Innovating on schedule, without compromising on quality
In the field of medical devices, the ability to reduce time-to-market while maintaining high standards of safety and reliability has become a key competitive advantage. Increasing regulatory pressure, technological evolution, and growing system integration demand ever faster response times from development teams.
In this context, rapid prototyping plays a crucial role. It is not merely about accelerating the realisation of a device, but about implementing a controlled, iterative process that enables the validation of design choices, component testing, and risk reduction in a systematic and measurable manner.
Prototyping is no longer a marginal phase but rather a strategic element to optimise costs, timelines, and quality. When properly structured, it allows for the early identification of critical issues, better communication among multidisciplinary teams (hardware, software, regulatory), and faster adoption of the most suitable technologies for the intended context of use.
Eletech, the lead company of the IDC and R&D division of Elemaster Group, has developed a prototyping methodology specifically tailored to the medical sector, combining virtual simulations, functional mock-ups, and certified environmental testing, within a design environment that extends from initial validation through to pre-industrial certification.
From simulation to prototype: an integrated engineering approach
Every medical device begins with an idea, but it can only take shape through a structured development process. The first step involves gathering user, clinical, and technical requirements, which are then translated into verifiable design specifications. From here, a process must unfold that balances operational efficiency with technical robustness.
This initial phase is supported by advanced modelling and simulation tools – such as thermal analysis, EMC assessments, and, when needed, fluid dynamics – enabling evaluation of system behaviour before physical construction begins. This not only helps control costs, but also enables more informed architectural choices.
In the medical context, simulation is particularly useful for anticipating the interaction between the device and its operational environment: electromagnetic fields, temperature changes, vibrations, and impacts.
Reducing physical iterations improves overall efficiency and frees resources for real-world testing – which is ultimately what validates the clinical impact and ensures patient safety.
Functional mock-ups and 3D printing: physical validation in shorter timeframes
The physical prototyping phase is the natural evolution of the virtual simulation work. At this stage, speed and efficiency in producing mock-ups become essential to prevent development slowdowns.
Eletech uses 3D printing and additive manufacturing technologies to produce casings, mechanical components, and user interfaces quickly, enabling prompt validation of form, ergonomics, and mechanical-electronic integration.
In medical devices, which are often designed for direct use by healthcare professionals or patients, such aspects are critical. A poorly sized control surface, an illegible display, or non-sterilisable housing can jeopardise the entire project.
Thanks to in-house capabilities in PCB manufacturing, PCB assembly, and mechanical integration, Eletech is able to deliver fully functional prototypes that can reliably simulate the final behaviour of the device.
Pre-compliance testing: anticipating certification
The effectiveness of prototyping is not measured solely by execution speed, but also by how well it prepares the product for regulatory compliance. That is why pre-compliance testing is a key stage in the process – enabling teams to evaluate the device’s conformity to international reference standards in advance.
Eletech operates an ISO 17025-accredited laboratory, capable of performing:
- Electromagnetic Compatibility (EMC) testing
- Electrical Safety (LVD) assessments
- Resistance tests for shock, vibration, and extreme environments
The ability to conduct these tests in-house allows for timely corrective actions in the case of non-compliance, avoiding the risk that issues emerge only during final certification – when time and cost pressures are at their highest.
Hardware-in-the-Loop and automated testing: simulating reality
One particularly distinctive feature of Eletech’s methodology is the integration of automated testing and Hardware-in-the-Loop (HIL) systems into the prototyping workflow. These tools make it possible to simulate realistic, repeatable, and monitorable scenarios, ideal for devices that must operate in complex environments or with dynamic response logics.
Using these systems, it is possible to:
- Simulate both normal and anomalous operating conditions
- Identify unexpected device behaviours
- Verify response to specific clinical or environmental stimuli
In the medical field, this results in improved diagnostic or therapeutic reliability, as well as greater design robustness, even in the face of non-standard usage conditions.
From rapid prototyping to market readiness
In the medical world, where every detail counts, rapid prototyping is not only about speed – it’s about precision, methodology, and systemic vision.
A well-designed device is useless if it cannot be industrialised. Likewise, a well-built prototype is ineffective if it cannot pass regulatory testing.
That’s why prototyping, to be truly strategic, must encompass every dimension of the project – from simulation through to pre-industrial implementation.
By combining virtual testing, physical prototyping, regulatory validation, and production support, Eletech, the lead company of the IDC and R&D division of Elemaster Group, guides each Customer along a technical and methodological path that ensures innovation becomes a market-ready product, designed for patients and global compliance.