In most of the world, regulatory bodies approve medical devices based on safety. Seems like common sense. But, in the U.S., the FDA approves medical devices based on both safety and effectiveness. It’s the “E” word that is largely responsible for the long and protracted clinical trials that delay approval of novel medical devices. Read More
When most people think of novelty items, they are envisioning the trinkets you buy at a party store for a gag birthday gift. But, medical device intellectual property is no laughing matter. In patent parlance, novelty refers to whether an invention is unknown or not used before being filed with the patent office, and is non-obvious. Patent law experts can provide a better legal description of novelty than myself, but from a practical standpoint, I’m more interested in helping doctors gain preliminary insight into the novelty of their ideas? Read More
