Designing a wearable medical device may appear, at first, to be mainly a matter of miniaturisation: making the sensor smaller, reducing power consumption, adding wireless connectivity and ensuring that the device is comfortable to wear. The consumer electronics sector has been working on similar challenges for years.
The scenario changes, however, when the device is connected to a clinical objective, such as monitoring a fragile patient at home, supporting lymphatic circulation or detecting tumour activity. At that point, the engineering constraints do not simply become more demanding: they change in nature. In this field, development must be supported by evidence, compliance cannot be taken for granted and every design decision must leave a documented trail.
Regulated by design
For any company entering the medical device market, the starting point is ISO 13485, the quality management standard that defines how medical products must be designed, developed and manufactured. The medical device industry is among the most regulated sectors worldwide: standards such as ISO 13485, ISO 14971 and IEC 60601 affect every phase of development, from system architecture to validation and manufacturing.
For this reason, compliance cannot be approached as a final checkpoint. It must accompany the product throughout its entire lifecycle.
Eletech has been involved for many years in the development and industrialisation of medical technologies. It represents the core of the Elemaster Group’s International Design Centre network, with around 60 engineers based in Osnago, Lombardy, together with an additional engineering team at Elemaster Germany in Ulm, focused on research, development and industrialisation of high-technology electronic devices.
The Group has adopted ISO 13485 as a strategic framework across several companies, including international operations, some of which obtained certification years ago. This was intended to guarantee a single shared international standard and to create a common language for quality, compliance and product development across the whole organisation.
Marco Ferrari, CEO of Eletech, the Research & Development and Original Design Manufacturing, ODM, division of the Elemaster Group, explains clearly what this means in practice:
“Regulatory compliance should not be seen as an obstacle, but as the foundation of the efficacy and safety of a product. It shapes requirements before the first line of code is written, before the first component is selected. You build compliance in from the concept phase”.
Eletech addresses certification through two complementary paths. The first is analytical: design is guided from the beginning so that every architectural decision can be traced back to a normative requirement. The second is experimental: an accredited in-house laboratory performs electromagnetic compatibility tests, climatic stress tests and pre-compliance checks throughout the development process.
Carrying out tests iteratively during development, rather than validating the product only at the end, helps reduce both time to market and the cost of rework.
From patch to ecosystem
Today, the term wearable covers a very broad range of devices, and its medical applications are expanding rapidly. Eletech is currently working on several projects in this field.
One project is a multi-sensor adhesive patch, developed under the Serena programme, designed to collect ECG data, temperature and movement. The readings are transmitted to a cloud infrastructure, where AI algorithms monitor fragile patients in post-operative or home-care settings.
A second project concerns a wearable system for professional athletes, developed to track movement, breathing and other physical parameters in real time during training and competition.
A third project integrates a passive implanted pump for the lymphatic system with an external patch that connects to it magnetically, powering the device without the need for a surgical power source.
One interface, one responsibility
The value of Eletech’s proposition becomes particularly clear not through a single technical competence, but through the integration of different competences within the same structure.
Many engineering consultancies operate as fabless companies: they design, but they do not produce. This requires clients to manage two different relationships, two separate chains of responsibility and two distinct problem-solving processes.
“The client ends up between two interlocutors, and this creates many complications. In our model, engineering and industrialisation sit under a single interface. If something goes wrong, there is only one conversation to have.”
The value proposition is clear: reduce risk, accelerate industrialisation and shorten the transition from prototype to production. In the medical sector, where a problem emerging in a product can have both regulatory and clinical consequences, fragmentation between design and manufacturing is not a minor issue. It is often exactly where projects slow down or stop.
Eletech’s model removes this fragmentation. Industrialisation starts at the concept phase, not after design freeze. Design for manufacturing, assembly and test contribute to shaping the architecture before the first board is laid out.
The Group also develops proprietary functional test platforms, the Eletest system, which accompany the product into production lines and enable 100% functional testing on every manufactured unit. In this way, the test methodology created during the project becomes a permanent production asset, rather than a one-off activity.
The multidisciplinary horizon
Behind the technical development of wearable medical devices lies a structural challenge that is often underestimated: the integration of engineering expertise with clinical knowledge.
A device can work perfectly from an electronics perspective and still fail to obtain regulatory approval, fail to fit into hospital workflows or fail to satisfy the review of an ethics committee.
For example, startups entering the medical market and treating certification and clinical validation as downstream steps, to be addressed only after the technology has been proven, often discover the problem too late to solve it without significant rework.
The cost and complexity of clinical validation, the engagement with ethics committees and the documentation burden required for regulatory submission must all be anticipated within the architecture of the product, not added afterwards.
The future of wearable medical devices will depend on the ability to integrate technology, regulation, manufacturing and clinical practice into one single system. In this sense, the real challenge is not simply building the device, but integrating the ecosystem around it.
Even when the engineering of the product is robust, it must be supported by regulatory expertise, clinical understanding and a clear view of the environment in which the device will actually be used.
At their most advanced, wearable medical devices are not only hardware problems. They are system problems, and the systems surrounding them are as complex as the devices themselves.