Medical Device Development

Measurement solutions

2M has an extensive track record in sensing medical device product development & complete product creation. Our focus is on point of care measurement devices, often photonics based, and medical wearables. We excel at solution that require a truly multidisciplinary approach.

From A to Z

Our services range from partnering in early medical research to prototype and product development, certification, industrialization and production of medical devices.

 

medical device development of automated biomarker detection using intelligent algorithms
flexible-endoscope

Working with medical experts

We have a track-record in working together with companies, hospitals and medical professionals. We are able to translate clinical needs into practical and easy to use, quality medical solutions. Our focus and strength is always on the technology. For us it’s important that the solutions we work on solve a clear unmet need.

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

Broad technology perspective

We have a broad competence and technology scope. This shines in solutions that combine multiple technical disciplines. We are skilled in merging, (photonic) sensors, smart algorithms, mechanics, soft and hardware into a professional product.

Point of Care medical devices

Healthcare is moving in many cases from the hospital closer to the patient. Therefore also the requirements are changing: easy to use solutions that do not take up too much space and fit within the budget. 2M is specialized in miniaturization of (photonic) sensing and measurement principles.

We have built up a lot of expertise in biomarker / tissue characterization and cell counting in blood and other bodily fluids.

Photonic Biosensing

Over the years we have build up extensive and practical expertise in photonic biosensing solutions always starting with the medical application.

We are skilled with the full spectrum of existing photonic technologies. Besides that we are actively involved in applying innovative photonic techniques and solutions for biosensing solutions. 

We are skilled in multi-wavelength laser and diode illumination techniques, optics, light shaping, camera detection, raman spectroscopy and so on. We focus on product creation so want to bring the often research initiatives to product for which cost down and miniaturization of the opto-electronics is often a must. 

Medical Wearables

2M is since the beginning active in rehabilitation solutions. Tracking sleep, activity and quantifying quality of movements for specific patient groups or conditions. As training and rehabilitation is moving more to the home environment, our solutions follow this trend.

More recently we are actively working on smart patches and textiles. Integrating state of the are stretchable printed electronics with smart algorithms, highly integrated electronics and turning is into complete measuring solutions for a wide range of applications.

 

Examples of medical device developments

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 competences

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. 

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.

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.

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.

Industrialization & 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. 

Examples of Medical Devices 2M developed

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