Good point. Most of the job descriptions specifically call out FDA experience, ie “Prefer experience with IEC 62304, ISO 14971, and FDA guidance on medical devices”. PLUS, they have the cash! We’ll make the most money if they get to FDA on their own, but we’ll have to wait just a little longer. Im good with that.
Or these spots could already be filled. Public companies have to list a job publicly before filling it I believe. The company I work for does it all the time with candidates already "chosen" for said job.
Agree. I was bag holder from their sport platform. So been doing a little DD and 1) one issue was FDA wanted human trials. The Sport platform had only been used on cadaver and animals. Adds additional costs and delays. 2) they needed to raise close to $100m to enter manufacturering of the Sport system. Point is Sport platform was almost there.
Enter ENOS ... I believe it is the SPORT with some upgrades. It just needs to restart process i pointed to above. I think the jobs listed supports that.
Medtronic is important as 1) a funding source and 2) information resource/exchange. Doesn't mean they are not partnering up but don't think they have to ... funding for manufacturing will tell.
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