Point of care medical device development & certification

Innovative Measurement Solutions for Medical Devices

2M Engineering is a trusted leader in the development and creation of cutting-edge measurement solutions for medical devices. With a specific focus on point of care devices and medical wearables, we specialize in photonics-based solutions that require a multidisciplinary approach. Our extensive expertise spans the entire product development process, from early-stage research collaboration to prototype development, certification, industrialization, and large-scale production of medical devices.

medical device development of automated biomarker detection using intelligent algorithms

Comprehensive Services for Success

We offer a comprehensive suite of services to support our clients’ medical device initiatives. Whether you need a research partner, assistance with prototype development, or guidance in navigating the certification and industrialization processes, we are equipped to provide end-to-end solutions. Our commitment to excellence ensures that every aspect of your project is handled with utmost precision and expertise. Partner with us to turn your medical device vision into a reality that positively impacts healthcare.

Collaborating with Medical Experts for Cutting-Edge Solutions

At 2M Engineering, we have a proven track record of partnering with leading companies, hospitals, and medical professionals. By leveraging our expertise, we excel at translating clinical needs into high-quality, user-friendly medical solutions. Our unwavering focus lies in harnessing the power of technology to address clear unmet needs in the healthcare industry.

From Hospital to Home

Our innovative medical devices find applications in a wide range of settings, including hospitals, clinics, and even at home. We understand the unique requirements of each environment and strive to deliver practical solutions that enhance patient care and improve overall health outcomes. With our commitment to excellence and collaboration with medical experts, we ensure that our solutions align seamlessly with the needs of healthcare professionals and patients alike.

Get in touch with 2M Engineering today

Unleashing the Power of Diverse Technology

At 2M Engineering, we possess a broad range of competencies and an expansive technology perspective. Our expertise truly shines when we bring together multiple technical disciplines to create innovative solutions. By seamlessly integrating (photonic) sensors, smart algorithms, mechanics, and software and hardware components, we craft professional-grade products that push the boundaries of what is possible.

Medical Wearables

With a longstanding presence in the field of rehabilitation solutions, 2M has been at the forefront of tracking sleep, activity, and quantifying movement quality for targeted patient groups and conditions. As the focus on home-based training and rehabilitation increases, our solutions align with this evolving trend. Additionally, we have been actively involved in the development of smart patches and textiles, seamlessly integrating stretchable printed electronics, advanced algorithms, and highly integrated electronics to create comprehensive measurement solutions for a diverse range of applications.

Furthermore, we have expanded our expertise to include cardio monitoring and the development of multisensor wearables capable of integrating multiple vital signs, enabling comprehensive and real-time health monitoring.

Examples Wearable

Point of Care Devices

As healthcare continues to shift towards decentralized settings, such as clinics and homecare, the demands for medical devices have evolved. There is a growing need for user-friendly solutions that are compact, cost-effective, and deliver reliable results. At 2M Engineering, we specialize in the miniaturization of (photonic) sensing and measurement principles, allowing us to pioneer advancements in point-of-care medical devices.

With extensive expertise in biomarker and tissue characterization, as well as precise cell counting in various bodily fluids, we have developed a deep understanding of these vital areas. Our accumulated knowledge allows us to provide advanced solutions and accurate insights for a wide range of medical applications.

Examples Medical Device

Photonic Biosensing

With a strong focus on medical applications, 2M has accumulated extensive expertise in practical photonic biosensing solutions. Our proficiency spans across a wide range of photonic technologies, encompassing innovative techniques and solutions for biosensing. From multi-wavelength laser and diode illumination techniques to optics, light shaping, camera detection, and raman spectroscopy, we cover the full spectrum. Our ultimate goal is to transform research initiatives into marketable products, emphasizing cost reduction and miniaturization of opto-electronics.

More about Photonics Biosensing

Examples of medical device developments

Point of Care Medical 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 development projects that align with this decentralized approach, aiming to enhance the quality of care and support received by patients.

Example PC100 Platelet Counter

Easy to use PoC 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

Wearable products

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.

Smart Photonics & Laser Technology

At 2M, we have a firm belief in the potential of photonic 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.

Fluorescence imaging techniques for detection of oral cancer

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

Our competences

At 2M Engineering, we excel in designing and creating the best sensing technology for specific applications. With our extensive experience in developing innovative sensor system solutions for medical technology, we understand the unique requirements of your applications. Whether you need standard sensor solutions or custom-designed sensors, we provide accurate and reliable measurements to support patient health, faster screening, and improved treatment options. Our commitment to following medical device development standards ensures the highest quality and compliance with regulatory requirements. We also offer tailored solutions, including modifying existing sensor products or developing entirely new sensors and integrated medical devices to meet your precise needs.

Innovation & research

2M Engineering is a research performing SME and open to be your high-tech R&D partner for sensor product creation. Each year we dedicate a significant part of our turnover to R&D activities. 2M turns envisioned medical and industrial problems into high-quality and easy to use solutions and products. 2M works as a bridge between application and technology. Our challenge is always to find the best compromise between technology, manufacturability and user benefit.

More about innovation & research

Concept & prototype creation

2M is experienced in translating new ideas and applications in concepts, prototypes and products. Together with the client we clarify and sharpen the use case, intended use and write the user and product requirement specifications. This way the end-product is already clear from the beginning of the development cycle.

More about concept & prototype creation

product development

2M creates complete end-2-end medical devices including:

Complete hardware – physics, photonics, electronics, mechanics, design, connectivity
Smart algorithms & vision recognition
Embedded software
PC application, web, app and Cloud connectivity

Medical device certification

Our services include device certification & testing of a wide range of product classes (CE-IVD, 1m, 2a, 2b).

Verification and validation often together with leading medical institutes.

Industrialization

Once a product has been developed it needs to be industrialized to make sure every product meets the set performance requirements. This is the somewhat less creative but very essential industrialization part were consistency and proper documentation and traceability are key.

Production

We do small and mid size (upto 5k pcs) productions in house for normal CE products and also for highly specialized medical products that need to be produced under ISO13485 or require extensive calibration and/or release testing. For high volumes we can work with specialized high-volume partners.

Get in touch with 2M Engineering today

Unveiling Our Innovations in Medical Device Development

2M Engineering has a proven track record of designing and developing cutting-edge medical devices that empower healthcare professionals and enhance patient care. Our portfolio showcases a diverse range of successful projects that demonstrate our expertise and commitment to delivering high-quality solutions. From advanced point of care diagnostic tools to high-tech photonic devices, we have the experience and capabilities to bring your medical device ideas to life. Partner with us to revolutionize the future of healthcare.

Medical devices

Biomarkers - Platelets as biomarkers for cardiovascular disease