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Engineering Culture by InfoQ
Building Safe and Usable Medical Device Software: A Conversation with Neeraj Mainkar
Jan 3, 2025
Neeraj Mainkar, VP of Software Engineering at Procreo and an expert in medical device software, shares insights on the rigorous processes needed for safe design. He emphasizes the importance of user-centric design and regulatory compliance in improving patient outcomes. The conversation delves into usability challenges, advocating for intuitive interfaces that minimize cognitive load. Neeraj also discusses the impact of AI on medical software, highlighting its potential to enhance usability while managing complexities in data use and software updates.
29:25
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Quick takeaways
- Ensuring medical device software safety requires rigorous adherence to FDA guidelines, comprehensive testing, and meticulous documentation to minimize bugs.
- Balancing usability and performance in medical software design involves early user feedback, effective usability testing, and leveraging AI tools for enhancements.
Deep dives
The Importance of Safety in Medical Software Engineering
In medical software engineering, ensuring safety is paramount due to the potential life-or-death consequences of software bugs. Adhering to FDA guidelines is crucial, requiring companies to follow a rigorous and documented process to develop and test medical devices. This includes comprehensive documentation to track potential issues, thorough testing covering various user workflows, and a strong emphasis on verification and validation processes. By implementing a disciplined and repeatable methodology, engineers can significantly minimize bugs, thereby enhancing the safety and efficacy of medical devices.
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