MedTech competitive analysis is not a grid of feature checkmarks against incumbents. It is an honest map of how the decision-making unit in a hospital actually compares options, where the real switching costs live, and where your device creates an asymmetric advantage the incumbent cannot easily copy. Done right, it tells you whether you have a defensible position before you spend a cent on MDR certification. Done wrong — as a marketing deck with green and red dots — it gives you false confidence and an intended purpose you will regret eighteen months later.

By Felix Lenhard and Tibor Zechmeister. Last updated 10 April 2026.

TL;DR

  • MedTech competitive analysis has to start from the decision-making unit, not from the product. You are comparing how a hospital, a clinician, and a patient will choose — not how two feature lists stack up.
  • Incumbent inertia is a competitive force in its own right. A worse device already in the building often beats a better device that is not.
  • The real competitive set is wider than direct competitors. It includes the current workflow, the "do nothing" option, and adjacent modalities that solve the same clinical job with different technology.
  • Asymmetric advantages in MedTech are usually structural, not feature-based: narrower intended purpose, faster workflow, lower total cost of ownership, better integration with existing hospital infrastructure, or an evidence story the incumbent cannot match.
  • Any comparative claim you put in promotional material is regulated. Under MDR Article 7, it is prohibited to use text, names, trademarks, pictures, or any sign that may mislead the user or patient as to the device's intended purpose, safety, or performance. (Regulation (EU) 2017/745, Article 7.)
  • In small MedTech markets, "competition" is sometimes the wrong frame entirely. The real question is whether the market is large enough to sustain anyone at all.

The EUR 200 dinner and the EUR 50 device

A founder Tibor worked with built a device for an Austrian care-home market. The product was genuinely good. The nursing staff loved it. Every demo produced enthusiastic feedback from the people who would actually use it. On paper, the device beat everything else on the market for the specific workflow it supported.

Then the founder tried to sell it. The director of nursing — the actual decision-maker — would barely take a meeting. The device that beat the competition in every staff demo could not get past the buyer. The problem was not the product. The problem was that the founder had done competitive analysis at the wrong layer. He had been comparing his device to other devices. The director was comparing his device to everything else she could spend the same money on — new beds, a shift bonus, a contract with a physiotherapist, a better dinner at the annual staff event. A EUR 50 line item on the device budget was competing with a EUR 200 dinner in the director's mental model, and the dinner was winning.

That is the gap this post is about. Competitive analysis for MedTech is not a spreadsheet of feature checkmarks against the three loudest logos at the last trade fair. It is a disciplined map of how the real decision-making unit actually compares options — and most of those options are not other devices at all.

Why MedTech competitive analysis is different

Most founders arrive with a competitive analysis habit learned from consumer software or B2B SaaS. Pick three competitors. Make a grid. Put features down the left. Put logos across the top. Draw green dots where you win and red dots where you lose. Count the green dots. Ship the grid to investors.

That habit breaks in MedTech for three reasons.

Long buying cycles are not a bug, they are the terrain. A hospital does not buy a new device the way a team buys a new SaaS tool. Procurement cycles are measured in quarters, sometimes years. Value analysis committees meet monthly. Budgets are set annually. Infection control, IT security, medical engineering, and the clinical department all sign off separately. By the time a device enters the building, five different people have had five different opportunities to say no. A competitive analysis that ignores the length and shape of that cycle is useless. Your competitor is not just the other device — it is the next budget window.

Switching costs in a hospital are structural, not emotional. When a hospital adopts a new device, it pays in training time, in updated SOPs, in sterilisation and reprocessing workflow changes, in infection control sign-off, in integration with the existing equipment park, in IT security review for connected devices, and in the lost learning curve of the old system. The total cost of switching from an incumbent to a challenger is measured in months of department-level friction and tens of thousands of euros before a single clinical benefit shows up. Any competitive analysis that does not account for switching cost as a separate line item is wrong by default.

Incumbent inertia is its own competitive force. The incumbent does not have to be better. It has to be already there. A worse device that is already installed, already trained on, already in the reprocessing loop, already paid for out of last year's budget, and already defended by a champion in the department will beat a better device that arrives this month. Incumbency is worth real multiples. Your competitive analysis has to quantify that multiple, not pretend it does not exist.

These three forces mean that MedTech competitive analysis is less about "who else makes a similar device" and more about "what has to be true for a hospital to actually change what it is doing."

How to map the real competitive set (not just direct competitors)

The first mistake founders make is drawing the competitive set too narrowly. They list three direct competitors and stop. The real competitive set is almost always wider, and missing the wider set is how founders find themselves eighteen months into a regulatory project with a device the market was never going to pay for.

A disciplined competitive set has four layers.

Layer one — direct competitors. Other devices that do the same clinical job, for the same user, in the same clinical context. This is the obvious list. It is also the shortest list. Write it down honestly. If you cannot find three direct competitors, either your definition of the clinical job is too narrow or the market is too small to sustain a company.

Layer two — adjacent modalities. Devices or procedures that solve the same underlying clinical problem with a different technology. An imaging device competes not only with other imaging devices of its class, but with the other modality the department uses for the same diagnosis. A point-of-care test competes with sending the sample to the central lab. A connected monitoring device competes with a nurse walking the ward. These are competitors even though they look nothing like your device.

Layer three — the current workflow. The status quo is the most underrated competitor in MedTech. "Keep doing what we do today" is free from the hospital's perspective — no procurement, no training, no integration risk. Any new device has to beat the status quo by enough to justify the switching cost, not just beat a named competitor. If your device is 1.3 times better than the incumbent workflow, that is a rounding error in the procurement conversation.

Layer four — the budget alternative. This is the layer the care-home founder missed. Inside a hospital or care home with a fixed budget, your device is competing with everything else the buyer could do with the same money. Sometimes that is another device. Sometimes it is hiring staff. Sometimes it is a renovation. Sometimes it is the annual dinner. If you cannot make your device look obviously better than the budget alternatives the buyer actually considers, the competitive analysis is not finished.

Most founders stop at layer one. The founders who ship stop after layer four.

The DMU comparison filter

Once you have the competitive set, the next step is to run it through the decision-making unit. This is where the grid-of-green-dots method really falls apart, because the DMU does not compare on features. It compares on pains.

Run the competitive set three times, once for each DMU role.

Run one — the hospital as buyer. Procurement, finance, the medical director, the value analysis committee. They compare devices on cost per case, throughput per day, length of stay, readmission rates, reimbursement codes, and compatibility with existing contracts. A feature that does not move one of those numbers does not exist from their point of view. Your competitive position at this layer is the answer to one question: on the single metric the buyer counts, by how much do you beat the incumbent, the adjacent modality, the status quo, and the budget alternative?

Run two — the clinician as user. The specific doctor or nurse who picks up the device. They compare on workflow friction, cognitive load, training time, reliability under pressure, and how the device fits alongside the fifteen other things they do in a shift. A clinician's competitive comparison is almost never on features. It is on whether the device makes their day easier or harder. A device that wins on features and loses on workflow loses in the DMU.

Run three — the patient as beneficiary. The patient does not sit at the procurement table, but the regulator will apply the patient lens to every claim you make. A competitive analysis that ignores the patient lens will eventually produce an intended purpose that cannot be defended in clinical evaluation. Compare on outcome, safety, and quality of life, in language a clinician would defend in front of peers.

If your device wins against the full competitive set on all three DMU runs, you have a defensible position. If it wins on only one of the three, you have a features deck. If it only wins on two, you have a hard conversation to have before you commit to the regulatory project.

Asymmetric advantages that actually matter

The founders who survive the competition stage are the ones who find asymmetry — an advantage the incumbent structurally cannot copy, not one that is just a feature the incumbent has not built yet. Feature advantages evaporate in the eighteen months it takes to certify. Structural advantages compound.

Structural asymmetry in MedTech usually comes from one of five places.

A narrower intended purpose. You can afford to be the best device in the world for one specific clinical job because you are not trying to be the best device for six. The incumbent's intended purpose is broad, which means their classification, their clinical evaluation, and their labelling all have to cover a wider surface. You can go deeper on your narrow segment because you are not paying the width tax.

A faster or cleaner workflow. If your device collapses a ten-minute task to ninety seconds, or removes three steps from the clinician's day, that is not a feature. That is an asymmetry the incumbent cannot copy without redesigning its product. Time in the clinical workflow is the asset hospitals actually value.

A better total cost of ownership, not a better sticker price. Hospitals do not buy on sticker price. They buy on five-year cost — device, consumables, reprocessing, training, downtime, service contracts, integration. If your device is more expensive on the sticker but cheaper over five years, and you can prove it, you have an advantage the incumbent cannot respond to without cannibalising its own installed base.

Integration with existing hospital infrastructure. If your device plugs into the EHR, the imaging archive, or the lab information system the way the incumbent does not, that is not a feature. That is an integration asymmetry that costs the incumbent a full redesign to match. For connected devices, this is often the strongest moat available to a startup.

An evidence story the incumbent cannot match. If you have clinical evidence for a specific patient population that the incumbent's clinical evaluation does not cover, you can serve that population in a way the incumbent cannot legally claim. That is an evidence asymmetry, and under MDR it is a real competitive asset because the regulation forces every claim to be backed by data.

An honest competitive analysis identifies which of these asymmetries you actually have, not which one you wish you had. If the only honest answer is "we have a nicer UI," that is not an asymmetry. That is an invitation for the incumbent to copy you in the next release cycle while you are still in Notified Body review.

Comparative claims and MDR Article 7 discipline

The moment you put a competitive comparison into promotional material — a website, a sales deck, a brochure, a conference booth — you are in regulated territory. This is where a lot of first-time founders get themselves into avoidable trouble.

Under Article 7 of the MDR, it is prohibited to use text, names, trademarks, pictures, or figurative or other signs in the labelling, instructions for use, making available, putting into service, or advertising of devices that may mislead the user or the patient as regards the device's intended purpose, safety, or performance. Article 7 specifically prohibits ascribing functions or properties to the device which the device does not have, creating a false impression regarding treatment or diagnosis, and failing to inform the user or patient of likely risks. (Regulation (EU) 2017/745, Article 7.)

In plain language: every comparative claim you make in promotional material has to be true, specific, and supported by data you can produce on request. "The best device on the market" is a claim. "Faster than the incumbent" is a claim. "Preferred by clinicians" is a claim. Each of those will be tested — by a competitor, by a regulator, or by a journalist — against the evidence you actually have.

The discipline is simple, not easy.

  • Never make a comparative performance claim you cannot back with data you would be willing to show a Notified Body auditor.
  • Be specific about the comparison — device, configuration, patient population, endpoint, study design. Vague comparisons are the ones that get you into trouble.
  • Keep comparative claims out of the intended purpose itself. Intended purpose is where you define what your device does. Comparisons belong in marketing, and marketing has to be consistent with the intended purpose and the clinical evaluation behind it.
  • When in doubt, cut the claim. The legal risk from a bad comparative claim is orders of magnitude higher than the marketing upside from a good one.

Tibor has seen the consequences of sloppy claims more than once. It is rarely the market that catches you. It is the competitor who sues you, or the Notified Body that flags the mismatch between your website and your technical documentation at the next audit.

When competition is the wrong frame (small markets)

Not every MedTech startup is operating in a market where competitive analysis is the right first question. In narrow indications, rare diseases, or highly specialised clinical workflows, the real question is not "how do we beat the incumbent" but "is there a market at all, and is anyone — incumbent, adjacent modality, or newcomer — making a sustainable business inside it?"

The sign you are in this kind of market is straightforward. When you search for direct competitors, you find one or two small companies with thin revenue, a couple of research prototypes, and a handful of academic papers. When you search for adjacent modalities, the current workflow is "the department does it manually" or "the patient is sent to a specialist centre." When you ask hospitals about their budget for the device category, the answer is a shrug.

In that situation, competitive analysis is the wrong tool. The right tool is market sizing and reimbursement analysis. Can you identify enough patients, enough sites, and enough reimbursement to sustain a company after you pay for MDR? If yes, the absence of competition is an advantage — you have the market to yourself. If no, the absence of competition is a warning — the market is too small to carry anyone, and you winning against zero competitors is still a company that cannot pay for its own certification.

The founder who focuses on "beating the incumbent" in a market that cannot feed one company is solving the wrong problem. Felix calls this the "opportunity keeps you poor" trap — chasing a market that looks open because nobody else is there, without checking whether anyone could ever make a living there.

Common mistakes founders make

  • Listing three loud logos from the last trade fair as the competitive set. The loudest logos are rarely the real competition. The status quo and the budget alternative almost always are.
  • Running the comparison on features instead of on DMU pains. Features do not buy devices. Hospitals, clinicians, and patients do, and they compare on pains, not features.
  • Confusing doctor enthusiasm for a competitive win. A clinician liking your device at a conference is not a purchase order. Until the hospital procurement has said yes, you have not won anything.
  • Ignoring the switching cost of displacing an incumbent. If your advantage is smaller than the switching cost, the advantage is theoretical.
  • Making comparative claims in marketing that the technical documentation cannot support. Under Article 7, this is a legal risk, not just a marketing risk.
  • Treating the absence of competitors as a green light instead of a yellow one. Sometimes there is no competition because there is no market.

The Subtract to Ship angle

Every line in your competitive analysis has to earn its place by answering one of two questions: does this change the intended purpose, or does this change the business model? If a competitive insight does not move one of those two things, it is a slide for investors, not a decision tool.

Subtract to Ship applied to competitive analysis is short.

  • Cut the feature grid. Replace it with a DMU comparison across the four-layer competitive set.
  • Cut vague claims. Replace them with specific, dated comparisons you can defend under Article 7.
  • Cut the "3x10 logos in a box" competitor slide. Replace it with one paragraph per real alternative, including the status quo and the budget alternative.
  • Cut asymmetries you wish you had. Keep only the ones that are structural and defensible.
  • Cut the geography and the indication until the competitive position is obviously defensible in the narrow segment you actually chose. Expansion comes later. Read the beachhead strategy for MedTech for how narrow is narrow enough.

The goal is not a thicker competitive deck. The goal is a clearer answer to one question: in the narrow segment you actually chose, do you have an asymmetry the incumbent cannot copy, and is it worth the switching cost to the DMU? If yes, ship. If no, change the segment or the product before you commit to MDR.

Reality Check — Where do you stand?

Answer honestly. Two or more weak answers mean you are not ready to commit to a regulatory path yet.

  1. Can you name the four layers of your competitive set — direct competitors, adjacent modalities, current workflow, budget alternatives — with specific names, not categories?
  2. Have you run the competitive comparison separately for the hospital buyer, the clinician user, and the patient beneficiary, and do you win on all three?
  3. Do you know the real switching cost — in training hours, SOP updates, integration work, and budget lines — of displacing the incumbent in your target department?
  4. Can you state your asymmetric advantage in one sentence, and is it structural (intended purpose, workflow, total cost of ownership, integration, evidence) rather than a feature the incumbent could copy in one release?
  5. Is every comparative claim on your current website and in your current pitch deck defensible under Article 7 with data you could show an auditor tomorrow?
  6. If a competitor launched a copy of your best feature next month, would your position still hold?
  7. Have you checked whether the absence of competitors in your niche is a green light (untapped market) or a yellow one (market too small to sustain a company)?

Frequently Asked Questions

What is MedTech competitive analysis and how is it different from SaaS competitive analysis? MedTech competitive analysis is the disciplined mapping of how a hospital decision-making unit actually chooses between options — including direct competitors, adjacent clinical modalities, the current workflow, and budget alternatives — under long buying cycles, structural switching costs, and incumbent inertia. It differs from SaaS competitive analysis because in MedTech you cannot iterate features in front of paying users, the buyer and the user are usually different people, and the status quo is often the strongest competitor on the list.

Who are the real competitors for a MedTech startup? The real competitive set has four layers: direct competitors with similar devices, adjacent modalities that solve the same clinical job with different technology, the current workflow (the status quo), and budget alternatives the buyer could spend the same money on inside the hospital. Listing only direct competitors is the most common mistake and the reason many founders misread their own position.

How do I position a MedTech startup against established incumbents? You look for structural asymmetries the incumbent cannot copy: a narrower intended purpose, a faster workflow, a lower total cost of ownership, better integration with existing hospital infrastructure, or an evidence story the incumbent's clinical evaluation does not cover. Feature advantages are not enough — they evaporate in the time it takes to certify under MDR. Structural asymmetries survive.

Are comparative claims against competitors allowed under MDR? Comparative claims are allowed, but they are regulated. Under Article 7 of the MDR, any text, trademark, image, or other sign used in labelling, IFU, or advertising that may mislead the user or patient about intended purpose, safety, or performance is prohibited. (Regulation (EU) 2017/745, Article 7.) In practice, every comparative claim has to be specific, true, and supported by data you can produce on request.

What if there are no direct competitors for my device? Treat it as a yellow light, not a green one. The absence of competition sometimes means you have found an untapped market, and sometimes means the market is too small to sustain any company at all. Before you commit to MDR, run the market sizing and the reimbursement analysis. If the market can feed a company, no competition is an advantage. If it cannot, no competition is a warning.

How much time should a MedTech founder spend on competitive analysis before starting the regulatory project? Enough to answer the Reality Check questions in this post honestly, and no more. A week of focused work with real hospital conversations beats a month of desk research and competitor websites. The purpose is to sharpen the intended purpose and the business model, not to produce a deck.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, consolidated text. Article cited: Article 7 on claims. Official Journal L 117, 5.5.2017.

This post is part of the MedTech Startup Strategy & PMF series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Competitive analysis is a tool for sharpening the intended purpose and the business model, not a slide for investors. Use it that way.