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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  • Engineer interacting with digital blue gears, symbolizing manufacturing readiness alignment and scalable MedTech commercialization.

    Scaling Smart: Using MRL to Align Manufacturing Readiness with Market Readiness

    Being ready to build is not the same as being ready to scale. Successful market introduction requires manufacturing readiness that evolves alongside market readiness.

  • A healthcare professional in a sterile gown and gloves holds an endoscope, with a red arrow pointing toward the device. Beside it, a handheld cleaning brush is shown, symbolizing the manual cleaning process. Text overlay reads “Not sterile. Just safe?”

    Understanding Endoscope Reprocessing

    Ariana and Mark examine the complexities of endoscope reprocessing, one of the most difficult tasks in medical device hygiene.

  • Sterilizing medical devices using various FDA-approved methods - Image showing three medical-related items—a pulse oximeter, surgical scissors, and a catheter with a Luer lock—on a light background. A bold label at the top reads ‘How to sterilize?’ with an arrow pointing to the pulse oximeter, indicating a question about sterilization methods for these devices.

    Medical Device Sterilization Methods Explained

    Ariana and Mark walk through FDA-approved options and explain how to select the right one for your product. From metals to plastics and electronics, not all devices can handle the same process.

  • A row of metallic hex nuts anodized in vibrant colors including blue, pink, purple, and gold are arranged on a white surface. To the left, bold purple text reads "Illusion of Color," suggesting a theme about visual perception or surface treatment.

    How Anodized Titanium Enhances Medical Devices with Structural Color

    We explore the fascinating intersection of materials science and usability in medical device development. Mark Drlik and Ariana Wilson discuss how anodized titanium produces vibrant color without dyes, and how this visual property supports surgical safety, device differentiation, and biocompatibility.

  • 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.

  • Two laboratory professionals in cleanroom attire, including hair covers, masks, and gloves, working in a high-tech lab. One person is using a microscope at a workstation, while the other operates a machine in the background. The environment is clean and well-organized, featuring advanced scientific equipment and tools.

    8 Cleanroom Best Practices to Maintain a CLEAN State 

    Cleanroom best practices are crucial to maintain a contamination-free environment, especially in industries like pharmaceuticals, semiconductors, biotechnology, healthcare, and medical devices. Here are some essential guidelines for ensuring your cleanroom is indeed clean.

  • A team of professionals sitting in a conference room, engaged in a discussion. A large screen displays a colorful 3D design, while a whiteboard on the wall shows notes and diagrams. The table is equipped with laptops, notepads, and engineering tools, emphasizing a collaborative work environment.

    Medical Device Design Transfer Process

    Medical device design transfer is a critical phase in the development process, marking the transitory phase from the design and development stage to manufacturing.  This phase ensures that the medical device continues to meet its safety, effectiveness, and regulatory compliance once production begins.  It is the final phase in the development process and sometimes overlooks or underestimates the amount of time and effort required to ensure that final manufactured devices meet requirements. 

  • A stethoscope placed on a glowing digital circuit board, symbolizing the intersection of healthcare and technology in medical device innovation.

    Knowing the Limits for Successful Medtech Design Transfer

    In the fast-paced world of medical device development, ensuring a smooth design transfer is critical for product success. However, a common pitfall arises when limits around essential performance are not well defined. In his recent article for Medical Product Outsourcing (MPO), Dana Trousil, StarFish Medical’s Mechanical Engineering Team Manager, dives into the challenges and solutions for addressing these issues.

  • 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.