⚠ The Same Design Choice Is What Attracts a Right-to-Repair ArgumentModerate threat

Intuitive Surgical (ISRG) — threat to the moat

A device that refuses to work after a set count is a device somebody will argue should keep working.

A firmware lock on the useful life of a surgical instrument sits precisely where two live policy arguments meet: hospital cost pressure and right-to-repair.

What a right-to-repair rule would reachInstruments and accessories, use-limited$6,018.9MService, performed only by Intuitive$1,572.1MToll per procedure$1,825Precedent Intuitive set itself, on IonFive uses raised to eightThe two lines a repair or reprocessing rule would touch are 75% of 2025 revenue.
Intuitive has already proved that the original count was not the only safe one. That argument is now available to everybody else.

The clinical justification is strong and Intuitive states it — the count exists "to help ensure that its performance meets specifications during each procedure"1. A wristed instrument that fails mid-case is a patient-safety event, and the company rather than the hospital carries the regulatory and legal liability for that.

The counterargument is equally simple: hospitals and third-party reprocessors have argued for years that use limits on surgical devices are set conservatively for commercial as much as clinical reasons, and the FDA has an established framework for reprocessed single-use devices. Intuitive's own Ion extension — five uses to eight, cleared in 2024 and certified in Europe in 20252 — is evidence that the original number was not the only safe one.

There is a second front. Intuitive's systems and instruments are serviced exclusively by Intuitive, and service revenue was $1,572.1 million in 20253. Right-to-repair legislation aimed at medical equipment has been introduced in several American states; the industry has resisted it on safety grounds, so far successfully.

Neither argument is close to prevailing, and neither is going away. The number to watch is instruments and accessories revenue per procedure, roughly $1,825 in 20254. If it drifts down for several years while mix is stable, the use limits are being loosened, whoever is doing the loosening.

References
  1. ReportedThe clinical justification is strong and Intuitive states it — the count exists "to help ensure that its performance meets specifications during each procedure".
    Intuitive Surgical Form 10-K, fiscal year ended December 31, 2025 - Item 1 Business (the da Vinci and Ion platforms, instruments with a use count enforced in the instrument itself, training pathways and SimNow, enabling technologies, manufacturing sites, employees by function, and the seasonality of benign procedures) — FY2025 · publ. February 3, 2026 · source ↗
  2. ReportedIntuitive's own Ion extension — five uses to eight, cleared in 2024 and certified in Europe in 2025 — is evidence that the original number was not the only safe one.
    Intuitive Surgical Form 10-K, fiscal year ended December 31, 2025 - Item 1 Business: competition, intellectual property and government regulation (the fourteen named competitors, more than 5,600 patents in force and 2,500 pending, Class II devices cleared under section 510(k) on substantial equivalence, special controls, field actions and recalls) — FY2025 · publ. February 3, 2026 · source ↗
  3. ReportedIntuitive's systems and instruments are serviced exclusively by Intuitive, and service revenue was $1,572.1 million in 2025.
    Intuitive Surgical Form 10-K, fiscal year ended December 31, 2025 - Item 7 MD&A, results of operations (instruments and accessories $6,018.9M, systems $2,473.7M, service $1,572.1M, recurring revenue $8,465.3M, gross margin 66.0%, operating income $2,945.5M, average selling price, lease revenue recognition, and the discussion of procedure categories) — FY2025 · publ. February 3, 2026 · source ↗
  4. Moat Explorer calcThe number to watch is instruments and accessories revenue per procedure, roughly $1,825 in 2025.
    Moat Explorer calculation - arithmetic on figures reported in Intuitive's Form 10-K and Form 10-Q: instruments and accessories of $6,018.9M over 3,153,000 da Vinci plus 144,100 Ion procedures ($1,825 a procedure), service revenue of $1,572.1M over the installed base (about $134,000 a system), variable lease revenue of $531M over 1,810 usage-based systems (about $293,000), procedures over the average installed base (about 300 a system), each revenue line as a share of the $10,064.7M total, and US general surgery as a share of US procedures — FY2025 · publ. September 2026 · source ↗
Sources
Generated September 23, 2026