These 7 trends matter the most for medtech in 2019

5. FDA under fire

FDA has also found itself making a series of statements and proposed reforms to answer the harsh public criticism the agency and industry as a whole have received.

In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

FDA has announced plans to reorganize its Center for Devices and Radiological Health, reforming the way 510(k) clearances are handled, and increase scrutiny of materials in medical devices.

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