design of medical devices
We design and develop innovative new medical devices, like scanners, wheelchairs, monitoring systems, medical analyses devices and more. We are happy to help with our specialized knowledge.
creating medical products
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.
understanding the needs
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.
strategy
We start off with research into the use of the product on location, observations of patients, working conditions, technological limits, innovation opportunities, company identity and many other factors that are important for a successful design project.
In all cases ergonomics and human factors are important topics. We do not only try products ourselves and observe users, but also build mockups to replicate ergonomic issues and design better solutions.
Technical and regulatory information is part of this stage as well, to get really from the start an good overview of requirements and risks.
The research leads to a 60 – 80 pages strategy document with a clear innovation focus, potential risks and visual identity of the new product. This document serves as a strategic guide throughout the total design process of new medical devices.
kinematics
Kinematics and folding is an important aspect of the development of wheelchairs and mobility scooters to make sure they fit in the booth of a car or in the plane.
We use powerful CAD software, simulations and mockups to test the folding principles of the new product and check the dimensions in folded position.
concept development
Through rapid cycles of sketching our senior design team investigates many potential design idea’s and tests these with early mockups.
We identify and choose the best design directions from all the possible ideas and make choices based on testing, experience and strategy.
During the concept design phase, we hold a ‘look-in-the-kitchen’ session with your team. We present directions in sketch-form, functional and technical solutions, manufacturing solutions and mockups.
We discuss focus, risk, level of ambition and push the design direction further into a concept.
engineering
The first important milestone of the engineering is to bring the concept to a first fully functional prototype. This first prototype we call the P1.
During the next step we use powerful 3D CAD software to develop the product. We design all parts and select materials, production methods, treatments, possible coatings and colors.
In complex projects we work together with doctors, software engineers, electronics engineers and bring all parts together into a working device.
In addition to a set of 3D CAD files, we create a bill of materials and an early 2D package of drawings to be able to manufacture the first P1 prototype.
prototyping
Both during concept phase and design of new medical devices we build prototypes. Early prototypes are more like mockups and are mostly from 3D printed material. We use them mainly for testing shapes, ergonomics and engineering solutions.
At the end of the engineering stage we build the first P1 full functional prototype. These prototypes are high quality, often CNC milled, coated, with graphics and fully functional.
The fully assembled P1 prototype is now ready for testing, both on functional, ergonomic and performance aspects. We document all the learnings and develop improvements in stability, cost, weight and performance. Mostly this leads to an updated prototype P2.
After one or sometimes more cycles of improvements the product is ready for manufacturing on a larger scale.
regulations and production
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 (U.S. Food and Drug Administration) and CE (Conformité Européenne) 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.
Implementing a robust QMS, such as ISO 13485, helps to ensure consistent quality in the design, development, and manufacturing processes
Transitioning from prototype to production involves setting up manufacturing processes that can consistently produce high-quality devices.
The first step is to scale up production from small-batch prototypes to full-scale manufacturing. This includes optimizing manufacturing processes for efficiency and quality. Second is the establishment of a reliable supply chain for sourcing materials and components. Ensuring traceability and quality control throughout the supply chain is essential.
And finally assembly lines and testing protocols need to be set up to ensure each device meets the required specifications before it is shipped.
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.
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.
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.
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.
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.
We are product designers. Our team is based in Amsterdam and specialized in bicycles, e-bikes, mobility, sports and medical products.
Our products were tested, manufactured, won races, won awards and are used worldwide.
We can support your team from an early idea, through research, strategy, ergonomics, kinematics, component testing, concept design, full detailed engineering, prototyping till production.
We invest in our people and will not hire specific people for a project. Because we want to keep valuable knowledge inside of our own team.
Apart from that we fully finance ourselves. We are not part of a group, we have no bank loans and no investors. All with one reason: to be a stable, independent industrial design partner for you.
This makes that both start-ups as well as multinationals love to work with us.
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