As the complexity of medical devices grows, so does the complexity of the hardware, software, and number of lines of code. The FDA sets rules and guidelines to help insure that quality products enter a market, but the burden and risk assessment duty falls upon the product owner. With the pressures of getting your device to market quickly, how can you manage the quality of a product while ensuring a well thought out risk assessment?
There is a potential solution to this problem, and a more strict testing and review process is not necessarily the answer. Ensuring the quality and reliability of a product requires a strong understanding and use of software engineering practices, even as a hardware designer. Software engineering generally refers to a regimented and procedural methodology for designing, developing, and testing code. While multiple-process models for software engineering have emerged over the years, they almost all describe specific phases and criteria that must be met before moving on in the life-cycle process.
The following list describes practices from within the software engineering process for engineers developing medical devices. Off-the-shelf tools and software engineering practices merge with hardware elements, such as field-programmable gate arrays (FPGAs), in many medical designs. This article looks at the process, procedures, and tools including:
•Defining a process
•Using a change management system
•Leveraging FPGAs for critical components
•Separating prototypes from development
•Using prototypes to derive specifications and requirements
•Managing and tracking requirements traceability
The article "Leverage commercial off-the-shelf tools to create verifiable hardware and software solutions" examines these issues in greater detail; it originally appeared at Medical Electronics Design.
About the author
Carlton Heard is a Product Engineer for Embedded Systems at National Instruments, with a focus on NI CompactRIO and NI Single-Board RIO. He joined NI in 2007 in the Engineering Leadership Program (ELP) and then transitioned to the Application Engineering Specialist group where he focused on machine vision, industrial robotics and FPGA applications. Heard holds a bachelor’s degree in aerospace and mechanical engineering from Oklahoma State University.
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