Technology & Innovation
Detection methods, enzyme chemistry, and manufacturing techniques
Capillary Action and Sample Volume Physics
Counterfeit Strips and Third-Party Generics
The high cost of branded diabetic test strips has spawned three alternative markets: legitimate third-party generics, illegal counterfeits, and the gr...
Enzyme Chemistry: GOx vs. GDH
The choice of enzyme in diabetic test strips—**Glucose Oxidase (GOx)** versus **Glucose Dehydrogenase (GDH)**—represents a trade-off between specifici...
Hematocrit and Interference Correction
Hematocrit (Hct) and chemical interferences represent the two most significant challenges to the accuracy of electrochemical glucose test strips. **He...
Manufacturing: Screen Printing vs. Laser Ablation
The manufacturing of diabetic test strips is divided between **Screen Printing (Thick Film)** and **Laser Ablation (Thin Film)**. **Screen Printing*...
Direct Electron Transfer (3rd Gen Biosensors)
Electrode Manufacturing Techniques
Electrode manufacturing for diabetic test strips is dominated by two opposing methodologies: **Thick Film (Screen Printing)** and **Thin Film (Laser A...
Enzyme Chemistries: GOx vs. GDH
Enzyme Chemistry: GOX vs. GDH-FAD vs. GDH-PQQ
The enzyme chemistry within diabetic test strips dictates the system's accuracy regarding **Oxygen** and **Non-Glucose Sugars**. 1. **Glucose Oxidas...
Impact of ISO 15197:2013 on Product Discontinuation
The introduction of **ISO 15197:2013** marked a pivotal regulatory shift in the diabetic test strip market, tightening accuracy requirements from **±2...
Manufacturing Processes of Electrochemical Strips
The manufacturing of diabetic test strips is a web-based process dominated by two competing electrode technologies: **Screen Printing** (using carbon/...
Mediator Chemistry: Ferrocene vs. Osmium vs. Ruthenium
Post-Market Surveillance and Lot-to-Lot Variability
Post-market surveillance is critical for diabetic test strips due to the biological nature of the enzymes used, which causes inherent **Lot-to-Lot Var...
Screen-Printing vs. Laser Ablation Manufacturing
The manufacturing of diabetic test strips is divided into two primary technologies: **Screen-Printing (Thick Film)** and **Laser Ablation (Thin Film)*...
Smart Packaging and Anti-Counterfeit Technologies
To combat the severe health risks of counterfeit diabetic test strips and the economic loss from grey market diversion, manufacturers employ a **Defen...
Strip Manufacturing: Screen Printing vs. Laser Ablation
The 'Razor and Blade' Business Model in MedTech
Continuous Glucose Monitor (CGM) Sensor Fabrication
CGM sensor fabrication represents a technological leap from disposable test strips, requiring sensors to function accurately within the body for weeks...
Continuous Glucose Monitoring (CGM) vs. BGM Strips
The comparison between **Blood Glucose Monitoring (BGM)** strips and **Continuous Glucose Monitoring (CGM)** centers on the physiological difference b...
Digital Health Integration and Connectivity Standards (POCT1-A/Bluetooth)
The utility of diabetic test strips has expanded beyond simple chemistry through **Digital Health Integration**, transforming them into connected IoT ...
Electrode Material Composition (Carbon vs. Gold/Palladium)
The material composition of the working electrode is a primary determinant of test strip accuracy and manufacturing cost. The market is divided into t...
Environmental Impact and Recycling of Test Strips
Environmental Impact of Disposable Test Strips
The environmental impact of disposable diabetic test strips is driven by the massive aggregate volume of waste generated by over 537 million diabetics...
Environmental Impact of Disposable Test Strips
Environmental Stability and Packaging Engineering
The accuracy of diabetic test strips is heavily dependent on **Environmental Stability and Packaging Engineering**, as the electrochemical reagents (e...
Hematocrit Interference Mechanisms and Correction Algorithms
The **Hematocrit (Hct) Effect** is a physical interference phenomenon where the volume of red blood cells (RBCs) distorts blood glucose readings. **Hi...
Impact of Continuous Glucose Monitoring (CGM) on BGM Market Share
The rise of **Continuous Glucose Monitoring (CGM)** is actively cannibalizing the traditional **Blood Glucose Monitoring (BGM)** market, fundamentally...
Manufacturing of Continuous Glucose Monitoring (CGM) Sensors
Mediator Chemistries (Ferrocene vs. Osmium vs. Ruthenium)
Near-Field Communication (NFC) in BGM
Near-Field Communication (NFC) has transformed Blood Glucose Monitoring (BGM) by enabling **"Flash" glucose monitoring** and enhancing traditional met...
Non-Invasive Glucose Sensing Technologies
Non-Invasive Glucose Sensing aims to measure blood glucose without skin puncture, utilizing technologies like **Near-Infrared Spectroscopy (NIRS)**, *...
Non-Invasive Glucose Sensing Technologies
Non-Invasive Glucose Sensing (NIGS) aims to replace fingerstick test strips and invasive filaments with technologies that measure glucose through the ...
Signal Processing Algorithms in Glucometers
Signal processing in modern glucometers has evolved from simple linear regression of current (Amperometry) to complex, multi-variable dynamic analysis...
Wired Enzyme Technology
To overcome the limitations of oxygen-dependence and diffusive mediators, **Adam Heller** and **TheraSense** (now **Abbott**) developed **Wired Enzyme...
Alternative Site Testing (AST) Physiology
Alternative Site Testing (AST) allows patients to measure blood glucose from the forearm or palm to reduce pain, as these sites have fewer nerve endin...
Closed-Loop Control Algorithms (Artificial Pancreas)
Closed-Loop Control (CLC) algorithms, or **Artificial Pancreas** systems, automate insulin delivery by linking Continuous Glucose Monitoring (CGM) dat...
Connectivity standards (Bluetooth/NFC) in Modern Glucometers
Modern glucometers have evolved into IoT nodes using **Bluetooth Low Energy (BLE)** and **Near Field Communication (NFC)** to transmit test strip data...
Coulometry vs. Amperometry in Biosensors
The two dominant electrochemical detection methods in diabetic test strips are **Amperometry** and **Coulometry**. **Amperometry**, the industry sta...
Digital Lock-ins and Data Silos
Electrode Materials: Carbon Paste vs. Sputtered Gold
The construction of diabetic test strip electrodes is divided between **Screen Printed Carbon (Thick-Film)** and **Sputtered Gold (Thin-Film)** techno...
Enzymatic vs. Non-Enzymatic Sensor Chemistry
The chemistry of diabetic test strips is defined by the method used to transduce glucose concentration into electrical current. The market is currentl...
Enzyme Engineering and Stability
Foreign Body Response (FBR) Mechanisms in CGMs
The **Foreign Body Response (FBR)** is the primary biological limitation of Continuous Glucose Monitors (CGMs), preventing them from achieving the ind...
Integration of BGM/CGM into Automated Insulin Delivery (AID)
Automated Insulin Delivery (AID) systems integrate Continuous Glucose Monitors (CGM) and insulin pumps to automate dosing, but **Blood Glucose Meters ...
Minimally Invasive CGM Technology (Dexcom/Abbott)
Minimally Invasive Continuous Glucose Monitors (CGMs) measure glucose in **interstitial fluid (ISF)** rather than capillary blood, utilizing subcutane...
Multi-Analyte Test Strips
Multi-Analyte Test Strips (Glucose + Ketone)
Multi-analyte test strips have evolved to measure **β-hydroxybutyrate (β-HB)** alongside glucose, addressing the critical need for early **Diabetic Ke...
Non-Invasive Glucose Monitoring Technologies
Non-Invasive Glucose Monitoring (NIGM) aims to measure blood glucose without skin puncture, utilizing technologies like **Near-Infrared (NIR) Spectros...
Over-the-Counter (OTC) Biosensors for Metabolic Health
Smartphone as a Medical Device (SaMD)
The Economics of Remote Patient Monitoring (RPM) and Test Strips
The integration of **Remote Patient Monitoring (RPM)** has transformed the diabetic test strip market from a commodity sales model to a **service-base...
AC Impedance and Multi-Pulse Technology
Automated Insulin Delivery (AID) Integration
Electrochemical Interferences in BGM
Electrochemical interference in blood glucose monitoring (BGM) occurs when physical properties of blood or non-glucose substances distort the electric...
Implantable Fluorescence Sensing (Eversense)
The **Eversense** system by **Senseonics** (distributed by **Ascensia**) is the market's only long-term implantable CGM, utilizing **optical fluoresce...
Multi-Analyte Strip Chemistry
Sensor Chemistry and Mediators
Supply Chain Resilience in Diabetes Consumables
Supply Chain Resilience in Electrochemical Strip Manufacturing
Supply chain resilience in diabetic test strip manufacturing is uniquely challenged by the convergence of **biological fragility** and **regulatory ri...