When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting. For an optical subsystem, this de-risking is […] The post 10 Tips for Medical Device Optical-Breadboard Prototypes appeared first on StarFish Medical ..read more

Without sacrificing safety or quality Speed to market is a crucial part of medical device success. Our employee experts drew upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality. Read on to discover how to understand the intended […] The post 14 Ways to Increase Medical Device Speed to Market appeared first on StarFish Medical ..read more

Commercializing a medical device with optical components brings a unique set of challenges. We asked our multi-disciplinary team of engineers, regulatory, manufacturing and optics experts to share their experiences and lessons learned for commercializing medical devices with optics components and interacting with optics engineers. Learn what they pay attention to and how they change behavior […] The post Commercializing Medical Devices with Optics appeared first on StarFish Medical ..read more

Optical coherence tomography (OCT) is an imaging technique with many current and potential applications in medical devices. The most common medical uses of OCT are in ophthalmology and optometry, in which OCT is commonly used to take cross-sectional or 3D scans of the eye’s anterior and posterior segments. Other areas of active development include dentistry, […] The post A Comparison of Detection and Imaging Methods Used in Optical Coherence Tomography appeared first on StarFish Medical ..read more

The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The new guidance has pushed software composition and vulnerabilities up in importance when making a submission to the FDA. As such, Software Bills of Materials (SBOMs) have become a […] The post The Value of SBOMs and SBOM Analysis appeared first on StarFish Medical ..read more

Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple animation performs two purposes. One is simply that it looks good, plus companies can personalize and add their branding to it. But the second reason is arguably more important; it lets […] The post Creating a Medical Device Bootscreen for QNX appeared first on StarFish Medical ..read more

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity into the quality system management and premarket submission process for medical devices. It covers risk management, design controls, software validation, and other elements to ensure the safety, […] The post Overview of the New FDA Guidance on Cybersecurity appeared first on StarFish Medical ..read more

You have done your Software Risk Analysis and have identified your Firmware to be of Software Safety Class C. What next? There are 3 points of the IEC 62304 Standard specific to the design of Class C Medical Device Firmware: Segregation, Detailed Design for Interfaces, Additional Software Unit Acceptance Criteria. IEC 62304 standardizes the Software Life […] The post Developing Class C Firmware for Medical Devices appeared first on StarFish Medical ..read more

Generative language models, colloquially known as “AI”, have been making waves across many different sectors in a wide range of roles, ranging from customer support chatbots to programming assistants, and even to a new wave of web search tools. The invasion of so many (large language model) LLM-based products has also sparked furious debate about […] The post Using Language Models (AI) Responsibly In Medical Devices appeared first on StarFish Medical ..read more

Understanding Post-Market Surveillance: In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase, where vigilant surveillance becomes paramount. This blog delves into the significance of post-market surveillance (PMS) for medical devices, exploring its importance, challenges, and potential improvements. PMS is the […] The post How Post-Market Surveillance Enhances Medical Device Safety appeared first on StarFish Medical ..read more