From first prototype to large-volume production, we provide an end-to-end wearable medical device development platform for organisations in medical, sport and defense. Our multi-sensor hardware, patch & wearable design expertise and scalable manufacturing help you turn concepts into certified, field-ready products — faster and with less risk.
Complete Wearable Medical Device Development Platform – From Concept to Certified Wearable
Developing a high-quality wearable medical device is complex: sensors, electronics, firmware, data handling, comfort, certification and production all need to align. We bring these disciplines together in one wearable product development platform.
With our PCARDIO-based multi-sensor architecture, we support:
- Medical-grade wearables for monitoring and diagnostics
- Sports & human performance wearables for elite environments
- Tactical & defense wearables for demanding field operations
Whether you need a small series for a clinical study or large-volume production as an OEM product, we help you design, build and scale.
Platform Building Blocks for Wearable Product Development
We break wearable medical device development down into modular building blocks. You can use them individually, or as a complete end-to-end solution.
Sensor & Electronics Design
We design and integrate multi-sensor modules tailored to your application:
- Cardiac & hemodynamic: ECG, HR, HRV, BioZ/impedance cardiography (ICG), PPG/SPO2
- Respiration & stress: respiration via BioZ, strain/force sensing, Galvanic Skin Response
- Temperature: skin temperature
- Motion & posture: 9-axis IMU (accelerometer, gyroscope, magnetometer), & barometric pressure
- Muscle activity: EMG sensing
- Sound: heart & lung
- Other sensors on request
Key aspects:
- High-resolution signal acquisition
- Time-synchronised multi-sensor data
- Low-power design for extended wear
- Robust, compact hardware suitable for daily use
- Easily test new sensors via the digital device interface
Patch & Form-Factor Design
Comfort and usability are just as important as electronics. We support form-factor engineering for different use cases:
- Patch wearables (adhesive, disposable or semi-disposable)
- Chest straps and belts
- Textile integration (elastic bands, garments, accessories)
- Standard Ag/AgCl electrodes
We consider:
- Ergonomic placement of electrodes and sensors
- Skin contact quality and motion artefact reduction
- Materials, adhesives and comfort over long wear times
- Design for manufacturing and assembly
This is where our patch wearable design and manufacturing experience comes in: we can deliver complete, ready-to-use patch solutions that integrate seamlessly with the electronics.
Firmware, Data & Feature Extraction
Our platform is built as a wearable product development platform for data-driven applications:
- Raw data access: high-resolution biosignal recording for research and algorithm development
- Live streaming: real-time data via wireless BLE or other wireless technologies for monitoring, coaching or tactical applications
- Event logging: storing key moments (manual or automatic triggers) instead of full streams
- Embedded and offline feature extraction: on-device computation to reduce data volumes and enable intelligent edge applications
You decide how you want to work with data — we provide the tools and modes to support your workflow.
Software Integration, APIs & Tools
We provide developer-friendly integration options:
- APIs and SDKs for integration with mobile apps, cloud platforms and dashboards
- Data formats optimised for research and AI pipelines
- Support for time alignment, multi-sensor fusion and synchronisation across multiple devices
This makes the platform suitable for OEM wearable solutions, digital health platforms, research infrastructures and custom analytics systems.
Testing, Verification & Regulatory Support
Wearable medical device development always touches quality and regulation. We offer:
- Experience with medical-grade certification, verification and validation
- Development and production under ISO 13485
- CE-marked devices in our portfolio as a basis for your own applications
- Guidance on how to move from prototype to regulated device
We do not claim to “take over” your regulatory responsibility, but we can significantly simplify your path by starting from a proven, compliant platform.
Manufacturing & Scale-Up
Once the design is stable, we can support scale-up:
- Small-batch production for pilot studies, feasibility projects and early field trials
- Mid-scale production for multi-site clinical studies, sports or defense pilots
- High-volume production for OEM customers with established products
We pay attention to:
- Design for manufacturing (DFM) and testability
- Consistent quality and traceability
- Cost structure suitable for your business model
Developments and certification services are provided by 2M Engineering and partners.
Project Roadmap: From Concept to Clinical & Field Use
We support the whole lifecycle of wearable medical device development.
Concept & Feasibility
- Use-case definition (medical, sport or tactical)
- Sensor and form-factor selection
- Technical feasibility and risk assessment
Prototype & First Pilot
- Rapid prototyping using our existing multi-sensor platform
- Small series production for first clinical tests, sports testing or military evaluation
- Data collection and algorithm development with full raw data access
Design Refinement & DFM
- Optimisation of electronics, mechanics and patches
- Battery life, robustness, comfort and usability
- Preparation for certification and scaling
Regulatory Path & Certification Support
- Use of CE-marked platform where applicable
- Perform additional tests if required
- Support with documentation and test data for your regulatory strategy
Scale-Up & OEM Integration
- Production scaling from hundreds to thousands of units
- Integration into your product portfolio and ecosystem
- Long-term supply and platform evolution
You can join at any stage: from early concept to an existing design that needs to be industrialised.
Built for Real-World Demands
Applications in Medical, Sport and Tactical Domains
Our platform is used and designed for three main domains:
Medical & Medtech
- Remote patient monitoring and telehealth
- Cardiac and cardio-metabolic studies
- Digital therapeutics and clinical decision support
- Long-term, real-world data collection
Keywords: medical-grade wearable platform, clinical study wearables, remote patient monitoring.
Sport & Human Performance
- Elite sports performance analytics
- Training load management and recovery monitoring
- Stress, sleep and fatigue analysis
- Integration with coaching and performance platforms
Keywords: sports wearables, human performance monitoring, multi-sensor sport wearables.
Defense & Tactical Monitoring
- Soldier monitoring (heart, stress, fatigue, motion)
- Training and mission-readiness assessment
- Performance and safety in extreme environments
Keywords: tactical wearables, defense monitoring, multi-sensor tactical platform.
Across all domains, the same multi-sensor wearable development platform is used — only the configuration, software and client specific requirements are adapted to the mission.
Why work with us?
Medical-Grade Experience
Experience with CE-marked devices and ISO 13485 processes gives you a robust foundation for regulated environments.
Multi-Sensor, Modular Platform
ECG, PPG, BioZ, respiration, motion, skin temperature, GSR and more — configurable for your use case.
OEM-Friendly Approach
We design for OEM wearable solutions: branding, custom hardware variants and firmware features are possible.
Data-First Design
Full access to raw biosignals, event-based logging, live streaming and embedded feature extraction for AI and analytics.
Scalable Manufacturing
From a few dozen devices for a clinical pilot to thousands for global deployment.
Cross-Domain Proven
Used in clinical, sports and tactical contexts, so the platform is robust enough for challenging real-world environments.
We cannot promise to be the perfect fit for every project — but for organisations looking for serious wearable medical device development with a strong technical backbone, we can be a very effective partner.
Frequently Asked Questions
What is a wearable medical device development platform?
A wearable medical device development platform combines reusable hardware, firmware, data tools and manufacturing capabilities that can be configured and customised for different applications. Instead of starting from scratch, you build on proven building blocks tailored to your use case.
Can you support OEM wearable product development for medtech companies?
Yes. We work as an OEM development partner, offering multi-sensor hardware, patch and form-factor design, firmware, data integration tools and manufacturing support. You keep control over your product, brand and market, while we provide the technical and industrial backbone.
Do you also handle patch wearable design and manufacturing?
Yes. Patch design is an integral part of our platform. We can help define electrode placement, materials, adhesives and production methods, and deliver complete patch solutions that integrate with the electronics.
Is your platform suitable for sport and military applications?
Yes. The same multi-sensor platform is used in medical, sport and defense contexts, with different configurations and software. We focus on robustness, extended wear, data quality and comfort — all essential for high-demand environments.
How do we move from prototype to large-volume production?
We typically start with a small series for a pilot or clinical study, refine the design based on results, prepare for manufacturing (DFM) and then scale production according to your roadmap. Throughout this process we support quality, traceability and (where applicable) regulatory requirements.
Ready to Develop Your Next Wearable Device?
The P-CARDIO wearable ECG platform delivers high-precision monitoring of cardiovascular and physiological parameters, designed for If you are a medtech company, research organisation or defense partner looking for a wearable medical device development platform, we can help you:
- Define your concept
- Build and test prototypes
- Run clinical or field pilots
- Scale to certified, manufacturable products
Get in touch with our OEM team
Request a platform overview or technical call
