Medical Device Development

2M is specialized in medical device development, device certification and takes responsibility for the complete device production. We turn ideas into practical products that meet all requirements and specifications. 

2M’s focus areas

  • Point of Care medical devices
    Accurate measurements of biomarkers in blood and other bodily fluids 

  • Photonic Sensing Solutions
    Measuring solutions with laser, (photo) diodes, camera’s and a wide range of detectors. Miniaturization.

  • Medical wearables
    Accurate medical grade wearables, activity, motion and sleep tracking and monitoring of a wide range of vital body signs. 

Medical device development starting From the application

2M always starts from the application. Together with the other stakeholders we start at truly understanding the problem and needs. Our broad technology focus allows us to come up with the best technical solution that meet all requirements. We focus on the realisation of the complete solution.

Solutions that prevent people from becoming ill or increase the effect of medical treatment and pharmaceutics. Solutions that solve a clear unmet need.

Our medical devices are used in hospitals, clinics or at home.

Our expertise medical device development expertise areas

Point of Care Medical Devices

We see a strong trend in patient care and support moving from the traditional hospital environment closer to the patient at home. Many of the development projects we support this trend towards a decentralized better quality of care.

 

Point of care cell counting

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

See for more info DutchMedicalDevices.com

Wearable products

2M is experienced making small, low power wearable products that measure a wide range of vital signs, activity and motion. We deliver the complete solution consisting of sensor hardware, smart algorithms, product mechanics and also PC, Cloud or app software.

More information…

Wearable health patch

Smart Photonics & Laser techonology

We believe in the power of photonic and optical imaging solution for blood, tissue and cell diagnostics.

We have extensive experience with many optical sensing techniques including fiber optics smart laser & sensing technologies for medical devices.

Keywords

fluorescent measurement techniques, custom lasers, fiber optics and fiber-bragg gratings, Raman spectroscopy and camera based image processing. Research: OCT, MSOT, MPM, SERDS.

2M’s role

2M’s role is to bridge the medical application and photonic technology. We focus on the application, creation of proof of concept demonstrator, prototype creation & validation.  Miniaturization and industrialization for volume production is on request.

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 services

Design in or create the best sensing technology for a specific  application

Sensors play an ever more important role in medical technology with the aim of making medical devices even more effective and safer, while simplifying their operation. As a long-standing developer and supplier of innovative sensor system solutions for medical technology, we understand your applications. At 2M Engineering, you can find not only the standard but also the ideal sensor system solution for your custom measuring task.

Medical device development following the standards

We know that medical technology saves lives and are familiar with demanding measuring tasks and challenges. Our sensor solutions help to keep patients healthy and support both patient and medical experts with faster, more accurate screening and treatment possibilities.

Accurate measurements are crucial for the quality and reliability of the products we create. For this reason, we take great care in our development, production and service activities – working in accordance with certified processes and procedures. We comply with the high requirements for medical products. 

Custom developed sensors when needed

We offer tailored solutions, sensors and systems that are developed and manufactured in line with your requirements. This can range from modifying a standard sensor product to developing a completely new special sensor or designing an integrated medical device with multiple components and sensors. 

End-2-end product development

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

  • Complete hardware – electronics, mechanics, design, connectivity
  • Smart algorithms
  • Embedded software
  • PC application, web, app and Cloud connectivity
  • Verification and validation often together with leading medical institutes.

Medical device certification

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

Industrialization & production

Preparing and designing a product for small or large series production. Production is arranged based on requirements of the client and can be done inhouse or outsourced.

Examples of Medical Devices 2M developed

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