---
title: Razor-and-Blade Models in MedTech: Single-Use Components and Recurring Revenue
description: The razor-and-blade revenue model works well for MedTech when single-use consumables carry the margin. Here is how to structure it under MDR.
authors: Tibor Zechmeister, Felix Lenhard
category: MedTech Startup Strategy & PMF
primary_keyword: razor blade MedTech single use
canonical_url: https://zechmeister-solutions.com/en/blog/razor-blade-medtech-single-use
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Razor-and-Blade Models in MedTech: Single-Use Components and Recurring Revenue

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **The razor-and-blade model sells the base device at or near cost and earns margin on the single-use consumables the device requires to function. In MedTech it works when the consumable is a genuinely proprietary part of the system, when every procedure generates one or more disposables, and when the manufacturer has modelled the full MDR burden on the blade side as well as on the razor. Under the MDR, the consumable is almost always a medical device in its own right — which means its own intended purpose, its own classification under Article 52, its own technical documentation, its own conformity assessment, and its own vigilance chain. The model is attractive because it turns a one-time sale into recurring usage-linked revenue. It only works when the blade economics and the blade regulatory burden are both honest.**

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

---

## TL;DR

- A razor-and-blade MedTech model sells the base device at or near cost and earns margin on proprietary single-use consumables consumed during each procedure.
- The model works when the consumable is technically tied to the device, cannot be substituted by a generic, and is consumed on a predictable per-case basis.
- Under MDR Article 2(1), a consumable that has a medical intended purpose of its own is itself a medical device, with its own technical file and its own conformity assessment route under Article 52.
- Every blade that qualifies as a medical device carries its own QMS, PMS, vigilance, and Notified Body surveillance burden. Founders who ignore this side of the ledger build unit economics that do not hold.
- Hospital procurement knows this model. Expect contractual caps on consumable pricing, multi-year pricing commitments, and pushback on lock-in language.
- The base device still has to be clinically credible on its own. A razor that only exists to sell blades does not survive clinical evaluation.
- The most common mistake is modelling the blade as if it were software-grade margin. It is not. The blade is a regulated physical product with its own cost base.

---

## The razor-and-blade model

The razor-and-blade pattern is one of the oldest deliberate revenue models in commerce. Sell the durable item cheaply. Make margin on the thing the customer has to buy repeatedly to keep using it. In consumer categories the pattern is mostly a pricing choice. In MedTech it is a product architecture choice, a regulatory choice, and a pricing choice at the same time, and the three cannot be separated.

The structure in MedTech usually looks like this. The base device — an instrument, a reader, a console, a delivery system — is placed with the hospital at a price that covers the manufacturer's cost of goods and a modest margin, sometimes at cost, occasionally below cost. The hospital then buys single-use consumables for every procedure the device performs: sterile cartridges, proprietary catheters, dedicated reagent kits, disposable electrodes, purpose-built tips. Each consumable is priced to carry the margin the base device did not. Over the installed life of the device, the cumulative consumable revenue is a multiple of the base device revenue.

What makes this "razor and blade" rather than "device plus accessories" is the intentionality. The base device is designed so that its essential function depends on a consumable only the manufacturer supplies. The consumable is engineered to be a genuinely integrated part of the system, not a commodity add-on the hospital can source elsewhere. The pricing is deliberately shifted: the device is cheap because the blades will compound.

## Why it fits MedTech

The pattern fits MedTech for four reasons that do not apply equally to other industries.

First, many diagnostic and therapeutic procedures genuinely consume something per use. Sterility requirements mean reusable contact surfaces often cannot be cleaned reliably between patients. Single-use components are not a pricing trick — they are a clinical and infection-control necessity. If the device is the kind of device that needs a fresh disposable per procedure anyway, building a revenue model around that disposable is aligned with the underlying reality, not layered on top of it.

Second, hospital budgets are often easier to flex on consumables than on capital equipment. The capital budget is reviewed annually, politically contested, and frequently frozen. Operational line items for disposables move through procurement more routinely. A device that costs twenty thousand euros up front may sit in the capital budget queue for a year. The same device at five thousand euros plus consumables at a per-case price may move through the operational path in a quarter.

Third, recurring usage-linked revenue is fundable. Investors understand it. Unit economics are legible. A device that sells once and disappears from the P&L is a lumpy business. A device that generates a predictable per-procedure stream for five to ten years of installed life is a steadier asset. Early-stage MedTech companies that can credibly model blade revenue get valued differently from companies that cannot.

Fourth, the clinical evidence argument compounds with usage. Every procedure the device runs adds data to the PMS system, the clinical evaluation update cycle, and the real-world evidence base. A high-usage installed base is a regulatory asset over the device's life. The razor-and-blade model pushes the business toward the high-usage installed base the Regulation rewards.

## Regulatory implications of single-use components

Single-use carries specific MDR implications that founders from a consumer-products background often miss.

The consumable is very rarely "just packaging" or "just a mechanical part." If the disposable touches the patient, delivers the therapy, carries the reagent, transmits the signal, or is the part that actually performs the measurement or the intervention, then it has a medical purpose of its own. Under MDR Article 2(1), a medical device is defined by intended purpose — any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for a medical purpose listed in that article. (Regulation (EU) 2017/745, Article 2(1).) A consumable that meets that definition is itself a device, regardless of whether the founder thinks of it as a component.

This has several practical consequences. The consumable needs its own intended purpose, written deliberately. It needs its own classification under Annex VIII, which may or may not match the classification of the base device. It needs its own technical documentation, its own risk management file, its own clinical justification, and its own conformity assessment route under Article 52. It needs its own PMS plan and its own vigilance chain.

Labelling the consumable as "single-use" triggers additional obligations in Annex I — the device must be labelled accordingly, the risks associated with reuse must be addressed, and the design must prevent reuse where reuse would be hazardous. The manufacturer cannot rely on a contractual "do not reuse" instruction alone when the device architecture would allow reuse.

## Consumables as separate devices under MDR

For the purpose of conformity assessment, it is useful to treat the consumable as a separate device from the beginning of the project, not as an afterthought at the end. Two reasons.

The first is that the classification of the consumable can differ from the classification of the base device. A Class I instrument used with a Class IIa sterile disposable does not reduce the disposable to Class I. The disposable stays at its own class and follows its own conformity assessment route under MDR Article 52 and the corresponding annex. Treating the consumable as "part of the instrument" can mask a higher-class obligation that only surfaces late in the project, when the Notified Body flags it.

The second is that a system placed on the market as a combination — base device plus disposable — is still assessed on the basis of the individual devices that compose it. Each has its own technical file. Each has its own declaration of conformity. Each has its own UDI. The manufacturer who treats the system as one device will hit a Notified Body finding and have to restructure the submission.

A cleaner approach is to design the regulatory project from day one with two device records: the base device and the consumable. Shared risk analysis where the interaction is clinically relevant. Shared usability engineering where the user handles both. But distinct technical files, distinct conformity assessment routes, and distinct vigilance chains. This is more work up front and far less rework later.

## Margin structure

The margin structure of a razor-and-blade MedTech business only works if the blade economics are modelled honestly, including the full regulatory steady-state cost attributable to the blade.

On the revenue side, the blade price per procedure has to carry three things: the variable cost of goods for the disposable, the allocated regulatory and operational cost of maintaining the consumable as a regulated device over its market life, and the intended margin contribution. Skip any one of these and the model looks better than it is.

On the cost side, the blade carries its own share of QMS maintenance for the consumable's technical file, its own PMS data collection and reporting, its own vigilance processing, its own clinical evaluation updates, its own Notified Body surveillance fees if the consumable class requires them, its own PRRC time, and its own packaging, sterilisation, distribution, and traceability overhead. None of these are free. Founders who model the blade at gross margins comparable to software products are looking at the wrong comparison class.

A useful rule: when modelling the blade, write down every line item from the regulatory and operational cost base of the base device, ask whether an equivalent line item exists for the blade, and allocate it. In most cases the answer is yes, and the blade is closer to a "small regulated product" than to a "trivial add-on."

The business can still work. The blade margin can still be attractive. But only when the honest cost of delivering the blade is subtracted first, and the remaining contribution is what funds the company.

## The lock-in reality

The commercial appeal of the razor-and-blade model depends on the hospital actually buying the blades from the manufacturer rather than from a third party. Hospitals know this. Procurement knows this. The lock-in is visible, it is the point of the model, and it is exactly what procurement teams are trained to push back on.

Expect the following. Procurement will ask for guaranteed consumable pricing over multi-year horizons. Procurement will ask for contractual caps on annual price increases. Procurement will ask for clauses that allow alternative sourcing if the manufacturer discontinues the consumable or fails to supply. Procurement will sometimes refuse to place the base device unless the consumable contract is fixed in writing. In large hospital groups, the consumable contract is negotiated separately from the base device contract and reviewed annually.

A founder who has modelled the razor-and-blade revenue without accounting for these negotiations is modelling a world that does not exist. The realistic version of the model includes capped blade pricing, guaranteed supply commitments, and multi-year pricing visibility. The margins still work, but only at the disciplined level, and the founder cannot rely on freely raising blade prices every year to patch a thin base-device deal.

The second reality is that the "lock-in" is weaker than it looks. If a hospital is unhappy, the installed base can be replaced on a cycle of a few years. Competitors will target unhappy installed bases. A razor-and-blade business whose blade economics depend on customer unhappiness being ignored is a business with a short half-life. The discipline is to earn the recurring revenue by being clinically credible and commercially fair, not by trapping the buyer.

## Common mistakes

- **Treating the blade as pure recurring revenue without modelling the blade's MDR obligations.** The consumable is a regulated device. Its technical file, vigilance, and PMS costs belong on the blade cost line.
- **Assuming the base device classification determines the blade classification.** It does not. Each device is classified on its own.
- **Designing the base device as an excuse to sell blades.** If the base device cannot stand up to clinical evaluation on its own merits, the whole system is at risk, regardless of how attractive the blade margin looks.
- **Modelling blade pricing freedom year over year without accounting for hospital procurement caps.** Multi-year pricing caps are the norm, not the exception.
- **Forgetting that "single-use" labelling carries design obligations under Annex I.** The design must prevent or mitigate the risks of reuse. A warning sticker is not sufficient.
- **Underestimating the supply chain load of the blade business.** Sterile single-use products carry packaging, sterilisation validation, distribution, and traceability obligations that are not trivial.
- **Confusing accessories with consumables.** The Regulation treats them differently. Misclassifying a consumable as an accessory to escape obligations is the kind of shortcut that produces a Notified Body finding.

## The Subtract to Ship angle

Running the razor-and-blade model through the Subtract to Ship lens means treating the blade as a first-class regulatory artefact from day one, not as a follow-on.

- Write the intended purpose of the consumable at the same time as the intended purpose of the base device. Run both through the Purpose Pass described in [the Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr).
- Classify the consumable on its own. Do not inherit the base device's class.
- Build the technical file for the consumable in parallel with the base device technical file, sharing the parts that can legitimately be shared — usability, user interface, combined risk analysis where interaction exists — and keeping the rest distinct.
- Model the full cost of delivery for the consumable over the expected market life of the system, not just the first-year launch cost.
- Decide whether the base device can survive clinically and commercially if the blade pricing is capped at a realistic level. If it cannot, the model is not a business, it is a wish.
- Subtract every marketing claim about the blade that cannot be defended inside its own intended purpose. The blade's claims live inside the blade's file.

## Reality Check — where do you stand on your razor-and-blade model?

Answer honestly. If more than two are weak, the model is not ready to commit to.

1. Can you state the intended purpose of the consumable in its own words, independent of the base device?
2. Do you know the consumable's classification under Annex VIII, with the specific rule that applies?
3. Have you modelled the full steady-state cost of delivery for the consumable — QMS share, PMS, vigilance, Notified Body surveillance, PRRC, packaging, sterilisation, distribution — at realistic volume?
4. Can the base device survive clinical evaluation on its own merits, independent of the blade business?
5. Have you run a procurement scenario with multi-year blade pricing caps and tested whether the unit economics still work?
6. Do you know whether the consumable qualifies as a medical device in its own right under MDR Article 2(1), and is that decision documented?
7. Does the base device design prevent or mitigate the risks of reusing the single-use consumable, or does the model rely on a warning sticker?
8. Have you talked to a real hospital procurement team about the blade contract, not just to a friendly clinician about the product?
9. If the Notified Body required a separate technical file and conformity assessment for the consumable, is your project plan ready for it?
10. If a competitor entered with a cheaper compatible blade, what would protect your installed base — the law, the design, the contract, or the clinical credibility of the system?

## Frequently Asked Questions

**Does the razor-and-blade model actually work in MedTech?**
Yes, and it is one of the most common revenue models in the industry for devices that genuinely consume single-use components per procedure. It works when the consumable is a proprietary, integrated part of the system, when the base device is clinically credible on its own, and when the full MDR burden on the consumable has been modelled. It fails when founders treat the blade as a costless recurring stream or when the base device has no clinical standalone value.

**Is a single-use consumable always a medical device under the MDR?**
Not always, but usually, when the consumable has a medical purpose of its own. MDR Article 2(1) defines a medical device by intended purpose. A disposable that touches the patient, delivers the therapy, carries the reagent, or performs the measurement typically meets that definition and must be treated as a medical device in its own right, with its own classification, its own technical documentation, and its own conformity assessment route under Article 52.

**Can I use the same technical file for the base device and the consumable?**
No. Each device on the market has its own technical file, its own declaration of conformity, and its own UDI. Shared elements — for example a combined risk analysis where the interaction is clinically relevant, or shared usability engineering where the user handles both — are legitimate, but the technical files remain distinct. Treating the system as one device is the kind of structural mistake a Notified Body will flag at submission.

**How do hospitals negotiate razor-and-blade contracts?**
Hospital procurement teams know the model and negotiate accordingly. Expect multi-year pricing commitments, annual price-increase caps, guaranteed supply clauses, and sometimes alternative-sourcing provisions if the manufacturer fails to supply. The blade side of the contract is often negotiated separately from the base device side and reviewed annually. Founders should model the capped, negotiated version of blade pricing, not the list-price version.

**Does classification under Article 52 differ between the base device and the consumable?**
Yes, often. The base device and the consumable are classified independently under Annex VIII. A lower-class instrument can sit alongside a higher-class consumable, or the other way around, and each follows its own conformity assessment route under Article 52 and the corresponding annex. Founders who assume the classifications will match get surprised by the Notified Body.

## Related reading

- [The No-Bullshit Guide to MDR Compliance for First-Time Founders](/blog/no-bullshit-mdr-guide-first-time-founders) — the direct orientation on what MDR asks of a startup.
- [The Subtract to Ship Framework for MDR](/blog/subtract-to-ship-framework-mdr) — the methodology behind this post.
- [Product-Market Fit for MedTech Startups](/blog/product-market-fit-medtech-startups) — the hub post that frames PMF before the revenue model decision.
- [MedTech Business Model Analysis](/blog/medtech-business-model-analysis) — the companion post on choosing among the five realistic MedTech revenue models.
- [MedTech Pricing Strategy](/blog/medtech-pricing-strategy) — the companion post on pricing mechanics inside the revenue model.
- [MedTech Reimbursement Strategy](/blog/medtech-reimbursement-strategy) — the deep dive on the reimbursement filter that sits above every revenue model.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, consolidated text. Articles cited: Article 2(1) (definition of medical device), Article 52 (conformity assessment procedures). Official Journal L 117, 5.5.2017.
2. Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Official Journal L 80, 20.3.2023.

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*This post is part of the MedTech Startup Strategy and PMF series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The razor is only as good as the blade business that sustains it, and under the MDR the blade is a regulated device in its own right. Design both sides of the system at the same time, model both cost bases honestly, and the recurring revenue earned is recurring revenue that holds.*

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*This post is part of the [MedTech Startup Strategy & PMF](https://zechmeister-solutions.com/en/blog/category/startup-strategy) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*