Medical Device Product Development

2M has extensive experience in medical device product development. We support our clients from early research and proof of concept creation till complete product development, verification and validation. We deliver complete hardware and software sensing solutions including medical device certification and production.

Our focus

2M focuses on complete solutions and applications 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.

We focus on:

  • PoC solutions for bodily fluids and biomarkers 

  • Smart Photonic solutions

  • Medical wearables

2M's application 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…

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

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.

Sensors are crucial components for the quality and reliability of your products and solutions. 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. 

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

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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