Rollgard, I think the IDE filing will probably come shortly after the validation testing on the new instrument designs. It sounds like these changes were requested by some of the surgeons and it is typically as good idea to give the (eventual) customers what they want. Seems like everything else was pretty well in place except full software package, which requires failsafe strategy implementations, redundancies, and a host of nitpicky functions to ensure everything works exactly as specified. They may also be adding in some hooks to other Medtronic devices, e.g. data collection, motion tracking, etc. to conform to some of Medtronic's existing data structures and/or the new Digital Surgery acquisition they made in February.
I could see validation on the tools done as early as the end of this month or mid-September, with a strong chance that IS the October milestone. IDE shouldn't be too far behind, but with new software requirements likely imposed by Medtronic, could be later this year, I would guess. That could put 510(K) in early spring 2021, and approval by late summer, assuming one round of AI from the FDA.
I don't see Hugo coming back for a couple (2 to 3) years at best. I assume Medtronic will run with Enos as soon as possible to start building relationships with hospitals and surgicenters and to establish a foothold in the marketplace. They want to start competing with ISRG ASAP and collecting revenue from this giant science experiment they have been running for years with no end in sight. Titan is their shortcut to the marketplace.
When Hugo eventually rolls around, it will be billed as their "Cadillac" system, augmenting their product line offerings and allowing their early customer base to expand further into Medtronic's portfolio. Many disgruntled ISRG customers will need to wait for Hugo before jumping ship to the full-scale three-armed robot but I foresee a lot of these organizations jumping fully over, picking up Enos and Hugo systems as soon as budgeting allows.
They (MDT) need us quickly as their foot in the door and to create solid credibility in the market so Hugo can make a bigger splash. I won't be surprised if a lot of surgeons are happy enough with two arms that Enos will enjoy more market share than Hugo. Besides, who wants a half dozen scars when one hidden entry point is an option?
All my opinion, of course...
Message in reply to:
66Mustang Nice,Thank you.Care to share an opinion,
as to what the holdup is with IDE filing.I was assuming some improvements caused the delay-Cambridge,Digital Surgery etc...is that fair to say.
Would it be fair to say next milestone is IDE filing?lastly,in your opinion how does HUGO-fit in with IDE? Same time? months apart?
Just hard to see how MDT+TMDI get both robots near the same time to market unless HUGO is being implemented and the finished robot will be a Heinze57 (if you will) platform,being only ONE robot to compete with ISRG.
Thank you for your time.Roll
Message in reply to:
66Mustang Nice,Thank you.Care to share an opinion,
as to what the holdup is with IDE filing.I was assuming some improvements caused the delay-Cambridge,Digital Surgery etc...is that fair to say.
Would it be fair to say next milestone is IDE filing?lastly,in your opinion how does HUGO-fit in with IDE? Same time? months apart?
Just hard to see how MDT+TMDI get both robots near the same time to market unless HUGO is being implemented and the finished robot will be a Heinze57 (if you will) platform,being only ONE robot to compete with ISRG.
Thank you for your time.Roll
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