Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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In this episode of Bio Break, StarFish Medical experts Joris and Nick dive into the transformative concept of Continuous Analyte Monitoring (CxM) and its growing role in wearable medical devices. They discuss the value of tracking metabolic markers over time, as opposed to relying on static time-point measurements, and how this approach enhances precision in both diagnostics and treatment.
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Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
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Artificial intelligence (AI) has rapidly become a transformative force across industries, but its application in medical devices presents unique challenges. In his article “A Practical Future of Developing AI for Medical Devices” for MD+DI, Thor Tronrud, a Research and Data Analysis-Focused Software Engineer at StarFish Medical, sheds light on bridging knowledge gaps, navigating regulatory constraints, and developing robust AI solutions for medical devices.
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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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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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Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges explores effective delivery devices and solutions for advanced CGT therapies and their unique challenges.
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Aerosol Drug Delivery Systems, including Aerosol-based pulmonary-delivered drug devices, offer significant value by enabling targeted drug delivery directly to the respiratory system.
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Drug Delivery System Imaging Technology options include MRI, CT, and Ultrasound. This article highlights advantages and disadvantages for each technology in guiding drug delivery.
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In this engaging episode of Bio Break, Nick and Joris dive into the complex world of platform technologies in product development, exploring the pros and cons of this widely discussed concept. From in-vitro diagnostics to point-of-care instruments, the term “platform” often sparks excitement—and sometimes hesitation. But what does it truly mean to build a platform-based product, and when does it make sense?
