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

Two men sit at a table discussing the science behind freeze-drying. One of them holds a jar of freeze-dried coffee, illustrating the topic. The text overlay reads "The Science Behind Freeze Drying" in bold letters. A whiteboard with diagrams is visible in the background, reinforcing the technical discussion.

Nick and Joris dive into the fascinating world of freeze-drying, exploring how this process extends shelf life and maintains the integrity of various products—including reagents used in in vitro diagnostics and even instant coffee!

Two men, Nick and Joris, are seated at a table, engaged in a discussion. Both are wearing checkered shirts and have coffee mugs with their names on them. The background features a whiteboard with faint blue writing. The text overlay reads "Imaging for Targeted Drug Delivery" in bold, purple and black letters. The setting resembles a laboratory or office environment.

In this episode of Bio Break, Nick and Joris discuss the fascinating world of real-time imaging for targeted drug delivery. When delivering drugs to precise locations in the body, how do we ensure they reach the right spot? The answer lies in medical imaging technologies such as MRI, CT, and ultrasound, which play a crucial role in guiding complex drug delivery devices.

packaging plant line and signal.

ASTM D4169 is a standard test method for performance testing of shipping containers and packaging systems. It evaluates the ability of shipping units to withstand the expected distribution environment. FDA recognizes it as a consensus standard as part of sterility testing that is commonly applied to all sorts of medical devices.

What are the most important medical device success factors during development and manufacturing? StarFish employees from QA/RA, NPI, Optics, Computational Analysis, Project Management and Manufacturing answer that question with the factors they deem most important for their area of expertise.