Equipment and Facility Checklist

Before any financial model, a maker of eye surgery equipment needs to know what has to physically exist for the first sellable unit. A cataract knife, a vitrectomy cutter and a phacoemulsification console share a customer but almost nothing else. The checklist below is grouped by the stage of production, and every price band is an Avvale planning estimate drawn from typical vendor quotes. Treat the numbers as placeholders until you hold written quotes, because a lender or investor will ask to see them.

Stage 1: Design and prototyping

• CAD and simulation seats: SolidWorks or Autodesk Inventor for mechanical work, plus Ansys or COMSOL if the product involves fluidics or ultrasonic handpieces. Budget $8,000 to $25,000 a year per seat for a professional configuration.
• Benchtop prototyping: a precision 3-axis mill, a stereo microscope with a measurement stage and a polishing station. Expect $35,000 to $90,000 for a small prototype bench.
• Eye model and bench-test rigs: porcine or synthetic eye models for surgeon feedback, pressure sensors and a flow bench for any fluid-handling product. Often built in-house for $10,000 to $40,000.
• Surgeon advisory time: two to four practising surgeons on paid advisory agreements. Typical consulting honoraria run from $250 to $600 an hour, so $20,000 to $60,000 in year one is realistic.

Stage 2: Production floor

A business that plans to outsource machining to a contract maker can skip the first three rows and cut the production floor budget by more than half. That is the commonest choice for a first product, and the plan should state clearly which route it takes, because it changes margin, lead time and the audit trail your quality system must cover.

Stage 3: Quality, test and release

• Electronic quality system: a purpose-built eQMS such as Greenlight Guru or MasterControl, roughly $15,000 to $60,000 a year depending on seats. A paper system is possible but harder to defend in an audit.
• Product lifecycle management: Arena PLM or Jama Connect for design controls and traceability, $10,000 to $40,000 a year.
• Electrical safety and EMC testing: for any powered console, IEC 60601-1 and 60601-1-2 testing at a third-party lab, commonly $25,000 to $80,000 per design iteration that fails and has to be retested.
• Biocompatibility testing: ISO 10993 cytotoxicity, sensitisation and irritation for patient-contacting parts, $15,000 to $60,000 for a typical instrument set, far more for an implant.
• Sterilisation validation: ethylene oxide or gamma validation, $20,000 to $50,000, plus per-lot processing fees.
• Packaging and shelf-life study: accelerated ageing to support a stated shelf life, $12,000 to $40,000.

The sums above explain why the cost to launch varies so widely between product types, which is the subject of the next section. If you would rather start from a structure that already has these line items, the free business plan template is the plain starting point, and the industry-specific template adds the manufacturing sections.

What It Costs to Launch, by Product Type

"Eye surgery equipment" covers three business models, and each has a different regulatory class, a different cash need and a different kind of customer. Picking one is the first decision in the plan. Mixing them in a single forecast is the usual reason a first draft gets rejected.

The classification column is based on FDA product classification: as summarised by Registrar Corp, phacoemulsification systems and ophthalmic surgical lasers are Class II devices reached through 510(k), while an intraocular lens is Class III and needs premarket approval, as shown in the FDA product classification entry for intraocular lenses. The cash columns are Avvale modelling ranges built from published development-cost guides such as the one from Starfish Medical, which puts simple Class I devices at $100K to $500K and complex Class III devices with clinical trials above $5M.

A worked budget for a single-use cutter line

Consider a founder who wants to make a disposable vitrectomy cutter probe, a Class II product that would be sold into ambulatory surgery centres. The 18-month budget below is a composite, not a quote.

The contingency line is not decoration. Device programmes rarely run to plan, and the tooling and testing lines are where overruns concentrate. Plans that show a 0% contingency tell a reviewer that the founder has not built a device before.

Funding routes that fit this business

• SBA 7(a) loan: available to small manufacturers, up to $5 million, usable for equipment, working capital and inventory. NAICS 339112 (surgical and medical instrument manufacturing) carries an SBA size standard of 1,000 employees, so almost every start-up qualifies on size (see the NAICS 339112 listing). Lenders want collateral and cash flow, which suits an existing machine shop or contract maker adding an ophthalmic line more than a pre-revenue design team.
• SBA 504 loan: a fit for the CNC, EDM and cleanroom purchases in the table above, since it finances fixed assets at long fixed terms through a certified development company and a bank. The standard debenture limit is $5 million, rising to $5.5 million for manufacturers.
• NIH SBIR and STTR: the National Eye Institute funds small-business device work. Phase I awards are typically in the low hundreds of thousands of dollars, and the grant pays for the verification data that makes a seed round possible without giving up equity.
• Venture and strategic capital: recent rounds show the range. Avisi Technologies closed a $10.7 million Series A for a glaucoma device heading into a pivotal trial, while ForSight Robotics raised $125 million to take a cataract-surgery robotics platform into human trials. Those two numbers frame what a clinical-stage ophthalmic start-up can ask for at different stages.
• UK routes: Innovate UK Smart grants for the development phase, a Start Up Loan of up to £25,000 per founder for living costs, and SEIS then EIS for equity. A UK manufacturer with HMRC advance assurance can raise its first £250,000 under SEIS.

For a start-up that wants help turning this into a document a lender will read, the Research + Content package writes the market, regulatory and operations sections with citations, and our business plan writer service page explains how the engagement works.

Named Suppliers, Contract Makers and Test Labs

A device plan reads as more credible when each external dependency has a name next to it. The list below is a starting set of real organisations active in medical device supply, grouped by the job they do. Inclusion is not an endorsement and Avvale has no commercial relationship with any of them. Get quotes from at least two in each category before putting a number in your model.

Two practical points. First, a contract maker with an established ISO 13485 certificate lets you borrow part of their quality system for the production steps they own, but you remain the legal manufacturer or specification developer with FDA and need a supplier-control procedure that proves you audit them. Second, sterilisation and test labs book out. Pencil in the validation slot at the same time as the design freeze, not after, or a three-week task becomes a three-month delay in the timeline.

For the commercial side of a similar manufacturing business, our contact lens manufacturer business plan template covers lens-grade materials and finishing, and the eye care clinic business plan template shows the buyer side of the same market.

FDA, UK, EU and Canada Compliance

Regulatory work is the longest line on the Gantt chart for any eye surgery equipment maker, so the plan has to set out the route market by market. Costs and timelines in this section come from the cited agency pages or from published industry guides, and each is labelled.

United States: the FDA route

• 510(k) premarket notification: the route for most Class II surgical equipment, including phaco systems and ophthalmic lasers. For FY2026 the standard user fee is $26,067 and the small-business fee is $6,517, according to the FDA user fee page. The FDA's stated goal is a decision within 90 FDA days, which excludes any time the file is on hold for questions (see the 510(k) submission process). A realistic calendar allowance is 5 to 9 months from submission.
• Premarket approval (PMA): required for Class III products such as intraocular lenses. The FY2026 PMA fee is $579,272 standard or $144,818 for a small business, and that is before clinical study costs.
• Small-business status: the reduced fee applies to businesses with gross receipts or sales of $100 million or less, including affiliates. File the small-business qualification before the submission, since it takes time to process.
• Establishment registration: $11,423 for FY2026, payable every year once you manufacture for the US market.
• Quality system: from 2 February 2026 the FDA's Quality Management System Regulation replaced the old QSR and incorporates ISO 13485:2016 by reference, as explained in this TÜV SÜD briefing. Complying with ISO 13485 alone is not enough, because FDA added a small number of extra requirements.
• Predicate search: a 510(k) rests on a legally marketed predicate. Pull the product code and past clearances for your device type from the FDA database in the first month, because the available predicates decide whether you need a 510(k) at all or a longer De Novo request.

United Kingdom: MHRA

Devices placed on the Great Britain market must be registered with the MHRA. Current GOV.UK guidance on regulating medical devices sets out the UKCA route, and CE-marked products can still be sold in Great Britain for a transition period. As reported by Burges Salmon, CE recognition for MDR-certified devices currently runs to 30 June 2030, and the MHRA has been consulting on accepting EU MDR compliant devices indefinitely. For a plan, the safest position is to budget for CE marking first and treat UKCA as a later option. A maker based outside the UK also needs a UK Responsible Person to register devices with the MHRA, which is a small fixed cost to add to the plan.

European Union: MDR

The EU Medical Device Regulation requires a notified body for anything above Class I. Industry cost guides, including this CE marking cost breakdown, put total certification cost at roughly EUR 70,000 to 220,000 for Class IIb and EUR 200,000 to 600,000 or more for Class III implantables. Timelines run 12 to 24 months for Class IIa and IIb and two to four years for Class III, and the mandatory expert-panel scrutiny for some Class III devices adds 30 to 90 days. Notified bodies publish hourly rates that average around EUR 317 to 325. For a first product, the EU route often costs more calendar time than the FDA route, which is why many US-first start-ups sequence their markets.

Canada: Health Canada

Class II, III and IV devices need a Medical Device Licence, and the manufacturer needs an MDSAP certificate demonstrating ISO 13485 compliance. From 1 April 2026 the application fee is CAD 643 for Class II and CAD 14,163 for Class III, with a CAD 460 annual right-to-sell fee, per the Health Canada fee schedule. Because MDSAP audits cover several regulators at once, building the quality system to an MDSAP standard from the start saves duplicated audits later.

A sequencing example

A sensible market sequence for a Class II capital device might be: US 510(k) in months 14 to 22, Canada in months 18 to 26 using the same MDSAP audit, CE marking in months 20 to 38, and UK registration afterwards on the strength of the CE certificate. The business plan should show cash use by market, so an investor can see which regulatory step each tranche of funding buys.

How the Money Comes In

The revenue model for an eye surgery equipment maker is built on one idea: the reusable or capital item gets you into the operating room, and the single-use or serviced item that follows pays for the business. Surgeons choose a platform they trust, ambulatory surgery centres standardise on it, and the recurring orders arrive for years. A forecast that treats every sale as a one-off misses the largest line.

The five revenue lines

1. Reusable instrument sets: forceps, scissors, hooks and speculums sold by the set. Margins are steady and replacement happens every few years as tips wear.
2. Single-use packs: cutter probes, tips, tubing and drapes sold per case. This is the high-volume, repeat line.
3. Capital equipment: consoles, lasers and microscopes sold or placed under a lease or reagent-rental style agreement tied to consumable commitments.
4. Service and reprocessing: sharpening, calibration, preventive maintenance and annual service contracts.
5. OEM supply: making components or finished products for a larger brand, a route many small makers use for their first revenue.

Worked example: a microsurgical instrument and pack business

Here is a model for a company with one instrument family and one single-use pack. The inputs are illustrative planning assumptions, not market data, and the plan you write should replace them with your own quotes.

If fixed costs (salaries, rent, quality system, regulatory upkeep and sales) are $2.1 million a year, break-even revenue is $2.1 million divided by 0.617, about $3.40 million. At the volumes above the company clears break-even with about $0.27 million of revenue to spare, which is a margin of safety under 8%. That is a thin cushion, and it explains why most plans for this business show two years of losses before reaching break-even. An investor will also notice that single-use packs carry 67% of revenue, so a forecast needs to show how 40,000 packs are reached: roughly 200 surgical sites each running 200 cases of this procedure a year.

Why the consumable is the business

Take a console sold at $68,000 with a 45% gross margin, which earns $30,600 on the sale. Suppose the console runs 6 cases a week for 48 weeks, so 288 cases a year, with a single-use pack priced at $85 and a 70% margin. Each console then produces $17,136 of pack gross profit a year, $85,680 over a five-year life. The pack stream is about 74% of the lifetime gross profit from that placement. This arithmetic is the basis of the razor-and-blade argument, and it is also the reason surgeons and purchasing managers look hard at consumable prices before agreeing to a new console. Larger rivals know the same sum, and their implant and consumable lines are where most of their money sits: Alcon's 2025 annual report shows $5.8 billion of surgical sales, of which about $3.03 billion was consumables and $1.8 billion implantables, leaving roughly $1 billion for equipment and other items.

Pricing pressure points

• Used-equipment market: listings on resale sites put used phaco systems at $8,000 to $40,000, with used Alcon Centurion units commonly at $20,000 to $35,000, per this phaco machine cost guide. New systems from leading makers start around $60,000 and can pass $150,000. Your console price has to be defended against both ends.
• Group purchasing: large ASC chains and hospital groups buy through contracts. Breaking in often means one pilot site first, then a trial price.
• Reimbursement: surgeons and ASCs are paid a bundled fee for a cataract case, so every extra dollar spent on a disposable comes out of the facility's margin. Prices that look reasonable per item may still lose when summed per case.

The marketing plan for eye surgery equipment maker businesses on our site goes deeper on the sales motion once the revenue model is set.

Market Size, Surgeon Demand and Rivals

Published figures for the ophthalmic surgical market differ a good deal, which is a definition issue. Some reports count only surgical devices, some add consumables and implants, and some include pharmaceuticals used in surgery. A plan should say which definition it uses and give the reader the lower figure first.

The three headline estimates come from Global Market Insights (surgical devices at $11.6 billion in 2025, growing 5.1% a year to 2035), Future Market Insights ($14.7 billion in 2025 rising to $25.0 billion by 2035 at 5.4%) and Market Research Future ($31.28 billion in 2025 to $45.69 billion by 2035). For a maker of a single product, the serviceable market is a fraction of any of these: you sell one procedure type, in one set of countries, to one type of buyer. Build the market section bottom-up, by procedures per year multiplied by your price per case, and use the top-down figures as a cross-check.

Demand starts with procedure volume

Cataract surgery is the volume driver. Industry commentary, such as this piece from Surgical Direct, puts US cataract procedures at about 4.2 million in 2024, up from roughly 3.1 million in 2006, and expects close to 6 million a year by 2030. In England the NHS performed about 600,000 cataract operations in 2022/23, and by January 2024 independent sector providers carried out 59% of NHS-funded cataract surgery, according to The Ophthalmologist. That shift matters for a manufacturer, because independent providers buy differently from NHS trusts: fewer committee approvals, more focus on theatre throughput, and a willingness to switch consumables for a price or a time saving.

Glaucoma, retina and refractive surgery are smaller by volume but richer in price per case. A plan aimed at any of them should give procedure counts for that procedure rather than lean on cataract data.

The competitors, with real numbers

The sources for that table are Carl Zeiss Meditec's annual report release, Glaukos's October 2025 filing, the MedTech Dive report on STAAR, and Bausch + Lomb Surgical. Note the STAAR episode: a bid at a 74% premium was rejected by shareholders, which tells a founder that strategic buyers are willing to pay up for differentiated ophthalmic technology and that independent owners will not sell cheaply.

Where a small maker can win

Outspending these companies is not an option. Small makers win in four places. The first is a narrow clinical niche the majors treat as too small, for example paediatric or oculoplastic instruments. The second is a procedure being moved from the hospital operating room to an office-based setting, where lower-cost equipment matters. The third is a cost-down on a disposable the majors price high. The fourth is a component or OEM deal that gets your technology into a larger brand's catalogue. Write the plan around one of these and show it in the first page, not the fifth.

Questions Buyers and Backers Ask

These are the questions that come up most often when a manufacturer pitches a surgeon, a purchasing group or an investor. Answer each in the plan before they are asked.

Is an eye surgery instrument a Class I or a Class II device?

It depends on the product code. Some simple hand-held instruments are Class I and exempt from 510(k), but still need establishment registration and device listing. Instruments that cut tissue in the eye, powered handpieces and anything that delivers energy are typically Class II. Check the FDA product classification database for your exact device before you commit a budget.

What margin do single-use ophthalmic packs earn?

In Avvale planning models for small makers, single-use packs land at 60% to 75% gross margin once volumes pass about 20,000 units a year. Below that, moulding tooling and sterilisation lot sizes pull the margin down to the 45% to 55% range. The plan should show the volume at which each step gets cheaper.

Should I sell direct or through distributors?

Direct sales need clinical specialists who can attend cases, and one specialist covers perhaps 8 to 12 surgical sites. Distributors give reach in markets where you have no team and typically keep 20% to 35% of the price. A common route is direct in a home region where the founder is known to surgeons and distributors everywhere else, with exclusivity limited to two years and tied to minimum volumes.

How do surgeons choose a new instrument supplier?

Mostly through peers. A surgeon is more likely to try an instrument after seeing it used by a colleague, at a wet-lab session or in a conference demo, than after reading a brochure. Plan for 12 to 24 months of surgeon advisory work, a small number of high-profile first users and a training budget for wet labs.

Is it cheaper to make in-house or outsource?

Outsourcing wins on cash for the first 12 to 24 months and on speed. In-house production wins once volumes make machine utilisation high, usually above $2 million of annual revenue in machined parts, and it removes supplier markup of 25% to 40% on those parts. Many plans outsource at launch and set a trigger in the model for bringing machining in-house.

Six Mistakes That Weaken an Equipment Maker's Plan

1. Assuming the wrong device class. A plan that budgets a 510(k) for an implant, or a PMA for a simple instrument, is wrong by millions of dollars or by a year. Name the product code in the plan.
2. Using a top-down market share. "We will take 1% of a $12 billion market" tells a reviewer nothing. Show procedures, sites and price per case.
3. Skipping the consumable economics. Capital equipment on its own rarely supports the business. Show the attach rate and price of the disposable.
4. Leaving out the surgeon. Investors want to see named surgeon advisers and a first-user plan. A device built without clinical input is a red flag.
5. Underfunding quality. The quality system under the FDA's 2026 QMSR is a standing cost, not a one-time task. Include audit, supplier control and complaint handling as annual lines.
6. A single-market regulatory plan. A US-only plan can still win funding, but the plan should show when Canada, the EU and the UK are added, and how much each step costs.

Sample Plan Extract

A faded preview of how the executive summary reads in a finished plan for an eye surgery equipment maker. The company is a composite, and the structure is what the template gives you.

The paid packages go further. The Research + Content package writes the market, competitor and compliance sections with citations, and the Bespoke package adds a five-year Excel model with product-line tabs for instruments, packs and service.

What Is in the Template

Every Avvale business plan template includes these sections, pre-structured for your industry. For a maker of eye surgery equipment we recommend giving extra weight to the sections marked below.

• Executive Summary: product, device class, ask and use of funds on one page
• Company Overview: legal entity, ownership, intellectual property and founder background
• Industry Analysis (heavy): procedure volumes, market definition and the named incumbents
• Customer Analysis (heavy): surgeons, ambulatory surgery centres, hospital groups and purchasing contracts
• Competitor Analysis: head-to-head comparison with Alcon, Zeiss, Bausch + Lomb and niche rivals
• Regulatory Plan (heavy): product code, route, fees, calendar and market sequence
• Operations Plan (heavy): in-house or outsourced manufacture, suppliers, quality system and sterilisation
• Marketing and Sales Plan: surgeon advisory model, wet labs, conferences and distributor terms
• Management Team: founders, clinical advisers and planned quality and regulatory 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 equipment makers we model each product line separately and add a regulatory milestone schedule. Related reading: the healthcare and medical business plan case study shows a finished healthcare plan.

Frequently Asked Questions

Useful Links & Resources

• Contact lens manufacturer business plan template
• Eye care clinic business plan template
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