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

A laboratory or engineering workstation featuring a high-precision stereo microscope mounted on an articulated arm, positioned beside two computer monitors displaying 3D CAD models or imaging of a complex mechanical or biomedical device. The workspace also includes a keyboard, mouse, and a metallic container, all situated on a clean white desk in a dimly lit, modern lab environment.

In a sophisticated world of ever increasing complexity, we need our tools to evolve alongside us and assist in complex decision making, allowing us to understand the consequences of choices ahead. Computational Modelling and Simulation (CM&S) is emerging as an essential tool in building evidence for medical device development.

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.

I routinely engage in the development of prototype medical devices. These prototypes typically incorporate at least one printed circuit board (PCB) installed within a plastic or metal enclosure, featuring numerous connections to external components through various connectors.

A laptop on a wooden desk displays a digital document icon on its screen. Beside it, bold text reads "Design History Files Explained," highlighting the topic of regulatory documentation in medical device development.

Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle.

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.

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.