Posts by Mark Drlik

Mark Drlik

Six tips for medical device CFD simulations

Knowing when to use simulation versus when to physically build a device depends on the problem and what you are trying to do. Computational Fluid Dynamics (CFD) is a powerful tool for predicting and optimizing fluid and thermal paths. Medical device CFD simulations offer the added benefit of being able to generate images and videos with […]

Mark Drlik

Proposed ISO 10993-1 Change Could Significantly Impact your Biocompatibility Plans

The FDA released a proposal to change the guidance document for ISO 10993-1 in April of this year. Most of document UCM348890 seems straight forward – things like implementation details associated with genotoxicity, how to go about labeling your device as BPA-free, and a logical workflow diagram, were updated… However, once you work all the […]

Mark Drlik

Why You Should Add Barium Sulfate Radiopacity in Plastics for Medical Device Design

Sometimes radiopacity is required to visualize the location of your device during a procedure, or perhaps to make sure it’s where you left it. When x-rays are utilized with metallic objects, the image can suffer from shadowing effects due to the strong contrast with the surrounding tissue or bone. An ideal radiopaque solution is a […]

Mark Drlik

Top 5 Ways to Leverage Grant Money in Medical Device Design

The Industrial Revolution was, at least partly, funded by the Spanish pillaging the new world of gold and silver. Fortunately, since then we have found more controlled and focused programs to assist smart, capable people to achieve their goals. This is especially true in the medical field, where the final product has a direct impact […]

Mark Drlik

The Usefulness of Computational Fluid Dynamics in Medical Device Design

First principles calculations are the best way to give a design concept a reality check and worthy fluid dynamics books have a wealth of reference information on drag coefficients, major/minor losses, hydraulic diameter calculations, and a trusty Moody diagram. However, sometimes the problem is less intuitive… For example, non-Newtonian fluid flow, actual flow from a fan, […]

Mark Drlik

Getting Your Hands Dirty in Medical Device Design

Many of us understand the benefits provided by workflow investigation, procedural observation, literature searches, and contextual research – and another piece of the product development puzzle is hands on exploration. This often requires getting your hands bloody, slimy, or sometimes worse. There are a few avenues to explore – but, when appropriate, my favorite is […]

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