Intra-aortic balloon assist devices reduce the heart's workload and improve blood flow throughout the patient, but may not adequately provide circulatory support for patients with severely diseased or damaged hearts. Researcher H. Fred Downey at the University of North Texas Health Science Center in Fort Worth, Texas believes there is a way to enhance the device's effectiveness by adding an external pumping module. The external module works with the internal pump when conventional balloon pumps are unable to maintain adequate flow. The device was patented earlier this year.
As manufacturers add new technologies to their products, designing for compliance becomes more difficult. Prepare for the certification testing process. Otherwise, you increase the risk of discovering a safety issue after a product leaves the assembly line. That will cause significant time-to-market delays, be much costlier to fix, and damage your brand in the eyes of customers.
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