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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In this episode of Bio Break, StarFish Medical experts Joris and Nick tackle an intriguing question: can alternative bodily fluids like sweat, saliva, or urine offer viable alternatives to blood sampling for medical diagnostics? While blood remains the gold standard for clinical testing, advancements in non-invasive sampling methods are opening new possibilities, particularly in wearable devices and at-home diagnostics.
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Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
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Crafting powerful business presentation materials requires a subtle balance between visual appeal and clearly written content.
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Continuous Integration (CI) firmware will help medical device software developers show regulators that their code is of high quality.
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In this episode of Bio Break, Nick and Joris dive into the fascinating realm of biosensors, showcasing how nature’s biological processes inspire groundbreaking innovations in medical device technology. From jellyfish to fireflies, the natural world has provided invaluable tools that are transforming diagnostics and research.
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In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss an advanced category of combination devices: drug activation devices. Unlike drug delivery devices that transport medication to specific locations, drug activation devices ensure the drug becomes active precisely where it is needed in the body, reducing systemic side effects and enhancing therapeutic effectiveness.
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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.