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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  • Two professionals in plaid shirts and microphones sit in a discussion within a laboratory setting. The text overlay reads "Innovative Olfactory Drug Delivery: Bypassing the Blood-Brain Barrier," highlighting a focus on advanced medical techniques.
  • Two professionals wearing plaid shirts and microphones engage in a discussion in a laboratory setting. The text overlay reads "Designing SAFE Drug Delivery Systems," emphasizing the focus on precision and safety in medical device design.

    In this episode of Bio Break, Joris van der Heijden and Nick Allan explore one of the most critical challenges in drug delivery device design: shear stress. When designing systems for biologics and gene therapies, avoiding shear stress is essential to ensure the viability and activity of biomolecules like proteins, antibodies, and viruses.

  • A syringe aimed at the center of a black-and-white target, symbolizing precision. The text overlay reads "Precision Drug Activation" with a blurred laboratory background.

    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.

  • A medical vial with liquid and several teal-and-white capsules floating in the air, with a text overlay reading "Drug & Device: Why combine?" in a lab setting background.

    In this episode of Bio Break, Joris and Nick explore the increasingly important world of drug-device combination products, discussing what they are, why they matter, and the unique challenges associated with their development. As modern pharmaceuticals become more complex, the role of engineered medical devices in delivering these therapies safely and effectively has never been more critical.

  • 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."

    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.

    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.

  • 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.

    In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

  • 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.

    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.

    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.