OEM-Grade Medical Devices and Point-of-Care Diagnostics
2M Engineering develops OEM-grade medical and diagnostic device platforms for organizations that require clinical validity, regulatory compliance and scalable production.
We partner with medical OEMs, medtech scale-ups, research institutes and industrial partners to translate clinical needs into certified, manufacturable medical devices. From early feasibility and proof-of-concept to MDR/IVDR certification and ISO13485 production, 2M takes full technical ownership of the development trajectory.
When This Medical OEM Platform Is the Right Fit
This OEM platform is typically used when:
- The product is intended for clinical, diagnostic or regulated medical use
- Measurement accuracy and repeatability are critical
- Regulatory approval (MDR / IVDR / CE-IVD) is part of the roadmap
- The device must move beyond research into routine clinical use
- You want to reduce risk by building on proven medical technology
The platform provides a robust medical foundation that can be adapted, extended or fully customized per application.
What You Get as an OEM Medical Partner
As an OEM partner, you gain access to a complete medical device development ecosystem, not just engineering capacity:
- Proven medical sensing architectures
- Integrated hardware, firmware and algorithms
- Design for safety, usability and clinical workflows
- Regulatory strategy and documentation support
- ISO13485-certified production readiness
This approach ensures faster decision-making, lower technical risk and smoother regulatory trajectories.
From Clinical Need to Market-Ready Medical Device
Medical device development starts with a real clinical problem. At 2M Engineering, we work closely with hospitals, clinicians, research institutes and medical companies to translate clinical needs into practical, validated medical solutions.
Our development approach is application-driven and grounded in regulatory reality. Certification, risk management and usability are considered from the earliest design stages, enabling smoother transitions from prototype to clinical validation and market entry.
From Clinical Need to Market-Ready Medical Device
Medical device development starts with a real clinical problem. At 2M Engineering, we work closely with hospitals, clinicians, research institutes and medical companies to translate clinical needs into practical, validated medical solutions.
Our development approach is application-driven and grounded in regulatory reality. Certification, risk management and usability are considered from the earliest design stages, enabling smoother transitions from prototype to clinical validation and market entry.
Typical OEM Development Trajectories
Medical OEM projects usually follow one of three paths:
1. Platform Configuration
Minor adaptations to existing medical platforms (sensor selection, firmware, interfaces, mechanics).
2. Platform Customization
Application-specific changes including sensing principles, algorithms, form factor, power management or clinical workflow integration.
3. New Medical Platform Development
Creation of a new medical device architecture based on clinical requirements, with feasibility, validation and certification built in from the start.
2M supports all trajectories with clear phase boundaries, traceable requirements and regulatory alignment.
Medical & Diagnostic Focus Areas
The Medical OEM Platform covers a broad range of diagnostic and monitoring applications.
Point-of-Care Diagnostic Devices
We design and develop compact, reliable pCompact, accurate diagnostic devices designed for decentralized healthcare environments.
- Optical and photonic biosensing
- Cell counting and biomarker detection
- Sample preparation and microfluidics integration
- CE-IVD and IVDR experience
Typical use cases include platelet counting, biomarker analysis and rapid diagnostic testing.
Example: PC100 & PC200 platelet and cell counters
Medical Wearables & Remote Monitoring
Wearable and ambulatory devices for physiological monitoring in clinical and home settings.
- ECG (1–12 lead), respiration and hemodynamics
- Activity and motion analysis
- Long-term physiological data collection
- MDR Class I–IIb experience
These devices support the shift from hospital-centric to decentralized care models.
Optical & Photonic Medical Devices
Advanced medical devices based on light-based measurement principles.
- Fluorescence imaging and spectroscopy
- Raman, OCT and multispectral techniques
- Endoscopic and non-invasive diagnostics
These platforms are typically used in oncology, tissue characterization and advanced diagnostics.
Medical OEM Technology Building Blocks
Many medical products developed by 2M build on validated OEM building blocks that reduce development risk.
Key building blocks include:
- Point-of-Care Diagnostic Platforms
Optical biosensing, imaging and cell counting
→ DutchMedicalDevices.com - Multi-Sensor Medical Wearable Platforms
ECG, BioZ, PPG, motion and temperature sensing
→ PCARDIO-wearables.com - Optical & Photonic Sensing Modules
Laser-based diagnostics, fluorescence imaging and spectroscopy - Sample Preparation & Microfluidics Systems
Automated centrifugation, fluid handling and disposable integration
These building blocks can be configured or extended into fully certified OEM medical products.
From Clinical Need to Certified Medical Product
2M Engineering integrates all disciplines required for medical device development:
- Clinical requirement translation
- System architecture and risk analysis
- Hardware, firmware and algorithm development
- Usability engineering and human-factors design
- Verification, validation and clinical alignment
Certification and production are not afterthoughts — they are integrated from the first design decisions.
Regulatory, Industrialization & Production
Medical OEM development at 2M includes:
- MDR & IVDR classification strategy
- Risk management (ISO 14971)
- Technical documentation and test coordination
- ISO13485-certified production (small to medium series)
- Production transfer support for higher volumes
This ensures medical devices are safe, compliant and commercially deployable.
Medical OEM Platform – Selected Outcomes
The Medical OEM Platform has resulted in:
- CE-IVD point-of-care diagnostic devices
- Wearable cardiac and respiratory monitoring systems
- Optical cancer detection technologies
- Automated sample preparation and centrifugation devices
→ View medical & diagnostic device projects
Looking to Develop a Medical or Diagnostic Device?
If you are developing a medical or diagnostic device and need a partner who can take full technical and regulatory ownership, from clinical concept to certified production, 2M Engineering is ready to support your OEM development.
Highlighted Medical & Diagnostic Platform Projects
Point of Care Diagnostic Devices
At 2M, we recognize the significant shift in patient care, with a growing emphasis on bringing healthcare closer to individuals in their homes. We actively contribute to custom medical device development projects that align with this decentralized approach, aiming to enhance the quality of care and support received by patients.
Example PC100 Platelet Counter
- Accurate platelet counting in Platelet Rich Plasma and Whole Blood
- Easy to use PoC diagnostic device
- Fast, accurate & validated
- Count in whole blood and PRP using a single drop of blood
- Certification: CE-IVD, FDA pending
- Biochemics combined with smart imaging and feature extraction
- Roadmap: early diagnosis & prevention of cardiovascular problems
Medical Wearables
2M specializes in the development of small, low-power wearable products designed to measure a diverse range of vital signs, activity, and motion. Our comprehensive solutions encompass sensor hardware, smart algorithms, product mechanics, as well as PC, Cloud, or app software, ensuring a seamless and integrated user experience.
More on wearable product development
Optical Sensing, Photonics & Laser Technology
At 2M, we have a firm belief in the potential of optics and optical imaging solutions for diagnostics in blood, tissue, and cell analysis. Our extensive expertise lies in various optical sensing techniques, encompassing fiber optics, smart lasers, and sensing technologies specifically tailored for medical devices. With a focus on bridging the gap between medical applications and photonic technology, we excel in developing proof-of-concept demonstrators, creating prototypes, and conducting validation processes. We also offer miniaturization and industrialization services for volume production upon request, ensuring a comprehensive approach to bring these innovations to market.
Keywords
fluorescent measurement techniques, custom lasers, fiber optics and fiber-bragg gratings, Raman spectroscopy and camera based image processing. Research: OCT, MSOT, MPM, SERDS.
Example Early cancer detection using auto fluorescence
- Mouth & throat cancer
- Multiple wavelength lasers and LEDs
- Single illumination and sensing fiber
- Data analysis & algorithm development by 2M
- Spot localization system
- Clinical trial completed
All Medical & Diagnostic Platform Projects
Our portfolio includes projects such as advanced diagnostic tools for rapid biomarker detection, wearable multisensor systems for chronic disease management, and compact devices for cell counting and tissue characterization.
Micro Clot Counter (MCC): Turning Unexplained Symptoms Into Measurable Diagnoses
PC200 Point-of-Care Device for Fluorescent Cell and Platelet Analysis
PoTT Personalisation of Thrombosis Treatment
Point of Care Platelet/Thrombocyte Counter
Point of Care Biomarkers
Fluorescence imaging
Laser-Based Diagnostics & Bio-Photonic Imaging
Sample Preparation & Microfluidics
Medical device control module with integrated display
Effective disinfection of medical devices with LEDs
Contactless Height Measurement Sensor
ThromboSpin – full automatic LTA sample preparation
Noninvasive monitoring of blood glucose – multi-laser Raman Spectroscopy
Frequently Asked Questions
What services does 2M Engineering offer in point-of-care medical device development?
We provide comprehensive services including concept development, prototyping, certification guidance, industrialization, and support for large-scale production of point-of-care medical devices.
What types of point-of-care devices has 2M Engineering developed?
Our portfolio includes diagnostic tools for rapid biomarker detection, wearable multisensor systems for chronic disease management, and compact devices for cell counting and tissue characterization.
How does 2M Engineering ensure compliance with medical device regulations?
We adhere to international medical device development standards and collaborate with certification bodies to ensure all products meet necessary regulatory requirements.
Can 2M Engineering assist with the miniaturisation of medical devices?
Yes, we specialize in miniaturizing optical biosensing and measurement technologies to create compact, cost-effective, and reliable point-of-care devices.
What is the typical development timeline for a point-of-care device?
Timelines vary based on project complexity, but we focus on efficient development processes to bring devices from concept to market readiness promptly.
Does 2M Engineering provide support for clinical validation?
Yes, we assist in planning and executing clinical validation studies to ensure the efficacy and safety of the developed devices.
How does 2M Engineering integrate multiple sensing technologies into devices?
We combine various sensing modalities, such as optical, mechanical, and chemical sensors, to develop comprehensive point-of-care solutions tailored to specific medical applications.
Can 2M Engineering develop custom medical devices for specific applications?
Absolutely, we design and develop custom medical devices to meet the unique requirements of each client and application.
What industries does 2M Engineering serve with its point-of-care devices?
We serve various sectors, including healthcare providers, diagnostic laboratories, and research institutions, offering solutions that enhance patient care and diagnostic capabilities.
How does 2M Engineering ensure the reliability of its point-of-care devices?
Through rigorous testing, quality control, and adherence to industry standards, we ensure our devices deliver accurate and reliable performance in diverse healthcare settings.