by Randal Chinnock
Slide 3 of 12
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So let me define Disposable Medical Optics — “An optical device or subsystem that can be produced in volume at a cost low enough to be successfully commercialized as a single- or limited-use medical device or accessory.”
That’s a long and detailed definition but the most important part of it is “successfully commercialized”. Meeting engineering requirements, getting FDA clearance, and good trial results mean little if clinicians ultimately don’t adopt your product.