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Development Pathway for Devices

August 4, 2009

There is often the question of “how different is the development pathway for devices than for drugs?”  Even for those of us on one side of the industry, we may know a little, but perhaps not as much as if we were entrenched.

The June 2009 issue of J. Med. Devices has an article that provides a good top level overview of the general development process of devices.  Note that this is general – not specific to one company – but a good read.  It also compares the pathway with that of drugs and offers insights on the unique issues with drug/device combo development.

Stage-Gate Process for the Development of Medical Devices
J. Med. Devices 3, 21004 (2009)

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