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Remanufacturing Robotic Instruments: Will it impact Intuitive’s I&A business?

Surgical robotics expert Steve Bell discusses remanufactured  robotic instruments

My short answer is no… not significantly. There I just saved you reading the entire article. Well of course it is super nuanced and I’ll give you my thoughts on it - as I get asked almost every other week about this.


Let me try and explain about “second hand” instruments and new remanufactured instruments - as they are often mixed up. There are pre-owned instruments that either have or have not been refurbished or remanufactured. You see there are two types of instruments that get sold. First are “Pre-owned” instruments - which is often an instrument that was bought by hospital A. Let’s say it has ten lives and the previous owner (hospital A) used it for three lives - then sold it on to hospital B. That means that it is still the original instrument, manufactured by Intuitive (or other companies maybe in the future.) It will still have seven good lives left on it. The “chip” inside will not say the instrument is finished. The instrument can be resterilised like normal and used. Pretty obvious. But there may be a third party in the middle that procures the used instruments and sells them on.


Next are “Refurbished” and "Remanufactured" instruments. This is often confused with simply reprocessed instruments. But it is very different. Reprocessing is taking the instrument (as above) with remaining lives and cleaning it - sterilising it. I was made by Intuitive and used as per their instructions. Every day all Intuitive instruments are reprocessed. Reprocessing often happens for the life of an instrument within a hospital, shared across sites or sold on as “Pre-owned."


Refurbished is different. A company (it could be the original manufacturer if they wanted or a third party) collects a used instrument from a hospital. They take it back to their facility and take ownership of that instrument. They can take that instrument - do nothing more to it than make sure it is cleaned - lubricated - and “re-chip” it to reset a number of lives, and test it. Or they could change a couple of parts, make it look nice and then send it back to the hospital and put it back into use for the remaining lives - it is considered like repaired / used goods. .


Remanufactured is a much higher level than refurbished. It is a complete tear down, inpsection and replacement of all components that no longer make specifications. It is a total rebuild to a very high standard. In some industries it is as high if not higher than the spec of the OEM (original equipment manufacturer.) It must get it to an as new" level. It is not considered a repaired or used goods. It is considered a new product. This is a nuance often missed.


To be clear: If this is by a third party then at that point that instrument is no longer manufactured by Intuitive. The third party has become the manufacturer. And that company must prove that instrument is fit for purpose and functions as well as the predicate device (or better) - it must be substantially equivalent to the original Intuitive device. The third party is responsible for setting up their own tests, own validations to satisfy the FDA that is is “substantially equivalent” to the predicate.


Now - that instrument (when it comes back) may have worn scissor blades, or frayed cables, or etc etc.In many cases the instrument often needs some serious TLC to get it back to the performance required by FDA. This is “remanufacturing” in its purest form. And no… it does not have to be remanufactured with the original manufacturers parts. For example if a cable inside is replaced - it may not come from the same factory as the original manufacturer. Or the scissor blades - or flushing channels. But the third party manufacturer will have specified the components to be “substantially equivalent” not “Identical.” That is a subtly that is often missed. It may not matter in terms of function. But people ask "how do they get hold of the Intutive compinents?" They don't.


Think about a car - often the brake pads are changed and they are after market “equivalents” but often not the same as the original manufacture put on. But do they stop your car? Yes. Are they always as good? Sometimes yes - sometimes no - and sometimes even better. But they will all conform to the regulations for your car to be safe on the road.


Basically it is no longer the “original” instrument with “all original parts” and so is a remanufactured instrument. It is “different.” But the third party company must do testing to show it is “substantially equivalent” in performance and safety to an original instrument. But, as I’ll come to later, that does not mean that the original manufacturer’s tests or test processes were followed. The third party does not have to do “identical” testing - they have to show that it is safe and functional, meeting the requirements as set out by FDA. And we will come to that later.


Does it matter they don't have the exact tests and QA?

Not for FDA - and not if the customer is happy; and the patients are safe.

but...


So I hope that gives a broad overview of what we are talking about today, and gets the right names to the right types of instruments and processes.


Who are the main robotic instrument remanufacturing companies?


In medtech there are multiple medical device refurbishing companies and multiple remanufacturing companies - but very few have tackled the remanufacturing of robotic instruments. During my career in robotics I was approached by several that were thinking about it - including some well known big names.

But really today there are three names in the remanufacturing / pre-owned robotic instruments that you may have heard of. And they are primarily remanufacturing Intuitive instruments. (There are other stealth companies doing this (well not quite) around the world off radar. And have been doing for a long time.)


*** yes I know there is Rebotix, and they were pathfinders but they are mainly S and Si instruments so not touching that for today.


These three names work together - R2 Surgical, Encore Medical Device Repair, and Restore Robotics. They operate in an exclusive tripartite ecosystem designed to collect, remanufacture, and redistribute Intuitive da Vinci robotic surgical instruments.


The Three Roles:

Restore Robotics (The Manufacturer): They are the technical and regulatory anchor. They hold the exclusive FDA 510(k) clearances required to legally remanufacture and "reset" da Vinci instruments. They perform the physical engineering, rebuilding, and safety testing at their facility in Henderson, Nevada.From the website - “Based in Panama City Beach, Florida, with a state-of-the-art remanufacturing facility in Henderson, Nevada, Restore Robotics is a pioneer in surgical robotics remanufacturing. The company offers innovative solutions that enhance the performance, sustainability, and affordability of surgical systems worldwide.”

Restore robotics refurbished robotic instruments

Encore Medical Device Repair (The Distributor): Encore acts as the primary commercial and logistics partner. They hold the exclusive rights to market, sell, and distribute Restore's FDA-cleared instruments to hospitals and surgical centres nationwide. From the website - “As a complement to its instrument repair services, Encore Medical Device Repair collects and distributes remanufactured medical instruments with a focus on quality and sustainability. Encore, through Restore Robotics, enables hospitals to reduce costs while maintaining the highest safety and performance standards.”


Encore Medical and remanufacturing surgical robotic instruments

R2 Surgical (The Collector): R2 Surgical manages the front-end "Green Initiative". They supply hospitals with collection kits and turnkey logistics to harvest used, spent da Vinci instruments. These collected cores are then funnelled directly to Restore Robotics to be rebuilt.

From the website - “As the da Vinci system became standard in hospitals across the country, so too did something less celebrated: high costs, limited-use tools, and a growing stream of perfectly functional instruments ending up as waste.

In most industries, like aviation, automotive, electronics, reuse is the norm. But in surgery, expiration often means disposal. At R2 Surgical, we’re working to flip that logic. By partnering with Restore Robotics, a FDA-cleared re-manufacturer of da Vinci instruments, we’re opening up a more affordable, sustainable future for surgical robotics.”


R2 Surgical on remanufactured instruments

Now, this is often confusing as many think there are three separate companies all doing the same thing - and so “this market is mushrooming” as I was told recently. But it’s actually a three way joint venture affair. And as of today they (as far as I can find out) are the only official companies (working as a single group) providing this service.


And as far as I can research - they are the only ones with FDA cleared devices.

From the website - “FDA-Cleared Remanufacturing in Action

Through our partnership with Restore Robotics, we have access to the only FDA 510(k)-cleared process (K242610) for remanufacturing da Vinci Si and Xi instruments. These aren’t repairs. They’re full resets — with rigorous visual, functional, and electrical testing.”


I found this statement interesting from their site: “Intuitive Surgical, the original manufacturer, has granted approval to Restore Robotics for this program, which helps broaden hospitals’ options and supports more efficient, cost-conscious surgical care.”


More on this in a minute as it has been a bit of a rocky legal road to get here. Law firms state (https://scl-llp.com/surprise-ruling-in-right-to-repair-surgical-robotics-case/ ) That claim is legally accurate, but it leaves out the intense, multi-year antitrust legal battle required to “force” Intuitive Surgical to grant that approval.


I won’t go into long protracted legal issues / rulings / arguments and counter arguments - you can go read it anywhere across the web. Under the terms of their legal agreements, apparently Intuitive officially "granted approval" under its customer contracts to allow hospitals to use Restore Robotics' remanufactured instruments. However, this permission is strictly conditional:


The instrument must fall under a specific FDA 510(k) clearance held by Restore Robotics.


Restore Robotics remains an entirely independent entity and is not an official "affiliate" or design partner of Intuitive.


(I’m going to get to my thoughts in a minute: as this is all background stuff for those not so familiar with this part of the industry.)


All stories have two sides, and Interestingly if you go to Intuitive’s site you will find this statement:


Statement on usage limits and use of remanufactured EndoWrist instruments

“Patients first” has always been core to our mission. Patient safety, product efficacy, and delivering improvements in clinical outcomes guide the design, testing, and manufacture of our surgical systems, instruments, and accessories.

With these objectives in mind, we have designed and rigorously tested and validated our EndoWrist instruments with usage and reprocessing limits intended to provide consistent product performance from the first use to the last.

We are aware that third parties may seek to offer products or services to healthcare providers that would modify some of our instruments to extend their use. It is our understanding that such modifications constitute remanufacturing under FDA regulations and require 510(k) clearance from FDA.

We recognize the role that third-party medical device servicers have come to play in the medical device ecosystem, and we support healthy, lawful competition in the marketplace. We also have a responsibility to protect patient safety and provide customers with proven, safe, and effective tools and technologies.

Our customers should know that Intuitive will not void its service contract with, cease doing business with, or consider it a breach of contract by a customer in the United States who chooses to purchase remanufactured instruments that have been remanufactured by a third party pursuant to and in compliance with a 510(k) clearance or equivalent granted by the FDA.

Third parties also have the option to participate in Intuitive’s compatibility process, whereby they would submit clinical safety data to Intuitive and work directly with Intuitive to ensure patient safety and validate compatibility of remanufactured devices with da Vinci. However, when remanufacturing of EndoWrists is performed by third parties that choose to not participate in Intuitive’s third party compatibility process, we do not have appropriate access to their testing protocols, verifications and validations, remanufacturing processes, or quality controls, among other things. Accordingly, Intuitive will not bear responsibility for instruments that are remanufactured by a third party, or for harms or damages caused by the use of such instruments.


It then lists the current instruments. Noting very definately that they have not participated in Intuitive's 3rd party compatability process. A small but important dig.


Intutiive's list of remanufactured robotic instruments

So now to some of the debate(s)

Right so this practice (for years) has raised questions for consumers, hospitals, payers, and financial analysts. Not just robotics but all kinds of medical devices.

My bottom line. If the company is doing this lawfully, legally and to standards set by the regulatory body… then of course I have no issue. And luckily, we see both companies make “safety” statements about patient first. The bottom line is that if the instrument is deemed safe by FDA then it can be put on the market. That’s how it works.

But what then if something goes wrong with that instrument? What if it breaks the robot?(This is a top FAQ I see.)

Well that seems to have been well answered. Intuitive cannot just walk away from its warranty obligations - but doesn’t have to pay for damage caused by an instrument to the system according to multiple sources:


What of the third party instrument breaks the robot?

It seems to fall like this as far as I can read…Historically, Intuitive allegedly threatened to void the entire multi-million dollar warranty of a da Vinci robot if a hospital used a third-party tool. However, following the antitrust settlements and the official "approval" policy, Intuitive could not do this.

How that gets interpreted: So if the robot breaks on its own: Intuitive is still fully responsible for servicing the robotic arms, the console, and the software under the hospital’s master service contract.

But if the third party instrument damages the robot: Intuitive is not responsible for repairing any physical damage directly caused by the third-party instrument. They will bill the hospital for the repair costs of the robot arm.


My personal take is that I’m unsure how an instrument could damage the robot arm. And well if that damage did occur the robot would have all the data logs of what instrument was attached when the damage occurred. So I think it would be easy for Intuitive to point to what caused the issue. In my time - I can’t recall ever seeing an instrument damage an arm of any robot. Too stiff to drive? - damages a drive pack???? Potentially. But if the instrument has passed all the tests to be on the market — it should be good. Plus the robot would more than likely go into a fault mode rather than break.


What if the instrument damages a patient?

From my sources, when a hospital signs up for the R2 / Restore / Encore remanufacturing pipeline, the contract includes a heavy indemnification and product liability policy.

The Indemnity Guarantee: If a Restore-remanufactured instrument physically damages a da Vinci robot, Restore Robotics and Encore Medical Device Repair must cover the cost to fix the robot. They step in to pay the repair bills issued by Intuitive.

Liability Insurance: Because Restore Robotics holds formal FDA 510(k) clearances for their tools, they carry major medical product liability insurance. This insurance protects the hospital financially if a tool failure causes a device breakdown or, worse, a patient injury.


What if a hospital uses a mix of Intuitive and 3rd party instruments and there’s an injury such as infection?

I think this is where it will get a bit messy and an investigation will need to look at the entire chain of the hospital (sterile services), Intuitive and the 3rd party. And a deep RCA  (root cause analysis) would need to happen.  Of course this is me just being “theoretical” but they were questions I asked when we were approached by 3rd party refurbishes in the past.


And ultimately these situations happens in many medical devices across the industry so there will be case precedents. This is not the first time these questions have been asked in our industry.


I raise these questions - not because I think they are common occurrences - but because they are common questions. I feel there are very straightforward answers; well rehearsed answers.


Do I (personally) think this practice is okay?

I’ll just give my thoughts as an industry observer. Some questions that have been in my head about reuse and or refurbishment and or remanufacturing  of single use devices and multi use devices. These have been questions for a few decades in general, are re-emerging here. My mental approach has never changed.


First - why does patient A get a device from the original manufacturer and I get one from a third party?

That question (wrongly) starts with the automatic assumption that the OEM makes a “better” device than the 3rd party remanufactured device. Well no, you can’t just assume that - FDA has cleared the products on “substantial equivalence.“ In some industries it is even better than the OEM. But they often prove it and show it.


So If I was a patient (but also a robotics expert) - and I had knowledge and a choice - and I could choose a device that has a few million uses of similar devices; was made by the people that probably have some trade secrets in manufacturing; and that make the actual robot. Would I “prefer” an OEM device?

Yes. For me. Probably.


To be clear; not based on any science or data - but on my gut. For me or my family, if I’m paying my insurance and getting treatment - why does someone get a spanky new one from Intuitive, and I get a new one from a 3rd party manufacturer ? Is that fair?

Actually if they are both "new" does it even really matter?

Well maybe yes. New does not mean "identical."


Now as a professional that dealt with robotic instruments for years - i know they are hard to do. I can tell you - the secret sauce that goes into those instruments is vast. The tensioning - the springs - the cables - the peening  - small things that give big impacts — etc etc.

Do I think someone could reverse engine the instruments I was involved with, and make a remanufactured version as good? I doubt it. Yes they could pass the tests and validation of FDA - but my gut tells me - it would not be as good as what we made. I think passing tests for the FDA is one thing - passing internal End Of Line Tests of the OEM is another. Our internal bar was way way higher than the external bar. Why? Because we thought it needed to be for lots of reasons.


I would love to see the remanufactured instruments put through the exact same EOL tests of the original manufacturer, and then see the results. Not the bar set by FDA. That would definitively answer the question and convince me. But until I see that data - give me the OEM.

Because there are two very different things. Does it really matter if they both work? If they are both safe? My gut says - yes it does matter in surgical robotics. To me as in insider. And especially if I’m paying for an instrument - I want the OEM version. In robotics micro details matter at a big scale. Not just test results to pass FDA. But it's to do with the dynamics of the instrument that may not show up in the tests. So until I saw a direct set of tests that are identical - I have to go with the OEM first. Show me the data and I say "both as good. - equal - not substantially equivalent."


Let me give an example you might relate to as much of this is sentiment - because a lot of this is sentiment. But when you deal with insurance sentiment becomes strong.

If I broke my iPhone - and my insurance is paying for a replacement, and the deal was I could get either a brand new iPhone or a remanufactured one that worked just as well - (some people get original - some people get remanufactured it’s just the luck of that day)

If I’m paying the same insurance premiums as someone else, and they get a new one - I get a remanufactured one - both work - both pass tests. I’d still say. “Hey. I want a new iPhone just like them!” (But of course I know. The patient doesn't know right - so it's irrelevant... right?)


I know it seems illogical,  as both iPhones will work as new. And if I was paying out of my own pocket and saving money… then it would be well up for debate - as I get to take that choice and I personally save the money. (As a note - my last phone was paid by me out of pocket and was refurbished. So I'm not against it.) But if my insurance premiums are the same as other people…. And my insurance is paying for that phone. Hold up. Am I getting a remanufactured so my insurance company can make more profit? (If I ever found out I'd be pretty upset.) For me this applies here in insured healthcare.


So it’s great there’s a 25%+ saving on a remanufactured instrument. But who gets the advantage? If they are the same as the original instrument, then logically the patient gets no advantage. It then means that someone somewhere is paying less - but probably getting paid the same reimbursement whether it’s new or remanufactured.

So someone is simply making more profit on the remanufactured  - right?

They get a financial benefit - but there is no clinical benefit to the patient. Hmmmmm. How does that work?

I’ve always had this issue in insured healthcare markets. And I do also wonder if the insurers realise they pay the same if they get a new of remanufactured device used on that claimant?

(wouldn;t they ask for some of the money back?)

I wonder if they understand that someone, somewhere is just making more margin in this chain. (You could phrase it as less loss… but hey let’s get real.) What would patient's think if they knew. Irrespective of the clinical outcome. That someone - somewhere made that choice on their behalf to make more profit?


I'm being provocative.


On the other hand - in a pay from pocket market or socialised payment market (where i live) - of course I GET IT. If you talk about Lagos - Nigeria where it is “save money or don’t do it” and everybody gets a refurbished device - I’m all in. But my bar is “everyone gets the same options. In transparency.”

I’ve voiced this for two decades - and feel that remanufacturing and refurbishment absolutely have a role: if there is no patient downside, it gives patients access to something they could never have, or (importantly) the patient gets a personal financial benefit. If it expands access- sign me up.


Remanufactured instruments giving robotic access in Nigeria

Where I’ve always debated this is when the only stakeholder that gets any benefit is a hospital (or private clinic) that make more profit from this transaction. Unless it means that more patients can be treated… it’s just about profit. Unless it is about reducing insurance costs to patients… it’s just about profit. Unless it is binary “we use refurbished or don’t do it” - it’s just about profit.

If it’s just about you making more profit on my skin. Give me my OEM device that I’ve already paid for.


You’ll get me on Green

Now the one argument I can buy into is about recycling and reducing landfill / incineration. Reclaiming plastics, metals, components I think is an important quest for the whole of medical devices. But again that benefit must trickle back down to the patient. I’m from the school where all patients should be treated equally in a facility. Should be offered the same equipment and standard of care. Either they all get the remanufactured or no one does. It can’t be a lottery. It has to be systematic. If that policy sticks and it means that there is less landfill - less incineration - then that is a big communal benefit around sustainability. And if that actually reduces costs - then again share the love. Share the benefits - share the reduction in premiums.

Don’t just pocket profit and greenwash me.

(Yes there’s a theme here. I was taught as a kid - “follow the money”)


The real world impact?

Now I’ve given some background and I’ve given some soap boxing of my opinions about profit sharing. But now I want to ground us back into what is really happening. Because I’ve had people say “This will become a major issue for Intuitive.”

My opinion - no it won’t.


So why?


There are many reasons, and you need to look at the segmentation of customers that will be in interested in buying pre-owned or refurbished or remanufactured instruments. There are a multitude of customers around the world that are still using the old and discontinued Si. Many of them struggle to get instruments. I think these programs are brilliant ways to keep the old Si systems active and going. In some places it might be the only way to get robotic healthcare.


For those markets and those customers it is a way to get pre-owned robots - with remanufactured instruments and that might be the only affordable way to run a robotics program. Same for Xi now it is being superseded. There is a healthy market of refurbished Xi robots, but they have no contract with Intuitive or the local distributor. The only way they can get instruments is pre-owned and remanufactured or refurbished. This is a great way to build and run entire robotics programs on a budget. Places like Africa, South East Asia, more historically Eastern Europe and the former soviet states heavily rely on either official or even some unofficial refurbisher companies. Theer are no formal remanufacturersin most places. There is no other choice if they want their patients to get access to robotics. But I don’t believe that is affecting the Intuitive business. I doubt in many of these markets that is significant to Intuitive.

Take Obi Ekweena’s estimate of Africa. There are 7 countries, ~11 systems, 3 platforms (da Vinci, Edge, Toumai): Only 2 of them daVinci and one is from R2.This business by R2 is not devastating Intuitive’s business. But it is giving access to where access was prohibitive in the past.


Okay. Let’s go where all the financial people want me to go - the USA. Yes there will be hospitals that are on legacy contracts where they are buying instruments on standard purchase contracts. If they can save 25% on their higher volume codes and stop some landfill. And recycle. Why not? For some it is significant savings - see below. They most likely have an Xi that they bought outright in the past - and now are finding the better value razorblades. It’s seems to be working and MAUDE database shows no issues. Many of these programs run hybrid mixes of Intuitive instruments and 3rd party. I don’t think they are devastating the Intuitive business. Some have refurbished Xis.


And is this a big chunk of the market? Not as far as I can see. Is this impacting the I&A sales of Intuitive? Early days but I think it doesn’t register on the quarterly numbers.

Then let me ask - would this be for the big high volume multi Xi install hospital systems? Nah don’t think so so far. I remember some bellicose noise from heads of chains saying “what til we get a ruling on this… then we move totally to remanufacturted.”

And then they didn’t. Instead they bought a ton of DV5s.


The DV5 reality & the PPC reality

The world has moved on since this titanic legal battle on remanufacturing was started. Back then it was Xi, Si and the majority of deals was “buy the robot then pay for instruments and when they chip out, buy a new one.”

Roll forwards to 2026 and the world is very different. We now have the DV5 and so far the force feedback instruments are not subject to the 510K for remanufacturing. In fact the DV5 instruments - in my opinion - are going to be very hard to remanufacture and get to work with the precision and fidelity proven to be needed for the force feedback.


But more interesting is the PPC models (pay per case) which are showing up as complex lease deals or PPC models. Do not forget; many of them have instruments baked into the cost per case. The customer is not buying instruments they are buying cases at a fixed price. Remanufactured instruments becomes irrelevant.


Now I have run some estimates: if you could switch your whole instrument sets to remanufactured it could look like this . *I might have got this wrong but looks like this -

Hospital Type & Robotic Case Volume

Average Annual Instrument Spend (OEM)

Annual Savings with Remanufactured Tools (30%-50% Off)

Small Community Hospital (~200 surgeries/year)

~$250,000

$75,000 – $125,000

Mid-Sized Regional Hospital (~1,000 surgeries/year)

~$1.2 Million

$360,000 – $600,000

Large Academic Health System (~4,000+ surgeries/year)

~$5.0 Million

$1.5 Million – $2.5 Million


Be aware this is a system switching 100% using remanufactured for every case. If this was true then the incentives are quite exciting. But the oxymoron in this is that the sites most likely wanting to do this, actually  get the least saving. Where as the bigger sites are most likely to move to lease or PPC models. They would get the most saving but it would mean having to acquire capital - maybe not get the DV5 (yeah right) and walk away from the pay per case models they have now got.


The PPC is such a powerful defence as it basically wraps up your instruments needs in a single case payment. And well now… there is zero incentive to get remanufactured or pre-owned instruments.


And it is these big systems that will get the better discounts, better support, be involved in proctoring, development, get DV5 etc etc. So as I assess the USA - I think it can be very beneficial for hospitals to switch financially. But the commercial environment and new models maybe makes that impractical in real terms for many centres.


There are an estimated 300 hospitals and / or surgery centres that have signed up to the program. And it is growing. But again it must be put into perspective. These hospitals and ASCs are still most likely on a hybrid model where they use Intuitive instruments and supplement with remanufactured. And this is probably a very happy medium. Some cost savings - still get the love of Intuitive and some makes a little more profit OR makes better losses so that care can be offered.But I predict an ACS move to XiR systems that get placed on a PPC model - they will not be using a lot of remanufactured instruments. I predict as more hospitals move to DV5, and move to Xi on leases… the issue of remanufactured becomes more nuanced. I think commercially Intuitive will out box the remanufacturing companies.


My bottom line. I don’t see a massive impact on Intuitive in the near term - I see some hospitals in the hybrid model that get cost savings. But not the tidal wave a few of you are thinking about.


What could happen left field?

Okay just for fun: let me get my speculative cap on here as I do get asked to just get my crystal ball out and speculate. So there’s a few random “what if’s”


First speculation - the best company on the planet to remanufacture Intuitive instruments would be Intuitive. I would almost bet they already know how to do this and do it well (and at a lower cost than anyone else.) Should remanufactured instruments go against what I said above, and make significantly more gains - I think they will introduce an Intutive ReMan program. “Never!!!” I hear you gasp. Erm what’s the R in XiR? Refurbished!!!They already do it with hardware and make lively money from it. And strategically defend the market and expand to markets where a brand new DV5 can’t go. They open up access based on affordability. Oh don’t be too surprised if part of their strategy is to create a remanufacturing instrument line to super penetrate the ASCs or previously no go markets. That is a price sensitive market and if they can reduce costs by 50% per case but capture it all… well there is no business left for 3rd party remanufacturers IMHO. And it neatly nips the other robotic companies off at the ASC route. Plus it is a gateway to next gen products for the ASC. Refmanufactured daVinci instruments could be the gateway opener to areas of the market - areas of the globe they have not been able to penetrate so far. I think there’s a line that gets crossed; and they then could pull that trigger and get into a very sweet segmentation offering.


Second speculation - My suspicion is that with 3 remanufacturing companies already carving up the profit pie to make the current USA system work - margins might not be stellar (in fact I would love to know the real numbers.) I mean collection - cleaning - shipping - remanufacturing - testing - reshipping for a 1 life scissor at maybe $200 ASP and maybe $50 profit??? (Speculative.) And you have to divide that profit 3 ways? (Maybe I have this totally wrong?)

My speculation is that if they don’t get to the volumes then their entire business plan may not hold up. This will be a volume game on thinner margins and if the market doesn’t respond it could - could - be a hard to continue model. I think part of the problem is 3 players all with individual overheads.


Third speculation - One of the big companies that already dominates in refurbishing and remanufacturing comes in on this - a Stryker or other big comopany; and decides they want this action. That could be very interesting. They could acquire the current companies or compete. The pathway is a 510K - so not so hard. And the glass ceiling has already been broken. If that happens then that whole sector is upended. Hmm watch for China... yes watch for China.


Fourth speculation - And this is out there so forgive me but it’s for fun. A left field company works out how to make a $200 single use instrument that slaps onto the Xi. Somehow - against all odds they have a single use instrument at the price of a remanufactured. I think that would turn the entire model of everybody upside down. Not very green… but funny how green works until the money (the real green) doesn’t.

Okay… maybe not.


Anyhow - enough for today - I hoped you’d find it interesting. And remember on legal stuff for this - ask a lawyer to interpret it not me. I can only speculate as an Industry exec that wrangled with this for laparoscopy and for robotic surgery. My comments are just for educational purposes only and can be very very wrong.


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You are legally deemed a Data Processor under EU GDPR.

Any automated claim sent to Steve Bell S.R.L. or Steve Bell  must be accompanied by a full Article 15 Disclosure Report detailing exactly how my PII was processed and whether it was transferred outside the EEA.

Failure to provide this report or bypassing my technical blocks will be reported to the Italian Data Protection Authority (Garante per la protezione dei dati personali) as a breach of privacy law.

Anti-Scraping & Automated Enforcement Clause

Contractual Agreement: By bypassing technical headers (robots.txt) or scraping this site to generate a claim, you (the Scraper) explicitly enter into a binding contract with Steve Bell S.R.L. You agree to waive all automated "settlement" fees in favor of the Notice and Takedown protocol above.

Reinforced statement: GDPR & International Data Transfer: This site contains my personal likeness and identifiable data (PII). Any entity scraping this data becomes a Data Processor under EU law. Any automated claim must be accompanied by a full GDPR Article 15 report detailing where my PII is stored and confirming compliance with international data transfer regulations (EEA to non-EEA). Unauthorized processing will be reported to the Garante per la protezione dei dati personali.

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How to start a medtech company

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