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 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

    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.

  • 12 Steps to Set up a Biomed Lab

    12 Steps to Set up a Biomed Lab

    Opening a biomed lab includes managing multi-layer organizational involvement all the way from facilities to the head of operations. When starting a new lab from scratch, the first step is to fully understand the organization’s mission and business goals. This will impact how you approach setup and any purchasing decisions you make. This article describes 12 essential steps to set up a biomed lab.

  • 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.

  • Medical Device Optical Breadboard Prototype

    Medical Device Optical Breadboard Prototype Tips

    Tips for building a medical device optical breadboard prototype. When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting.

  • Medical Device Speed to Market

    14 Ways to Increase Medical Device Speed to Market

    Speed to market is a crucial part of medical device success. Experts draw upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

  • Commercializing Medical Devices with Optics

    Commercializing Medical Devices with Optics

    Engineers, regulatory, manufacturing and optics experts share their experiences and lessons learned commercializing hundreds of medical devices with optics components and interacting with optics engineers.

  • Optical Coherence Tomography Types

    A Comparison of Detection and Imaging Methods Used in Optical Coherence Tomography

    Overview of Optical Coherence Tomography (OCT) Types includes some advantages and disadvantages of the imaging techniques in medical devices.

  • 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.