With the intelligence and informatization of medical devices, many off-the-shelf software (OTS) are being applied in medical devices. On August 11, 2023, the FDA released the Guidance for Industry and Food and Drug Administration Staff on Off-The-Shelf Software Use in Medical Devices, which aims to provide information that applicants should include in the documentation submitted before marketing for FDA evaluation of the OTS software used in medical devices.
What is OTS Software?
OTS software refers to software components that have been fully developed and widely used, which medical device manufacturers integrate into their devices to achieve specific functions. However, since this software is not developed by the manufacturers themselves, they cannot fully control the entire software lifecycle (for example, operating systems, printer drivers, or display libraries).
Application Scenarios of OTS Software
Operating Systems: Some common medical imaging device control software, such as CT and MRI control console software, run on the Windows operating system; some medical devices with high requirements for safety and stability, such as pacemakers and insulin pumps, typically use Linux as the low-level operating system.
Data Management: In hospital equipment management systems and patient medical record management systems, some databases can serve as OTS database software for data storage, management, and querying, efficiently processing large amounts of medical information.
Communication Modules: Bluetooth and WiFi technologies are widely used in some portable medical devices, such as blood glucose meters, blood pressure monitors, and heart rate monitors, allowing developers to quickly implement their functions using their drivers and protocol stacks.
Image Processing: In medical imaging devices, such as ultrasound image processing, endoscopes, and X-ray machines, some OTS software can assist in medical image analysis.
Advantages and Challenges of OTS Software
Advantages
· High Development Efficiency: Using ready-made software libraries and tools shortens the development cycle.
· Cost Savings: Reduces the time and human resources spent on self-research.
· Standardization and Reliability: OTS software usually complies with certain international standards, and market-validated software is more reliable and stable.
Challenges
· Compliance: While using OTS software reduces self-research time, it still requires verification and confirmation of its compliance.
· Risk Management: To ensure the safe use of OTS software, medical device manufacturers need to comply with relevant regulatory requirements.
· Customization Needs: OTS software may not fully meet the specific needs of certain medical devices and medical scenarios, requiring manufacturers to develop additional functions.
· Software Updates and Compatibility: Version updates of OTS software may affect product stability, requiring additional costs for maintenance.
Conclusion
OTS software plays an indispensable role in the registration and development of medical devices. Through scientific and systematic risk management and comprehensive compliance assurance, it can not only fully leverage its advantages in accelerating medical device development, reducing costs, and improving quality but also bring more innovative possibilities to the medical device industry.
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