. process control tolerances and algorithms
  6. error-handling
  7. alignment/calibration

In addition to performance analysis, systems engineers also analyze the risk management of a medical device. Performing this analysis, KMC meets compliance standards.  The risk management process is relevant through the entirety of device development, starting at the onset of product design, carrying through development into production and all the way into post-market. Hazard analysis includes techniques such as Failure Mode Effects and Criticality Analysis (FMECA or FMEA) and Fault Tree Analysis (FTA).

Through the understanding of the Total Product Lifecycle from initial concept to completion of the medical systems we design, we can rapidly identify any potential safety or error use risks.

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After identifying such risks, KMC's systems engineers create industry-recognized processes to mitigate the risks. Our detailed quality and risk management process with integrated hazard analysis meets the requirements of the FDA’s Quality Systems regulation and respective International standards.

Following these industry best practices, our systems engineers are able to successfully introduce medical devices to market.  To find out how mechanical, electrical and software engineers integrate processes for successful manufacturing projects

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Topics: medical device design, medical device design and manufacturing, medical device quality assurance, Systems Engineering