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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  • medical device development partner

    9 Questions for your medical device development partner search

    Questions and resources to help you find the right medical device development partner for your unique needs and requirement.

  • Rohs

    RoHS 2 vs RoHS 3 impact on medical devices

    RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.

  • Medical Device Artificial Intelligence

    Beyond the hype: Medical Device Artificial Intelligence (AI)

    Medical device artificial intelligence (AI) overview of  AI, applications and devices, investment landscape, and regulatory implications. 

  • Battery safety for medical devices

    Battery safety for medical devices

    Overview of battery safety for medical devices addressing design issues related to size, form, capacity and performance demands on batteries.

  • Ingress Protection for Home Healthcare medical devices

    Addressing ingress protection for home healthcare medical devices

    Ingress protection for home healthcare medical devices covers the 60601-1-11 collateral standard and what developers should know.

  • The image depicts a group of people engaged in a collaborative discussion or brainstorming session. A woman is writing on a flip chart with a marker, while a man on her right is pointing at the chart with a marker, and another man on her left is attentively observing. The flip chart includes a list of numbered topics under the heading "Risk & Issues." The setting appears to be a professional or corporate environment.

    How much does it cost to develop a medical device?

    The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.

  • functional 3D models

    How to turn patient imaging data into functional 3D models

    How to create accurate and functional 3D models from patient imaging data. Develop anatomically accurate prototypes for medical device design.

  • Water Ingress in Medical Devices

    Three Considerations for Water Ingress in Medical Devices

    One of the key requirements for ISO 60601-1 is the protection against water ingress in Medical Devices. Three areas to watch are discussed in this article..

  • The image shows a professional workspace divided by a glass window. In the foreground, a person is seated at a desk with multiple computer monitors and a laptop, seemingly observing or recording data. Through the glass window, two individuals are visible in a clinical or lab-like setting. One is seated in a chair, wearing a mask and scarf, while the other, dressed in scrubs and gloves, appears to be conducting a procedure or simulation. The environment suggests a usability testing scenario.

    Planning and Conducting Summative Usability Testing

    There are a lot of things to consider when creating a summative usability test. The first time can be overwhelming. What scenarios do I test? How do I identify a critical task? How many participants do I need? Do I need to test the training? In this eGuide I will help you avoid common mistakes, like using a formative test structure for a summative usability test. I will also provide some tricks and tips to help you get the most out of your test participants and testing.