GROWTH HACKING STRATEGIES FOR IN VITRO DIAGNOSTIC REAGENTS Industry

A medical device is any device that is intended to be used for medical purposes. Medical devices benefit patients by helping healthcare providers diagnose and treat patients, and by helping patients overcome disease and improve their quality of life. When using a device for medical purposes, there is a significant risk potential. Therefore, medical devices must be proven to be safe and effective with reasonable assurance before government regulations allow the device to be marketed in their country. Typically, as the risk of the device increases, so does the amount of testing required to determine its safety and effectiveness. As the associated risk increases, the potential benefit to the patient must also increase.

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Some of the key players of In Vitro Diagnostic Reagents Industry:

Roche, Danaher, Abbott Laboratories, Thermal Fisher, Sysmex Corporation, Biomerieux, Siemens, Ortho Clinical Diagnostics, BD, Bio-Rad, Myriad Genetics, Hologic, QIAGEN, Mindray Medical, Wondfo, KHB, Da An Gene, Leadman, Biosino

The discovery of what would be considered a medical device by modern standards dates back to year c. 7000 BC In Balochistan, where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also reveals that many types of medical devices were widely used during the time of ancient Rome. In the United States, medical devices were not regulated until the Federal Food, Drug and Cosmetic Act (FD&C Act) of 1938.

Later in 1976, changes to the FD&C Medical Device Act introduced the regulation and supervision of medical devices as we know them in the United States today. The regulation of medical devices in Europe as we know them today came into force in 1993 with the so-called Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD.