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 laptop on a wooden desk displays a digital document icon on its screen. Beside it, bold text reads "Design History Files Explained," highlighting the topic of regulatory documentation in medical device development.

    Bio Break: Why the Design History File (DHF) Matters in MedTech

    Nick and Joris break down what a DHF is, why it's required, and how it plays a vital role throughout the development lifecycle.

  • A visual project roadmap titled "Finding the Path to MedTech Innovation" shows five development phases: Phase Zero (Pathfinder Product Definition), Phase One (Engineering Detailed Design), Phase Two (Transfer), and Phase Three (Manufacturing). Each phase includes activities such as contextual research, usability engineering, IP generation, design input development, regulatory strategy, prototyping, verification, manufacturing process development, and volume manufacturing. Arrows represent workflows across multiple functions like product development, quality, and regulatory support, with milestone gates marked by stars.

    Bio Break: Finding the Path to MedTech Innovation with the Pathfinder Program

    Nick and Joris explore one of the most dynamic early-phase services at StarFish Medical: the Pathfinder Program. If you're a medtech innovator with a promising concept or prototype, Pathfinder helps you identify the right path forward—before you invest millions in development.

  • Health care, medicine, people eyesight and technology concept

    Making an Ophthalmic Instrument Safety Assessment

    Optics Physicist and Engineer share approaches to performing pre-screen Ophthalmic Instrument Safety Assessment testing in-house.

  • A close-up of a person's skin with a smart bandage applied. The bandage contains an embedded green-glowing electronic circuit, resembling a microchip, suggesting advanced medical monitoring or theranostic technology.

    Is there a Theranostic wound dressings market?

    With the recent developments and seemingly ubiquitous nature of real time glucose monitoring and availability of smart wearable tech, the development of a theranostic band-aid seems inevitable. But how practical would this be? Is there a Theranostic wound dressings market?

  • A close-up image of a hand drawing on a whiteboard with a marker, illustrating a brainstorming or planning session. Bold text on the left reads 'Cost to develop Medical Device' with the word 'develop' highlighted in purple. The image conveys the concept of medical device development costs and design planning.

    Bio Break: How much does it cost to develop a medical device?

    What are the real costs of developing a medical device? In this episode of Bio Break, Nick and Joris dive into one of the most frequently asked questions they hear from clients: How much does it cost to develop a medical device?

  • White and colored label rolls isolated on white background with shadow reflection. Color reels of labels for printers. Labels for direct thermal or thermal transfer printing. Abstract background.

    Medical Device Labeling Requirements: Compliance and Best Practices

    We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

  • Room for sterilization of medical instruments in a modern outpatient clinic

    Medical Device Sterilization Methods and EtO

    Sterilization is a critical process in the medical device industry as it provides a reliable way to ensure that devices are free from harmful microorganisms when they are used on patients. This blog talks about the categories of sterilization currently used on medical devices in manufacturing settings. It also addresses concerns surrounding the use of ethylene oxide (EtO), an indispensable method for sterilizing heat and moisture sensitive devices.

  • Female professional doctor showing medical test result explaining prescription using digital tablet app visiting senior woman patient at home sitting on sofa. Elderly people healthcare tech concept

    Interesting 2025 Medtech Trends

    Predicting the trends of a new year is always interesting and a bit unpredictable. We asked our medical device design and development professionals to submit their most interesting medtech trends for 2025 and the reasoning behind their prediction. The results were surprisingly focused on two major trends: Home Healthcare and Wearable Devices. Within these categories, several technologies were identified including edge computing, IoT, and connected devices. In no particular ranking, here are our 2025 predictions:  

  • A person adjusting a medical device in a clinical setting.

    FDA Final Guidance on Remanufacturing of Medical Devices: Key Takeaways and Implications

    In May 2024, the FDA released an updated guidance document to help manufacturers, third-party service providers, and healthcare facilities determine whether their modifications fall under the category of remanufacturing. This guidance enables these entities to continue ensuring patient safety, regulatory compliance, and the effectiveness of remanufactured medical devices.