In this article, American College of Clinical Engineering “Hall of Famer” Binseng Wang calls for the development of a widely accepted set of failure cause codes (FCCs) to help the FDA and servicers to better understand the extent and root causes of servicing errors and, ultimately, improve safety and effectiveness.
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Continuing cyberattacks and threats against hospitals, an aging population demanding more chronic disease management, and an increasing need for interconnected medical technology is expected to drive market growth.
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The defibrillators market is forecast to reach $10.88 billion by 2022 from $9.32 billion in 2017 at a compound annual growth rate (CAGR) of 3.1%, according to market research firm ReportsnReports.
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The wearable medical devices market is expected to reach $14.41 billion by 2022 from $6.22 billion in 2017, at a compound annual growth rate of 18.3%. Key factors driving market growth include the increasing penetration of smartphones and the growing preference for wireless connectivity among healthcare providers.
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In a statement, U.S. FDA Commissioner Scott Gottlieb, MD, revealed that the FDA has completed its first qualification of a medical device development tool to provide a more objective platform for developing devices in a key area of medicine: cardiovascular health.
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