From Legacy Pager to MDR-Compliant Medical Device
For Alert‑iT Care Alarms, a long‑established provider of assistive technology for care homes and domestic care, the evolution of European medical device regulation posed a clear challenge. Planned functional and design updates to their wireless care pager meant that, under the Medical Device Regulation (MDR), the product would now be classified as a medical device.
This shift brought significantly higher expectations around safety, risk management, usability and regulatory evidence. At the same time, Alert‑iT wanted to modernise the pager to better fit carers’ day‑to‑day workflows, introduce new communication features and refresh the product’s industrial design, all without disrupting existing systems already deployed in the field.
Alert‑iT partnered with eg technology to help them navigate this transition, combining regulatory‑compliant development with a user‑centred redesign of a well‑established product.
Understanding the problem and user context
The brief was to develop a new MDR‑compliant pager with a refreshed form factor, expanded software functionality and improved usability for care environments.
This involved transitioning an established product into a regulated medical device framework while introducing a larger display and an internal sub‑GHz antenna. In parallel, new pager‑to‑pager communication features were required, with backwards compatibility essential to ensure the device continued to work seamlessly with existing systems and established care workflows.
eg technology’s usability engineering team worked closely with Alert‑iT from the outset to understand how the pager fitted into real‑world care settings. Site visits, interviews and working sessions with care staff explored how alerts were managed during busy shifts, how devices were carried, and which new capabilities users hoped to gain over previous versions.
Initial design concepts were used to prompt discussion and feedback, helping to refine requirements around display size, alarm acknowledgement, device handling and practical considerations such as how the pager should be worn or removed quickly when needed.
Designing a Compliant and Compatible Solution
With a clear understanding of user needs and regulatory context, eg technology brought together a cross‑disciplinary team spanning electronics, embedded software, mechanical engineering and industrial design.
A key challenge was introducing new functionality without disrupting compatibility with monitors and infrastructure already deployed in care homes. The radio protocol was extended to support bidirectional sub‑GHz pager‑to‑pager communication, enabling features such as alarm acceptance to reduce duplicate responses and requests for assistance during urgent events. This was achieved while preserving backwards compatibility with existing systems already in the field.
To support efficient development, eg created a “works‑like” hardware and software platform that allowed electronics, embedded software and user interface development to progress in parallel with mechanical and industrial design. This approach ensured that new workflows introduced through the graphical user interface were tested against realistic use cases as the design matured.
Industrial and mechanical design efforts focused on accommodating the larger display and internal antenna within a compact, robust enclosure suited to continuous use in care environments. An improved belt clip was also developed, informed by discussions with care staff around secure attachment and ease of access during active shifts.
A proven care product was successfully transitioned into an MDR‑compliant medical device without compromising usability, compatibility or performance in real‑world environments.
Addressing key engineering challenges
Several technical challenges were addressed as part of the development programme, arising from the combination of a new form factor, expanded functionality and the need to maintain reliable performance in real‑world care environments.
Transitioning to an internal sub‑GHz antenna required careful electro‑mechanical and RF design to achieve reliable radio performance within a compact enclosure. Multiple antenna technologies were assessed through iterative prototyping and range testing in both open and built environments to confirm performance met user needs.
The addition of a larger display and bidirectional communication significantly changed the device’s power profile. eg designed the power management architecture and developed battery characterisation tools to support reliable fast charging, accurate state‑of‑charge estimation and a consistent user experience throughout a shift.
Changes to the form factor also introduced new EMC considerations. Pre‑compliance testing, using a combination of eg technology’s in‑house facilities and certified test houses, allowed potential issues to be identified early and mitigated ahead of formal compliance testing.
All development was carried out within eg technology’s ISO 13485 quality management system and in accordance with ISO 14971, IEC 60601 and IEC 62304.
RF design and power management expertise enabled robust sub‑GHz performance, sub‑two‑hour NiMH charging and dependable operation across care environments.
Delivering a regulated product ready for market
The project covered the full development lifecycle, including requirements definition, risk management, concept development, proof‑of‑principle builds, alpha and beta prototypes, formative usability studies, EMC compliance testing and transfer to manufacture.
The resulting pager is UKCA and CE marked and is now being supplied into UK and European markets, with multilingual software support already implemented. eg technology continues to support Alert‑iT through an ongoing support contract, enabling continued software enhancement and future feature expansion.
By combining regulatory rigour with a deep understanding of user workflows, the programme demonstrates how established care products can be successfully evolved into compliant medical devices without losing the familiarity and reliability clinicians and carers depend on.
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Focused sub‑system engineering and standards‑driven development enabled meaningful functional upgrades while preserving the familiarity clinicians and carers depend on.
About Alert-iT Care Alarms
Based in Leicestershire, Alert-iT Care Alarms is part of the part of the Abilia Group and produce assistive technology for both care home and domestic use across the UK, Norway and other European countries and have over 25 years’ experience in Plesiocare Technology.
They boast a wide range of products including a variety of monitors as well as a wireless pager to allow carers to respond to the needs of patients, operating as a self-contained and extendable system.
Are you ready to develop your product or idea?
For further information on how eg technology can support in getting your technology or ideas to market or to chat with one of the eg team about your product design and development requirements, please get in touch.
