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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  • A close-up of a medical professional wearing blue gloves and a white lab coat, working with a combination medical device on a mannequin arm. The text overlay reads "Combination Devices in Clinical Trials: Bridging Two Worlds."

    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.

  • A close-up of a hand holding a small, capsule-shaped robotic device with visible internal components. The text overlay reads "Innovative Drug Delivery Methods Explained." The background is blurred, showing a clean, modern indoor setting.

    Bio Break: Innovations in Drug Delivery Systems

    In this episode of Bio Break, Joris and Nick explore groundbreaking innovations in drug delivery systems, focusing on how advanced technologies are transforming the precision and effectiveness of medical treatments. From delivering medications to hard-to-reach areas like the brain to targeted oral delivery, this discussion highlights solutions that are redefining modern healthcare.

  • Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations. A scientist in a lab coat and purple gloves examines a specimen under a microscope, while another scientist works in the background in a laboratory setting. The text overlay reads "And now? New FDA LDT Ruling.

    Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

    Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations.

  • A close-up of a scientist in a white lab coat, wearing a hairnet and blue gloves, examining a device in a biotech laboratory. In the blurred background, several other scientists in lab coats are working at lab benches. The text overlay reads "Biotech facility essentials.

    Bio Break: Core Facilities for Medical Device Development

    In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss the critical role of specialized facilities in the successful development of medical devices. From testing laboratories to clean rooms, they explore the infrastructure needed to support innovation and ensure safe, effective products reach the market.

  • A smiling man with a beard and checkered shirt, sitting in front of a background with the text 'Don't miss this step' and an illustrated arrow pointing downwards.

    Bio Break: Target Product Profile

    Whether you're in the early stages of a new project or refining a product concept, this episode of Bio Break delves into the foundational importance of a well-defined Target Product Profile (TPP) in medical device development. It's packed with practical advice and expert insights to set you on the path to success.

  • A man wearing a blood glucose monitoring system on his upper arm sits at a table looking at his smartphone. Bold white text on the image reads, "This changes healthcare forever." A red arrow points to the CGM device, with an inset close-up image of the Dexcom-branded sensor.

    Bio Break: Over-the-Counter Blood Glucose Monitoring Systems

    In this episode of Bio Break, StarFish Medical experts Joris and Nick explore the groundbreaking FDA clearance of the first over-the-counter continuous blood glucose monitoring system. This exciting development marks a significant milestone in the world of diagnostics and opens new possibilities for patient-centered healthcare.

  • biomedical product development

    3 “P’s” of Biomedical Product Development Pitfalls

    Three common elements can be observed in biomedical product development projects that are doomed to failure. They are the Three “P’s” – Platform, Point of Care, and Program Manager.

  • Canadian SR&ED program

    Canadian Medtech Entrepreneurs: Reduce your Medical Device R&D costs by 50%

    Overview of the Canadian SR&ED program and a 5 step high-level guide on how to prepare an SR&ED tax form (or T661).

  • Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference

    How an Autonomous Clinical Chemistry Assay diagnostics design with kinetic read out helps mitigate interference challenges.