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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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  Making an Ophthalmic Instrument Safety Assessment

  Optics Physicist and Engineer share approaches to performing pre-screen Ophthalmic Instrument Safety Assessment testing in-house.

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  When FDA Trust Is Broken: Lessons from the MedLink Scandal

  In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik examine what happened, what it means for medical device innovators, and how the FDA’s ASCA (Accreditation Scheme for Conformity Assessment) program helps reduce regulatory risk.

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  Medical Device Labeling Requirements: Compliance and Best Practices

  We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

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