The current device is used about 1.5 billion times annually, at a retail cost of about $1.3B. The replacement does not cost any more to manufacture or distribute.
Hi, Andy Jacob here....I haven't heard you mention that people want the product? I would make sure people actually will replace what they are currently using first..
I have a ton of experience in the device world (past clients include 2 of the top device makers in the world). Bigger question here is how you're handling IP. The incumbent manufacturer could sue you for patent infringement; you want to get your own patent application(s) in the pipeline ASAP; etc. IP is what makes the medical device industry go.