Robot reliability and uptime counts - get it right!
- Steve Bell
- Oct 10, 2024
- 11 min read
Updated: Jul 30
NOTE: I want to be clear - this is in no way to single out Medtronic - it just happens to be the company in the headlines the day I write my blog on reliability being a major factor in the launch of a successful soft tissue surgical robot.
I've said it before and I'll say it again. Making a prototype surgical robot is relatively easy. Making several that all do the same thing is harder. Making production quality is super hard - and pushing out hundreds that will be reliable in the market place time and time again is really the realm of the few.
One of the biggest challenges for any company (big or small) coming into the soft tissue robotics market place is the incredibly high bar (in all aspects) set by the incumbent Intuitive.
They now have a 99.5% plus up time of their system. Which means that it more or less always turns on - and then when it is in operation in a case, it works for the duration of the case as intended.
With such complex mechatronic systems - that is no mean feat. If just one thing goes wrong then the case has the potential to be cancelled. If cases get cancelled then you will not only disappoint the patient (the worst part of this) but the surgeon will become frustrated and the hospitals will become distrustful. Systems will come back.
As I was writing this blog on reliability - my news radar lit up, and three articles came across the wire - which was timely. And this is not any news that in any way helps competition in our space. No one should relish in this news or use it to score points. It does not help our industry.
From the press: Patients were sedated unnecessarily – the operating robot at Sundsvall Hospital did not start.
Several patients with prostate cancer have been sedated to be operated on with the new operating robot at Sundsvall Hospital. But when they woke up, they had no surgery. This is clear from the deviation reports read by SVT Västernorrland.
After several instances of technical problems, the Västernorrland region has decided to pause the use of the robot from the medical technology company Medtronic. The purchase cost about SEK 15 million.
SVT has read the reports from the four occasions when the technology went wrong.
How are patients affected?
In the first deviation from January this year, errors appear on the robot arm. Something that had consequences for the person who was to be operated on.
"The patient needs to be put to sleep one more time. Extended wait for surgery.”
There is always a certain risk of being sedated.
The supplier does not answer questions
We have searched for responsible persons at the supplier Medtronic , but they do not show up for an interview but answer that they must ensure that there are no disruptions in patient care. Unclear how.
The region has used the robot about 60 times. An analysis of the errors is currently underway and it is unclear if and when there will be any continuation.
Are you considering canceling the purchase?
- It is too early to draw any conclusions yet, replies operations manager Roger Westerlund.
In the video, you can see what is written in the four deviation reports.
(Through Google translate)
Now this is tragic on several levels - primarily for patients that were dissapoiunted. But it is clear there was no patient harm and that is the most important thing. However it does not help the use of robotics as it gives doubts about reliability in competitive systems.
The fact this is one of the best companies in the field of helathcare - Medtronic - is the bigger issue. I have written extensively about how Medtronic and JNJ are held up to very high standards - and healthcare providers expect nothing but excellence. And people say "If they can't do it ... no one else will do it."
It adds concerns to the market to deviate away from the tried and trusted system of Intuitive.
It is clear this has been a long term issue - with events since January being considered at the hospital. This has already been seen in several field safety corrective action reports across Europe.
(one of several - https://laegemiddelstyrelsen.dk/da/nyheder/senest-opdaterede-indhold/~/media/540610F1DBE34393A18CEF9617A1DC11.ashx )
So some of these are known issues. Some issues seem to have been resolved. But what you see in this hospital is a "stacking of frustration" and over the time since January issues have continued to impact patients to the point where hospital management have suspended use of the system. That is not good for anyone.
I'm not going to point at Medtronic here - this is just one example. Surgical robots are hard - very hard and this just highlights that again. And when people continually ask me why I think Intuitive will dominate for the next decade - it's because they have already surpassed these growing pains. They have taken over a decade to work all this out. All new robots that come onto the market are by that very fact "New" with a lot of unknown unknowns.
Medtronic is not the only system on the market that has seen reliability issues, nor will they be the last. It is just as Medtronic, their huge reputation sets the expectations higher than the smaller start ups. (I've said this in other articles.)
So put this example to one side for a minute - what I wanted to focus on was to give some advice of how you deal with this in the market place.
If it goes wrong - how you deal with it counts
As someone that has lived in this medtech space I can guarntee you that things just go wrong with medical devices. Components fail, instruments break or wear out, software has bugs, imaging has issues. And most of that you never find out until you are a few thousand patients in, and over 50 systems out there. And in robots that brings all those risks to one single system.
I seem to remember (vaguely) that Intuitive had issues in the early days - but what was impressive was the way they dealt with the issues and supported their customers. In effect I believe they knew that not doing so was existential to them.
From the press: The world-leading company Medtronic does not answer questions about the surgical robot in Sundsvall
The major company Medtronic describes itself as the world leader in the market. But despite the fact that they do big business with tax-financed activities, including the region of Västernorrland, it will turn out that they do not answer questions from the media.
It was at the beginning of the week that the region Västernorrland, for the second time in a short time, pauses the operations with the new surgical robot from the medical technology company Medtronic, based in the USA and in Ireland.
According to the region, these are technical problems. This means that operations for prostate cancer patients cannot be performed as planned with that technology.
What does the contract say?
SVT Västernorrland has read the agreement between the region and the supplier. It states that in certain circumstances the buyer has the right to cancel the purchase, demand a deduction from the purchase price or demand replacement delivery.
The buyer, in this case the region, may also be entitled to compensation, the contract states:
"...for all incurred additional costs that are attributable to the complaint."
You can see our questions to the company in the clip.
In the video, you can see when our reporter Anna Beijron tries to get an answer from Medtronic.
(From Google Translate)
If there's one thing I have learned in 34 years of doing mediucal devices - if you have an issue deal with it like your life depends on it. Plus media management also needs to be done in a very tactful way. I'm sure Medtronic are dealing with this - but my advice to all is "have your media plan ready and action plan ready because it's going to happen to you."
Of course the media will play this up - that is what they do well. For me it will be how well companies deal with this adversity that will be part of the bigger success of their soft tissue robotics programs. And this is where I will start to opine about how I would deal with this sort of event - no matter how big a company I was.
Reliability will be an issue - so have a plan
If any soft tissue robotic company is reading this (launched or about to launch) I want to shout to you that reliability and how you deal with it will determine much of your company or program survival. And this is not easy.
I'll say it yet again - these are not simple staplers - or energy devices - even navigation robots - they are super complex mechatronic - software driven - multi complexity devices where arm movements are not simple small - slow positioning movements like in spine robots. The arms are doing the work continously for hours. The instruments are working under stress for hours.
So you will have issues. So have a plan.
Let me start with this statement: If - pre launch - you are sat smug in your meetings saying "we have cracked reliability of the system" we are a great company and we don't have those issues. Be ready to eat humble pie. Because I do not care how many cadaveric labs your KOLs have done with laptop engineers plugged in... the rubber hits the road when real users in the real world get their hands on the system with no software laptop support. The unknown - unknowns will then get you.
Software patches will get you.
Instrument tweaks will get you.
New feature sets will get you.
Real world environment will get you.
Cables and plugs... will get you.
Firstly - the one thing you will need to do is smother your sites in service engineers. If that means you need to have a service engineer camping in that site for every case for a year - then sorry to say... that is what it takes.
If there is the slightest "worry" from telemetry then get the arm fixed - get the console fixed before any case, and make sure that when the power button is turned on - the system starts - runs through its checks - and is ready for use. Period.
You do not want anaesthetised patients waiting - or waking up not having had their cancer operation. And NO !!!! the "Well they could always do it manual lap" is a stupid shitty answer that will kill your product. Because if they could "just do it lap" then cut out the robot from day one!!!
The real alternative is - "Then maybe we should just use a reliable robot..."
So do everything to make sure that the robot starts for the case and finishes the case. SAFELY !
Safety - then reliability trumps feature sets. What I mean is - ensure that the basic system works every time - and for the duration of the case. (not easy) - and make it so that a good clinical team in the room can do their magic and keep the case going. Make it feel smooth.
Second - Design the system right. During the case you want a system that does not go down if one single arm goes down. Period. If in any way you have a system when one arm faults it means the whole system stops and is out for the case - then you are doomed. That is just not tenable as a system design.
The ability to continue with 3 arms is critical. You can finish a case with three arms. But if your system architecture means that one dead arm is the end of the case: That is a terrible design. If you are about to launch a system that does not allow redundancy of one arm - then stop now. Go back and redesign it.
Better still - if you are a modular design - make sure that you can "Hot swap" arms. Because in the early days arms fail - and if you can hot swap them with a spare arm. You are golden!!!!
Third - have the world's best implementation teams in the OR until the system is stable. You need a clinical team member that can do their magic if something goes wrong. And they understand every single dydnamic of how that system works from instrument tip to plug in the wall. If your entire management team does not understand that - from CEO down - they you my friends are in the wrong business. The robot is secondary to you. And that will do you in. If your C suite cannot run a full demo including setting up the system - getting it running - switching out for problems - then you have the wrong culture for a robotics company (or robotics division.)
As the Chief Commercial Officer - I could strip the system down - I knew all the components inside ths sytem and how every part of the system worked. I would go into a room - set up the system - run a full demo - explain every part of the system in insane details - do things to make suboptimal parts of the system work (better) - know when failures were about to happen - anticipate issues - trouble shoot - run a full demo (or clinical case) and ensure that we got through every demo or case - and then pack the thing down - clean it - store it.
I was not the only one. Several of my C-suite colleagues could do that - it was impressive.
I'll bet you everyone at Intutive (especially in the early days) could do that. I'll bet you the current C-suite can all do that today.
Can your management team do that? If not - it's time to upskill - because you will need that culture from the top.
The best of the best implementation teams can ensure that even when things are going wrong - the case continues - the instruments get swapped at the first signs of issues - arms can get rapidly swapped out - the engineers can get that arm back ready for use in minutes (when they can) and the case continues. It's a madatory culture of excellence. It is the price of early days when the system is new and unstable. It buys your home base engineers time to fix the underlying issues without the market going to the press. If it's a software issue of a new release - ensure you can roll back fast to the old release until the new one is fixed.
"Soft tissue surgical robots are not a product - they are a culture."
Fourth - Fix the damned issues and fix it fast. It is that culture of implementation that will then buy the time to sort out the bugs and the issues. But you NEED to sort them out and sort them out with urgency. You need a management culture that does not sleep until the post market problems are sorted. I hope that Medtronic has their entire C-suite - including Geoff Martha flying to that hospital to personally sort out that issue. Yes it is that important!
Then they need to listen to the customers - HEAR the facts - and then create a solid plan to the engineers to turn that around. If it is that particular system - replace it immediately. No questions - no hesitation - replace it.
If it is something wider - then I would have a crack team of engineers focused on getting those issues fixed with an urgency like nothing on earth. Get the thing safe - then relaible - then add features (carefully). That's the order.
Safety seems to be a given in this report - so the focus is reliability - and get that sorted because this is often the tip of a very dangerous iceberg. I know they will be all over this. So I'm writing to other companies coming out withy systems.
It will be soooo tempting for management to say about any site - "This is just an isolated incident and these users are just over reacting." - NOOOOOOOOOOO!
They are the ones that have found the issues first and are helping you to understand that. listen to them. Listen to them. Whichever company you are. Listen to them and HEAR them and fix the damned robot.
The bar is so high that Intuitive has set - and that is what you are to be measured against "Good enough" is absolutely not "Good enough!". Intuitive's bar is "Good enough" end of story. And until you get there (which could be five years) you will need to throw resources at the sites to make sure they have the best experience they can despite the state of your robot.
When you put a robot into a hopsital - you are living on trust. It's a two way deal. The customers will run a robotics program - basically changing the very way that they will run their side of the business. Everything changes for them. And your side of the deal is to make sure - by hook or by crook - that the system allows them to deliver safe - reliable patient care.
Your goal - 99.8% uptime !
The media articles in this post are directly from the source and not opinions of the author. The rest of the article are just opinions of the author for educational scope.
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