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
  • FDA use of AI in medical device review - A computer chip labeled "AI" on the left side is connected by a black arrow pointing to the right, where wooden blocks stacked vertically spell out "FDA." Above the image is a bold caption that says "They're doing it!" in white text on a black background. The image suggests the FDA is adopting AI technology.

    How the FDA Is Using AI in Regulatory Review

    Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.

  • A man in a blue shirt and glasses, wearing a lapel microphone, smiles while holding a small circular device with wires. Large bold purple text on the left side of the image reads "From Prototype to Impact" against a white background.

    Cystic Fibrosis Therapy Device Uses Voice Coil Technology to Improve Mobility

    In this episode of MedDevice by Design, we follow the development journey of a transformative chest therapy device for cystic fibrosis patients. Host Mark Drlik introduces a voice coil prototype from an early-stage project that would eventually evolve into the Hill-Rom Monarch—a commercial system delivering high-frequency chest wall oscillation therapy.

  • 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.

  • Purple text reads 'FDA rejects Lab Results?' next to a rubber stamp marked 'REJECTED' resting on a document.

    When FDA Trust Is Broken: Lessons from the MedLink Scandal

    In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

  • Thumbnail with the text 'Will your MedTech Product succeed?' in bold black and purple font. On the right, Mark Drlik wearing glasses gestures toward a whiteboard with triple Venn diagrams labeled with terms like 'Desirability,' 'Feasibility,' 'Viability,' and 'Regulatory.'

    Venn Diagram MedTech Success – Aligning Product and Business Strategy

    Ariana Wilson and Mark Drlik break down a powerful visual framework for understanding what makes a medtech product, and the company behind it, truly successful. Using a triple Venn diagram, Mark explains how strategic alignment across feasibility, viability, and desirability can drive better product outcomes and business success in the medical device industry.

  • Thumbnail image with the text 'Targeted Brain Drug Delivery – CED!' in black and purple font. On the right side, there is a medical illustration of a brain in profile with a needle inserted, representing Convection-Enhanced Delivery (CED).

    Convection-Enhanced Delivery: Infusing Precision into Neurosurgery

    What if the next leap in brain therapy didn't require open surgery? We explore how convection-enhanced delivery (CED) is changing the way clinicians administer therapeutic agents to the brain. Join us as we look inside this advanced technique—and the high-precision tools that make it possible.