The Securement Device Market in 2026

A catheter stabilization device, also sold as a catheter securement device, is a small piece of medical hardware that anchors a line or tube to the patient's skin so it cannot slide, kink or pull out. The category covers peripheral IV catheters, PICCs and central lines, arterial lines, urinary (Foley) catheters, epidural and nerve-block catheters, chest and surgical drains, feeding tubes and endotracheal tubes. The product is usually an adhesive foam or fabric pad with a molded retainer that grips the catheter hub or wings. It is cheap per unit, consumed in huge volume, and bought by hospital supply chains rather than by individual clinicians.

Published market estimates for 2025 disagree widely because each publisher draws the category boundary differently. A Research and Markets strategic report puts the global figure at about $1.6 billion in 2025, rising to $2.4 billion by 2032 at a 5.4% compound annual rate. A DelveInsight summary sizes the market at $1,768 million in 2024 and $2,862 million by 2032, a 6.31% rate. Precedence Research goes higher, projecting $3.74 billion by 2035. Across the sources we reviewed, 2025 estimates run from roughly $1.4 billion to $2.2 billion. A lender will ask which number you used and why, so pick one, cite it, and show a bottom-up check next to it.

Why the incumbents are beatable in niches

The top five suppliers hold about 55% of the market in the DelveInsight-sourced summary, which also means roughly 45% sits with smaller firms, private-label makers and regional distributors. The incumbent product most clinicians know is the BD StatLock family, which is sold in separate versions for IV, PICC, Foley, arterial and drain lines. BD's own marketing claims that up to 48% of tape-secured IV catheters develop complications such as phlebitis or infiltration, and that its device resists dislodgement 32% better than a 3M PICC securement device. Those are manufacturer claims, not independent trial results, and a good plan treats them that way. What matters for a startup is the pattern: the leader wins on clinical familiarity and breadth, and leaves openings for products that fit one awkward anatomy, one patient group, or one price point.

Other named products a buyer will compare you with include Vygon's Universel Griplok, the TIDI Products Grip-Lok range (the subject of a PubMed-indexed evaluation of universal adhesive securement), subcutaneously anchored systems such as SecurAcath from Interrad Medical, and the plain transparent dressings and tapes that nurses still use in many units. Medline sells BD StatLock under its own catalogue as a distributor, which tells you something about channel power: the distributor is happy to carry whichever securement line the hospital contract names.

Demand drivers with money attached

The commercial case for a securement device rests on avoided cost. The US Agency for Healthcare Research and Quality estimated that a hospital-acquired central line bloodstream infection adds about $48,108 in additional inpatient cost, and a catheter-associated urinary tract infection about $13,793. A university hospital study of PICC securement and bloodstream infection tied engineered securement to fewer line-related infections. Medicare stopped paying for certain hospital-acquired conditions in 2008, although a study of that policy found the financial penalty was small enough that its effect on infection rates was minimal. The practical reading for your plan: infection-prevention teams already budget for this problem, but the dollar penalty on the hospital is modest, so your pitch must lean on nurse time, restart rates and patient comfort as much as on infection numbers.

Three further drivers show up in every market summary. Hospitals are moving more infusion therapy into outpatient and home settings, where a patient may wear a PICC or midline for weeks and the line must survive showers and sleep. Adhesive technology has improved, with gentler skin-contact materials and antimicrobial-coated pads. And procurement teams are consolidating, which rewards suppliers who can serve a whole health system rather than a single unit. North America is the largest revenue region, with the UK, Germany and France forming the next tier of well-organised buyers.

Where a new company can win

• Neonatal and paediatric lines: tiny anatomy, fragile skin, and few products designed for it. A low-profile pad for a 1 kg infant is a different engineering problem from an adult PICC pad.
• Long-dwell outpatient lines: midlines and PICCs worn at home for 2 to 6 weeks, where wear time and shower resistance matter more than a low unit price.
• Regional anaesthesia catheters: epidural and peripheral nerve-block lines that move with the patient and are easy to dislodge during transfers.
• Drains and tubes: chest drains, surgical drains and nasogastric tubes, where hospitals still tape or suture and a purpose-made anchor is a clear step up.
• Private label: making an equivalent device for a distributor or a GPO house brand, which trades margin for volume and a ready-made sales channel.

For wider context on the line types your device would anchor, see our guide to the catheters business plan template, and for the adjacent regulated-device route see the medical device business plan template.

Funding: SBA, Start-Up Loans and Device Grants

Class I medical devices that are exempt from 510(k) clearance are among the cheaper regulated products to launch, which makes them a better fit for debt than most devices. Lenders still look for a tangible collateral story, and a company with no inventory, no tooling and no customer contracts is difficult to finance with a conventional loan. Match the funding route to what you actually need to buy.

US routes

The SBA 7(a) loan is the main lender-backed route, capped at $5 million, with working capital, equipment and inventory all eligible uses. Medical device manufacturers typically fall under NAICS 339113 (surgical appliance and supplies manufacturing), though you should confirm the code that matches your product with your lender, because the NAICS code sets the SBA size standard. Expect lenders to ask for a personal guarantee, 10% to 20% owner equity, and evidence of a first customer or a letter of intent from a distributor. An SBA Microloan, up to $50,000 through a nonprofit intermediary, can cover a first tooling quote or the regulatory consultant but is too small to fund a full build.

Equity-free money is realistic here. The SBIR and STTR programmes run by the National Institutes of Health and other agencies fund early device development, and a securement device with a clear clinical-outcome hypothesis (fewer dislodgements, fewer restarts) is a credible Phase I proposal. Phase I awards typically sit in the low hundreds of thousands of dollars and take months to win, so they suit a team that can wait. State device clusters, such as those around Minneapolis, Boston and the Carolinas, also run pitch competitions and matching funds.

UK routes

The Start Up Loans scheme lends up to £25,000 per founder at a fixed 6% rate, with mentoring attached. It covers a first regulatory registration, a prototype run and a website, but not tooling. For larger needs, Innovate UK grants and the SEIS and EIS tax-relief schemes are the usual route: SEIS lets a young company raise up to £250,000 from investors who receive 50% income tax relief, and EIS covers larger rounds. Medtech investors in the UK expect to see a clinical champion on the team and a realistic route into NHS Supply Chain, so both belong in the plan.

What lenders actually test is whether a distributor or hospital has agreed to evaluate the product. A signed evaluation agreement with a 300-bed hospital, or a letter from a regional distributor stating the unit price it would pay, is worth more in a loan file than another page of market statistics. Our research and content package includes this lender-facing evidence section, and our free template has a placeholder for it.

Startup Costs for a Securement Device Company

The range for this category is wide because the business model decides most of the spend. A founder who designs an adhesive-pad securement device, has an ISO 13485 contract manufacturer build and sterilise it, and sells through two distributors can launch for roughly $145,000 to $260,000 (£115,000 to £205,000). A company that owns its injection-molded retainer tooling, runs a small assembly cell in rented cleanroom space, and funds a clinical comparison study sits closer to $380,000 to $720,000 (£300,000 to £570,000). These are planning ranges built from typical vendor quotes, not guarantees.

The line items that surprise first-time founders

Tooling. A single-cavity prototype mold for a retainer can cost $5,000 to $15,000, but production tooling with 4 to 16 cavities, hardened steel and validated gating runs from about $40,000 up to well above $100,000. The mold decides the unit cost, so the plan should show the unit cost at two production volumes rather than a single figure.

Biocompatibility. A skin-contact adhesive that stays in place for days normally needs cytotoxicity, sensitisation and irritation testing under the ISO 10993 series. A basic package from a lab such as Nelson Labs or WuXi AppTec commonly runs $15,000 to $40,000, and a failed adhesive means a repeat. Budget for one failure.

Sterilisation validation. Many securement devices are supplied sterile for use near insertion sites. Ethylene oxide validation under ISO 11135 and sterile-barrier packaging validation under ISO 11607 add $10,000 to $30,000 and several weeks of calendar time. A non-sterile product, where the clinical use allows it, avoids this line entirely.

FDA fees. Establishment registration is an annual fee (about $11,000 to $12,000 for the 2026 fiscal year, so confirm the current figure on the FDA site), and it applies even when the device is exempt from 510(k). Device listing itself is free.

Insurance. Product liability cover with $2 million per occurrence is the usual hospital contract requirement. A small device maker can expect $4,000 to $15,000 a year depending on sales volume and whether the device is sterile and used near a bloodstream access site.

Working capital. Hospitals and distributors often pay at 45 to 90 days, so a sale in month one is cash in month four. The plan should carry at least three months of operating expenses plus inventory for the first purchase order. A founder who budgets for the product and forgets the receivables gap is the most common reason these plans fail a lender's cash-flow test.

Equipment checklist for a small assembly cell

If you assemble in house rather than contract the work, the capital list below covers a small ISO Class 8 (about 100,000 particles per cubic foot) workspace. Most founders start with a contract manufacturer and move assembly in house only after volume justifies it.

• Rotary or flatbed die cutter for adhesive pads and foam, about $18,000 to $60,000 new, less used
• Laminating station for bonding film, foam and release liner, $12,000 to $45,000
• Validated pouch sealer for sterile-barrier packaging under ISO 11607, $4,000 to $12,000
• Tensile and peel tester such as an Instron bench frame or a Mark-10 force gauge, $3,500 to $25,000
• Modular cleanroom enclosure or leased ISO 8 bay, $15,000 to $50,000 to build, or $2,500 to $6,000 a month to rent
• UDI label printer such as a Zebra thermal printer with barcode verification, $1,500 to $5,000
• Environmental monitoring kit with a particle counter and temperature and humidity logging, $2,500 to $9,000
• Electronic quality management software such as Greenlight Guru or Qualio, about $6,000 to $24,000 a year

Whichever route you take, our industry-specific template carries the startup cost table pre-built, so you replace the figures with your quotes instead of starting from a blank sheet.

Suppliers for Adhesives, Resin and Sterilisation

A securement device is a short bill of materials: a skin adhesive, a backing material, a retainer, a release liner, a pouch and a label. Four of those six drive nearly all of the cost and the clinical performance, so a plan that names real suppliers and the lead times attached to them reads as credible. The firms below are named for orientation only. They are not endorsements, and prices must come from written quotes.

Two practical points save founders months. First, ask the adhesive supplier for its existing biocompatibility file before you commission your own, because you can often reference supplier data for the raw material and test only the finished device. Second, negotiate tooling ownership in writing. A molder that keeps the tool can raise your price or refuse to move it, and a lender reading the plan will ask who owns the mold.

Distribution partners matter as much as component suppliers. Large US distributors that hold hospital securement contracts include Medline, Cardinal Health, McKesson and Owens and Minor. Group purchasing organisations such as Vizient, Premier and HealthTrust set the contract terms that most hospitals follow. In the UK, NHS Supply Chain runs national frameworks that decide what trusts can order by default. Naming the channel you are targeting, and the stage you are at with each, is a Tier A proof point in a lender or investor read-through.

Unit Economics and Revenue Channels

A securement device company sells a high-volume disposable. Revenue is units multiplied by price, and almost everything else in the model is a consequence of the channel you sell through. The same pad can earn $2.60 per unit when sold directly to a hospital, $1.85 through a distributor, and $1.20 as a private-label product for a group purchasing organisation. The plan has to pick a lead channel and defend the price that goes with it.

Three ways to sell the same device

These bands are planning assumptions drawn from typical wholesale pricing for single-use medical accessories, not published price lists. The StatLock family and similar products are widely listed by retail medical suppliers at several dollars a unit, but hospital contract prices are lower and are rarely public. Validate your own price with two distributors and one purchasing contact before you commit to a forecast.

A worked year-one and year-two model

The example below uses a distributor-led model with a blended net price of $1.85 per unit in year one, easing to $1.82 as volume discounts take hold. Landed cost per unit is $0.64 in year one (adhesive and foam about $0.21, retainer resin and molding $0.17, pouch and label $0.09, sterilisation $0.08, assembly and scrap $0.09) and falls to $0.58 once the tool is fully loaded.

Two ratios from this model belong in the plan. Contribution per unit is $1.85 less $0.64 cost less about $0.055 GPO fee, which is $1.155. Divide year-one operating costs of $680,000 by that figure and the business breaks even at about 590,000 units, or roughly 49,000 a month. Volume per account is the number that makes the unit count believable. If a 400-bed acute hospital uses an estimated 35,000 to 45,000 securement devices across IV, central, arterial, urinary and drain lines each year (an assumption you should verify with a purchasing contact), then 600,000 units means winning about 15 comparable accounts in twelve months. That is the sales target a lender will test, so show how many value-analysis presentations it takes to land one.

Revenue beyond the pad

• Kits: bundling a securement device into a central line dressing-change kit or a PICC insertion kit raises revenue per patient and locks in the channel. Kit assemblers such as the large infusion-set makers buy components in the hundreds of thousands.
• OEM supply: catheter manufacturers sometimes source a branded securement accessory to sit with their line, with an annual volume commitment.
• Home infusion: pharmacy providers supplying patients on long-term infusion buy dressing and securement in monthly packs, a smaller but steadier stream with a lower sales cost.
• International distribution: a UK, German or Gulf distributor can take a container load per year once the product holds a CE or UKCA mark.

Clinicians trial products in small lots before committing. Budget a free-sample line of 3% to 5% of year-one revenue, because the evaluation pack is how securement devices are actually sold.

Regulation: FDA, MHRA, EU and Canada

Most intravascular securement devices sit in a favourable regulatory class, which is why this category is realistic for a small team. Favourable does not mean unregulated. The company must still register, hold a compliant quality system, label correctly and report adverse events.

United States

The FDA's classification database lists intravascular catheter securement devices under product code KMK as Class I, governed by 21 CFR 880.5210 within Part 880 of the Code of Federal Regulations. Class I devices in this category are exempt from the premarket notification (510(k)) requirement, subject to the standard limitations on exemption, so a new securement device usually reaches the market without a clearance review. Two cautions apply. First, the exemption has limits: a product that makes new claims, uses new technology such as a drug-eluting or antimicrobial layer, or is intended for a different line type may fall outside it. Second, other catheter types, such as urological or epidural securement, can sit under different regulations and product codes, so confirm the exact code for your target line before you plan around exemption. A pre-submission query to the FDA or a regulatory consultant's classification memo costs far less than an unplanned 510(k).

• Establishment registration and device listing with the FDA, renewed every year. Annual fee roughly $11,000 to $12,000 for FY2026, to be confirmed on the FDA fee page. Timeline: 2 to 4 weeks after you have a legal entity and a facility.
• Quality Management System Regulation (QMSR): FDA's updated rule, which aligns US requirements with ISO 13485 and took effect on 2 February 2026. Class I devices are not exempt from it in the way older guidance suggested, so budget for design controls, supplier controls and complaint handling from day one. Build cost: $20,000 to $50,000 with a consultant and eQMS software.
• Labelling and UDI: labelling under 21 CFR Part 801 and unique device identification under Part 830, including a record in the GUDID database. Include a latex-free statement only if your supplier data supports it.
• Medical device reporting: a procedure to report deaths, serious injuries and certain malfunctions under 21 CFR Part 803 and to run corrections under Part 806.
• State-level: some states, including California, require a manufacturer licence for device makers, with fees from a few hundred to a few thousand dollars.

United Kingdom

Devices placed on the Great Britain market fall under the UK Medical Devices Regulations 2002 as amended. Manufacturers must register devices with the MHRA through its online system (DORS), and a manufacturer outside the UK must appoint a UK Responsible Person. Guidance such as the BHTA overview of UK market access and a Class I compliance guide explain that a non-sterile, non-measuring Class I device is normally self-declared: you write a technical file, a declaration of conformity and apply the UKCA mark yourself. A sterile device adds a third-party step for the sterile aspects. One published 2026 guide, Worldwide Device Solutions, quotes a registration fee of about £300 per year per GMDN category, with the MHRA reviewing applications in around five working days. Verify the fee, and the status of CE recognition in Great Britain, on gov.uk before you publish a budget. NHS suppliers should also expect to supply product information for NHS Supply Chain listing, and a UK Responsible Person typically charges an annual retainer in the low thousands of pounds.

European Union and Canada

In the EU, a securement device generally sits in Class I under Regulation (EU) 2017/745, with Class Is where it is supplied sterile, which brings a notified body into the sterile aspects. Requirements include EUDAMED registration, an EU authorised representative if you are outside the bloc, and a person responsible for regulatory compliance. In Canada, Health Canada treats a Class I device as the lowest risk tier: no device licence is needed for Class I, but the manufacturer, importer or distributor needs a Medical Device Establishment Licence unless it sells through a licensed party. Canadian hospital buying runs through provincial purchasing groups, which makes a Canadian distributor the usual first step.

Add a standards row to the regulatory section of your plan: ISO 13485 for the quality system, ISO 10993 for biological evaluation, ISO 11135 for ethylene oxide sterilisation, ISO 11607 for packaging and ISO 14971 for risk management. Tying each to a cost and a date turns a regulatory paragraph into a schedule a lender can check.

Five Mistakes That Sink Securement Startups

These are the patterns we see most often when a medical device founder brings us a plan that has stalled with lenders or investors.

1. Pricing against the list price instead of the contract price

Founders find a retail listing for a branded securement device, set their price a little below it, and build a forecast on that number. Hospitals do not pay list. They buy under a GPO or system contract at a discount, and a start-up that undercuts list may still be above contract. Ask a purchasing contact for the contract price range of the incumbent before you set yours.

2. Selling infection numbers the hospital does not feel

The AHRQ cost figures are real, but as the study of Medicare's 2008 non-payment policy showed, the financial penalty is small, so a pure infection-cost pitch can fall flat with a procurement team. Lead with measurable ward outcomes: dislodgements per 1,000 line days, nurse minutes per dressing change, restart rate, and patient skin complaints. Then add the infection point.

3. Skipping wear-time and skin-injury data

A device that lifts at day three, or leaves medical adhesive-related skin injury on fragile patients, loses clinical champions quickly. Run a bench test for peel strength and a small in-use evaluation, and report the numbers with their limits. A modest honest dataset beats a glossy claim.

4. Budgeting for the product but not the sales cycle

A value-analysis committee meets monthly or quarterly, wants clinical evidence, and may trial for 60 to 90 days. Plan for 6 to 12 months from first contact to first purchase order at a new hospital. If your cash runway is shorter than that cycle plus payment terms, the plan fails regardless of product quality.

5. Leaving tooling and second-source risk unaddressed

A single molder, a single adhesive supplier and a single sterilisation site mean a single point of failure. Lenders and strategic partners ask what happens if one of them stops. Name a qualified alternative for each critical input, even if you do not use it yet, and confirm in the supply agreement that you own the mold.

Sample Plan Extract

The extract below shows the tone and numbers used in a funded securement device plan. It is a composite, not a real company.

A funded plan places the evaluation agreements and distributor letters directly after the summary, not at the back. The full template includes this layout with editable fields.

What Is in the Template

Every Avvale business plan template includes these sections, pre-structured for your industry:

• Executive Summary - Your device, line types and buyers at a glance, written to hold a lender for 60 seconds
• Company Overview - Legal structure, ownership, facility and the regulatory status of the device
• Industry Analysis - Market size, incumbent products, procurement structure and standards
• Customer Analysis - Hospitals, home infusion providers, distributors and the clinicians who approve them
• Competitor Analysis - Positioning against StatLock, Grip-Lok, Griplok, SecurAcath and tape, with a gap map
• Marketing Plan - Clinical education, evaluation packs, conference presence and GPO contracting
• Operations Plan - Suppliers, tooling, sterilisation, quality system and inventory plan
• Management Team - Founder bios, clinical advisers, regulatory consultant and key hires

The optional Financial Forecast add-on (included in our $300/£250 and $1,000/£800 packages) provides a 5-year Excel model with income statement, cash flow, balance sheet, break-even analysis, and startup capital requirements. For a manufacturer it also carries a per-unit cost build, a channel price table and a receivables schedule. To start from the structure, take the free template; if you want a writer, see our business plan writer service.

Frequently Asked Questions