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.
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ADVICE

Document Everything for Traceability

  • Follow a documented and repeatable process when developing safety-critical software.
  • This ensures traceability and allows you to identify the source of potential issues.
ADVICE

Instill a Culture of Quality

  • Train engineers on regulations, documentation, and testing procedures.
  • Emphasize the seriousness of medical device development and the potential impact of bugs.
ADVICE

Hire for Experience and Attitude

  • Hire experienced engineers for key roles like principal architects and test managers.
  • Assess candidates for a methodical approach and ability to collaborate cross-functionally.
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