Is Medtronic’s Venture into soft tissue surgical robotics with HUGO struggling?
- Steve Bell
- Jul 2, 2024
- 17 min read
Updated: Jul 30
Up front disclaimer:
It’s really important for me to stress up front that I am in no way intending to troll HUGO and Medtronic. Far from it. I’m the biggest advocate of their being multiple competitive platforms out there on the market. Competition is good for patients.
I also have a very strong respect for Medtronic as a historical medical device company - that has done some amazing things.
So I need you to read this as an interpretation of what I am seeing real world with HUGO. The feedback I get from multiple global sources. Information dripped in from actual users, former users, and industry experts.
Some of this comes from factual based sources (Government bulletins), some is more akin to hearsay, some is speculation on my part by joining the dots.
But with all that said - I want to explain why I’ve come to the conclusion that Medtronic is struggling with HUGO. Let’s dive in.
The concerning noise in the market about Medtronic HUGO
The no show at SRS 2024 of Medtronic actually with the HUGO robot was sort of understandable to me, and sort of not. I know that when corporates are going through IDEs they don’t want to have the FDA feel they are promoting ahead of clearance. But there were 45 robots at the meeting and 90% had no clearance with FDA. Half are in some form of FDA pathway. FDA was even there - and they seemed to have zero issue with the other systems on display. I mean it is a genuinely international meeting that was just heard in the USA. There shad bold disclaimers as not available in USA.
The icing on the cake for me was the Medtronic Hugo presentation at SRS 2024 when I saw Germany as a major market missing from the European roll out, the seemingly long IDE, the dancing around advanced instrument availability and what felt like a lack of confidence by the speaker. Almost apologetic.
After 34 years of doing this you start to get a sense of how a product is succeeding or not in the market. My spider sense is telling me - Hugo is not going well.
I add that to noise in the market about “systems being sent back”, I see Field notices that are pretty significant. I see clinical studies that are slow to recruit, even with relatively small numbers and the clinical conclusions that are not raving about the system. Conclusions like “For a first generation system it works.” Don’t get me wrong there are other more glowing clinical papers - but there are too many neutral papers.
I see the drying up on “new installs” on linked in - there was a big buzz and now there isn’t. The lack of noise by actual users, and a general backing away of news at quarterly reviews by the company. If it was going gangbuster then they’d be crowing about it and their gains at each investor opportunity.
When I put it all together in my head, It all just has a sense of gloom. And for me it starts to say that they are probably struggling.
And maybe I’m biased, because if I analyse the system - and the market approach - it feels obvious to me they should be struggling. In my opinion, HUGO is an inferior product compared to da Vinci, and honestly, most other systems out there. Let me go deeper as I do not want to troll them - I want to help review why I think this.
The overall issues with the HUGO robotic system
For me, the trouble with the HUGO system dates back to 2013 (and earlier) when Medtronic licensed part of the MIRO system from DLR ( MiroSurge Telesurgery System).
Medtronic took some of the core components of the German system and that was part of the foundation of the HUGO system.
Roll forwards to to June 2021 and they completed the first human cases in Chile. But the robot that performed those cases was far from the vision of the bed mounted MiroSurge. That was small - elegant - low footprint and focused on robotic surgery.
My read of the monstrosity that came out as HUGO was that the company had become obsessed with “We need to get our staplers and Ligasure on the system.”
It also appears that they wanted to move to a Z-rail, trapezoid arm structure with drive packs big enough and strong enough to hold their Signia staplers.
The entire issue with this logic where you try and make the robot a delivery system for staplers using Z-rails is that everything becomes massive. HUGE — hence Huge-go. I can’t be sure but I have enough experience in the corporate world to speculate how the meetings went on this - and the “design choices” that came out to make everyone happy.
Fred Moll said it eloquently last week at the SRS 2024 meeting. The da Vinci was born to be the superlative suturing machine. 3D vision - wristed instruments. Everything else gets added around that core. If you start there and work forwards, you end up with a da Vinci 5 - that also does stapling and advanced energy. Also… not the primary function!
So any obsession with staplers and advanced energy is pretty obvious for any company that has a multi billion dollar business of staplers and advanced energy that is under attack by robots and cheap commodity versions of staplers. The motivation is just wrong. So decisions get built on needs of the stapling and Ligasure division, not the ground up robotic intent.
(Maybe I’m wrong but what I see as Hugo screams to me alike these design decisions and for me it points to that.)
You need robotic people building surgical robots - and building the strategies. Not stapling and suture former sales people. (I’ll throw that to all of the big companies.) This is not how it works - and you inevitably end up with a bastardised monster. And that becomes a monster that no body wants because it is a bag of compromises.
People don’t want your robot just so they can use your staplers and advanced energy on a robot. That is delusional. That is a company centric internal hype way of thinking. They want a fully capable robot - and it would be nice if they could get your lap technologies morphed onto it, But in a genuine robotic format (more later).
Fundamentally - the HUGO of today is just wrong in my opinion. And if the core robot is the wrong design then all woes come from that.
Too big too bulky too heavy
One of the underlying complaints about the da Vinci for years has been - it’s too big - too bulky and you end up with dedicated operating rooms for robots.
The world was crying out for a smaller alternative that could easily be moved into any OR - and even moved between ORs. Half the surgical community wanted something that would not drive them down a pure robotic pathway. They wanted it to be more laparoscopic feeling - more a robotic adaption of what they did today.
Asensus was launching the industrial Senhnace - and they read that call to action totally wrong. They ended up with a Dalek looking - sit down - straight stick - laparoscopic controlled digital laparoscopy system. A failure in the making. They interpreted the “laparoscopic” too literally and missed the requirements of the robotic parts that made the robot great. Wristed instruments and natural hand movements.
But one little perky startup form the UK - CMR Surgical - had understood the gap in the market. And with Versius they knew they could get to a laparoscopic paradigm - and to do that it needed a modular cart based system. But what they also knew was that it had to be small - light - portable. And that means no Z-rails and absolutely zero focus on staplers and advanced energy. They were focused on delivering a suturing machine in a modular small form factor format.
In 2019 they got to market a whole year ahead of Medtronic and set the standard for what a modular robot with an open console should be like. Small.
HUGO appeared a year later and each arm was nearly as big and heavy as an entire da Vinci boom. It required four of those massive arms - and occupied most of the operating room.
So it was massive - heavy - and far from what people were thinking as “mobile.” It was basically a Z rail version in size of Senhance which had been heralded as too massive to be practical in most of the world.
You know the size was an issue when several dry demos were done with one arm only because the rest of the system was too big to get in to the demo room.
It was too big and is still too big. It is a common complaint by much of the surgical community.
Hard set up - science to work out
The next issue with the design of the Z-rail that docked to the ports. Combined with oversized and overweighted Z-rails was the inevitable arm clash. I won’t go into the physics of it in this post but the longer your Z rail the more it has to move around outside the body to get the instrument to move inside the body. And not just more - but way faster (especially when working close to the port.)
Watch any video of HUGO and think of the poor bedside assistant between those moving arms - with a mass of drive unit at head height. It’s not great and been the subject of a lot of commentary by bedside teams. And that team also determines if a program succeeds.
What that then means is you end up with complex port placement rules to help to avoid clash. Distance between them and location from anatomical structures. And that drives the surgeon even further from the desire they had to be more like lap. “Give me a more laparoscopic system.”
The next issue is that (and just go - download their manuals from their websites) the arms need to be at specific angles and setup poses and distances. It’s like a geometry test. It’s the only robot that has angulation markings on its arms for the bedside team to set it up as per the manual. It’s bizarre.
It is probably a result of engineers that are being directed to “Make this get our staplers on it.” In my opinion. Everything then becomes a compromise and the robot gets out of control.
When you follow the guidance of what the surgeon wants - still having docked ports - and Z-rails - but you are not trying to force fit you laparoscopic hardware on it - you end up with Ronovo Surgical Carina.
It is modular - small and elegant. They will have to work hard to get a stapler on it (like da Vinci did) but the robot is the hero. The robot is the highly focused suturing machine and the rest has to fit around it.
There’s no arm angle counters and few set ups rules. It’s small - the carts are small - so it is mobile and lighter.
This is what happens when the engineers are told. “build a small modular robot.” Period.
Instruments - lack of… and issues
Let’s not stop with the hardware. You can imagine that surgeons were promised HUGO for years and years. They were fed with the lines that “Medtronic knows instruments.” And then they launch with just five instruments that barely make the required range compared to Intuitive - or even a lap set. There’s not even a hook - the most basic instrument for a lap chole.
Surgeons that had been waiting for a mind blowing robot with a full suite of instruments - and a system that “worked” were pretty actually upset with what was delivered. I know - I heard them first hand.
But not only that - just because you can make straight and articulating instruments - it does not mean you can make wristed instruments. That is a mistake many have made and many more will make. Reliable - repeatable - reusable instruments with a real wrist are hard.
Reports quickly circulated of scissor issues (the most common instrument to have problems.)
Then reports that the promised 10 lives were actually down at one or two lives. (That is an issue for any company from a profit point of view.)
And in the past weeks, reports are coming in that they have stepped out of Germany due to the inability to hit the strict German sterilisation rules. That is a big big issue. That is redesign territory if it is correct.
[Added note 19:28 2/6/2024 - conflicting reports that they are still in Germany - and others saying - not still in Gemany - if it has passed the German standards and anyone has insights then happy to stand corrected.]
[Added note 08:28 3/6/2024 - the answer seems to be that they have submitted the "resusable" instruments in Germany as "Single use" instruments. So they are used and disposed of so no re-processing needed.]
System issues?
Even early on (as is absolutely normal) there were reports of software issues and mechanical arm issues. There were filed notices that circulated with regulatory bodies.
Normally this should go away a few years in - but even just a few months ago there was another batch of Field notices that hit Europe. Three of them. Some for the console and some for the tower and all around comms issues and software issues. This really should not be happening a few years in.
This just brought official concerns around what many people had been reporting back from the field. That the system was “Flaky” and software was unreliable and buggy. Some users felt it was not yet at the level of stability that they had hoped for.
The biggest issue seemed to be that the close down of the system - and boot up time combined was in the order of 20 minutes plus. That is insanity for any robot. And to me it says there is a major issue with the embedded software at a fundamental level. No system should require that time to shut down or boot up.
Especially if there are patients on the table under anaesthesia. That would be an immediate issue for any users. It would prolong surgery and add possible adverse events.
One of the biggest attributes of da Vinci is that it rarely goes wrong. That is the benchmark. So if a robot from the stables of Medtronic is off their benchmark, that gets highly noted.
If Medtronic cannot get ahead of this curve - and do a software drop that reduces boot time - then this is potentially a major issue. You only need a few of those, and any normal paying customer (not hand picked clinical sites) will be sending that system back (more later).
Advanced instruments - or rather lack of
If you are Medtronic and you tout that everyone wants your staplers and Ligasure on a robot… and you “will be the only robot to take advantage of the Medtronic staplers and Ligasure.” Well you better damned well launch with them on it. Especially when in your initial launch video back in 2021 you showed a Ligasure end effector and intimated it was being driven by a robot (when anyone in the know understood it was being held by someone and hand operated.)
If in your initial instrument line up you show a stapler - you damned well better have a stapler on your system at launch.
Nothing. The silence is deafening, and it screams of internal issues of validation or design or something else.
How can you build your entire thesis on making a da Vinci killer robot because it has Ligasure and Signia - and then three years after launch stand up at SRS 2024 and say “we are working hard to get them for you.”
Sorry but the market is scratching its head -and the initial customers are not happy. Not happy at all - especially the general surgeons who are the group that are close to Medtronic.
Ligasure - straight
Now let me dig in more. Ligasure is a pretty difficult instrument to get a wrist on it. The initial promo video was a straight Ligasure - and I am sure that HUGO will launch (at least at first) with a “straight stick”Ligasure (non wristed.)
If they do - then of course some people will be satisfied. But many robotic enthusiasts will not be. You see, they buy robots for wristed instruments. If they have delays in getting Ligasure straight on the system - then be assured it will be super difficult to get ligasure wristed on.
The issue is that Ligasure relies on very specific closure pressures and compression for its algorithms. Unfortunately even inaccurate straight robotic instrument - if you use cable drives for jaw closure - the variance in forces can be enough to end up with non consistent seals. And that will make it hard to get enough seals to pass with a small enough variance to be acceptable.
This is the problem with trying to take your product off the lap shelf and stick it on a robot. It just doesn’t work that way (well not easily.)
Signia Staplers
I suspect that looking at the drive packs (shape and size) - they have been designed to take a signia stapler.
Remember, they are not wristed, they are articulated - and well the world wants fully wristed staplers like Sureform. Because that is now the gold standard of a robotic stapler.
The same issue will apply here - just because you can do it lap - does not mean it can be easily adapted for the robot. I’m just speculating, but I also imagine that validation and verification of staplers will be a hot topic in the HUGO team at monthly meetings.
And after all that work - if it is Signia on a bot - then as per my other post on staplers - they will not make that many people happy. You can’t have a slow moving articulated stapler on a robot. It needs to be fast and wristed.
Medtronic and JNJ would be best building from the ground up - starting with the robot and working backwards. Not trying to mate two halves of a puzzle, where one half is already existing.
That is why Sureform is how it is - and Synchroseal is how it is. It is ground up technology based on the robot, not the other way around.
No ICG - Fluorescence
At SRS there was not even a mention of this (well I didn’t hear it.) And I’m going to guess why.
You see HUGO used an old 3D HD non ICG camera system supplied by Storz.
Now Storz have the world class 3D 4K White light ICG with Rubina - but it was never allowed onto the HUGO (or other robots.) Probably because they didn’t want cannibalisation. So sensible.
In the meantime Medtronic acquired Visionsense (2018) - but there has been no sign they have adapted that for HUGO. (I’m not sure if they even still have it as a program?)
Anyhow - today HUGO has no ICG. And I guarantee with the acquisition of Asensus - that Rubina is not appearing on HUGO any time soon. In fact - if I was Medtronic I’d be looking hard at my supplier agreement and making sure I had 2 years get out clause minimum (To not risk being left without a vision system.)
To get another imaging system on Hugo will not be quick or easy - so I see a risk here.
Wrong thing too late
So when you start to sum all of this up… In my opinion, it is the wrong product - too late - with no real killer features. It’s reportedly flaky, unstable, and way too big for most people’s needs. There are plenty of alternatives and it doesn’t have the thing that makes it unique - their Ligasure and their staplers.
All of this has led to what I would call “lack of headway.”
The best estimates I can work out is that there are about 70 systems of HUGO out in the wild. But a lot of those systems (just looking at the clinical papers) seem to be doing very few cases. In fact some seem to have ground to a halt after the initial enthusiasm and reports say that some surgeons just don’t have faith in the system.
I’m taking a wild stab in the dark here - but my estimate is that almost 25% of the systems have stopped or come back. (Based on field reports, social media posts and field visits.)
Why? In my mind it’s simply the wrong thing and too late for many surgeons. There are way more alternatives to try - and da Vinci seems to be looking pretty good nowadays. Flexible purchase models - fully loaded systems with acceptable advanced energy and great Sureform stapling. ICG - and a new model on the horizon (DV5) for Europe, which is already getting great acclaim in the USA.
I’ve been watching the EU tenders closely - and the landscape is not pretty for HUGO. Bundle deals will only get you so many deals and then the robot better work, and work well. If it doesn’t then the whole thing might unbundle.
Lack of FDA - slow - only urology
Crossing the Atlantic, the IDE has been a long trial for such a small number of patients. Rumours suggest some of the IDE sites stopped short and didn’t continue. It’s a long clinical trial -
Starting Dec 2022 and doing 122 patients in roughly 6 centres. It’s June 2024 -
So if my math is right - and it can be wrong often - that is 18 months and they are just finishing.
If it is 6 centres - that is just about 7 patients per month across all six centres so about 1.2 patients per centre per month.
That is a very low recruitment rate - and I ask “why?’
If the trial recruits by end of June - then they could possibly have a Urology claim by end of the year and a clearance - and that would mean a launch say April 2025. For 1 specialty. In the most aggressive area for da Vinci - where da Vinci reigns supreme. That will be interesting.
To get Gyn and Hernia claims will be at least another 18 months after they start the clinical trials.
Too little, too late?
What can they do now?
Okay so I’ve railed hard enough on them in this article. And hey - maybe I’m wrong?
But I can only give my external observations and say why I think they may be in trouble. Because a lot of what I said above is not a quick fix. The underlying platform - for me - is inherently wrong and not what the market wants or has been asking for.
In an upbeat finish to the article - and to not always been seen as such a negative pundit - let me offer some advice and thoughts.
Firstly I would get Ligasure on the system as a priority - it’s a signature product and if you can get it working - even straight - it will be a big plus. (I know you know that.). But as fast as you can you need two move to wristed Ligasure. If you want to be competitive in the next 5 years - wristed advanced energy is here to stay.
Get Signia on the system as fast as possible (I know you know and are screaming we are f’ing doing it as fast as possible) but as soon as possible (if it is articulated) move to a fully wristed Signia as fast as your engineers can achieve that. If you can’t beat Sureform on wristing you will struggle as it is the new standard. It will be hard for users to go backwards.
I know you think your staplers are better — the massive volumes of users going from your staplers to Sureform say different.
Buy a world class 4K white light ICG system and integrate as fast as possible; and get Storz off your system (if they haven’t already pulled the plug). You need to own your own vision chain and hence destiny. But go buy someone that already has one ready to go - but own it. Or if you still have ViisionSense as a plan B - get cracking on plan B.
HUGO 2 - No doubt you have some ideas of this and some people working it. Well I advise to not make the same mistake again. Abandon your thoughts on staplers and advanced energy and build the world’s best HUGO. Small compact - capable with 30 life instruments that can pass German regs on sterilisation. Make it smart, and just stop the “open lap robotic” and build the world’s best robot. Av robot that can compete with da Vinci.
If you want to jump all of that and get a great robot. Get out the cheque book and go buy Ronovo Carina tomorrow… before someone else does. It is everything HUGO 2 should be, and you then are for5ced to come from the philosophy of robot first. They have price points and it works. You can always mod your stapling tech and Ligasure and get it on later. But it will be the dog wagging the tail and not the tail wagging the dog.Good luck to Medtronic - because (IMHO) unless you fix HUGO - you will need all the luck you can get.
These are just opinions and speculations by the author for educational purposes only. Much of the information is based on experience and assumption. The author has no inside knowledge - and all assumptions come from public domain sources. All trademarkes owned bey their respective companies.
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