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  Commercializing Medical Devices with Optics

  Engineers, regulatory, manufacturing and optics experts share their experiences and lessons learned commercializing hundreds of medical devices with optics components and interacting with optics engineers.

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  The Value of SBOMs and SBOM Analysis

  SBOM Analysis and Value covers the FDA “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance, role of Software Bills of Materials (SBOMs), and how to create them.

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  Creating a Medical Device Bootscreen for QNX

  QNX Medical Device Bootscreen tips for the popular micro-kernel OS designed for embedded systems and safety critical hardware.

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  FDA Guidance on Medical Device Cybersecurity Overview

  2024 FDA guidance on medical device cybersecurity covering risk management, design controls and software validation is explained in this article. Cybersecurity, Risk Management, Secure Product Development Framework (SPDF) are also covered.

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  Developing Class C Firmware for Medical Devices

  3 points of the IEC 62304 Standard specific to the design of Class C Medical Device Firmware are Segregation, Detailed Design for Interfaces, Additional Software Unit Acceptance Criteria. This article shares StarFish Medical development approach to Segregation.

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  Using Language Models (AI) In Medical Devices Responsibly

  Risks, potential roles, and tips for using Large Language Models (LLM) or (AI) in medical devices effectively and responsibly. Role of AI in medical devices: In the medical field, generative language models, colloquially known as “AI” or “LLM” must be used responsibly to enhance the skills of clinicians or improve patient experience without exposing either to increased risk.

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  Medical Device Design for Testability

  Medical Device Design for Testability during development explores the pros and cons of its application throughout the entire design process design concern throughout the whole design process, ensuring that all parts of the product can be both manipulated and monitored allowing for thorough testing.

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  3 “P’s” of Biomedical Product Development Pitfalls

  Three common elements can be observed in biomedical product development projects that are doomed to failure. They are the Three “P’s” – Platform, Point of Care, and Program Manager.

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  Medical Device Post-Market Surveillance Enhances Safety

  Medical device post-market surveillance (PMS) is important to identify and address potential safety issues and improving device performance. Article covers regulatory landscape, challenges, innovations and collaborative efforts.

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