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.

Archive Filters
Actions
  • Colorful candy-coated chocolates float in the air against a blurred indoor background. Bold purple and black text on the left reads: "Medical Device Safety – A lesson from Van Halen."

    Bio Break: The Van Halen Secret to Medical Device Safety

    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.

  • Abstract image depicting financial growth in the medical device industry. A silhouetted figure points to a glowing dollar sign on a rising graph, symbolizing successful funding strategies. The design is complemented by floating dollar signs and a sleek, modern digital aesthetic.

    Bio Break: Funding Strategies for Medical Devices

    Nick and Joris tackle a topic that’s more relevant than ever—raising funds for medical device development in today’s challenging financial landscape. With economic headwinds and cautious investors, startups and even established organizations face significant hurdles in securing funding. But there are ways to mitigate these challenges, and Joris shares strategic insights to align product development milestones with fundraising cycles.

  • Filter Integrity Biopharmaceutical Manufacturing

    Validating Filter Integrity for Biopharmaceutical Manufacturing

    Filter Integrity Biopharmaceutical Manufacturing explores the relationship between microbial retention tests and integrity tests essential for validating the effectiveness of filters in critical applications.

  • Biocompatibility Evaluation ISO 10993-1 Accessibility Alt description: FDA sign in front of FDA building that says "U.S. Department of. health and Human Services Food and Drug Administration"

    FDA Guidance on Biocompatibility Evaluation ISO 10993-1

    Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

  • Service Design Medical Device Development Description: Healthcare worker looking at screen of her equipment

    Service Design in Medical Device Development

    Integrating service design with user-centered design when developing medical devices can enhance device usability, efficiency, and outcomes.

  • Voice of the Customer Medical Device Research

    Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

    7 Tips for conducting Voice of Customer medical device research in Low- and Middle- Income Countries (LMICs) is an integral component in user-centric design and development. It is increasingly an expectation of regulatory bodies.

  • Sensory Design Medical Devices

    Sensory Design for Medical Devices

    The medical devices in the masthead above have vastly different purposes. One thing that’s common is they all have some combination of sensory aspects. Sensory design uses affordances (perception of design features intuitively suggesting a functional task) and semantics (conveying meaning and information about the product’s use and function through sensory cues). Both can be communicated through our five senses with the most common being visual, tactile and auditory.

  • Developing Medical Devices With Software

    Tips for Developing Medical Devices With Software

    Developing medical devices with software involves a wide-ranging set of unique challenges. Our software engineering team offer advice on offered advice on software in medical devices, FDA, Software as a Medical Device (SaMD), risks, cybersecurity, and Open Source software.

  • AI Medical Device Development

    9 Ways to Use AI in Medical Device Development

    9 ways to use AI in medical device development from our experts include Connected Medical Devices, QA/RA, Developing (real time) Simulations, Expedite Design Process, Analysis and Research, Supplier Evaluations, Project Reviews, Brainstorming, and Administrative Help (Faster than Google).