Medical Device Development for Medical Wearables and Point of Care Diagnostic Devices
2M Engineering is a leader in developing advanced medical wearables and Point of Care diagnostic devices. With expertise in multidisciplinary medical devices development, we support the entire product lifecycle—from early research and prototyping to certification, industrialization, and production. Our focus on innovation ensures reliable, high-performance medical devices tailored to meet the highest standards.
From Concept to Reality
We provide a full range of services to bring your medical device vision to life. Whether you require a research partner, prototype development, customized medical device solutions, or guidance through certification and industrialization, we deliver end-to-end expertise. Our dedication to precision and excellence ensures every phase of your project is executed seamlessly. Partner with us to create innovative medical devices that transform healthcare.
Bridging Clinical Needs with Innovative Medical Solutions
At 2M Engineering, we specialize in collaborating with leading companies, hospitals, and medical professionals to create cutting-edge medical devices. With a strong track record in medical device development, we excel at transforming clinical needs into high-quality, user-focused solutions. Our mission is to harness advanced technology to address critical unmet needs in healthcare, driving impactful innovations for the industry.
Seamless Medical Solutions from Hospital to Home
Our advanced medical devices are designed for diverse applications, spanning hospitals, clinics, and home care. By addressing the unique needs of each setting, we deliver practical, patient-centered solutions that enhance care and improve health outcomes. Through collaboration with medical experts and a commitment to excellence, we ensure our devices meet the expectations of both healthcare professionals and patients.
Custom Medical Device Development
2M Engineering specializes in developing advanced medical devices, focusing on point-of-care diagnostic devices, medical wearables, and optical sensing technologies. By integrating photonic sensors, smart algorithms, strap and patch technology, mechanical design, and hardware/software components, we create innovative, reliable solutions that redefine healthcare technology..
Innovative Point-of-Care Medical Devices
2M Engineering leads in miniaturizing optical biosensing technologies for point-of-care diagnostics. With expertise in biomarker analysis, tissue characterization, and cell counting, we deliver compact, reliable solutions that meet the demands of decentralized healthcare in clinics and homes.
Advanced Medical Wearables
2M Engineering develops innovative medical wearables for sleep tracking, activity monitoring, and movement analysis. Further more we focus on cardiac monitoring solutions (1-12 lead ECG) and multisensor wearables. Our expertise spans smart patches, textiles with stretchable electronics, and cardiorespiratory multisensor devices, enabling real-time monitoring of vital signs. As healthcare shifts to decentralized care, we focus on miniaturized, low-power, user-friendly devices that enhance patient care and outcomes.
Experienced in Optical Biosensing Solutions
2M Engineering specializes in optical biosensing, utilizing light, lasers, photodiodes, cameras, and fiber-based technologies. Our expertise spans photonic techniques like multi-wavelength laser systems, optics, and Raman spectroscopy. We focus on miniaturized, cost-efficient, and scalable solutions, transforming research into innovative medical sensing products.
Our Competences in Custom Medical Device Development
At 2M Engineering, we specialize in developing innovative medical devices tailored to specific applications. With extensive experience in sensor system solutions for medical technology, we understand the unique demands of your projects. Whether providing standard or custom-designed sensors, we deliver accurate, reliable solutions that enhance patient health, streamline diagnostics, and improve treatments.
Our commitment to medical device development standards ensures top-quality products that meet stringent regulatory requirements. From modifying existing sensors to creating entirely new integrated devices, we offer customized solutions designed to meet your exact needs. Besides development we also handle medical device certification, quality management systems, industrialisation and ISO 13485 certified production facilities.
Core Expertise Areas in Detail
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
Examples of our Point of Care Medical Products and 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.