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 design transfer is a critical phase in the development process, marking the transitory phase from the design and development stage to manufacturing. This phase ensures that the medical device continues to meet its safety, effectiveness, and regulatory compliance once production begins. It is the final phase in the development process and sometimes overlooks or underestimates the amount of time and effort required to ensure that final manufactured devices meet requirements.
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Systems-thinking must always be present in medical device development. Systems Engineers (SEs) live where complex development needs managing. In a very small project team people can communicate continuously and tightly enough that everybody understands where they’re headed and what’s going on.
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In this episode of Bio Break, StarFish Medical experts Joris van der Heijden and Nick Allan celebrate Thanksgiving by sharing a heartwarming and hilarious family tradition: preparing the perfect turkey. Through this tale of generations working together to create the iconic holiday meal, they uncover a surprising lesson that applies to medical device development and procedural design.
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In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.
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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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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?
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Nick and Joris dive into the surprising connection between rock bands and medical device safety. What do jelly beans and 1980s rock legends Van Halen have to do with developing safe and effective medical technologies? More than you might think.