What changed, what needs review

Medicare cannot reach an admitted patient, so a camera or sensor monitoring an inpatient ward is funded through state virtual-care budgets, not a national line, exactly as the pricing authority itself describes.

Australia · Care.ai · Q1 Current reimbursement

There is no published Australian price for avoided sitter-hours or falls, so any ambient-monitoring payback has to be modelled from the national efficient price of A$7,418 per activity unit or borrowed from overseas vendor case studies, neither of which is a measured Australian number.

Australia · Care.ai · Q2 Adequacy of payment

A ceiling camera inferring a patient's condition needs express admission consent under Australian privacy law, because unlike Japan there is no exception for sensitive information visually obvious from filming.

Australia · Care.ai · Q3 Policy drivers

State health procurement owns the budget for a camera or sensing purchase exactly as it would for any Smart Care technology, and every state sets its own threshold.

Australia · Care.ai · Q4 Bundled or separate

No ARTG entry exists for care.ai, and the open question is not whether to file but whether the product reads as Class IIa routine-check monitoring or Class IIb continuous surveillance of vital physiological parameters, a distinction that does not arise for Vocera's radio-equipment gate at all.

Australia · Care.ai · Q5 Readiness to obtain outcome

63,182 hospitalisations a year involve a harmful fall, the exact outcome care.ai's fall-detection and virtual-sitting features target, and Australia is the only one of these markets that publishes a national rate for it.

Australia · Care.ai · Q6 Prevalence / burden

67,300 public beds and 34,300 private beds is the denominator, but care.ai sells per monitored room, and the one comparable Australian deployment (a clinical-communication rollout, not ambient monitoring) ran at 2.4 devices per bed, a reminder the unit of sale is not the bed itself.

Australia · Care.ai · Q7 Annual volume

Care.ai's actual competitors, AvaSure and Artisight, are researched absent from Australia, and Alcidion, sometimes named alongside them, is a patient-flow and clinical-coding vendor, not an ambient-camera one, so the ambient-monitoring lane in Australia is genuinely open rather than contested.

Australia · Care.ai · Q8 Technology in market

Australia's MBS pays for shoulder replacement under eight dedicated item numbers, but no separate MBS item exists for computer-assisted, navigated, or robotic-assisted shoulder surgery, so Blueprint/Mako Shoulder use is not separately reimbursed.

Australia · Mako Blueprint / Shoulder · Q1 Current reimbursement

Whether using Blueprint/Mako Shoulder increases payment in Australia is explicitly undetermined - the academic literature on the relevant Prostheses List reform says its effect on shoulder-technology access and pricing is 'yet to be determined.'

Australia · Mako Blueprint / Shoulder · Q2 Adequacy of payment

In Australia the decision sits with the Department of Health and Aged Care's Prostheses List reform process and the Prostheses List Advisory Committee (PLAC), not a robotic-specific pathway.

Australia · Mako Blueprint / Shoulder · Q3 Policy drivers

Shoulder implants sit inside the Prostheses List's generic 'Specialist Orthopaedic > Upper limb' subcategory (unlike hip and knee, which have dedicated categories), and technology (robotic/navigation) has no confirmed separate listing pathway.

Australia · Mako Blueprint / Shoulder · Q4 Bundled or separate

Stryker's Blueprint Mixed Reality System is TGA-registered in Australia (ARTG 441154, active since 15 Feb 2024) for shoulder prosthesis surgery, and a first Australian clinical trial of Mako for shoulder is now recruiting, so comparative outcome evidence does not yet exist locally.

Australia · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

Total shoulder replacement use in Australia rose 242% from 2009 to 2019 and is forecast to rise a further 43% to 567% by 2035, with associated system cost projected between AUD 312.6 million and AUD 1.46 billion.

Australia · Mako Blueprint / Shoulder · Q6 Prevalence / burden

The AOANJRR recorded 11,795 additional shoulder replacements in Australia in 2024, up 6.9% on 2023, taking the cumulative registry total to 107,581 shoulder procedures since inception.

Australia · Mako Blueprint / Shoulder · Q7 Annual volume

Zimmer Biomet's ROSA Shoulder System is TGA-registered in Australia (ARTG 449788, active since 28 May 2024) for total shoulder arthroplasty, a direct competitor to Mako Blueprint/Shoulder already present in the same market.

Australia · Mako Blueprint / Shoulder · Q8 Technology in market

Prevalence is large, well measured and not the constraint on volume.

Australia · Mako full platform · Q6 Prevalence / burden

There is nothing to reimburse, because there is nothing on the Australian market.

Australia · Mako RPS · Q1 Current reimbursement

No Australian cost offset can be computed, because there is no Australian price and no Australian case.

Australia · Mako RPS · Q2 Adequacy of payment

This is an entry gate, not a dossier gate: the ARTG comes first, and Australia's null is the weakest of the six.

Australia · Mako RPS · Q5 Readiness to obtain outcome

Same population as full Mako. RPS does not change the size of the Australian knee market.

Australia · Mako RPS · Q6 Prevalence / burden

Different competitive set from full Mako: RPS enters the handheld segment, where CORI has held an ARTG listing since July 2021.

Australia · Mako RPS · Q8 Technology in market

The funding route is a hospital-redevelopment trade package, and one competitor has already used it: Hills Health Solutions sold a branded 'smart hospital room' nurse-call platform into the new Footscray Hospital for more than A$7 million across 500-plus beds.

Australia · SmartHospital · Q1 Current reimbursement

There is no published Australian payback figure for the SmartHospital bundle: two state capital budgets naming billions of dollars in hospital construction spending mention the word 'robot' zero times, and the one branded platform sale on record (Footscray) is reported as a capex commitment with no return figure attached.

Australia · SmartHospital · Q2 Adequacy of payment

The binding constraint is structural absence from the trade-package channel itself, not a regulatory block: Ascom already holds five ARTG device entries and Alcidion holds one, so the entry gate is passable, but Stryker's SmartHospital, Vocera and care.ai brands have won zero named contract-award notices anywhere in the NSW public procurement register.

Australia · SmartHospital · Q3 Policy drivers

The budget owner for a platform sale is the hospital-redevelopment project office, not a clinical department: Health Infrastructure NSW, Queensland's health capital works program and Health Infrastructure Victoria each let named trade packages years ahead of the ward that will use them.

Australia · SmartHospital · Q4 Bundled or separate

The entry gate is a union and only one part of it has been tested: the TGA ARTG device register was searched for the exact term 'SmartHospital' itself and returned zero entries, alongside zero for care.ai and the whole Vocera family, but Australia runs no searchable radio-equipment register equivalent to Japan's TELEC or Korea's RRA, so the wireless-badge half of the union is not researched, and the construction-tender half (see Q3/Q4) is the gate that actually appears to bind.

Australia · SmartHospital · Q5 Readiness to obtain outcome

The operational driver is the same nursing and falls picture the care.ai/Vocera contexts already carry, but the platform-specific addition is that Australia is building new hospital capacity at multi-billion-dollar scale right now, which is the natural insertion point for a day-one platform fitout rather than a ward retrofit.

Australia · SmartHospital · Q6 Prevalence / burden

The addressable base for a platform is not the 704 public and 633 private hospitals the component contexts size Australia on; it is a short, named list of hospital redevelopments currently in the capital works pipeline, and no state publishes a count of how many of those are still open to a platform trade package.

Australia · SmartHospital · Q7 Annual volume

Two incumbents actually hold the Australian platform-adjacent channel, Rauland and Hills Health Solutions, plus a systems integrator, Acetek, that has installed connected infrastructure in more than 100 NSW and Canberra hospitals; the vendors most associated with the category internationally, Ascom, Vocera, Hillrom and Austco, hold zero named NSW public contract awards between them.

Australia · SmartHospital · Q8 Technology in market

NSW Health classifies a Vocera deployment as ICT spend, routed above $150,000 to eHealth NSW under the SCM0020 scheme, not as a clinical service seeking a Medicare item.

Australia · Vocera · Q1 Current reimbursement

Sydney LHD's own trial reports emergency and ICU call reach-time falling from 70 seconds to 15 seconds; that is the real Vocera effect size, not a bed-day substitution model.

Australia · Vocera · Q2 Adequacy of payment

The binding constraint is incumbency, not regulation: nurse-call systems run 10-to-15-year replacement cycles, and Ascom's own executives name vendor-neutral integration with that installed base as the reason customers choose them.

Australia · Vocera · Q3 Policy drivers

In NSW the sign-off sits with eHealth NSW under the SCM0020 ICT scheme, not with a clinical-funding committee, because the state itself classifies clinical communication as ICT.

Australia · Vocera · Q4 Bundled or separate

The TGA has nothing to say about Vocera because a comms badge is not a medical device; the radio gate that actually applies is already self-declared met under ACMA and Radio Spectrum Management.

Australia · Vocera · Q5 Readiness to obtain outcome

A 70,707 FTE nursing gap by 2035 is the same shortfall care.ai cites; what is Vocera-specific is the reach-time evidence showing where nurses' time is actually lost to call and response delay.

Australia · Vocera · Q6 Prevalence / burden

704 public and 633 private hospitals is the shared denominator, but Vocera is sold per device and per staff member, not per bed: 850 devices across 6,000 staff at a 350-bed hospital.

Australia · Vocera · Q7 Annual volume

Ascom, Rauland and Austco hold the field; Vocera returns a genuine zero against Rauland's 18 NSW contract awards in the same search.

Australia · Vocera · Q8 Technology in market

India's national scheme pays a fixed all-in package for the admission, so a monitoring platform is a cost inside that package rather than a line item, exactly as for any Smart Care technology, but this is also the market where the category is already proven at scale by a domestic rival.

India · Care.ai · Q1 Current reimbursement

Length of stay is the only lever inside a fixed package, and Dozee's own claimed effect, a 40 per cent reduction in nurse workload and detection 6-8 hours faster than manual checks, is the nearest category-specific comparator, though it is a vendor claim rather than a measured Indian study.

India · Care.ai · Q2 Adequacy of payment

Data-protection law is unresearched and its dates unconfirmed, but the sourced cyber-security layer is severe and camera-specific in effect: system logs, which for an always-on ambient sensor are voluminous, must be retained in-country for 180 days with breach reporting inside six hours.

India · Care.ai · Q3 Policy drivers

Foreign suppliers are barred from central tenders below Rs 200 crore, so the real buyer is the private hospital group, which purchases with its own capital outside any procurement regime, exactly as for any Smart Care technology.

India · Care.ai · Q4 Bundled or separate

No CDSCO registration exists for care.ai, and unlike Korea or Singapore this is the market where the first question is not whether it is registered but whether ambient camera-AI needs to be a regulated device at all: no source in this file classifies the category either way.

India · Care.ai · Q5 Readiness to obtain outcome

18.67 per cent of sanctioned public nursing posts sit vacant, the operational number an Indian hospital administrator will recognise, though it is public-sector only and six years old, leaving the private buyer (the realistic one) undescribed by it.

India · Care.ai · Q6 Prevalence / burden

840,455 government beds is a floor, not a total, and Apollo and Max's own build programmes alone (4,300 and roughly 4,500 new beds respectively) are of the same order as several entire national hospital estates in this file, making group-level capacity data the only usable India denominator.

India · Care.ai · Q7 Annual volume

Dozee, an Indian contactless monitoring vendor selling directly into care.ai's category, states 200+ hospitals and 15.5K+ beds on its own current homepage, materially lower than the 280-380+ hospital figures circulating in press and investor material, while care.ai holds zero public India footprint after a named sweep.

India · Care.ai · Q8 Technology in market

India's Central Government Health Scheme (CGHS) reimburses 'Total Shoulder Joint Replacement (Unilateral)' as a fixed package (Rs 1,29,000 at the top tier), with the implant priced/reimbursed as a distinct line item, not folded silently into the procedure fee.

India · Mako Blueprint / Shoulder · Q1 Current reimbursement

Payment does not increase for robotic/navigation-assisted shoulder arthroplasty under CGHS - the current official rate schedule contains no robotic or navigation billing code anywhere.

India · Mako Blueprint / Shoulder · Q2 Adequacy of payment

For central government employees CGHS (Ministry of Health & Family Welfare) is the rate-setting body for shoulder arthroplasty; for the broader population it is the National Health Authority via PM-JAY Health Benefit Packages - India has no ACE-equivalent clinical-effectiveness gatekeeper for this technology.

India · Mako Blueprint / Shoulder · Q3 Policy drivers

Under CGHS, shoulder replacement sits as a bundled procedure package with the implant reimbursed as a separate ceiling-rated or actual-invoice item; the NPPA implant price-ceiling regime that exists for knee implants does not extend to shoulder implants.

India · Mako Blueprint / Shoulder · Q4 Bundled or separate

CDSCO's import-licence register confirms Blueprint planning software and the full Tornier Perform shoulder implant range are licensed for import into India, while the Mako robotic system's Indian licence - like Singapore's - is scoped to knee/hip only, with no shoulder indication.

India · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

An India-specific 2025 study puts asymptomatic rotator-cuff-tear prevalence at 21.1% among Indian patients over 40, giving a proxy figure for rotator-cuff-arthropathy-driven shoulder-arthroplasty demand in the absence of dedicated ICMR/National Health Profile shoulder-OA data.

India · Mako Blueprint / Shoulder · Q6 Prevalence / burden

India's one orthopaedic-society registry, the (voluntary) Indian Joint Registry run under IOA auspices, explicitly covers only hip and knee arthroplasty - shoulder arthroplasty is not tracked, so no credible national shoulder-arthroplasty volume figure exists.

India · Mako Blueprint / Shoulder · Q7 Annual volume

Zimmer Biomet's Signature ONE shoulder planning system is CDSCO-licensed for import into India as a direct Blueprint competitor; ROSA Shoulder, Arthrex VIP, Medacta NextAR and DePuy/Exactech shoulder-planning equivalents are not found on the same register.

India · Mako Blueprint / Shoulder · Q8 Technology in market

Full Mako is already commercial in the premium private tier. The deferral applied to Mako RPS, not to this.

India · Mako full platform · Q5 Readiness to obtain outcome

India is the one market where Mako is not the leader: fourth of six on a 290-unit base led by a domestic partnership.

India · Mako full platform · Q8 Technology in market

No disclosed registration, and no reimbursement pathway to pursue even after one.

India · Mako RPS · Q1 Current reimbursement

No Indian cost offset exists, and Indian procedure economics are the reason this product was deferred here before.

India · Mako RPS · Q2 Adequacy of payment

The lever is an import licence with mandatory clinical evaluation data, and there is no funding lever behind it.

India · Mako RPS · Q3 Policy drivers

Entry gate, not dossier gate, and India's evidence infrastructure would not support a dossier anyway.

India · Mako RPS · Q5 Readiness to obtain outcome

Roughly 200,000 joint replacements a year, on a competitor's 2021 estimate, because India has no comprehensive registry.

India · Mako RPS · Q7 Annual volume

Data law is the constraint and the 13 May 2027 date is now confirmed at the gazette.

India · Smart Care · Q3 Policy drivers

No registration found, and whether this class is even a regulated device in India is unsettled.

India · Smart Care · Q5 Readiness to obtain outcome

India's central government transparency portal proves the platform has no public funding route at all: a six-year sweep of every award-of-contract record finds zero civilian nurse-call, zero hospital-information-system, zero telemedicine and only two medical robots, both single-bid, both at AIIMS, so the money is entirely private hospital capital.

India · SmartHospital · Q1 Current reimbursement

No platform-level payback exists in India, and the only real budget signals are Apollo's and Max's undifferentiated build-programme envelopes, Rs 8,000 crore for 4,300 beds and a path to roughly 9,500 beds by 2028, neither of which discloses a technology line to price the platform against.

India · SmartHospital · Q2 Adequacy of payment

The binding constraint is the same data-residency and breach-notification regime the care.ai and Vocera contexts already carry, but a bundled platform compounds it: three simultaneous data streams, badge audio, ambient camera feed and connected-bed telemetry, all have to be logged in-country for 180 days rather than one.

India · SmartHospital · Q3 Policy drivers

The private hospital group is the budget owner, confirmed twice over: procurement law bars foreign suppliers from central tenders below Rs 200 crore and does not bind the state governments that run most public hospitals, and the government's own award record independently shows zero civilian purchases in every one of the platform's component categories across six years.

India · SmartHospital · Q4 Bundled or separate

The union of gates in India has more open questions than closed ones: no CDSCO filing was found for care.ai and whether the product class is even a regulated device is unsettled, Vocera's radio type-approval position with India's telecom regulator has never been checked in any pass, and the CERT-In hosting requirement is the one part of the union that is actually settled.

India · SmartHospital · Q5 Readiness to obtain outcome

The operational driver is the same vacancy rate the care.ai and Vocera contexts already use, 18.67 percent of sanctioned public nursing posts vacant, and it applies to the platform exactly as it applies to either component since it is a national workforce statistic rather than a product-specific one.

India · SmartHospital · Q6 Prevalence / burden

The addressable base is the same private-capital build programmes the component contexts already name, Apollo's 4,300 new beds and Max's path to roughly 9,500, corroborated independently by the AOC sweep showing the government estate is not a meaningful counterweight: only two robots and zero smart-ward-category purchases centrally in six years.

India · SmartHospital · Q7 Annual volume

No platform incumbent exists in India: Dozee's installed base, now corrected to 200-plus hospitals and 15,500-plus beds after its own site quietly revised down from earlier 280-plus claims, is a single-component ambient-monitoring position, not a bundle, and no source in this pass names an Indian hospital group or vendor combining communications, ambient monitoring and connected-bed infrastructure into one offer the way Samsung SDS and ezCaretech now do in Korea.

India · SmartHospital · Q8 Technology in market

India pays for the admission as a fixed package with no separate line for anything inside it, the same mechanism that blocks care.ai; India's central procurement register shows nurse call has never been bought as a distinct hospital purchase in six years.

India · Vocera · Q1 Current reimbursement

No Indian payback figure exists for Vocera; the only sizing is a US$52.87 million (2025) nurse-call market naming Ascom, Hillrom, Honeywell and Austco, none with an evidenced Indian deployment site.

India · Vocera · Q2 Adequacy of payment

CERT-In's six-hour breach-reporting clock and 180-day in-country log residency requirement are named as binding a Vocera tenancy exactly as much as a care.ai one.

India · Vocera · Q3 Policy drivers

Foreign suppliers are barred from central tenders below Rs 200 crore, and India's own procurement data shows nurse call has been bought exclusively by military engineers as a building-works line, never by a civilian hospital administrator.

India · Vocera · Q4 Bundled or separate

No WPC radio type approval was found for Vocera in India, and the gap is now corroborated rather than merely unsearched: Vocera's own current regulatory guide, which names eight other jurisdictions, is silent on India entirely.

India · Vocera · Q5 Readiness to obtain outcome

18.67 per cent of sanctioned public nursing posts sit vacant, the same statistic care.ai cites; no Vocera-specific communication-burden figure exists for India.

India · Vocera · Q6 Prevalence / burden

840,455 government beds is a floor, not a total, shared with care.ai; Apollo and Max's private build programmes alone add more beds than several other markets in this portfolio own in total.

India · Vocera · Q7 Annual volume

No incumbent is established for Vocera's own category in India: the four analyst-named nurse-call vendors have no evidenced site, and Vocera's own visible Indian presence is a Bengaluru engineering hub building the product, not selling it.

India · Vocera · Q8 Technology in market

Japan funds care.ai's category through two separate levers, a hospital nurse-staffing relief that names monitoring cameras and sensors as one of three required legs, and an aged-care subsidy, 生産性向上推進体制加算, that pays for 見守り機器 directly, and the sector's own numbers show real money already moving on the second one.

Japan · Care.ai · Q1 Current reimbursement

Japan's aged-care sector shows exactly what happens to ambient-monitoring revenue when subsidy allocation tightens even for the category leader: Econavista's own filing attributes a 16.2 per cent revenue decline to falling subsidy award rates, not competition, the sharpest demand-rationing evidence in this file.

Japan · Care.ai · Q2 Adequacy of payment

Japanese privacy law contains a camera-specific exception that helps care.ai in a way no other market in this file does: sensitive information visually obvious from filming is exempt from consent, though the exemption stops exactly where a deterioration or fall-risk model starts inferring beyond what a person could see.

Japan · Care.ai · Q3 Policy drivers

There is nothing to unbundle because nothing is bundled: the hospital's own capital and subsidy budget buys care.ai exactly as it buys Vocera, since neither has a fee-schedule code and the medtech procurement code treats a Smart Care purchase as one acquisition regardless of which of the three ICT legs it fills.

Japan · Care.ai · Q4 Bundled or separate

PMDA returns nil for care.ai, and unlike Vocera's radio-certification gate, care.ai's Japanese question is a SaMD classification question the industry itself is not sure needs answering: the sector's own position paper calls monitoring/command-centre systems non-medical-device software producing no direct patient benefit.

Japan · Care.ai · Q5 Readiness to obtain outcome

Japan publishes no national falls rate, so care.ai's usual operational hook is unavailable here; the honest operational argument is the FY2026 overtime condition itself, which turns a national nursing shortfall into a ward-level purchase criterion with a number attached.

Japan · Care.ai · Q6 Prevalence / burden

1,394 hospitals of 300+ beds is the reachable Japanese base out of 8,060 total, the same tier that also happens to hold the electronic-record integration density (91.2 per cent of 400+ bed hospitals) an ambient platform needs to be useful.

Japan · Care.ai · Q7 Annual volume

Ambient sensing in Japan is dominated by two elder-care vendors, Paramount Bed's 眠りSCAN (187,000 cumulative units, ~7,000 facilities) and Konica Minolta's HitomeQ (19,000+ units, per the vendor's own site), neither with an evidenced acute-hospital case study despite marketing language naming hospitals as a target, so care.ai's acute-ward lane is empty even though the adjacent long-term-care lane is thoroughly won.

Japan · Care.ai · Q8 Technology in market

Conventional shoulder arthroplasty (TSA/rTSA) is reimbursed in Japan's national fee schedule under K082 人工肩関節置換術, but no Mako Shoulder/Blueprint-specific code exists because PMDA has not approved a shoulder indication.

Japan · Mako Blueprint / Shoulder · Q1 Current reimbursement

No robotic/navigated payment premium exists for shoulder arthroplasty in Japan because Mako Shoulder is unapproved - but Japan's fee system does create a distinct, higher-paying code for robot-assisted arthroplasty once a device is cleared, as shown for hip.

Japan · Mako Blueprint / Shoulder · Q2 Adequacy of payment

Japan's chuikyo (中央社会保険医療協議会)/MHLW biennial 診療報酬改定 cycle is the body that decided the existing hip robot-assist code and would decide any future Mako Shoulder coverage.

Japan · Mako Blueprint / Shoulder · Q3 Policy drivers

Japan keeps the shoulder arthroplasty procedure fee (K082 K-code) and the implant cost separate: implants are individually priced under 材料価格基準/特定保険医療材料, with reverse-specific components (baseplate, glenosphere, humeral stem) each carrying their own reimbursement price.

Japan · Mako Blueprint / Shoulder · Q4 Bundled or separate

PMDA has NOT approved any shoulder indication for Mako/Blueprint - the current approval (22900BZX00325000, 8th-revision package insert, Aug 2023) covers only THA, TKA, and PKA, and the word 肩 appears only once, describing the robot arm's own mechanical 'elbow or shoulder' joint.

Japan · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

No quantified national prevalence figure for shoulder OA or rotator-cuff-tear arthropathy in Japan could be independently verified from a directly-opened source.

Japan · Mako Blueprint / Shoulder · Q6 Prevalence / burden

Japan's JOANR/JSRA joint registry reports 7,610 total shoulder arthroplasties for FY2024 (surgeries April 2024-March 2025): 6,855 reverse TSA (6,608 primary + 247 revision) and 755 anatomical TSA (746 primary + 9 revision).

Japan · Mako Blueprint / Shoulder · Q7 Annual volume

At least two Mako-Blueprint competitor shoulder planning/navigation systems are confirmed present in Japan: Medacta's NextAR Shoulder (MHLW-approved, first cases Jan 2023) and Exactech's ExactechGPS navigation platform (launched Sept 2020); Zimmer Biomet's reverse shoulder implant is separately approved (2014) without confirmed navigation/robotics.

Japan · Mako Blueprint / Shoulder · Q8 Technology in market

Population burden is large and is not the constraint on adoption.

Japan · Mako full platform · Q6 Prevalence / burden

Nothing to reimburse, but the code that would pay is written in a way that does not exclude a handheld.

Japan · Mako RPS · Q1 Current reimbursement

No Japanese cost offset exists, and two structural facts would bound one if it did.

Japan · Mako RPS · Q2 Adequacy of payment

Entry gate, not dossier gate. Japan's answer for full Mako was a won submission; for RPS there is nothing to submit yet.

Japan · Mako RPS · Q5 Readiness to obtain outcome

Same population as full Mako, and the same unresolved citation. RPS changes neither.

Japan · Mako RPS · Q6 Prevalence / burden

Different segment from full Mako: the image-free handheld field, which in Japan is barely measured and barely occupied.

Japan · Mako RPS · Q8 Technology in market

A crowded domestic field with no acute-care ambient incumbent, and the two layers that are audited are both under strain.

Japan · Smart Care · Q8 Technology in market

Japan pays for the platform by relaxing nurse staffing, and only the platform triggers it: the FY2026 rule requires monitoring cameras and sensors, voice-input nursing records, and hands-free clinician communication running together before a ward may staff at 90 percent of the required nurse headcount with no deduction.

Japan · SmartHospital · Q1 Current reimbursement

The payback is released nursing hours, not revenue, and unlike either component alone it can only be realised by a deployment that clears all three categories: no Japanese cost study prices what one relieved nursing post is worth, and the capital-carrying tier able to fund the attempt is a counted 1,394 hospitals of 300 beds or more.

Japan · SmartHospital · Q2 Adequacy of payment

The binding constraint is the all-or-nothing structure of the funding rule combined with a per-vendor security-certification gate, and Japan's procurement law happens to reward exactly the kind of integrated bundle a single-vendor platform can offer, above a threshold this file cannot yet confirm applies to most Japanese hospitals.

Japan · SmartHospital · Q3 Policy drivers

The budget owner is the hospital's own capital and subsidy budget, with a published tender required above 20,000,000 yen and mandatory overall-value scoring above 77,000,000 yen, but whether that national-government procurement code even reaches the private medical corporations that hold most Japanese hospitals is unresolved.

Japan · SmartHospital · Q4 Bundled or separate

Nothing is filed and nothing is certified for any component: PMDA returns no entry for care.ai, SmartHospital, Vocera, Smartbadge or Engage, and MIC/TELEC returns no radio type certification for Vocera, which in Japan is not a paperwork gap but a legal bar, Wi-Fi badges cannot lawfully transmit without it.

Japan · SmartHospital · Q5 Readiness to obtain outcome

The operational driver is the same nursing shortfall the care.ai and Vocera contexts already carry (61,000 to 273,000 personnel short of ministry demand projections), and the platform-specific link is that the FY2026 rule's sub-10-hour overtime condition turns that national statistic into a ward-level purchase criterion.

Japan · SmartHospital · Q6 Prevalence / burden

The addressable base is the same counted tier the component contexts use, 1,394 hospitals of 300 beds or more out of 8,060, but Japan's own capital-spending outlook cuts against it: the country's leading care-sensing vendor tells its own investors to expect continued hospital capital-spending restraint, which is a headwind this bundle does not face in Australia or Singapore's construction-driven channels.

Japan · SmartHospital · Q7 Annual volume

No single incumbent holds the Japanese platform layer; the three categories the funding rule requires sit with three separate, unconnected vendors, a struggling nurse-call duopoly member, a shrinking ambient-sensing division, and a systems-integration channel that has just gone private and stopped disclosing its numbers.

Japan · SmartHospital · Q8 Technology in market

Vocera is explicitly one of three legs of Japan's FY2026 staffing-relief bundle, hands-free clinician communication, but Vocera alone cannot unlock it; the other two legs belong to care.ai.

Japan · Vocera · Q1 Current reimbursement

The nurse-call incumbent Aiphone is running at half its planned margin, the clearest Japanese price signal in this category, and only about 1,394 hospitals are large enough to carry the capital either way.

Japan · Vocera · Q2 Adequacy of payment

The badge cannot legally transmit in Japan today: no TELEC radio type certification exists, which is a harder constraint than the vendor-security certification that gates the software side.

Japan · Vocera · Q3 Policy drivers

Above the national medtech procurement threshold of 20,000,000 yen a Vocera sale becomes a 40-day published tender, but small deployments and pilots have a named low-value carve-out this document explicitly flags for Vocera trials.

Japan · Vocera · Q4 Bundled or separate

Nothing is filed and nothing needs to be with PMDA; the actual gate is MIC/TELEC radio certification, which is also zero.

Japan · Vocera · Q5 Readiness to obtain outcome

A shortfall of 61,000 to 273,000 nursing personnel is the shared statistic; the Vocera-specific driver is Japan's 2023 PHS network shutdown, which is actively pushing hospitals toward smartphone- and Teams-based communication.

Japan · Vocera · Q6 Prevalence / burden

8,060 hospitals and 1,394 of 300+ beds is the shared denominator; EMR adoption reaching 91.2% at 400-bed-plus hospitals matters equally for a badge that must integrate with the record system.

Japan · Vocera · Q7 Annual volume

Allm's Join is a reimbursed software-as-a-medical-device clinical-communication product already in more than a thousand Japanese hospitals; Vocera has no visible install base and no Japanese legal entity.

Japan · Vocera · Q8 Technology in market

Korea's route for care.ai's exact category is non-covered use for three to four years under the 선진입 early-entry track, and it is not a theoretical route: VUNO's DeepCARS has run 비급여 since August 2022 and its waiver only ended 2026-03-05, with formal 급여 assessment targeted for Q4 2026 and coverage targeted early 2027, a roughly 4.5-year non-covered runway for the category's own bellwether product.

South Korea · Care.ai · Q1 Current reimbursement

Willingness to pay for care.ai's exact category is demonstrated at scale by four Korean vendors, VUNO at more than 48,000 beds, AITRICS at roughly 45,000, Seers at roughly 12,000 and Puzzle AI at roughly 170 hospitals, and the billing basis itself, roughly 7,000 KRW per bed per day non-covered, is a per-inpatient-day rate rather than a per-use fee, which is the shape any future covered price is expected to follow (5,000-6,000 KRW discussed).

South Korea · Care.ai · Q2 Adequacy of payment

A Korean inpatient ward is legally a non-public place, so every person in a camera's frame must individually consent, and audio recording by a fixed camera is a criminal offence, two constraints that fall on care.ai specifically and have no equivalent for a communications badge.

South Korea · Care.ai · Q3 Policy drivers

The hospital pays out of its own operating or capital budget, and for a public buyer an imported platform crosses into central procurement at USD 200,000, low enough that most multi-ward deployments go through the Public Procurement Service rather than the hospital directly.

South Korea · Care.ai · Q4 Bundled or separate

No MFDS SaMD filing exists for care.ai, and the register does return results for this exact product class, VUNO holds at least twelve approvals and Lunit is registered, so the absence is about these products specifically, not a gap in the register's coverage; Vocera's gate is a different regulator (KCC radio approval) entirely.

South Korea · Care.ai · Q5 Readiness to obtain outcome

298,554 working nurses, not the 1.44 million licensed figure, is the honest Korean workforce denominator, and no traceable national falls or deterioration rate exists to give care.ai its own outcome hook.

South Korea · Care.ai · Q6 Prevalence / burden

46,269 tertiary beds is the certification-bound first market, but VUNO and AITRICS already bill across more than 45,000-48,000 beds each, which exceeds the entire tertiary tier, proving the real commercial base for care.ai's category already extends into the 113,563-bed general-hospital tier.

South Korea · Care.ai · Q7 Annual volume

VUNO and AITRICS each hold more Korean beds than the entire tertiary tier, and a domestic camera-ambient entrant (Samsung Meditech) has already shown at a trade exhibition, so the deterioration-monitoring lane is lost and the camera-ambient lane is closing fast; Vocera, by contrast, has no Korean entity at all.

South Korea · Care.ai · Q8 Technology in market

Shoulder arthroplasty is reimbursed in Korea's national fee schedule under 자71 인공관절치환술 (grouped with knee, distinct from hip), but Mako Shoulder/Blueprint is not MFDS-approved, and even Mako's approved hip/knee robotic component currently sits entirely outside insurance coverage as 비급여 (non-covered), billed to patients out-of-pocket.

South Korea · Mako Blueprint / Shoulder · Q1 Current reimbursement

Unlike Japan's insurance-point premium for robot-assisted hip, Korea currently gives no increase in NHI payment for Mako-assisted arthroplasty at all - the robotic component is entirely non-reimbursed and billed as a private out-of-pocket add-on, with formal HIRA coverage review only starting April 2026.

South Korea · Mako Blueprint / Shoulder · Q2 Adequacy of payment

Korea's three-step pathway - MFDS device approval, then NECA's 신의료기술평가 (New Health Technology Assessment), then HIRA/MOHW coverage-and-price listing - is the mechanism that would decide any future Mako Shoulder reimbursement or premium.

South Korea · Mako Blueprint / Shoulder · Q3 Policy drivers

Korea keeps the shoulder arthroplasty procedure fee (자71 행위료), implant cost (치료재료, separately MFDS-listed and priced), and any new-technology component (신의료기술평가 gate) as three distinct payment tracks - with the robotic technology track currently unresolved (비급여) rather than folded into either of the other two.

South Korea · Mako Blueprint / Shoulder · Q4 Bundled or separate

MFDS has NOT approved Mako for any shoulder indication in Korea - every corroborating source (company site, trade press 2018-2026, MFDS-indexed approval/recall records) describes Mako in Korea as limited to hip and knee, and Korean clinical shoulder-arthroplasty literature does not mention Stryker/Mako/Blueprint.

South Korea · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

Rotator cuff tear arthropathy is overwhelmingly the driver of shoulder arthroplasty in Korea - HIRA-cited reporting states over 95% of shoulder arthroplasty surgeries stem from arthritis caused by neglected rotator cuff tears.

South Korea · Mako Blueprint / Shoulder · Q6 Prevalence / burden

HIRA claims data show Korean shoulder arthroplasty volume grew more than sevenfold in a decade, from 511 cases in 2010 to 3,961 cases in 2020.

South Korea · Mako Blueprint / Shoulder · Q7 Annual volume

Curexo (a domestic Korean robotics/medtech firm) acquired exclusive Korean distribution rights to Exactech's shoulder implants in March 2025 - but with no navigation/planning software (ExactechGPS/Predict+) mentioned as part of the deal; no evidence was found of Arthrex VIP, Zimmer Signature ONE/ROSA Shoulder, Medacta NextAR, or DePuy TruMatch being present in Korea.

South Korea · Mako Blueprint / Shoulder · Q8 Technology in market

Commercially proven without reimbursement: one hospital alone reports 14,373 cumulative Mako procedures.

South Korea · Mako full platform · Q5 Readiness to obtain outcome

Korea's domestic challenger is globalising faster than anyone else in the field, from a home market it already sits in.

South Korea · Mako full platform · Q8 Technology in market

No MFDS approval is disclosed, so no Korean reimbursement question arises at all.

South Korea · Mako RPS · Q1 Current reimbursement

No Korean cost offset exists, but the shape of the earn is known: a consumables charge of roughly ₩1.5 to 2.0 million a knee.

South Korea · Mako RPS · Q2 Adequacy of payment

The robot is paid for outside the benefit, and an approved RPS would be paid the same way.

South Korea · Mako RPS · Q4 Bundled or separate

Entry gate, not dossier gate, and the Korean gate has a named fast track behind it.

South Korea · Mako RPS · Q5 Readiness to obtain outcome

Full Mako leads Korea's CT-arm segment. RPS would enter a different segment that Korea does not measure at all.

South Korea · Mako RPS · Q8 Technology in market

VUNO and AITRICS hold the ward with more than 45,000 beds each, and Vocera has no Korean entity of its own.

South Korea · Smart Care · Q8 Technology in market

The platform's real funding route is a hospital information system or systems-integration capital contract, not per-bed non-covered billing: ezCaretech scoped Kangwon National University Hospital's KRW 11.18 billion HIS build as a 'smart-hospital foundation', and Samsung SDS delivered Samsung Medical Center's AI-powered smart hospital rooms in April 2026 the same way.

South Korea · SmartHospital · Q1 Current reimbursement

No platform-level payback exists in Korea: AITRICS and VUNO's 45,000-to-48,000-bed installed bases price a single ambient product each, and citing either as evidence a bundle would sell would be the category-answer-relabelled-as-platform-answer error this brief warns against.

South Korea · SmartHospital · Q2 Adequacy of payment

Bundling raises the stakes rather than lowering them: a combined platform priced as one contract crosses the USD 200,000 foreign-goods threshold that hands the purchase to Korea's central Public Procurement Service, on top of a public-procurement record where every one of the platform's component categories already clears at zero foreign share.

South Korea · SmartHospital · Q3 Policy drivers

The signer differs by route: a per-component sale clears as an operating-budget decision, evidenced at Seongnam Medical Center (KRW 3.81 billion HIS maintenance) and Seobuk Hospital (three-year ezCaretech renewal), while a bundled platform is closer to the facilities or IT-capital budget behind builds like Kangwon National University Hospital's KRW 11.18 billion HIS project.

South Korea · SmartHospital · Q4 Bundled or separate

The union of gates is three deep, not two: MFDS returns zero for care.ai/SmartHospital against a working VUNO/Lunit and Mako positive control, RRA/KCC returns zero for Vocera across all six windows from 2001-2026 against Stryker's own unrelated radio certifications, and compulsory hospital-side information-security certification sits on top of both, untouched by either.

South Korea · SmartHospital · Q5 Readiness to obtain outcome

The operational driver is largely the shared national nursing picture, 298,554 nurses actually working against 1,441,686 licensed, but ezCaretech's own smart-ward announcement names a platform-specific problem inside it: monitor data that is not automatically reaching the record, and deterioration signals that depend on a human noticing them.

South Korea · SmartHospital · Q6 Prevalence / burden

Unlike Australia and Singapore, no Korean hospital-construction or new-build pipeline evidence exists to give the platform a construction-driven denominator; the platform-specific base found instead is incumbency itself, ezCaretech alone already holds 26 per cent of the 46,269-tertiary-bed segment across 93 hospitals.

South Korea · SmartHospital · Q7 Annual volume

Samsung SDS and ezCaretech are the two live platform-shaped incumbents, not AITRICS or VUNO: Samsung SDS delivered Samsung Medical Center's own AI-powered smart hospital rooms in April 2026, and ezCaretech, holding 26 per cent of tertiary hospitals, is explicitly repositioning as a 'healthcare platform company' with platform revenue targeted above 50 per cent of total by FY2030; Vocera holds no Korean legal entity at all.

South Korea · SmartHospital · Q8 Technology in market

Vocera does not go through Korea's non-covered AI-evaluation route at all, because it is not a medical device seeking MFDS registration; its funding route is a straightforward hospital ICT purchase, sized against a nurse-call market worth US$20.45 million in 2025.

South Korea · Vocera · Q1 Current reimbursement

No Korean payback figure exists for Vocera; the demonstrated-willingness-to-pay evidence in this file (AITRICS, VUNO) belongs to AI monitoring vendors on a different funding track entirely.

South Korea · Vocera · Q2 Adequacy of payment

Korea's Communications Secrets Act flatly bans recording a non-public conversation with no consent exception at all, a one-to-ten-year custodial offence, which makes push-to-talk a design requirement rather than a feature choice.

South Korea · Vocera · Q3 Policy drivers

Public buyers must route imported goods above USD 200,000 to the Public Procurement Service, but the compatibility sole-source ground is explicitly the lane for expanding an installed Vocera or care.ai footprint ward by ward.

South Korea · Vocera · Q4 Bundled or separate

Vocera is blocked by a radio regulator, not a device one, and unlike Japan the filing process itself is not unfamiliar to the Korean entity.

South Korea · Vocera · Q5 Readiness to obtain outcome

298,554 working nurses against 1.44 million licensed is the same workforce-denominator question care.ai faces; no communication-specific figure exists to sharpen it for Vocera.

South Korea · Vocera · Q6 Prevalence / burden

46,269 tertiary beds is the shared concentrated first-target tier; Vocera's own sizing convention would run on staff headcount, not beds, though no Korean figure confirms this.

South Korea · Vocera · Q7 Annual volume

Samsung SDS holds smart-room and communications builds through Korea's chaebol systems-integration channel; Vocera has no Korean entity, no Korean-language stack and no radio approval.

South Korea · Vocera · Q8 Technology in market

New Zealand has decided not to fund remote care separately at all, it is absorbed into the existing Attendance unit of measure, so a camera or sensor generates no incremental billable volume however it is used.

New Zealand · Care.ai · Q1 Current reimbursement

Released nursing time is the only payback lever available, and New Zealand's private hospital estate averages just 25.5 beds, structurally too small for a per-room ambient platform to make a business case at all outside the public system.

New Zealand · Care.ai · Q2 Adequacy of payment

A privacy code written almost to the description of ambient inference already exists, and its carve-out misses exactly the part of a camera platform a vendor itself controls.

New Zealand · Care.ai · Q3 Policy drivers

Health New Zealand is a single national buyer across 86 sites, and open advertising is required once a purchase reaches NZ$100,000, a threshold almost any ward-scale sensing deployment clears.

New Zealand · Care.ai · Q4 Bundled or separate

WAND, New Zealand's device register, cannot be read from outside at all, so care.ai's status is unknown rather than absent, and the honest first move is a one-email enquiry, not a market-entry programme.

New Zealand · Care.ai · Q5 Readiness to obtain outcome

82,448 nurses hold a current practising certificate but only 65,717 are OECD-counted as actually practising, and New Zealand publishes no national falls or deterioration baseline for care.ai to point to at all.

New Zealand · Care.ai · Q6 Prevalence / burden

13 public hospitals of 300+ beds hold two thirds of all public capacity, and that short list, not the 12,267-bed national total, is care.ai's realistic New Zealand addressable base.

New Zealand · Care.ai · Q7 Annual volume

The ambient camera layer is empty across all 169 certified premises, public and private, and the country's most technology-forward private operator, which publicises every robot it buys, has never announced anything in this category either.

New Zealand · Care.ai · Q8 Technology in market

New Zealand's dominant private insurer, Southern Cross, explicitly excludes robot-assisted shoulder surgery from cover while approving robot-assisted primary hip and knee replacement - so Blueprint/Mako Shoulder is not reimbursed by the country's largest private payer.

New Zealand · Mako Blueprint / Shoulder · Q1 Current reimbursement

Payment does not increase for Mako Shoulder use in New Zealand in any confirmed sense - the largest private insurer excludes it from cover altogether, yet the first robotic shoulder replacement was already performed in a private hospital in January 2026, indicating the case is being funded outside standard insurance cover (self-pay or another channel), which this pass could not identify.

New Zealand · Mako Blueprint / Shoulder · Q2 Adequacy of payment

New Zealand shoulder-arthroplasty payment is set by two separate non-HTA bodies: ACC (Accident Compensation Corporation) fixes a national bundled price list for accident-related cases, while Southern Cross sets its own coverage rules for private-pay cases - neither runs a technology-specific health technology assessment.

New Zealand · Mako Blueprint / Shoulder · Q3 Policy drivers

ACC's national price schedule bundles procedure and implant into one flat per-code payment for shoulder replacement, with no separate line, code, or price differential anywhere in the schedule for robotic assistance or navigation technology.

New Zealand · Mako Blueprint / Shoulder · Q4 Bundled or separate

Mako Shoulder is already in clinical use in New Zealand (first case 20 Jan 2026, Allevia Hospital Ascot) even though its formal regulatory notification status cannot be independently confirmed, because New Zealand's WAND medical device database has no public search.

New Zealand · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

No New Zealand-specific figure for shoulder osteoarthritis, rotator cuff tear arthropathy, or proximal humerus fracture burden was located in this pass.

New Zealand · Mako Blueprint / Shoulder · Q6 Prevalence / burden

New Zealand recorded 1,779 shoulder arthroplasty procedures in 2024, up 17% on 2023 and 60% over the past two years, with reverse shoulder replacement now 77% of all total shoulder registrations.

New Zealand · Mako Blueprint / Shoulder · Q7 Annual volume

The New Zealand Joint Registry's own form design shows shoulder was excluded from robotic-assisted tracking as recently as the December 2020 form revision, even as Zimmer Biomet's ROSA platform is independently confirmed present in the New Zealand private-hospital market alongside Mako.

New Zealand · Mako Blueprint / Shoulder · Q8 Technology in market

About one in eleven to one in ten adults, with the older one-in-eight figure retired.

New Zealand · Mako full platform · Q6 Prevalence / burden

Adequacy is unassessable twice over: no product in market, and no published rate even for the platforms that are covered.

New Zealand · Mako RPS · Q2 Adequacy of payment

Same population as full Mako: about one in eleven to one in ten adults. RPS does not change it.

New Zealand · Mako RPS · Q6 Prevalence / burden

Alcidion holds the workflow layer. The ambient camera layer is empty across all 169 certified premises, public and private.

New Zealand · Smart Care · Q8 Technology in market

Health NZ is running a live national, multi-capability remote-monitoring procurement rather than paying for this category from an existing budget line: a Remote Patient Monitoring Platform Registration of Interest issued 1 December 2025 asks for interoperable vitals, clinician-patient communication and configurable care plans together, while day-to-day virtual care itself stays folded into the generic Attendance funding code with no separate price.

New Zealand · SmartHospital · Q1 Current reimbursement

There is no New Zealand payback figure at any level, and a platform specifically compounds the funding gap with a scale gap: only 13 of the country's 92 public hospitals hold 300 or more beds, and not one of its 77 private hospitals reaches 200.

New Zealand · SmartHospital · Q2 Adequacy of payment

The binding constraint is that no platform-adjacent vendor has a visible New Zealand procurement footprint at all: the tender ever explicitly titled a clinical communication tool closed with no winner in 2014, and every named platform-adjacent vendor sweep since then has returned the same pattern.

New Zealand · SmartHospital · Q3 Policy drivers

Health NZ is the single national budget owner for any platform sale, because it owns all 86 public hospital sites directly rather than through Australia's eight separate state regimes, and a construction-scale purchase clears a separate, higher NZ$9 million open-advertising threshold from the NZ$100,000 that applies to goods and services.

New Zealand · SmartHospital · Q4 Bundled or separate

New Zealand's device register cannot be searched from outside at all: WAND restricts access to sponsors holding a five-digit Sponsor ID and password, so the entry-gate status of care.ai, SmartHospital, Vocera and its variants is unknown rather than zero, and this file cannot say whether the union of gates is even closed.

New Zealand · SmartHospital · Q5 Readiness to obtain outcome

82,448 nurses hold a current practising certificate, but the OECD's employment-based count is 65,717, a gap between paper supply and ward supply that no monitoring platform can close but that every ward-efficiency argument assumes away.

New Zealand · SmartHospital · Q6 Prevalence / burden

The addressable base for a platform is concentrated in a handful of buildings: only 13 of New Zealand's 92 public hospitals hold 300 or more beds, and a widely repeated NZ$1.88 billion Dunedin Hospital rebuild figure has no primary source anywhere in this engagement's evidence base and should not be used until one is found.

New Zealand · SmartHospital · Q7 Annual volume

Alcidion is the closest thing New Zealand has to a platform incumbent, having won MidCentral DHB's combined hospital operations centre, patient-flow and monitoring solution in 2017, but every other named vendor holds one layer only and Ascom's sole New Zealand trace is as a security-integration subcontractor, not a nurse-call or communications award.

New Zealand · SmartHospital · Q8 Technology in market

Vocera has no New Zealand legal entity and no funding line; it would sell, if at all, through Stryker New Zealand Limited out of a hospital's own capital or ICT budget.

New Zealand · Vocera · Q1 Current reimbursement

No New Zealand payback figure exists for Vocera, and unlike a ward camera platform its unit economics do not depend on hospital scale, so the 25.5-bed average private hospital is not disqualifying the way it is for ambient monitoring.

New Zealand · Vocera · Q2 Adequacy of payment

The Biometric Processing Privacy Code is a camera-inference law and is not obviously Vocera's constraint; the two rules that clearly do bind a badge are IPP3A (indirect collection) and IPP12 (cross-border disclosure).

New Zealand · Vocera · Q3 Policy drivers

New Zealand has run exactly one clinical-communication tender in twelve years, and it failed for lack of a compliant bid; Vocera has zero notices in the national tender register in any field.

New Zealand · Vocera · Q4 Bundled or separate

WAND cannot be read for anyone, but that is a medical-device notification question a badge likely does not raise; the radio side is Vocera's own to answer, and its own regulatory guide already carries a New Zealand-only R-NZ compliance label.

New Zealand · Vocera · Q5 Readiness to obtain outcome

82,448 practising certificates against 65,717 people actually practising is the same gap care.ai cites; no New Zealand-specific communication-burden figure exists to sharpen it for Vocera.

New Zealand · Vocera · Q6 Prevalence / burden

12,267 certified beds across 169 premises is the shared denominator; because Vocera sells per device and per staff member, the 25-bed average private hospital that rules out ambient monitoring does not rule out a badge deployment.

New Zealand · Vocera · Q7 Annual volume

Austco holds New Zealand's visible nurse-call incumbency by default at two district health boards; Vocera, Rauland, Hillrom and Spok are all invisible in the national tender register.

New Zealand · Vocera · Q8 Technology in market

Singapore funds the model of care care.ai would sense inside, MIC@Home, at full inpatient parity, but there is no grant or code for the sensing layer itself, so care.ai enters as a cost inside a funded episode rather than as a separately billable line, exactly as any Smart Care technology would.

Singapore · Care.ai · Q1 Current reimbursement

No Singapore payback figure exists for ambient monitoring specifically, so the best available comparators are the same US vendor case studies care.ai's own competitors publish: AvaSure's claim of a 56 per cent cut in 1:1 sitter hours and Artisight's 52 per cent fall-rate reduction at WellSpan, neither of them Singaporean or independent.

Singapore · Care.ai · Q2 Adequacy of payment

Singapore privacy, AI-governance and cybersecurity law bearing on a camera-based monitoring product is entirely unresearched: a prior account was retracted as fabricated and nothing has replaced it.

Singapore · Care.ai · Q3 Policy drivers

Cluster capital through ALPS Pte Ltd buys a sensing platform exactly as it would any hospital technology; the statutory government-procurement regime does not reach the clusters at all.

Singapore · Care.ai · Q4 Bundled or separate

Singapore's 20,860-row device register returns zero entries not just for care.ai but for the entire ambient camera-AI category, AvaSure, Oxehealth, Artisight, Vayyar and Alcidion included, closing the abridged reliance route to every ambient vendor at once, since that route requires an existing approval from a reference agency that none of them holds.

Singapore · Care.ai · Q5 Readiness to obtain outcome

Singapore's nursing story is managed growth (50,389 registered, past 50,000 for the first time), not crisis, which weakens the workforce-shortage argument other markets use; care.ai's stronger Singapore hook is virtual-bed capacity under MIC@Home, not staffing relief.

Singapore · Care.ai · Q6 Prevalence / burden

12,767 acute beds across roughly 20 hospitals is the smallest, most concentrated base of the three original APAC markets, and 84 per cent of it is public, so a handful of cluster decisions covers most of care.ai's addressable Singapore market.

Singapore · Care.ai · Q7 Annual volume

Note Buddy, an ambient AI scribe built by the clusters themselves on a Microsoft stack, is already live across all three public clusters with 8,500+ users, which is the ambient incumbent care.ai would actually displace or partner with, distinct from Ascom, which holds the clinical-communication and nurse-call layer in every new build.

Singapore · Care.ai · Q8 Technology in market

Singapore's MediShield Life/MediSave scheme reimburses total and reverse shoulder arthroplasty as standard Table of Surgical Procedures (TOSP) items (codes SB714S-SB716S), with no separate line for planning software or robotic guidance.

Singapore · Mako Blueprint / Shoulder · Q1 Current reimbursement

Payment does not increase for robotic/navigation-assisted shoulder arthroplasty in Singapore - no separate or higher-tier TOSP code exists for it.

Singapore · Mako Blueprint / Shoulder · Q2 Adequacy of payment

Two bodies drive Singapore shoulder-arthroplasty payment policy: MOH sets the TOSP fee-band/claim-limit, while the Agency for Care Effectiveness (ACE), with procurement agency ALPS, runs the Implant Subsidy List (ISL) that groups and prices individual implants - neither has published shoulder- or robotics-specific guidance.

Singapore · Mako Blueprint / Shoulder · Q3 Policy drivers

For primary total shoulder replacement in Singapore, MOH's own bill-benchmark data shows procedure fee, implant fee and 'other fees' billed as separate line items inside one bundled patient bill - not paid as distinct reimbursement channels.

Singapore · Mako Blueprint / Shoulder · Q4 Bundled or separate

Singapore's HSA device register shows Blueprint planning software and Tornier Perform shoulder implants ARE registered, but the Mako robotic arm's Singapore registration is indicated for knee/hip only - no shoulder indication is registered.

Singapore · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

No shoulder-OA/rotator-cuff-arthropathy/proximal-humerus-fracture-specific national epidemiological figures for Singapore could be located.

Singapore · Mako Blueprint / Shoulder · Q6 Prevalence / burden

Singapore has no national joint replacement registry of any kind - the National Registry of Diseases Office (NRDO) covers only four disease areas, none orthopaedic - so no shoulder arthroplasty volume figures exist at a national level.

Singapore · Mako Blueprint / Shoulder · Q7 Annual volume

Zimmer Biomet's Signature ONE shoulder pre-op planning/guide system is HSA-registered and commercially present in Singapore as a direct Blueprint competitor; Arthrex VIP, DePuy TruMatch (shoulder) and ROSA/Medacta NextAR shoulder systems are not found on the same register.

Singapore · Mako Blueprint / Shoulder · Q8 Technology in market

No Singapore cost offset can be computed, and the payment channel would not carry one if it could.

Singapore · Mako RPS · Q2 Adequacy of payment

The Health Information Act 2026 is law but uncommenced: obligations readable, not yet binding.

Singapore · Smart Care · Q3 Policy drivers

The platform is funded as extra-low-voltage construction, not as a technology purchase: the Ministry of Health awarded S$130,074,420 for Alexandra Hospital's ELV package to Quantum Automation and S$76,393,900 for the new Integrated Acute and Community Hospital's ELV package to Honeywell, both through the GeBIZ award dataset.

Singapore · SmartHospital · Q1 Current reimbursement

No platform payback exists because the only public figures are construction envelopes: the S$130,074,420 Alexandra ELV award and MOH's S$2.47 billion FY2026 development budget both name a total with no technology split, and the word "robot" appears zero times anywhere in that budget.

Singapore · SmartHospital · Q2 Adequacy of payment

The binding constraint is channel fragmentation, not a single regulatory or clinical barrier: the platform's infrastructure half is bought by a main contractor years ahead of opening, while its sensing half needs a device filing that has never been made, and no single buyer or process governs both.

Singapore · SmartHospital · Q3 Policy drivers

The budget owner for the platform's infrastructure half is a construction project office inside MOH's development budget, not the cluster capital process (via ALPS) that governs standalone monitoring purchases.

Singapore · SmartHospital · Q4 Bundled or separate

The union of gates is: zero of 20,860 device-register rows for the sensing component, IMDA radio approval unchecked for the comms component, and a main-contractor pre-qualification for the infrastructure component that is commercial rather than regulatory.

Singapore · SmartHospital · Q5 Readiness to obtain outcome

The operational trigger for a platform sale is a hospital opening from scratch, not a workforce shortfall: Singapore's own workforce story is managed growth, past 50,000 registered nurses for the first time, while three named new hospitals must fit out their entire ward infrastructure at once.

Singapore · SmartHospital · Q6 Prevalence / burden

The addressable base is three named, dated hospital builds worth a combined S$4.68 billion-plus in development budget, not the 12,767-bed installed acute estate: Alexandra Hospital, the new Eastern General Hospital/Eastern Integrated Health Campus, and the Elective Care Centre.

Singapore · SmartHospital · Q7 Annual volume

Ascom, on its own account, is the standard for new Singapore public builds, entering through Honeywell as prime contractor at Eastern General Hospital; Austco holds the installed base at Jurong on a ten-year contract; and Synapxe's self-built Note Buddy, not a purchased platform, is the ambient incumbent.

Singapore · SmartHospital · Q8 Technology in market

Clinical communication in Singapore is bought inside hospital-build extra-low-voltage construction packages, not through the grants or MIC@Home inpatient-parity funding that pays for monitoring.

Singapore · Vocera · Q1 Current reimbursement

Payback for Vocera in Singapore is not bed-day substitution or occupancy economics; it is winning the construction specification once and holding it for the 10-to-15-year life of the nurse-call system.

Singapore · Vocera · Q2 Adequacy of payment

Telemedicine licensing binds care.ai's tele-monitoring use case, not Vocera; the genuine constraint, Singapore privacy, AI-governance and cybersecurity law, is unresearched for both products equally.

Singapore · Vocera · Q3 Policy drivers

The buyer is a construction prime contractor and the hospital's building programme, not the ALPS cluster-capital route that funds monitoring.

Singapore · Vocera · Q4 Bundled or separate

The medical-device register is the wrong register; IMDA's predecessor already certified Vocera's older B3000n badge (IDA Standards DA101094), but that certification is absent from the current V5000 Smartbadge's own documentation.

Singapore · Vocera · Q5 Readiness to obtain outcome

50,389 registered nurses and a managed-growth hiring plan is the shared workforce story; it is a weaker case for Vocera in Singapore than the shortage framing used in Japan or Australia.

Singapore · Vocera · Q6 Prevalence / burden

12,767 acute beds, 84 per cent public, is the shared denominator, but Vocera's actual unit of sale is the hospital build project, which is a small, named, countable list regardless of bed count.

Singapore · Vocera · Q7 Annual volume

Ascom is the de-facto standard in Singapore's new hospital builds, named at Woodlands, Sengkang and now Eastern General; Austco holds a ten-year A$4.2 million maintenance contract at Jurong Health Campus.

Singapore · Vocera · Q8 Technology in market

There is no CMS code for ambient monitoring, confirmed record by record across the full July 2026 HCPCS file, but CMS already prices exactly the two outcomes care.ai targets, falls and pressure injury, as non-paid hospital-acquired conditions since 2008, with two further programmes withholding real money against the same measures.

United States · Care.ai · Q1 Current reimbursement

Care.ai's own direct US competitors publish the only available payback comparators, and they are large: AvaSure claims a 56 per cent cut in 1:1 sitter hours and roughly $2.1M saved at one hospital, and Artisight's WellSpan case reports a 52 per cent fall-rate reduction and a 92 per cent cut in median 1:1 sitter hours, none of it independent or peer-reviewed.

United States · Care.ai · Q2 Adequacy of payment

HIPAA business-associate security is the shared US baseline for any Smart Care vendor, but the specifically camera-relevant layer, state biometric-privacy statutes such as Illinois BIPA and state video/audio-recording consent laws, is unresearched here and is the more consequential gap for care.ai than for a communications badge.

United States · Care.ai · Q3 Policy drivers

The purchase is signed jointly by the chief nursing officer and chief financial officer out of the hospital's own budget, with no patient billing and no payer approval, identically for any Smart Care technology.

United States · Care.ai · Q4 Bundled or separate

Openfda holds zero 510(k) clearances for care.ai, and the reason is specific to how it is positioned: a workflow-monitoring platform carrying no diagnostic claim is not regulated as a device at all, a materially different and more favorable gate than Vocera's, which clears via FCC equipment authorisation rather than FDA.

United States · Care.ai · Q5 Readiness to obtain outcome

Between 700,000 and 1,000,000 inpatient falls a year is care.ai's most direct US operational hook, and it is the market's own PSI 90 composite, not a falls rate, that should set the sales pitch, since pressure ulcer outweighs fall-associated fracture by nearly four to one inside it.

United States · Care.ai · Q6 Prevalence / burden

638,186 short-term-hospital beds nationally, but 1,110 hospitals of 200+ beds hold 72 per cent of them (457,621 beds), and those large IPPS hospitals are also the only ones exposed to the HAC/VBP penalties that fund the purchase.

United States · Care.ai · Q7 Annual volume

Care.ai's real US competitors are AvaSure (roughly 1,100-1,200 hospitals) and Artisight (417 hospitals, targeting ~1,000 more), a materially different competitive set from Vocera's, which sits against Spok, Honeywell/Rauland, Baxter/Hillrom and Teladoc; AvaSure's own August 2025 Ascom partnership was explicitly scoped 'for North America' only.

United States · Care.ai · Q8 Technology in market

Shoulder arthroplasty is a covered Medicare procedure, and CMS's CY2026 Hospital Outpatient/ASC final rule newly opened 'partial shoulder revisions' to ambulatory surgery centers, expanding where - but not how much extra - shoulder surgery is paid.

United States · Mako Blueprint / Shoulder · Q1 Current reimbursement

Payment does not increase for Mako Shoulder/Blueprint use in the US - two major payers explicitly state robotic assistance is bundled into the base procedure fee, and Aetna separately calls computer-assisted shoulder navigation experimental/investigational.

United States · Mako Blueprint / Shoulder · Q2 Adequacy of payment

In the US the policy driver splits by payer type: CMS sets Medicare payment through its annual OPPS/ASC and IPPS rulemaking cycle, while commercial insurers (UnitedHealthcare, Aetna, Cigna) each publish and independently maintain their own reimbursement/clinical policy bulletins governing shoulder arthroplasty and robotic assistance.

United States · Mako Blueprint / Shoulder · Q3 Policy drivers

Procedure, implant, and robotic/navigation technology are bundled into a single CPT payment for US shoulder arthroplasty (e.g. CPT 23472); Category III tracking codes for robotics (S2900) and navigation (0055T) exist but generate no incremental reimbursement.

United States · Mako Blueprint / Shoulder · Q4 Bundled or separate

Mako Shoulder Application (1.0) received FDA 510(k) clearance on 7 November 2024, but strictly and only for primary reverse shoulder arthroplasty with two named implants - not anatomic (non-reverse) total shoulder replacement.

United States · Mako Blueprint / Shoulder · Q5 Readiness to obtain outcome

No shoulder-specific US national prevalence figure for shoulder osteoarthritis, cuff tear arthropathy, or proximal humerus fracture burden was located this pass - only general (all-joint) osteoarthritis prevalence exists in what was found.

United States · Mako Blueprint / Shoulder · Q6 Prevalence / burden

The AAOS Shoulder & Elbow Registry recorded 19,357 total shoulder arthroplasty procedures across 2015-2023 from a voluntary sample of 424 surgeons at 82 facilities in 40 states - not a national census, since the US has no compulsory joint registry.

United States · Mako Blueprint / Shoulder · Q7 Annual volume

At least four competitor shoulder planning/robotics systems are independently FDA-cleared and active in the US market: Zimmer Biomet's ROSA Shoulder System and Signature ONE planning software, Arthrex's Virtual Implant Positioning (VIP) system, Medacta's NextAR Shoulder/RSA platform, and Exactech's GPS Total Shoulder navigation.

United States · Mako Blueprint / Shoulder · Q8 Technology in market

About 14 million with symptomatic knee osteoarthritis, on a modelled estimate built from 2007 to 2008 survey data.

United States · Mako full platform · Q6 Prevalence / burden

The knee replacement is reimbursed in both settings; the robotic technique adds nothing to the payment.

United States · Mako RPS · Q1 Current reimbursement

Per-case economics are negative by construction: the payer pays the same whether or not the robot is used.

United States · Mako RPS · Q2 Adequacy of payment

Two clocks govern this market: CMS annual rulemaking sets the setting economics, and each commercial payer reviews its robotic policy on its own annual cycle.

United States · Mako RPS · Q3 Policy drivers

Payment is bundled into the DRG, so the robot sits inside the hospital's cost base rather than beside its revenue.

United States · Mako RPS · Q4 Bundled or separate

Regulatory entry is complete and specific to this platform: FDA cleared the RPS system in September 2025.

United States · Mako RPS · Q5 Readiness to obtain outcome

The United States knee osteoarthritis burden has not been researched in this engagement and is not asserted here.

United States · Mako RPS · Q6 Prevalence / burden

Medicare fee-for-service volume is established at 69,949 knee replacement discharges; the all-payer United States total is not.

United States · Mako RPS · Q7 Annual volume

The handheld field is already occupied: Smith and Nephew reports more than 1,100 CORI systems installed worldwide and says it tracks slightly ahead in ambulatory centres.

United States · Mako RPS · Q8 Technology in market

A layered incumbency with no ambient leader, and no United States market-share figure retrievable for any of it.

United States · Smart Care · Q8 Technology in market

SmartHospital in the US is bought inside an undifferentiated hospital capital budget, not through a labelled construction or technology line: the four largest for-profit hospital operators and landlords checked (HCA, Tenet, UHS, Medical Properties Trust) report capex as a single aggregate figure with zero technology-category split, while Stryker's own Smart Care page offers Flex Financial vendor leasing as the alternative to an outright capital purchase.

United States · SmartHospital · Q1 Current reimbursement

No published payback figure exists for the SmartHospital bundle: the four largest hospital operators' and landlords' capex is a total envelope with no technology split (the same 'envelope is not a payback' pattern this file records in Australia, Singapore and India), and the only quantified fall-reduction outcomes on record in this category, 40 to 52 percent, belong to a named competitor's own deployments, not Stryker's.

United States · SmartHospital · Q2 Adequacy of payment

SmartHospital inherits every one of its components' individual constraints in full and adds none of its own except a competitive one: no CMS billing code exists for any of the three underlying product categories, eleven states require all-party consent for in-room video, a real deployment (Henry Ford Health's care.ai/SONIFI build) required hardwired rather than Wi-Fi network infrastructure, and a well-funded, NVIDIA-backed rival, Artisight, already occupies 417 hospitals under an explicit 'smart hospital platform' brand.

United States · SmartHospital · Q3 Policy drivers

No source names a specific SmartHospital budget owner: Stryker's launch materials name only its own executives and speak of 'our customers' and 'health systems' generically, and because the funding route (Q1) is an undifferentiated hospital capex line rather than a labelled technology budget, the realistic owner is each health system's own capital-planning or facilities process rather than a single named role such as CIO or CNO.

United States · SmartHospital · Q4 Bundled or separate

The entry gate is a union and the device half was tested live with a genuine surprise: FDA's 510(k) and registration-listing databases return zero for 'care.ai', 'careai', 'SmartHospital', 'Vocera' and 'ProCuity' against a working Stryker (326 clearances) and Mako (31 clearances) positive control, yet Stryker does hold a real, current Class II clearance for connected smart-bed technology under a different name, K202964 'iBed Wireless with iBed Mobile' (2021), and the FCC radio-equipment half of the union could not be checked at all.

United States · SmartHospital · Q5 Readiness to obtain outcome

The operational driver is the same nurse-workforce and falls burden that motivates Vocera and care.ai individually (700,000 to 1,000,000 inpatient falls a year; 3,379,720 employed RNs), and the platform-specific addition is that a named competitor, Artisight, has already turned that burden into a priced commercial argument: a stated $17 billion annual US cost of patient falls and 40-52 percent fall-rate reductions at named sites.

United States · SmartHospital · Q6 Prevalence / burden

The realistic near-term SmartHospital buyer base is smaller than the full US hospital count: 3,567 of the AHA's 5,121 community hospitals belong to a multi-hospital or diversified system, and an enterprise-wide bundle spanning communication, ambient sensing and connected beds is a system-scale procurement decision, not one a standalone independent hospital is likely to make alone.

United States · SmartHospital · Q7 Annual volume

No single competitor sells an identical bundle, but two have already assembled a functional equivalent at real scale: Artisight, an explicitly branded 'AI-based smart hospital platform', is live in 417 hospitals and aiming for roughly 1,000 more, and AvaSure has built toward the same position by acquisition (Ouva's Smart Room AI, Nurse Disrupted virtual nursing) and by a North America partnership with Ascom announced five months before SmartHospital's own launch; a concrete, priced example of the loss is UMass Memorial Health's brand-new North Pavilion, which specified Caregility and GetWell, not Stryker, into its 72-bed, $220 million 2025 build.

United States · SmartHospital · Q8 Technology in market

No CMS code exists for clinical communication, the same absence care.ai faces, and CMS already prices the outcomes it drives at hospital level through non-payment and two performance programmes.

United States · Vocera · Q1 Current reimbursement

No US payback figure exists for Vocera; released nursing hours, not avoided falls, is the correct half of the shared HAC-exposure mechanism to lead with.

United States · Vocera · Q2 Adequacy of payment

Vocera Engage and Ease are HIPAA business associates under the same unfinalised Security Rule that binds care.ai; Illinois' biometric-privacy law is a live, unresearched risk specific to a voice-recognition badge.

United States · Vocera · Q3 Policy drivers

The hospital's own chief nursing officer and chief financial officer sign, with no patient billing and no payer approval, the same structure as care.ai.

United States · Vocera · Q4 Bundled or separate

FCC ID QGZV5000, registered to Vocera for the V5000 Smartbadge and tested to Part 15 Class B, closes the gap this review had left unconfirmed; no FDA gate exists or is needed.

United States · Vocera · Q5 Readiness to obtain outcome

The AHRQ falls figure is care.ai's operational-need statistic, not Vocera's; no US communication-failure or interruption-burden statistic was found for Vocera specifically, and that gap should be stated rather than papered over.

United States · Vocera · Q6 Prevalence / burden

3,209 short-term hospitals and 1,110 of 200-plus beds is the shared denominator; Spok's own ARPU model, $8.29 per device per month, is the correct Vocera-comparable sizing convention.

United States · Vocera · Q7 Annual volume

Spok is the one listed pure-play competitor and is explicitly harvesting, not growing; Rauland (AMETEK) and Honeywell hold nurse call, and Baxter's Hillrom connected-care line is declining across every disclosed metric.

United States · Vocera · Q8 Technology in market