Wearable biodiagnostics

01Overview and value chain

Markers: [EC: Medical Device Regulation (MDR) Class IIb/III Wearables | OECD: 3.3 Health | Regulator: FDA (USA), EMA (EU), NMPA (China)]

Wearable biodiagnostics and continuous monitoring represent a dynamically developing sector of personalized medicine, moving from simple physical activity trackers to clinically validated molecular and biophysical analysis devices. The sector is based on the continuous real-time reading of physiological and biochemical parameters of the human body using minimally invasive or non-invasive sensors attached to the body, such as smart patches, microneedle sensors, and smartwatches. This approach allows for early detection of life-threatening conditions, precision control of chronic diseases, and a radical shift in health management from reactive treatment to proactive prevention, capturing over 80% of the continuous monitoring market.

The key directions of wearable biodiagnostics are:

1. Continuous Glucose Monitoring (CGM): Microneedle sensors measuring interstitial glucose levels continuously, eliminating the need for routine finger pricks.
2. Sweat Diagnostics: Non-invasive smart patches performing microfluidic collection and continuous analysis of electrolytes, metabolites, and hormones.
3. Clinical ECG Monitoring: Disposable smart patches recording medical-grade electrocardiograms for 7 to 14 days to detect arrhythmias.
4. Non-invasive Blood Pressure Monitoring: Smartwatches and patches using photoplethysmography (PPG) and pulse transit time (PTT) for cuffless monitoring.

Sectoral value chain

[Microneedles & Enzyme Sensors] ──> [Reading & Conversion] ──> [Wireless Data Transmission]
                                                │
                                        (ASIC, ADC, Films)
                                                │
                                                ▼
[Clinical Decision Making] <─── [AI Trend Analysis & Alerts] <─── [Smartphone Integration]

Value chain levels

Cross-cutting technologies of the sector:

• Enzyme-Electrochemical Detection: Sensors utilizing enzymes like glucose oxidase covalently linked with electron transfer mediators to generate microcurrents proportional to substance concentration.
• Roll-to-Roll Screen Printing: High-throughput deposition of conductive tracks from silver, gold, or carbon nanotube inks onto flexible polyester films.
• Diffusion-Controlled Membranes: Thin layers of polyurethane and silicone copolymers restricting glucose access to the electrode and preventing oxygen starvation.

02US

The United States is the absolute locomotive of the global CGM and wearable biodiagnostics market, possessing advanced R&D centers and leading transnational corporations.

Dexcom and Abbott dominance, Biolinq microneedles, Epicore Biosystems

• CGM Global Giants: American companies like Abbott and Dexcom control the vast majority of the global CGM market with devices like FreeStyle Libre 3 and Dexcom G7.
• Biolinq Microneedle Patch: An innovative startup developing a first-in-class smart patch based on an array of silicon microneedles measuring glucose directly in the epidermis.
• Epicore Biosystems: Commercializing sweat patches such as the Gx Sweat Patch, which collects sweat during exercise to measure dehydration and salt loss.

03CN

China is rapidly increasing the production volumes of CGM and medical-grade wearable electronics, integrating them into national smart gadget ecosystems.

Sinocare breakthrough, Huawei medical smartwatches, WeChat integration

• Domestic CGM Leaders: Companies like Sinocare have successfully launched affordable CGM systems like iCan, competing actively on price in Asia and Europe.
• Medical Certification of Consumer Electronics: China pioneers the legalization of smartwatches as full-fledged medical devices, such as the Huawei Watch D with cuffless blood pressure monitoring.
• WeChat Ecosystem: Continuous monitoring results of elderly patients are automatically transmitted to WeChat mini-programs of relatives and family doctors.

04EU

The European Union prioritizes strict medical data protection standards (GDPR) and long-term implantable biodiagnostics.

Eversense (Roche), PKvitality (K’Watch), IMEC research center

• Long-term Implantable Eversense: The Swiss pharma giant Roche Diagnostics distributes the Eversense CGM system, a tiny glass capsule implanted subcutaneously for up to 6 months.
• PKvitality Smartwatch: A French startup developing the K’Watch smartwatch with a replaceable K’apsul cartridge featuring a microneedle array for painless interstitial fluid sampling.
• IMEC Research Center: The Belgian microelectronics center develops ultra-low-power chips and flexible sensor substrates for next-generation smart medical patches.

05Leading companies and research institutes

06Tech stack and innovations

Modern production of wearable biodiagnostic systems relies on precision manufacturing and low-power electronics.

1. Precision Enzyme Layer Deposition:
   • High-precision non-contact microdispensing of aqueous enzyme solutions (GOx) in nanoliter volumes onto working gold contacts of microneedles.
   • Ensures standard sensor sensitivity from batch to batch, eliminating the need for user calibration with blood.
2. Photolithography and Polymer Microneedle Molding:
   • Manufacturing arrays of painless microneedles using biocompatible polymers polymerized under UV light.
   • Forms pyramidal needles 800 µm high, strong during skin insertion but softening in interstitial fluid for wearing comfort.
3. Low-power Electrochemical Potentiostats (ASIC):
   • Developing specialized analog integrated circuits containing a potentiostat to maintain a constant potential difference.
   • Electronics operate at consumption currents less than 5 µA, allowing continuous operation for 14 days from a tiny battery.

07Value chains and production pipelines

Industrial pipeline of CGM sensor manufacturing (ISO 13485)

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Screen Printing        │ ───> │ 2. Enzyme Nanodispensing  │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Applicator Assembly    │ <─── │ 3. Protective Membrane    │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. EtO/Gamma Sterilization│ ───> │ 6. NFC Batch Calibration  │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Screen Printing

In an ISO 6 cleanroom, a 125 µm thick polyester (PET) film is fed into an automatic roll-to-roll screen printing machine. Three layers of conductive pastes are sequentially applied: silver polymer for contact, carbon paste with nanotubes for the working electrode, and silver chloride for the reference electrode.

Stage 2: Enzyme Nanodispensing

Printed rolls are cut into individual flexible sensor strips. A piezoelectric print head dispenses a 5-nanoliter drop of an aqueous cocktail containing glucose oxidase (GOx) and cross-linking agents precisely onto the carbon working zone.

Stage 3: Protective Membrane

Sensors are washed with deionized water. A solution of polyurethane and silicone copolymer is applied to the sensor tip via dip coating or precision spraying. The resulting membrane, strictly 2 µm thick, controls glucose diffusion.

Stage 4: Applicator Assembly

In an ISO 7 assembly shop, the flexible sensor is mounted inside a sterile steel introducer needle within a mechanical disposable applicator. The applicator housing is molded from high-impact medical-grade ABS plastic.

Stage 5: EtO/Gamma Sterilization

Hermetic containers with applicators are subjected to gamma irradiation (Cobalt-60 source) at an absorbed dose of 25 kGy. This method guarantees complete sterility of the subcutaneous sensor and needle without thermal damage to the enzyme.

Stage 6: NFC Batch Calibration

Random sensors from the batch are tested with model glucose solutions to calculate the batch’s individual calibration coefficient. This unique digital calibration code is written into the NFC chip’s memory or printed as a QR code, ensuring accurate measurements for 14 days.