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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Medical device development is a complex process that requires careful attention at every stage.
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Nigel and Nick explore how contrast agents in imaging support medical device trials and diagnostics. While bones appear clearly in standard X-rays, soft tissues like those in the nasal cavity often require contrast agents to become visible.
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In the highly regulated world of medical device development, ensuring product safety, quality, and compliance is essential. One critical yet often overlooked aspect of this process is test method validation (TMV) in medical device development.
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You have a great MedTech innovation idea and are trying to decide whether to build a team to commercialize a medical device…
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The impact of shear stress is critical to effectively design medical devices that handle biological fluids such as proteins or cell culture media. For example, non-physiological shear stress (NPSS) on blood is a key factor because hemolysis (cell rupture) could occur due to accumulated stress.
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The costs of early-stage medical device development in North America and Europe continue to rise. Increasing technical complexity and the compounding costs of nonclinical and clinical evaluations are driving this trend.
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Today, 85% of the top 50 healthcare companies use Computational Modeling and Simulation (CM&S) to develop their products and processes. Whether it’s refining overall device parameters or optimizing critical requirements, engineering simulations help reduce development timelines and enhance design exploration.
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Computational Modeling and Simulation (CM&S) for medical devices has become a pivotal tool across the medical device industry, complementing and often enhancing traditional bench testing and clinical studies.
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Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.
