Bio Break: Achieving a 20-Year Resolution – Biofilm Testing Standard

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Bio Break: Achieving a 20-Year Resolution – Biofilm Testing Standard

Sector: Diagnostics
Topic: Bio Break

In this special New Year’s episode of Bio Break, Joris van der Heijden and Nick Allan reflect on resolutions, persistence, and a 20-year journey to establish a new standard for biofilm testing in medical devices.

Nick shares the story of his two-decade-long mission to develop a standardized test method for growing and monitoring biofilm on medical device surfaces. This effort, initiated through the ASTM E35 Committee (American Standard Test Method Organization), recently culminated in the release of ASTM Standard E3435. This method enables researchers and developers to evaluate biofilm growth and assess the effectiveness of materials designed to inhibit or prevent biofilm formation—an essential consideration in medical device development.

Nick showcases a prototype from 20 years ago that played a critical role in this process. The device uses loops of various catheter materials, some treated with antimicrobial agents, to test biofilm growth under controlled conditions. This tool allows developers to measure the performance of materials against biofilm formation, offering a reliable way to test and improve medical devices.

Key takeaways from the episode include:

  • The importance of standardized testing in ensuring the safety and efficacy of medical devices.
  • How the ASTM E3435 standard supports innovation by providing consistent methods for evaluating biofilm interactions with materials.
  • The value of persistence and long-term vision in bringing impactful projects to fruition.

This episode highlights the critical role of biofilm testing in advancing medical devices and the dedication required to turn a passion for innovation into a tangible outcome.

Whether you’re a medical device developer, materials scientist, or healthcare professional, this episode offers valuable insights into the process of creating industry standards that drive innovation and improve patient outcomes.

Achieving a 20-Year Resolution – Biofilm Testing Standard

Three engineers are assembling or troubleshooting a large industrial or medical device prototype in a workshop. One person is seated in a wheelchair, another is standing behind the structure, and a third is kneeling on top of the machine for internal access. The workspace includes tools, laptops, electronic parts, and a large diagram of the device on the wall.

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Bio Break: Why the Design History File (DHF) Matters in MedTech

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Two colorful paper boats—one red and one yellow—float on a blue background with illustrated white waves beneath them. Bold text reads "From Idea to Impact," symbolizing innovation and progress in medical device development.

Bio Break: From Concept to Clinical – Pathfinder Program Case Study

Nick Allan and Joris van der Heijden revisit one of StarFish Medical’s most successful Pathfinder journeys, showcasing how a bold research concept evolved into a fully realized clinical diagnostic device.

A visual project roadmap titled "Finding the Path to MedTech Innovation" shows five development phases: Phase Zero (Pathfinder Product Definition), Phase One (Engineering Detailed Design), Phase Two (Transfer), and Phase Three (Manufacturing). Each phase includes activities such as contextual research, usability engineering, IP generation, design input development, regulatory strategy, prototyping, verification, manufacturing process development, and volume manufacturing. Arrows represent workflows across multiple functions like product development, quality, and regulatory support, with milestone gates marked by stars.

Bio Break: Finding the Path to MedTech Innovation with the Pathfinder Program

Nick and Joris explore one of the most dynamic early-phase services at StarFish Medical: the Pathfinder Program. If you’re a medtech innovator with a promising concept or prototype, Pathfinder helps you identify the right path forward—before you invest millions in development.