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Ep7 - Blood Behaving Badly - Effectively Manage Blood During Testing
Manage episode 322648410 series 3326488
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Managing Blood When Evaluating Consumable / Durable Medical Devices
“Blood is thicker than water” the old saying goes. There’s truth in that adage, especially when it comes to designing and running de-risking experiments of blood processing systems.
Whole blood is a two-phase fluid, comprised of both cells and plasma. Under pressure, it’s fickle and unpredictable. And those unique fluidics present distinctive challenges in designing medical devices.
Blood management is the central concept in cardiac care, the largest segment of the medical device market. As the home care market continues to grow and devices become smaller, blood management becomes a more and more critical design issue.
This month, Mechanical Engineer Katie Goetz and Andy Rogers of Key Tech talk blood: how it poses problems in medical device design, and how to get blood to do what you want it to do.
Need to know:
Why blood fluidics are different
How to engineer your device for optimum flow control
How storage methods, freshness of samples, and interactions can affect test results
How to deal with bubbles
The nitty-gritty:
A blood analog may work fine in the early stages of testing, but nothing replaces testing with the real thing. Whole blood is thick and complex, and the viscosity varies due to many factors. That makes for some challenges when you want to make blood flow the way you want it in a complex consumable. Blood differs from person to person too, so medical devices must be capable of dealing with a wide range of conditions. Blood also interacts with metals, plastics, and air differently, which can also skew test results, so proper cleaning of prototypes is critical. And then there’s foaming, which adds risk and time to your test planning.
Even the logistics of blood are complex. Anyone who’s doing testing needs to be trained how to work with blood and clean it up. Ordering blood takes a few days, and sample blood may need to contain additives like EDTA or other anticoagulants, so when you are designing and running experiments, you have to take this into account.
As we said, blood is complicated. But if you take it step-by-step, and follow the protocols, you can make blood behave the way you want it to. And you’ll make your device all that more robust.
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