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 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.

  • Medical Device High Level Program Planning

    High Level Program Planning: A Journey, Not the Destination

    Six common medical device product development destinations and overview of a High Level Program Planning (HLPP) approach.

  • 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.

  • MAUDE database Accessibility description: screenshot of the MAUDE database

    Is the MAUDE database part of your development or due diligence process?

    Engineers, regulatory advisors, and patent filing teams should review the MAUDE database as part of development and due diligence process.

  • medical device CFD simulations CFD of StarFish Logo star

    Six tips for medical device CFD simulations

    Medical device CFD simulations allow you to generate images and videos with little effort to predict and optimize fluid and thermal paths.

  • emerging medical device technology

    4 QFD Tips for Emerging Medical Device Technology

    4 tips to collect meaningful user data for emerging medical device technology and take an appropriate level of risk and reward.