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Run your analysis now →https://www.patsnap.com/resources/blog/rd-blog/insulin-pump-safety-and-compliance-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Biomedical Devices · Patent LandscapeInsulin Pump Safety and Compliance Patents
- Filing has cooled since a 2020 peak of 8 records, with the most recent full year sitting below the 2022 midpoint — a flattening rather than a growth curve, even accounting for publication lag.
- A61M and G16H co-occur in the large majority of records, showing that dosing-safety claims are now routinely paired with software/informatics claims rather than filed as pure mechanical art.
- The United States receives more than two-thirds of filings, with Europe a distant second and China, India and PCT filings each in single digits — a narrow geographic footprint for a device category sold worldwide.
55
Published Records
-80%
Filing Growth 2021→2024
US
Leading Jurisdiction
12
Active Filers Ranked
Filing growth compares 2021 (5 records) with 2024 (1) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field.
Published byPatsnap Research··7 min readSourced from Patsnap Eureka
Overview
What this landscape covers
This dataset tracks patent families at the intersection of insulin delivery hardware and the safety mechanisms layered on top of it: dosing-safety logic, alarm systems, fail-safe design and the informatics that support IEC 60601-class compliance. The search combines device-level IPC codes (A61M5/168, A61M5/172, G16H40) with title/abstract terms for artificial pancreas and insulin delivery, so it captures both the pump mechanism and the control software that governs when and how much insulin it releases.
Coverage runs from 2015 through the 2026-07-31 cut-off. Because publication typically lags filing by around 18 months, the most recent year understates real filing activity and should be read as a floor, not a ceiling.
Filing activity and technology composition, 2015–2026
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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The Data
Filing trend and technology composition
Two views of the same 55-family dataset: how filing volume has moved year over year, and which IPC subclasses carry the claim weight.
A peak in 2020, then a plateau
Filings rose from 2 in 2017 to a peak of 8 in 2020, then eased back toward the 2022 midpoint of 4. That pattern points to a technology whose core safety-claim space filled up early in the artificial-pancreas push and has not reaccelerated since, though the final 2025–2026 count will firm up as later publications land.
Device claims dominate, informatics is close behind
A61M (body-fluid delivery devices) leads at 47 of 55 records, with G16H (healthcare informatics) close behind at 45 and A61B (diagnosis/surgery) at 37. The overlap between A61M and G16H is the story: safety claims are rarely filed as mechanical-only anymore. G06F, G01N, H04L and H04W appear only in single digits, marking connectivity and sensor-analytics claims as a comparatively open flank rather than a crowded one.
Shares are the percentage of the 55 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Source: Patsnap Eureka. Filing trend and technology composition. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.
Go deeper on Insulin Pump Safety and Compliance with Eureka
This page is one run against one query. Ask Eureka your own question about insulin pump safety and compliance and every answer comes back with the patent numbers behind it.
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The most-cited prior art in this space
Representative Record
US20140200559A1 — Daily periodic target-zone modulation in the model predictive control problem for artificial pancreas for type I diabetes applications
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
A controller for an artificial pancreas for automated insulin delivery to patients with type 1 diabetes mellitus (T1DM) that enforces safe insulin delivery throughout both day and night, wherein the controller employs zone model predictive control, whereby real-time optimization, based on a model of a human's insulin response, is utilized to regulate blood glucose levels to a safe zone, and time-dependent zones that smoothly modulate the controller correction based on the time of day, wherein the controller strategically strives to maintain an 80-140 mg/dL glucose zone during the day, a 110-220 mg/dL zone at night, and a smooth transition of 2 hour duration in between.Filed by The Regents of the University of California; illustrates how zone-based model predictive control is claimed as the safety mechanism rather than a fixed dosing threshold.
Highest-citation records in the dataset
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US4435173A | Variable rate syringe pump for insulin delivery | 739 |
| 2 | US20160354543A1 | Multivariable artificial pancreas method and system | 165 |
| 3 | WO2010099313A1 | CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction insulin delivery | 153 |
| 4 | US8562587B2 | CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction of insulin delivery | 139 |
| 5 | US20140200559A1 | Daily periodic target-zone modulation in the model predictive control problem for artificial pancreas for typ… | 119 |
| 6 | US20120059353A1 | CGM-Based Prevention of Hypoglycemia Via Hypoglycemia Risk Assessment and Smooth Reduction of Insulin Delivery | 82 |
| 7 | US9750438B2 | CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction of insulin delivery | 46 |
| 8 | US20210085861A1 | Blood glucose control system switching without interruption of therapy delivery | 37 |
| 9 | US9936910B2 | Method and apparatus for providing analyte monitoring and therapy management system accuracy | 29 |
| 10 | US20140046159A1 | CGM-Based Prevention of Hypoglycemia Via Hypoglycemia Risk Assessment and Smooth Reduction of Insulin Delivery | 28 |
Citation counts accumulate over time and favour older filings; treat them as a measure of influence on later filers, not of current commercial relevance.
Each row carries its publication number; clicking a row searches Eureka by that number.
Source: Patsnap Eureka. Citation counts and representative records. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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What the numbers mean for a filing decision
Three patterns worth acting on before drafting claims in this space.
Filing Momentum
Peak 8 (2020)
records in the strongest year
The safety-claim rush has already happened
Volume peaked in 2020 and has since eased back toward the 2022 midpoint of 4 records. A flattening curve in a device category still growing commercially usually means the obvious control-loop and alarm claims are already staked out, and new filers need a genuinely different mechanism to clear prior art.
Based on the 2015–2026 filing trend
Claim Overlap
47 vs 45
A61M vs G16H record counts
Device and informatics claims now travel together
A61M and G16H appear in near-equal counts across the corpus, meaning most applicants are claiming the pump hardware and the decision logic in the same family rather than splitting them. Drafting a pure mechanical fail-safe without a software layer is increasingly the exception.
Based on IPC subclass composition
Jurisdiction Concentration
38 of 55
records filed via the US receiving office
Filing strategy is US-heavy, not global
The United States accounts for the large majority of receiving-office filings, with Europe a distant second and China, India and PCT each in single digits. For a device sold under CE and other regional regimes, that narrow footprint suggests compliance-driven filing has concentrated on the largest single reimbursement market rather than following the product's actual sales geography.
Based on receiving-office distribution
Collaboration Pattern
9 pairs
co-assignee pairings identified
Named-inventor clusters, not corporate joint ventures
The strongest co-assignee links in this dataset sit between individual named inventors rather than between companies, pointing to academic research groups filing as co-inventors more often than formal cross-company licensing or joint development deals.
Based on co-assignee pair analysis
Eureka AI Agent
Looking for what nobody has claimed yet?
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to insulin pump safety and compliance, with the prior art for and against each one.
Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Players
Who is active, and where the field is still open
Recent-year momentum across the leading assignees has gone flat: every one of the top-tracked organisations and named inventors shows zero filings in the latest year, consistent with the broader plateau in the trend data and with publication lag masking the most recent activity.
Academic Anchor
0 in latest year
recent-year momentum
University-affiliated filers set the early art
Organisations such as the University of Virginia Patent Foundation and the Regents of the University of California appear among the most-cited and earliest filers in this dataset, having established zone-based and model-predictive-control approaches to dosing safety that later filers now have to design around.
Momentum reflects the latest tracked year only
Device Incumbents
0 in latest year
recent-year momentum
Diabetes-care device makers hold applied claims
Assignees including Abbott Diabetes Care and Beta Bionics sit in the ranking with commercialisation-oriented claims covering alarm systems and fail-safe delivery logic, translating the academic control-theory art into product-ready mechanisms.
Momentum reflects the latest tracked year only
Named-Inventor Clusters
2 shared filings
strongest co-assignee pair
A small research network drives the co-filing signal
Turksoy Kamuran, Hajizadeh Iman and Cinar Ali each pair with one another on two shared filings, the strongest co-assignee links in the dataset — a signature of a tight academic collaboration rather than a broad industry consortium.
Based on co-assignee pair strength
Recent-year filing momentum by assignee
| Assignee | Recent year | YoY |
|---|---|---|
| University of Virginia Patent Foundation | 0 | -100% |
| Abbott Diabetes Care Inc. | 0 | — |
| Beta Bionics, Inc. | 0 | — |
| The Regents of the University of California | 0 | — |
| TURKSOY KAMURAN | 0 | — |
| HAJIZADEH IMAN | 0 | — |
| CINAR ALI | 0 | — |
| Mengkang (Chongqing) Medical Technology Co., Ltd. | 0 | -100% |
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
What's Next
Where to take this analysis
The filing and citation patterns above point to specific next steps depending on what you are trying to decide.
Map claims against your own device architecture
Run your actual dosing-safety and alarm mechanisms against the most-cited records to see which specific claim elements you would need to design around versus which are already expired or narrowly drafted.
Explore in EurekaTrack the named-inventor clusters
The academic co-assignee network identified here is small enough to watch directly; new filings from the same names are a leading indicator of where the next wave of control-loop claims will land.
Set up monitoring in EurekaStress-test the white-space chips
Sub-areas like sensor-fusion fault detection and multi-hormone dosing interlocks carry low filing density in this corpus — worth a freedom-to-operate check before assuming they are open.
Run a search in EurekaSource: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
FAQ
Common questions on insulin pump safety patents
This dataset identifies 55 patent families published between 2015 and the 2026-07-31 cut-off, drawn from a search combining artificial-pancreas and insulin-delivery terms with dosing-safety, alarm-system and fail-safe-design language, restricted to core delivery-device and healthcare-informatics IPC codes. That figure covers the specific safety and compliance intersection, not the much larger universe of general insulin pump patents. Filing families are the fairer unit to compare here because they neutralise duplicate continuation filings and multi-jurisdiction copies of the same invention.
Not on the current data: filings rose from 2 in 2017 to a peak of 8 in 2020, then fell back to 4 by 2022, and the trend has not reaccelerated since. Because publication lags filing by roughly 18 months, the final year or two in any dataset always looks artificially low, so the true 2025–2026 picture will firm up later. Even allowing for that lag, the shape looks like a plateau rather than a fresh growth phase.
The most-cited records in this corpus include early foundational work on variable-rate insulin delivery alongside more recent artificial-pancreas control patents from academic assignees such as the Regents of the University of California, with device-focused claims held by diabetes-care companies including Abbott Diabetes Care and Beta Bionics. Citation counts favour older filings simply because they have had more time to accumulate citations, so a high count signals influence on later filers rather than current market strength. For a live competitive read, pair the citation ranking with the recent-year filing momentum data.
IEC 60601 is the medical electrical equipment safety standard, and many of the alarm-system and fail-safe-design claims in this dataset are drafted specifically to demonstrate a path to that compliance regime, particularly around dosing-error detection and system shutdown behaviour. That is why the search string pairs device IPC codes with compliance-oriented title/abstract terms rather than searching on the standard's name alone, since few patents cite the standard directly even when the claimed mechanism addresses it. Readers doing freedom-to-operate work should treat compliance language in a claim as a signal of intended regulatory use, not a guarantee of certification.
The IPC composition shows dense claim coverage in core device (A61M) and informatics (G16H) codes but comparatively thin coverage in wireless communications (H04W, H04L) and materials analysis (G01N), each appearing in only single digits across the 55-family set. That gap suggests sub-areas like wireless alarm-relay redundancy, sensor-fusion fault detection and CGM-to-pump link integrity checks are less thoroughly claimed than the core dosing-safety logic. Any of those should still get a dedicated freedom-to-operate search before being treated as genuinely open, since low volume in this specific search string does not rule out coverage under a differently worded filing.
Answers are grounded in the same dataset. Derived from a Patsnap search on Insulin Pump Safety and Compliance covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Research Insulin Pump Safety and Compliance in depth with Eureka
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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.
Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company's registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.