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  FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

  This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

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  Bio Break: Strategies for Expanding Market Reach

  Nick and Joris explore the fascinating world of repurposing existing medical device technologies for new market sectors. As engineers and innovators, we often focus on creating brand-new solutions, but what about leveraging tried-and-true technologies to expand into untapped markets? This strategy not only opens doors to new revenue streams but also maximizes the potential of existing innovations.

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  Fluid-Structure Interaction (FSI) Modeling is Transforming the Medical Device Industry  

  Fluid-structure interaction (FSI) modeling is transforming the medical device industry by simulating complex dynamics between biological fluids and medical devices. In a field where safety and precision are paramount, FSI modeling offers engineers and researchers a powerful tool to design, test, and optimize devices in a virtual environment before physical prototypes are created or clinical trials are conducted. 

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  8 Cleanroom Best Practices to Maintain a CLEAN State 

  Cleanroom best practices are crucial to maintain a contamination-free environment, especially in industries like pharmaceuticals, semiconductors, biotechnology, healthcare, and medical devices. Here are some essential guidelines for ensuring your cleanroom is indeed clean.

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  Medical Device Design Transfer Process

  Medical device design transfer is a critical phase in the development process, marking the transitory phase from the design and development stage to manufacturing.  This phase ensures that the medical device continues to meet its safety, effectiveness, and regulatory compliance once production begins.  It is the final phase in the development process and sometimes overlooks or underestimates the amount of time and effort required to ensure that final manufactured devices meet requirements. 

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  Benefits and Role of Systems Engineering in Medical Device Development

  Systems-thinking must always be present in medical device development. Systems Engineers (SEs) live where complex development needs managing. In a very small project team people can communicate continuously and tightly enough that everybody understands where they're headed and what's going on.

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

  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.

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  Bio Break: Microbes – Heroes of Medicine

  In this episode of Bio Break, Joris and Nick explore the fascinating ways microbes and nature inspire medical innovations, showing how these tiny organisms play an outsized role in advancing healthcare and biotechnology. From lifesaving antibiotics like penicillin to revolutionary technologies like CRISPR-Cas9, they dive deep into the surprising and transformative contributions of microbes to medicine, shedding light on their critical role in shaping modern science and improving patient outcomes.

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  Medtech Adventures: Ramgopal “Ram” Rao and the LensGen Story

  Explore the inspiring story of Ramgopal Rao, a trailblazer in the ophthalmic medtech industry. From humble beginnings in India during the era of partition to building groundbreaking innovations in the U.S., Ramgopal’s journey epitomizes resilience, vision, and entrepreneurial success.

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