design of medical devices
We design and develop innovative medical devices, like scanners, wheelchairs, monitoring systems, medical analyses devices and more.
creating medical devices
The design and development of medical devices is a critical and complex process that plays a pivotal role in advancing healthcare.
These devices, ranging from simple diagnostic tools to sophisticated therapeutic machines, require meticulous planning, rigorous testing, and stringent regulatory compliance. The journey from concept to market involves a multidisciplinary approach that integrates engineering, medical science, user-centered design, and regulatory knowledge to create products that are safe, effective, and user-friendly.
patient centered
The cornerstone of medical device design is a deep understanding of clinical needs. First of all this means engaging with healthcare professionals to identify gaps in current medical practices and the challenges they face in patient care.
After that we need to translate the clinical needs into detailed product requirements that will guide the design process. These requirements include performance metrics, safety standards, and usability criteria.
But most of all we aim to consider the patient’s experience and comfort, ensuring the device is non-invasive or minimally invasive, and easy to use.
regulations
Medical devices are subject to strict regulatory oversight to ensure their safety and effectiveness.
First there needs to be a good understanding and adhering to the regulatory requirements of bodies such as the FDA in the US and CE marking in Europe.
Then comprehensive documentation needs to be made, including design history files, risk management reports, and clinical trial data, to demonstrate compliance with regulatory standards.
We are happy to help you in the process of obtaining the right documentation in cooperation with notified bodies.
lymph PET
This device is used for the study of breast cancer and involvement in the axilla by positron emission tomography (PET).
PET uses small amounts of radioactive materials called radiotracers or radiopharmaceuticals, a special camera and a computer to evaluate organ and tissue functions. By identifying changes at the cellular level, PET may detect the early onset of disease before other imaging tests can.
This system is similar to conventional mammograms, but with several important differences. There is no need for a mammography equipment “cap” that hides the X-ray tube. Also there is no need to compress the breast as the technology remains in fixed positions, thus making the procedure a less unpleasant experience.
Integrated wheels make the device mobile to help medical personnel easy transportation. Patients can both stand during the procedure or choose to sit, whatever is more comfortable for them.
our role:
design strategy, research, ergonomic mockups, concept development, 3D engineering, sourcing of components, integration of electronics, cooling system design, 2d documentation.
e-wheelchair
Enjoy new freedom with this new electric wheelchair. The wheelchair rides up to 6 km/h and folds into a small package that can be placed in a car.
The seat is adjustable and fold-up armrests make it easier to get into the seat. The brushless and maintenance free motor is powerful and quiet.
Our design studio designed this wheelchair from the bottom up, although we took into account all experience that our client had with the older generation wheelchairs.
Starting from strategy, concept design and folding kinematics, we continued with the full 3D CAD development up to a production ready level and intermediate scale models to test functionality.
our role:
design strategy, research, ergonomic mockups, kinematics folding design, geometry design, concept development, 3D engineering, sourcing of components, prototyping, testing.
vsm
The FastFocus Vital Signs Monitoring System is intended for frequent, non-invasive measurement of functional oxygen saturation of arterial haemoglobin (O2-saturation), pulse rate, respiratory rate during standstill, measurement of physical activity, including posture and exercise intensity.
The goal is the monitoring of rehabilitation and early detection of deterioration in adult patients. The Vital Signs Monitoring System is intended for use by healthcare professionals in healthcare facilities.
The position behind the ear appeared to be the best place to measure acceleration and movement of patients.
We designed the full product from strategy to manufacturing in cooperation with FastFocus. This includes user research, strategy, concept design, product engineering and integration of pcba’s.
our role:
design strategy, research, ergonomic mockups, concept development, 3D engineering, integration of electronics, prototyping, testing, documentation.
potok virus bio-inactivation
The Potok 300 bio-inactivation device is a high quality medical air treatment device. The device is specially designed for applications in hospitals and dental clinics.
The medical device is based on Potok technology used in the Mir orbital station and the International Space Station.
The technology is based on special nano materials and bio-inactivation technology to kill 99,8% of all viruses, bacteria and fungus.
The devices are at this moment in operation in obstetric departments, neonatal units and operating rooms. They serve as a highly efficient supplementary infection control device.
our role:
design strategy, research, ergonomic mockups, concept development, 3D engineering, integration of electronics, prototyping, testing, documentation.
labonovum ser-col
Ser-Col reduces the amount of blood required for standard blood analyses. Approximately 95% of all blood collected from patients for laboratory diagnostics is discarded at the end of the day.
In practice, this means that for the vast majority of blood tests a single finger prick producing 5 drops of blood would suffice. In these cases there is no more need for needles nor test tubes.
The Ser-Col allows patients to do this at home when and where they see fit. The Ser-Col also serves as a ventilated storage item; allowing the client to send their blood sample by post to the laboratory.
Ser-Col starts from a special strip of LF paper that seperates the red blood cells from the plasma. After this separation, which takes place in thirty seconds, the serum is stable for month within a vast range of temperatures.
Once the Labonovum laboratory receives the sample, the strip of paper is removed from its housing and the blood serum can be analysed fully automatically.
our role:
design strategy, research, ergonomic mockups, concept development, 3D engineering, prototyping, testing, documentation.
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