Medical device development is more affordable than ever – but also more complex to manage. Regulatory requirements, miniaturization, data connectivity and cost pressures place high demands on technical and process mastery of the project.
And this is often where it’s decided whether a good idea turns into a functional product or a dead end.
The medical technology market is also changing rapidly. Doctors and patients alike want smaller, more affordable and easy-to-use devices, not only in specialty clinics, but also in practitioners’ offices or at home.
V EGMedical We help companies, startups and research teams to translate an idea for a medical device into a technically, legally and commercially feasible form. We are development and production partnerthat understands medicine, electronics, software and certifications.
Together with our clients, we look for solutions that make sense – professionally, technically and commercially.
The key is to understand the real environment and users
When a doctor or investor comes to us, it is not enough to know “what the instrument is supposed to measure”. In order to get a truly accurate picture of what the outcome of our collaboration should be, we first need to understand exactly how the new device will be used. This is where we draw on our experience in medical electronics development – we know what questions to ask, and can guide our clients so that the resulting specification is technically and economically feasible.
At the beginning of the project we map together with the client:
- who will use the device (doctor, health professional, patient, laboratory staff,…),
- in what mode (in a hurry, long term,… ),
- what are the limits of the environment (power supply, sterility, handling, data transfer),
- and what the regulatory frameworks and certification requirements are (e.g. MDR, IVDR, IEC 60601 or FDA requirements for example).
To understand the whole problem, we often test solutions that are already on the market ourselves. We want to know how doctors today follow a given diagnosis, what they are comfortable with and where complications arise. And, of course, where competitors have hit an imaginary “wall” and how to cross it.
Finding the ideal technical solution
Once we have a clear understanding of the user, the environment and the regulatory requirements, we move on to the design of the device architecture itself.
This phase determines, what is technologically possible, what is efficient and what makes economic sense.
Our role is not just to “program and install the PCB”, but to help the client choose the right path – one that leads to an approved and manufacturable product.
It is in the conceptual phase that our experience with medical projects is most evident. We discuss everything together with the customer and focus on these issues:
- Choice of sensors, actuators and combinations – whether to focus on accuracy or comfort, what the limits of measurement are, the possibilities of MDR approval and the availability of components.
Sometimes it is more advantageous to combine multiple sensors, explore new technologies or, on the other hand, to stick with a time-tested and thus easy to master technology.
- How to evaluate the results. Should the device generate the message itself or just store and forward the data? This determines not only the complexity of the electronics, but also the software and certification requirements. So we address local or cloud-based data processing, transmission via BLE / Wi-Fi / Ethernet / USB, connection to HIS systems (e.g. DICOM). Software can account for up to 80% of development costs: so it is advisable to be smart about the scope of work and future extensibility. At the same time, the software environment is very fragmented and difficult to support for typical users.
- Connection to other devices in the officei. Is there any consideration now or in the future to connect the device under development to a more complex system?
- Power supply, energy efficiency and miniaturization – Battery life, charging, power consumption at rest, miniaturisation and associated thermal limits.
Shrinking the device will usually reduce the manufacturing cost to the point where miniaturization requires the use of atypical technologies, and the price in turn starts to skyrocket, or we lose the possibility of implementation altogether: for example, because the battery simply won’t fit.
- Mechanical design and sterility – choice of materials, ergonomics, cleaning, reusability, IP protection.
The mechanical design also speaks to the expected serialisation of production: for higher volumes we can afford more custom parts, typically moulded plastic parts with high input costs per mould but low production cost and all the advantages of a great bespoke part.
- Safety, EMC and certification – Design in accordance with IEC 60601-1, IEC 60601-1-2, software documentation, documentation for MDR certification.
The requirements of the standards must be taken into account upfront at the conceptual stage: dealing with non-compliant biocompatibility or exceeded surface temperatures of equipment just before production … nobody wants that.
- Role of other partners – Mechanics, clinical trials, software, manufacturing and certification support – all need to be clearly separated at the start of the project. We are usually able to offer the production of the device with an estimate of the production cost in our production centre. However, the documentation is always yours once development is complete, so you can manufacture wherever is best for the project – we don’t want to tie our customers to our manufacturing.
Our goal is that the result is not just a perpetual laboratory prototype, but a technically proven conceptthat can be produced, certified and put into practice.
That’s why we’ve been thinking about mass production, service and price optimization.
We are therefore trying to set the concept so that the resulting device is not only theoretically interesting, but also realistically manufacturable and commercially viable.
Model example: sleep apnoea screening
At EGM, we have already had our hands on many different types of medical devices, from prototypes of wearable metabolic analyzers, to imaging devices (special cameras) with their own monitors, image processing and storage, to controlling anti-bed mattresses. Unfortunately, we are bound by NDAs for most of these, so we will illustrate our approach with a hypothetical model – a sleep apnea screening device. This is an existing device that has many variations and illustrates well what all needs to be addressed.
Here comes the crucial question: why develop a device at all when similar ones already exist?
Typical client responses are:
- we want better accuracy or reliability,
- we want a different target group (e.g. easier to use for the elderly),
- we need a lower price, which we want to achieve by optimizing the design,
- or we have a new idea that will enhance the user experience.
Current devices usually combine chest sensors, a nasal sensor and a finger oximeter.
Each has its limitations – the patient moves in sleep, the sensors shift and the data can be inaccurate.
Therefore, the task may be: Find a combination that gives a reliable result without being a nuisance to the user, and that even an elderly person will be able to
For example:
- how much it’s worth sacrificing some accuracy for convenience,
- what are the effects of miniaturisation on battery life,
- what algorithm will process the data and where the calculation will take place,
- what requirements this implies for MDR Class IIa certification.
This example shows that technology is only part of success – the key is to balance precision, comfort, economy and manufacturability.
Specifying needs instead of a list of requirements
Every successful project starts with a good assignment.
In practice, this doesn’t mean having a ready-made technical specification, but being able to accurately describe why and what the device should solve. We then derive specific technical parameters together from these needs.
We often help customers to divide their requirements into three levels:
- Required – without them, the device will not fulfil its purpose,
- Important – significantly increase the use value,
- Nice to have – add comfort or marketing advantage.
This approach simplifies decision-making, reduces the risk of unrealistic ambitions and allows you to find balance between technology, regulation and business objectives.
What comes next
👉 If you’re considering your own medical device, it pays to start this way – by clearly defining your needs and discussing your options.
But of course, this is the beginning of the whole collaboration. We will discuss the next steps in more detail in the following articles.
In the next parts of this series we will look at:
- design of the device architecture and selection of the technical platform,
- prototyping and testing,
- Preparation of certification and transition to production.
Do you have an idea for a new medical device?
Or do you already have a working prototype and need to verify its technical and regulatory feasibility?
Contact us at EGM and together we’ll find a way from an idea to a solution that really works.
