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  Medical Device Drop Testing in Action

  Medical device drop testing helps ensure that products and packaging survive real-world handling. We demonstrate in-house drop testing on an actual device and its packaging using a custom-built drop tester.

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  Test Method Validation in Medical Device Development

  In the highly regulated world of medical device development, ensuring product safety, quality, and compliance is essential. One critical yet often overlooked aspect of this process is test method validation (TMV) in medical device development.

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  Medical Device Sterilization Methods Explained

  Ariana and Mark walk through FDA-approved options and explain how to select the right one for your product. From metals to plastics and electronics, not all devices can handle the same process.

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  8 Client Traits That Maximize Your MedTech CDMO Partnership

  You have a great MedTech innovation idea and are trying to decide whether to build a team to commercialize a medical device…

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  How Shear Stress and Residence Time Simulations Shape Safer Biological Fluid Handling Devices

  The impact of shear stress is critical to effectively design medical devices that handle biological fluids such as proteins or cell culture media. For example, non-physiological shear stress (NPSS) on blood is a key factor because hemolysis (cell rupture) could occur due to accumulated stress.

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  How Computational Modeling and Simulation Accelerates Medical Device Innovation

  The costs of early-stage medical device development in North America and Europe continue to rise. Increasing technical complexity and the compounding costs of nonclinical and clinical evaluations are driving this trend.

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  Tissue Simulation: Advances for Next-Gen Medical Devices

  Today, 85% of the top 50 healthcare companies use Computational Modeling and Simulation (CM&S) to develop their products and processes. Whether it’s refining overall device parameters or optimizing critical requirements, engineering simulations help reduce development timelines and enhance design exploration.

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  Regulatory Clearance through Computational Simulation: Industry Opinion, FDA Strategy, & Successful Case Studies

  Computational Modeling and Simulation (CM&S) for medical devices has become a pivotal tool across the medical device industry, complementing and often enhancing traditional bench testing and clinical studies.

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  How the FDA Is Using AI in Regulatory Review

  Ariana Wilson and Mark Drlik dive into how the FDA is adopting artificial intelligence to modernize its regulatory processes. With a new chief AI officer in place and rumors of collaboration with OpenAI, the agency is taking major steps to automate review workflows and improve efficiency.

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