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investors, patent, patent application, first to file, medical device, patent office, law, Innovation, first to invent, us patent law, patent system

Patent Law Changes

For over 200 years, the US has operated under a “first to invent” rule. This..


Medical Devices, medical device development, March Madness, medical device industry, Innovation

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still..

best practices, Quality System, autonomy, Guidance Document, Innovation, regulatory, improvements, quality

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our..

medical device, Innovation, Cleveland Clinic

Rethinking Innovation

One of my favorite topics about the medical device industry and technology in..

Medical Devices, Stents, Innovation, PMA, de novo, Disruptive Technology

Blockbuster is no more - A discussion on ...

Every time I go home to visit my parents, one thing that comes up more often..

Mission, Medical Devices, Substantial Equivalence, Innovation, Intellectual Property, 510(k)

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and..