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  Understanding Human Errors in Medical Device Root Cause Analysis

  Root Cause Analysis (RCA) is a cornerstone process for identifying and resolving nonconformities in the medical device industry. Yet, a critical aspect often overlooked is the role of human error. In her online-exclusive article "Understanding Human Errors in Medical Device Root Cause Analysis" for Medical Product Outsourcing (MPO), StarFish Medical's Vinky Kohli examines how integrating human factors into RCA can lead to safer devices and improved processes.

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  Bio Break: Understanding Clinical Trials – Key Steps and Expert Insights

  In this engaging episode of Bio Break, Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you're a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.

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  Impact of FDA Laboratory Developed Tests Policy

  The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.

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  Bio Break: Drug-Device Combination Products

  In this episode of Bio Break, Joris and Nick explore the increasingly important world of drug-device combination products, discussing what they are, why they matter, and the unique challenges associated with their development. As modern pharmaceuticals become more complex, the role of engineered medical devices in delivering these therapies safely and effectively has never been more critical.

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  FDA Guidance on Biocompatibility Evaluation ISO 10993-1

  Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

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  Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

  7 Tips for conducting Voice of Customer medical device research in Low- and Middle- Income Countries (LMICs) is an integral component in user-centric design and development. It is increasingly an expectation of regulatory bodies.

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  Tips for Developing Medical Devices With Software

  Developing medical devices with software involves a wide-ranging set of unique challenges. Our software engineering team offer advice on offered advice on software in medical devices, FDA, Software as a Medical Device (SaMD), risks, cybersecurity, and Open Source software.

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  Bio Break: Clinical Trials for Medical Devices vs. Pharmaceuticals

  In this episode of Bio Break, StarFish Medical experts Joris and Nick break down the key differences and similarities between clinical trials for medical devices and pharmaceutical products. As the conversation unfolds, they provide valuable insights into the distinct processes and challenges associated with these two types of trials, including the complexities of combination devices that bridge both worlds.

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  9 Ways to Use AI in Medical Device Development

  9 ways to use AI in medical device development from our experts include Connected Medical Devices, QA/RA, Developing (real time) Simulations, Expedite Design Process, Analysis and Research, Supplier Evaluations, Project Reviews, Brainstorming, and Administrative Help (Faster than Google).   

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